Vaccines

The American Academy of Pediatrics is urging physicians and hospitals to take steps to mitigate the wave of pediatric respiratory illnesses following its unsuccessful bid to have the government declare a national emergency.

Updated guidance from the group outlines measures to optimize resources to manage a surge of patients filling hospital beds, emergency departments, and physicians’ practices.

A separate document from the AAP endorses giving extra doses of palivizumab, a monoclonal antibody used to prevent severe infection in infants at high risk of respiratory syncytial virus (RSV), as long as the illness is prevalent in the community.

Upticks in rates of RSV and influenza, along with a crisis in children’s mental health, prompted the AAP and the Children’s Hospital Association to petition the Biden administration on Nov. 14 to declare an emergency. Such a move would free up extra funding and waivers to allow physicians and hospitals to pool resources, the organizations said.

Despite those challenges, the AAP stressed in its new guidance that routine care, such as immunizations and chronic disease management, “cannot be neglected.”
 

Shifting resources

Officials at some children’s hospitals said that they have already implemented many of the AAP’s recommended measures for providing care during a surge, such as cross-training staff who usually treat adults, expanding telehealth and urgent care, and optimizing the use of ancillary care spaces.

“A lot of this is just reinforcing the things that I think children’s hospitals have been doing,” Lindsay Ragsdale, MD, chief medical officer for Kentucky Children’s Hospital, Lexington, said. “Can we shift adults around? Can we use an adult unit? Can we use an occupied space creatively? We’re really thinking outside the box.”

Andrew Pavia, MD, chief of the division of pediatric infectious diseases at University of Utah Health, Salt Lake City, said large children’s hospitals have been actively sharing practices for handling a surge through various channels, but the new guidance could be a useful “checklist” for small hospitals and physician practices that lack well-developed plans.

The AAP’s suggestions for pediatricians in outpatient settings include stocking up on personal protective equipment, using social media and office staff to increase communication with families, and keeping abreast of wait times at local emergency departments.
 

Addressing a subset of kids

In updated guidance for palivizumab, the AAP noted that earlier-than-usual circulation of RSV prompted pediatricians in some areas to begin administering the drug in the summer and early fall.

Palivizumab is typically given in five consecutive monthly intramuscular injections during RSV season, starting in November. Eligible infants and young children include those born prematurely or who have conditions such as chronic lung disease, hemodynamically significant congenital heart disease, or a suppressed immune system.

The AAP said it supports giving extra doses if RSV activity “persists at high levels in a given region through the fall and winter.” Published studies are sparse but contain “no evidence of increased frequency or severity of adverse events with later doses in a five-dose series nor with doses beyond five doses,” the group added.

The guidance may encourage payers to pick up the tab for extra doses, which are priced at more than $1,800 for cash customers, Dr. Pavia said. However, that recommendation addresses “a pretty small part of the problem overall because the injections are used for a very small subset of kids who are at the highest risk, and more than 80% of hospitalizations for RSV are among healthy kids,” he added.

Dr. Ragsdale and Dr. Pavia have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The American Academy of Pediatrics is urging physicians and hospitals to take steps to mitigate the wave of pediatric respiratory illnesses following its unsuccessful bid to have the government declare a national emergency.

Updated guidance from the group outlines measures to optimize resources to manage a surge of patients filling hospital beds, emergency departments, and physicians’ practices.

A separate document from the AAP endorses giving extra doses of palivizumab, a monoclonal antibody used to prevent severe infection in infants at high risk of respiratory syncytial virus (RSV), as long as the illness is prevalent in the community.

Upticks in rates of RSV and influenza, along with a crisis in children’s mental health, prompted the AAP and the Children’s Hospital Association to petition the Biden administration on Nov. 14 to declare an emergency. Such a move would free up extra funding and waivers to allow physicians and hospitals to pool resources, the organizations said.

Despite those challenges, the AAP stressed in its new guidance that routine care, such as immunizations and chronic disease management, “cannot be neglected.”
 

Shifting resources

Officials at some children’s hospitals said that they have already implemented many of the AAP’s recommended measures for providing care during a surge, such as cross-training staff who usually treat adults, expanding telehealth and urgent care, and optimizing the use of ancillary care spaces.

“A lot of this is just reinforcing the things that I think children’s hospitals have been doing,” Lindsay Ragsdale, MD, chief medical officer for Kentucky Children’s Hospital, Lexington, said. “Can we shift adults around? Can we use an adult unit? Can we use an occupied space creatively? We’re really thinking outside the box.”

Andrew Pavia, MD, chief of the division of pediatric infectious diseases at University of Utah Health, Salt Lake City, said large children’s hospitals have been actively sharing practices for handling a surge through various channels, but the new guidance could be a useful “checklist” for small hospitals and physician practices that lack well-developed plans.

The AAP’s suggestions for pediatricians in outpatient settings include stocking up on personal protective equipment, using social media and office staff to increase communication with families, and keeping abreast of wait times at local emergency departments.
 

Addressing a subset of kids

In updated guidance for palivizumab, the AAP noted that earlier-than-usual circulation of RSV prompted pediatricians in some areas to begin administering the drug in the summer and early fall.

Palivizumab is typically given in five consecutive monthly intramuscular injections during RSV season, starting in November. Eligible infants and young children include those born prematurely or who have conditions such as chronic lung disease, hemodynamically significant congenital heart disease, or a suppressed immune system.

The AAP said it supports giving extra doses if RSV activity “persists at high levels in a given region through the fall and winter.” Published studies are sparse but contain “no evidence of increased frequency or severity of adverse events with later doses in a five-dose series nor with doses beyond five doses,” the group added.

The guidance may encourage payers to pick up the tab for extra doses, which are priced at more than $1,800 for cash customers, Dr. Pavia said. However, that recommendation addresses “a pretty small part of the problem overall because the injections are used for a very small subset of kids who are at the highest risk, and more than 80% of hospitalizations for RSV are among healthy kids,” he added.

Dr. Ragsdale and Dr. Pavia have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The American Academy of Pediatrics is urging physicians and hospitals to take steps to mitigate the wave of pediatric respiratory illnesses following its unsuccessful bid to have the government declare a national emergency.

Updated guidance from the group outlines measures to optimize resources to manage a surge of patients filling hospital beds, emergency departments, and physicians’ practices.

A separate document from the AAP endorses giving extra doses of palivizumab, a monoclonal antibody used to prevent severe infection in infants at high risk of respiratory syncytial virus (RSV), as long as the illness is prevalent in the community.

Upticks in rates of RSV and influenza, along with a crisis in children’s mental health, prompted the AAP and the Children’s Hospital Association to petition the Biden administration on Nov. 14 to declare an emergency. Such a move would free up extra funding and waivers to allow physicians and hospitals to pool resources, the organizations said.

Despite those challenges, the AAP stressed in its new guidance that routine care, such as immunizations and chronic disease management, “cannot be neglected.”
 

Shifting resources

Officials at some children’s hospitals said that they have already implemented many of the AAP’s recommended measures for providing care during a surge, such as cross-training staff who usually treat adults, expanding telehealth and urgent care, and optimizing the use of ancillary care spaces.

“A lot of this is just reinforcing the things that I think children’s hospitals have been doing,” Lindsay Ragsdale, MD, chief medical officer for Kentucky Children’s Hospital, Lexington, said. “Can we shift adults around? Can we use an adult unit? Can we use an occupied space creatively? We’re really thinking outside the box.”

Andrew Pavia, MD, chief of the division of pediatric infectious diseases at University of Utah Health, Salt Lake City, said large children’s hospitals have been actively sharing practices for handling a surge through various channels, but the new guidance could be a useful “checklist” for small hospitals and physician practices that lack well-developed plans.

The AAP’s suggestions for pediatricians in outpatient settings include stocking up on personal protective equipment, using social media and office staff to increase communication with families, and keeping abreast of wait times at local emergency departments.
 

Addressing a subset of kids

In updated guidance for palivizumab, the AAP noted that earlier-than-usual circulation of RSV prompted pediatricians in some areas to begin administering the drug in the summer and early fall.

Palivizumab is typically given in five consecutive monthly intramuscular injections during RSV season, starting in November. Eligible infants and young children include those born prematurely or who have conditions such as chronic lung disease, hemodynamically significant congenital heart disease, or a suppressed immune system.

The AAP said it supports giving extra doses if RSV activity “persists at high levels in a given region through the fall and winter.” Published studies are sparse but contain “no evidence of increased frequency or severity of adverse events with later doses in a five-dose series nor with doses beyond five doses,” the group added.

The guidance may encourage payers to pick up the tab for extra doses, which are priced at more than $1,800 for cash customers, Dr. Pavia said. However, that recommendation addresses “a pretty small part of the problem overall because the injections are used for a very small subset of kids who are at the highest risk, and more than 80% of hospitalizations for RSV are among healthy kids,” he added.

Dr. Ragsdale and Dr. Pavia have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

PHILADELPHIA – The new American College of Rheumatology Guideline for Vaccinations in Patients with Rheumatic and Musculoskeletal Diseases (RMDs) emphasizes that both adult and pediatric patients should receive recommended vaccinations whenever possible.

But the guideline, currently in press, also offers recommendations about whether and when to withhold vaccines from patients with RMDs, such as avoiding the use of live attenuated virus vaccines in patients who are on immunosuppressive drug regimens, such as conventional synthetic disease-modifying antirheumatic drugs (DMARDs), biologic DMARDs, or targeted synthetic DMARDs.

The new consensus guideline was formulated with the understanding that patients with RMDs are at increased risk for vaccine-preventable infections and more serious complications from infections, compared with the general population.

However, the guideline also acknowledges that the immunogenicity and safety of vaccines may differ among patients with RMDs, and that, depending on the patient age and disease state, individuals may benefit from modified vaccine indications, schedules, or modified medication schedules, said guideline panel member Anne Bass, MD, a rheumatologist at Hospital for Special Surgery and a professor of clinical medicine at Weill Cornell Medicine in New York, who presented the guideline with other panel members in a session outlining the recommendations at the annual meeting of the ACR.

“In addition, vaccination recommendations – since much of it relates to medications – really applies across diseases, and so the ACR felt that, rather than having vaccine recommendations tacked onto the end of treatment guidelines for each individual disease, that the topic should be discussed or tackled as a whole,” she said.

The guideline does not cover vaccinations in patients taking nonsteroidal anti-inflammatory drugs because this class of agents has minimal or no impact on antibody responses to vaccines. The guideline also does not address vaccinations against COVID-19 infections since the rapidly changing formulations would make the recommendations obsolete before they were even published, and because the U.S. Centers for Disease Control and Prevention provides up-to-date guidance on COVID-19 vaccinations in patients with compromised immunity, she said.
 

Guiding principles

The overarching principles of the guideline are to give indicated vaccines to patients with RMD whenever possible and that any decision to hold medications before or after vaccination consider the dosage used, RMD disease activity, and the patient’s risk for vaccine-preventable infection.

The guideline also states that “shared decision-making with patients is a key component of any vaccination strategy.”

Panel member Clifton O. Bingham III, MD, professor of medicine at Johns Hopkins University in Baltimore, outlined expanded indications for vaccinations against influenza, pneumococcal infections, varicella zoster virus (VZV) and human papillomavirus (HPV).
 

Influenza

The guideline conditionally recommends that patients with RMD aged 65 years and older and adults older than age 18 years who are on immunosuppressive medications should receive either high-dose or adjuvanted influenza vaccination rather than regular-dose vaccines.

“It’s recognized that the high-dose or adjuvanted vaccinations may be unavailable for patients when they’re seen in your practice,” Dr. Bingham said,” and we came out with two additional statements within the guidelines that said that any flu vaccine is recommended over no flu vaccinations, because we do know that responses are elicited, and a flu vaccination today is preferred over a flu vaccination delay.”
 

Pneumococcal vaccination

The panelists strongly recommended that patients with RMD younger than age 65 years who are on immunosuppressive medication receive pneumococcal vaccinations.

The ACR guideline is in sync with those issued by the CDC’s Advisory Committee on Immunization Practices, Dr. Bingham said. He urged audience members to visit a CDC-ACIP web page for more information on who should receive pneumococcal vaccination and when.
 

Recombinant varicella zoster

The recommendations strongly support that patients aged 18 years and over who are on immunosuppressive therapies should receive the recombinant VZV vaccine (Shingrix).

HPV

A less robust, conditional recommendation is for patients with RMDs who are between the ages of 26 and 45 years and on immunosuppressive medications to receive the HPV vaccine (if they have not already received the vaccine).

Non-live attenuated vaccines

Kevin Winthrop, MD, MPH, professor of infectious diseases and public health at Oregon Health & Science University, Portland, summarized the recommendations for managing immunosuppressive therapies in patients scheduled to receive vaccinations using killed or nonactive antigens.

“In influenza season, don’t pass up the opportunity to vaccinate,” he said, adding, “if you can wait on rituximab dosing, do it, and if you can’t, go ahead and vaccinate.”

The guidelines also recommend a 2-week methotrexate hold at the time of influenza vaccination; other DMARD dosing changes are likely not necessary at the time of vaccination, “but this is an area of fervent study, and I think in a year or two we’ll have more experimental hold data with regard to other DMARDs,” Dr. Winthrop said.

For other nonlive attenuated vaccinations, recommendations are similar to those for influenza, except with more flexible timing because these vaccinations are not seasonal. When and how to hold methotrexate is still up in the air, he said.

Additionally, it’s recommended that vaccinations be delayed in patients on high-dose prednisone until the drug is tapered to below 20 mg per day, and ideally to less than 10 mg per day, he said.
 

Live-attenuated vaccines

The guideline conditionally recommends deferring live-attenuated vaccines in patients on immunosuppressive drugs. It also recommends holding these medications “for an appropriate period before” vaccination and for 4 weeks afterward.

“Although the evidence around conventional synthetic DMARDs and TNF inhibitors is reassuring in terms of their safety at the time of live attenuated vaccines, as you can see the number of studies is quite small, and so the voting panel conditionally recommend against administering live-attenuated virus vaccines to patients who are on conventional synthetics, biologic, or targeted DMARDs,” Dr. Bass said.
 

In utero exposures

Most women with RMD who have recently given birth will consult their general pediatricians rather than rheumatologists for infant vaccinations, but pediatricians may not be aware of the affect that in utero exposures to biologic DMARDs can have on vaccine safety and immunogenicity in infants, Dr, Bass said.

“It’s important that you, as a provider, give your recommendations regarding infant rotavirus vaccination after in utero exposure to the pregnant rheumatic disease patient prior to delivery, and let that patient know that this is something that they should share with their pediatrician to be,” she advised audience members.
 

Getting the message out

In an interview, session moderator and guidelines panelist Lisa F. Imundo, MD, director of the center for adolescent rheumatology at Columbia University in New York, noted that rheumatologists don’t usually have the full schedule of pediatric vaccinations in stock and often leave the decisions about what to give – and when – to general practitioners.

“Pediatric rheumatologists sometimes will give patients flu vaccinations because they’re a high-risk population of patients, and we want to make sure that they’re getting it in a timely manner,” she said.

In addition, because pneumococcal polysaccharide vaccines are not indicated in the general pediatric population, children on biologic DMARDs who have completed their standard series of pneumococcal conjugate vaccines (PCV13 or PVC15) are recommended to get a 23-valent pneumococcal polysaccharide vaccine, Dr. Imundo said.

She also noted that communication between pediatric rheumatologists and general practitioners about vaccine recommendations can be challenging.

“It’s a huge issue, figuring out how we’re going to communicate all of this information to our pediatric colleagues,” she said. “With individual patients, we may sometimes remind doctors, especially with our younger patients who haven’t gotten their live vaccines, that they really shouldn’t get live vaccines until they’re off medication or until we arrange holding medication for some period of time.”

She said that ACR vaccine committee members are working with infectious disease specialists and guideline developers for the American Academy of Pediatrics to ensure guidelines include the most important vaccination recommendations for pediatric patients with RMDs.

The development process for the guidelines was supported by the ACR. Dr. Bass reported no relevant disclosures, Dr. Bingham disclosed consulting activities, grant/research support, and royalties from various corporate entities. Dr. Winthrop disclosed consulting activities for and research funding from various companies. Dr. Imundo reported no relevant financial relationships.

PHILADELPHIA – The new American College of Rheumatology Guideline for Vaccinations in Patients with Rheumatic and Musculoskeletal Diseases (RMDs) emphasizes that both adult and pediatric patients should receive recommended vaccinations whenever possible.

But the guideline, currently in press, also offers recommendations about whether and when to withhold vaccines from patients with RMDs, such as avoiding the use of live attenuated virus vaccines in patients who are on immunosuppressive drug regimens, such as conventional synthetic disease-modifying antirheumatic drugs (DMARDs), biologic DMARDs, or targeted synthetic DMARDs.

The new consensus guideline was formulated with the understanding that patients with RMDs are at increased risk for vaccine-preventable infections and more serious complications from infections, compared with the general population.

However, the guideline also acknowledges that the immunogenicity and safety of vaccines may differ among patients with RMDs, and that, depending on the patient age and disease state, individuals may benefit from modified vaccine indications, schedules, or modified medication schedules, said guideline panel member Anne Bass, MD, a rheumatologist at Hospital for Special Surgery and a professor of clinical medicine at Weill Cornell Medicine in New York, who presented the guideline with other panel members in a session outlining the recommendations at the annual meeting of the ACR.

“In addition, vaccination recommendations – since much of it relates to medications – really applies across diseases, and so the ACR felt that, rather than having vaccine recommendations tacked onto the end of treatment guidelines for each individual disease, that the topic should be discussed or tackled as a whole,” she said.

The guideline does not cover vaccinations in patients taking nonsteroidal anti-inflammatory drugs because this class of agents has minimal or no impact on antibody responses to vaccines. The guideline also does not address vaccinations against COVID-19 infections since the rapidly changing formulations would make the recommendations obsolete before they were even published, and because the U.S. Centers for Disease Control and Prevention provides up-to-date guidance on COVID-19 vaccinations in patients with compromised immunity, she said.
 

Guiding principles

The overarching principles of the guideline are to give indicated vaccines to patients with RMD whenever possible and that any decision to hold medications before or after vaccination consider the dosage used, RMD disease activity, and the patient’s risk for vaccine-preventable infection.

The guideline also states that “shared decision-making with patients is a key component of any vaccination strategy.”

Panel member Clifton O. Bingham III, MD, professor of medicine at Johns Hopkins University in Baltimore, outlined expanded indications for vaccinations against influenza, pneumococcal infections, varicella zoster virus (VZV) and human papillomavirus (HPV).
 

Influenza

The guideline conditionally recommends that patients with RMD aged 65 years and older and adults older than age 18 years who are on immunosuppressive medications should receive either high-dose or adjuvanted influenza vaccination rather than regular-dose vaccines.

“It’s recognized that the high-dose or adjuvanted vaccinations may be unavailable for patients when they’re seen in your practice,” Dr. Bingham said,” and we came out with two additional statements within the guidelines that said that any flu vaccine is recommended over no flu vaccinations, because we do know that responses are elicited, and a flu vaccination today is preferred over a flu vaccination delay.”
 

Pneumococcal vaccination

The panelists strongly recommended that patients with RMD younger than age 65 years who are on immunosuppressive medication receive pneumococcal vaccinations.

The ACR guideline is in sync with those issued by the CDC’s Advisory Committee on Immunization Practices, Dr. Bingham said. He urged audience members to visit a CDC-ACIP web page for more information on who should receive pneumococcal vaccination and when.
 

Recombinant varicella zoster

The recommendations strongly support that patients aged 18 years and over who are on immunosuppressive therapies should receive the recombinant VZV vaccine (Shingrix).

HPV

A less robust, conditional recommendation is for patients with RMDs who are between the ages of 26 and 45 years and on immunosuppressive medications to receive the HPV vaccine (if they have not already received the vaccine).

Non-live attenuated vaccines

Kevin Winthrop, MD, MPH, professor of infectious diseases and public health at Oregon Health & Science University, Portland, summarized the recommendations for managing immunosuppressive therapies in patients scheduled to receive vaccinations using killed or nonactive antigens.

“In influenza season, don’t pass up the opportunity to vaccinate,” he said, adding, “if you can wait on rituximab dosing, do it, and if you can’t, go ahead and vaccinate.”

The guidelines also recommend a 2-week methotrexate hold at the time of influenza vaccination; other DMARD dosing changes are likely not necessary at the time of vaccination, “but this is an area of fervent study, and I think in a year or two we’ll have more experimental hold data with regard to other DMARDs,” Dr. Winthrop said.

For other nonlive attenuated vaccinations, recommendations are similar to those for influenza, except with more flexible timing because these vaccinations are not seasonal. When and how to hold methotrexate is still up in the air, he said.

Additionally, it’s recommended that vaccinations be delayed in patients on high-dose prednisone until the drug is tapered to below 20 mg per day, and ideally to less than 10 mg per day, he said.
 

Live-attenuated vaccines

The guideline conditionally recommends deferring live-attenuated vaccines in patients on immunosuppressive drugs. It also recommends holding these medications “for an appropriate period before” vaccination and for 4 weeks afterward.

“Although the evidence around conventional synthetic DMARDs and TNF inhibitors is reassuring in terms of their safety at the time of live attenuated vaccines, as you can see the number of studies is quite small, and so the voting panel conditionally recommend against administering live-attenuated virus vaccines to patients who are on conventional synthetics, biologic, or targeted DMARDs,” Dr. Bass said.
 

In utero exposures

Most women with RMD who have recently given birth will consult their general pediatricians rather than rheumatologists for infant vaccinations, but pediatricians may not be aware of the affect that in utero exposures to biologic DMARDs can have on vaccine safety and immunogenicity in infants, Dr, Bass said.

“It’s important that you, as a provider, give your recommendations regarding infant rotavirus vaccination after in utero exposure to the pregnant rheumatic disease patient prior to delivery, and let that patient know that this is something that they should share with their pediatrician to be,” she advised audience members.
 

Getting the message out

In an interview, session moderator and guidelines panelist Lisa F. Imundo, MD, director of the center for adolescent rheumatology at Columbia University in New York, noted that rheumatologists don’t usually have the full schedule of pediatric vaccinations in stock and often leave the decisions about what to give – and when – to general practitioners.

“Pediatric rheumatologists sometimes will give patients flu vaccinations because they’re a high-risk population of patients, and we want to make sure that they’re getting it in a timely manner,” she said.

In addition, because pneumococcal polysaccharide vaccines are not indicated in the general pediatric population, children on biologic DMARDs who have completed their standard series of pneumococcal conjugate vaccines (PCV13 or PVC15) are recommended to get a 23-valent pneumococcal polysaccharide vaccine, Dr. Imundo said.

She also noted that communication between pediatric rheumatologists and general practitioners about vaccine recommendations can be challenging.

“It’s a huge issue, figuring out how we’re going to communicate all of this information to our pediatric colleagues,” she said. “With individual patients, we may sometimes remind doctors, especially with our younger patients who haven’t gotten their live vaccines, that they really shouldn’t get live vaccines until they’re off medication or until we arrange holding medication for some period of time.”

She said that ACR vaccine committee members are working with infectious disease specialists and guideline developers for the American Academy of Pediatrics to ensure guidelines include the most important vaccination recommendations for pediatric patients with RMDs.

The development process for the guidelines was supported by the ACR. Dr. Bass reported no relevant disclosures, Dr. Bingham disclosed consulting activities, grant/research support, and royalties from various corporate entities. Dr. Winthrop disclosed consulting activities for and research funding from various companies. Dr. Imundo reported no relevant financial relationships.

PHILADELPHIA – The new American College of Rheumatology Guideline for Vaccinations in Patients with Rheumatic and Musculoskeletal Diseases (RMDs) emphasizes that both adult and pediatric patients should receive recommended vaccinations whenever possible.

But the guideline, currently in press, also offers recommendations about whether and when to withhold vaccines from patients with RMDs, such as avoiding the use of live attenuated virus vaccines in patients who are on immunosuppressive drug regimens, such as conventional synthetic disease-modifying antirheumatic drugs (DMARDs), biologic DMARDs, or targeted synthetic DMARDs.

The new consensus guideline was formulated with the understanding that patients with RMDs are at increased risk for vaccine-preventable infections and more serious complications from infections, compared with the general population.

However, the guideline also acknowledges that the immunogenicity and safety of vaccines may differ among patients with RMDs, and that, depending on the patient age and disease state, individuals may benefit from modified vaccine indications, schedules, or modified medication schedules, said guideline panel member Anne Bass, MD, a rheumatologist at Hospital for Special Surgery and a professor of clinical medicine at Weill Cornell Medicine in New York, who presented the guideline with other panel members in a session outlining the recommendations at the annual meeting of the ACR.

“In addition, vaccination recommendations – since much of it relates to medications – really applies across diseases, and so the ACR felt that, rather than having vaccine recommendations tacked onto the end of treatment guidelines for each individual disease, that the topic should be discussed or tackled as a whole,” she said.

The guideline does not cover vaccinations in patients taking nonsteroidal anti-inflammatory drugs because this class of agents has minimal or no impact on antibody responses to vaccines. The guideline also does not address vaccinations against COVID-19 infections since the rapidly changing formulations would make the recommendations obsolete before they were even published, and because the U.S. Centers for Disease Control and Prevention provides up-to-date guidance on COVID-19 vaccinations in patients with compromised immunity, she said.
 

Guiding principles

The overarching principles of the guideline are to give indicated vaccines to patients with RMD whenever possible and that any decision to hold medications before or after vaccination consider the dosage used, RMD disease activity, and the patient’s risk for vaccine-preventable infection.

The guideline also states that “shared decision-making with patients is a key component of any vaccination strategy.”

Panel member Clifton O. Bingham III, MD, professor of medicine at Johns Hopkins University in Baltimore, outlined expanded indications for vaccinations against influenza, pneumococcal infections, varicella zoster virus (VZV) and human papillomavirus (HPV).
 

Influenza

The guideline conditionally recommends that patients with RMD aged 65 years and older and adults older than age 18 years who are on immunosuppressive medications should receive either high-dose or adjuvanted influenza vaccination rather than regular-dose vaccines.

“It’s recognized that the high-dose or adjuvanted vaccinations may be unavailable for patients when they’re seen in your practice,” Dr. Bingham said,” and we came out with two additional statements within the guidelines that said that any flu vaccine is recommended over no flu vaccinations, because we do know that responses are elicited, and a flu vaccination today is preferred over a flu vaccination delay.”
 

Pneumococcal vaccination

The panelists strongly recommended that patients with RMD younger than age 65 years who are on immunosuppressive medication receive pneumococcal vaccinations.

The ACR guideline is in sync with those issued by the CDC’s Advisory Committee on Immunization Practices, Dr. Bingham said. He urged audience members to visit a CDC-ACIP web page for more information on who should receive pneumococcal vaccination and when.
 

Recombinant varicella zoster

The recommendations strongly support that patients aged 18 years and over who are on immunosuppressive therapies should receive the recombinant VZV vaccine (Shingrix).

HPV

A less robust, conditional recommendation is for patients with RMDs who are between the ages of 26 and 45 years and on immunosuppressive medications to receive the HPV vaccine (if they have not already received the vaccine).

Non-live attenuated vaccines

Kevin Winthrop, MD, MPH, professor of infectious diseases and public health at Oregon Health & Science University, Portland, summarized the recommendations for managing immunosuppressive therapies in patients scheduled to receive vaccinations using killed or nonactive antigens.

“In influenza season, don’t pass up the opportunity to vaccinate,” he said, adding, “if you can wait on rituximab dosing, do it, and if you can’t, go ahead and vaccinate.”

The guidelines also recommend a 2-week methotrexate hold at the time of influenza vaccination; other DMARD dosing changes are likely not necessary at the time of vaccination, “but this is an area of fervent study, and I think in a year or two we’ll have more experimental hold data with regard to other DMARDs,” Dr. Winthrop said.

For other nonlive attenuated vaccinations, recommendations are similar to those for influenza, except with more flexible timing because these vaccinations are not seasonal. When and how to hold methotrexate is still up in the air, he said.

Additionally, it’s recommended that vaccinations be delayed in patients on high-dose prednisone until the drug is tapered to below 20 mg per day, and ideally to less than 10 mg per day, he said.
 

Live-attenuated vaccines

The guideline conditionally recommends deferring live-attenuated vaccines in patients on immunosuppressive drugs. It also recommends holding these medications “for an appropriate period before” vaccination and for 4 weeks afterward.

“Although the evidence around conventional synthetic DMARDs and TNF inhibitors is reassuring in terms of their safety at the time of live attenuated vaccines, as you can see the number of studies is quite small, and so the voting panel conditionally recommend against administering live-attenuated virus vaccines to patients who are on conventional synthetics, biologic, or targeted DMARDs,” Dr. Bass said.
 

In utero exposures

Most women with RMD who have recently given birth will consult their general pediatricians rather than rheumatologists for infant vaccinations, but pediatricians may not be aware of the affect that in utero exposures to biologic DMARDs can have on vaccine safety and immunogenicity in infants, Dr, Bass said.

“It’s important that you, as a provider, give your recommendations regarding infant rotavirus vaccination after in utero exposure to the pregnant rheumatic disease patient prior to delivery, and let that patient know that this is something that they should share with their pediatrician to be,” she advised audience members.
 

Getting the message out

In an interview, session moderator and guidelines panelist Lisa F. Imundo, MD, director of the center for adolescent rheumatology at Columbia University in New York, noted that rheumatologists don’t usually have the full schedule of pediatric vaccinations in stock and often leave the decisions about what to give – and when – to general practitioners.

“Pediatric rheumatologists sometimes will give patients flu vaccinations because they’re a high-risk population of patients, and we want to make sure that they’re getting it in a timely manner,” she said.

In addition, because pneumococcal polysaccharide vaccines are not indicated in the general pediatric population, children on biologic DMARDs who have completed their standard series of pneumococcal conjugate vaccines (PCV13 or PVC15) are recommended to get a 23-valent pneumococcal polysaccharide vaccine, Dr. Imundo said.

She also noted that communication between pediatric rheumatologists and general practitioners about vaccine recommendations can be challenging.

“It’s a huge issue, figuring out how we’re going to communicate all of this information to our pediatric colleagues,” she said. “With individual patients, we may sometimes remind doctors, especially with our younger patients who haven’t gotten their live vaccines, that they really shouldn’t get live vaccines until they’re off medication or until we arrange holding medication for some period of time.”

She said that ACR vaccine committee members are working with infectious disease specialists and guideline developers for the American Academy of Pediatrics to ensure guidelines include the most important vaccination recommendations for pediatric patients with RMDs.

The development process for the guidelines was supported by the ACR. Dr. Bass reported no relevant disclosures, Dr. Bingham disclosed consulting activities, grant/research support, and royalties from various corporate entities. Dr. Winthrop disclosed consulting activities for and research funding from various companies. Dr. Imundo reported no relevant financial relationships.

Reminder messages sent through electronic health records (EHRs) to patient portals increased rates of scheduling and completion of well-child visits for those overdue for well care, as well as vaccination rates, according to data published today in JAMA Network Open.

Anne E. Berset, BA, with general and community pediatrics at Cincinnati Children’s Hospital, led a randomized clinical trial conducted at three academic primary care practices from July 30 to Oct. 4, 2021.

The practices serve a mostly non-Hispanic Black, low-income population and provide more than 60,000 visits a year to 30,000 patients.

The study population included 945 patients, 62.4% of them non-Hispanic Black and 807 (85.4%) covered by public insurance.
 

Standard message and tailored message compared

The study population was randomized to get either a standard reminder message, a tailored message, or no message (control group).

The standard messages referenced the patient’s first name and reminded parents their child was due for a well-child visit, and asked them to schedule it using the portal or by calling the number provided.

The tailored message added the date of the last well-child check-up “to address distortions of time perception experienced during the pandemic,” the authors write.

The primary outcome was whether the well-child visit was completed within 8 weeks. Other outcomes included whether a well-child visit was scheduled within 2 weeks of the first reminder message and whether the patient received a COVID-19 vaccine within 8 weeks of the reminder.
 

Reminders outperform control group

There was a significant increase in scheduling and completion of appointments after parents received the standard and tailored messages compared with controls.

The results with the COVID reminders were particularly striking. While only 3.7% of the eligible patients got a vaccine when they got no message, 17.3% got the vaccine in that time frame when they got the standard message. Interestingly, only 2.7% received the shot after the tailored message.

J. Howard Smart, MD, with Sharp HealthCare in San Diego, told this publication he was not surprised that a patient portal reminder would increase the rate of scheduling overdue well-child visits. “Parents may indeed have lost track of when their children need to have check-ups” during the pandemic, he said.

Reminders without tailored information more effective

He said he was surprised, just as the investigators were, that the reminders without the tailored information seemed to be more effective for some outcomes.

The authors explained that a focus group found “that families with patient portal accounts prefer straightforward, brief, and user-friendly messages.”

That may help explain why the standard message outperformed the tailored message, the authors write.

“Families may have been distracted by the additional information related to the child’s age and date of last WCC [well-child check-up] in the tailored message,” they write.

Dr. Smart said, “Their discussion of why this might be the case sounds reasonable. Simple, short messages may be better received.”

“Evidence like this should stimulate portal software vendors to make this kind of outgoing messaging easy to set up for providers,” he said.

Simple measure, large effect

Tim Joos, MD, a pediatrician in Seattle, told this publication he “was impressed by how such a simple measure increased rates of well-child care completion.”

Minority and low-income patients have traditionally had more access challenges to completing health care visits and vaccinations on schedule, he noted, so he was glad to see positive results from the intervention in this study population.

The authors note that research on portal messages have largely looked at use in non-Hispanic Whites and the privately insured.

Dr. Joos said the intervention also offers convenience in that once patients get into the portal, they can schedule an appointment there without having to wait on the phone or leave a message.

Funding/support was received from the Center for Clinical and Translational Science and Training at the University of Cincinnati, which is funded by the National Institutes of Health. William B. Brinkman, MD, MEd, MSc, one of the study authors, holds common stock in Pfizer, Merck, Abbott Laboratories, Viatris, and Johnson & Johnson outside the submitted work. No other author disclosures were reported. Dr. Smart and Dr. Joos declared no relevant financial relationships.

Reminder messages sent through electronic health records (EHRs) to patient portals increased rates of scheduling and completion of well-child visits for those overdue for well care, as well as vaccination rates, according to data published today in JAMA Network Open.

Anne E. Berset, BA, with general and community pediatrics at Cincinnati Children’s Hospital, led a randomized clinical trial conducted at three academic primary care practices from July 30 to Oct. 4, 2021.

The practices serve a mostly non-Hispanic Black, low-income population and provide more than 60,000 visits a year to 30,000 patients.

The study population included 945 patients, 62.4% of them non-Hispanic Black and 807 (85.4%) covered by public insurance.
 

Standard message and tailored message compared

The study population was randomized to get either a standard reminder message, a tailored message, or no message (control group).

The standard messages referenced the patient’s first name and reminded parents their child was due for a well-child visit, and asked them to schedule it using the portal or by calling the number provided.

The tailored message added the date of the last well-child check-up “to address distortions of time perception experienced during the pandemic,” the authors write.

The primary outcome was whether the well-child visit was completed within 8 weeks. Other outcomes included whether a well-child visit was scheduled within 2 weeks of the first reminder message and whether the patient received a COVID-19 vaccine within 8 weeks of the reminder.
 

Reminders outperform control group

There was a significant increase in scheduling and completion of appointments after parents received the standard and tailored messages compared with controls.

The results with the COVID reminders were particularly striking. While only 3.7% of the eligible patients got a vaccine when they got no message, 17.3% got the vaccine in that time frame when they got the standard message. Interestingly, only 2.7% received the shot after the tailored message.

J. Howard Smart, MD, with Sharp HealthCare in San Diego, told this publication he was not surprised that a patient portal reminder would increase the rate of scheduling overdue well-child visits. “Parents may indeed have lost track of when their children need to have check-ups” during the pandemic, he said.

Reminders without tailored information more effective

He said he was surprised, just as the investigators were, that the reminders without the tailored information seemed to be more effective for some outcomes.

The authors explained that a focus group found “that families with patient portal accounts prefer straightforward, brief, and user-friendly messages.”

That may help explain why the standard message outperformed the tailored message, the authors write.

“Families may have been distracted by the additional information related to the child’s age and date of last WCC [well-child check-up] in the tailored message,” they write.

Dr. Smart said, “Their discussion of why this might be the case sounds reasonable. Simple, short messages may be better received.”

“Evidence like this should stimulate portal software vendors to make this kind of outgoing messaging easy to set up for providers,” he said.

Simple measure, large effect

Tim Joos, MD, a pediatrician in Seattle, told this publication he “was impressed by how such a simple measure increased rates of well-child care completion.”

Minority and low-income patients have traditionally had more access challenges to completing health care visits and vaccinations on schedule, he noted, so he was glad to see positive results from the intervention in this study population.

The authors note that research on portal messages have largely looked at use in non-Hispanic Whites and the privately insured.

Dr. Joos said the intervention also offers convenience in that once patients get into the portal, they can schedule an appointment there without having to wait on the phone or leave a message.

Funding/support was received from the Center for Clinical and Translational Science and Training at the University of Cincinnati, which is funded by the National Institutes of Health. William B. Brinkman, MD, MEd, MSc, one of the study authors, holds common stock in Pfizer, Merck, Abbott Laboratories, Viatris, and Johnson & Johnson outside the submitted work. No other author disclosures were reported. Dr. Smart and Dr. Joos declared no relevant financial relationships.

Reminder messages sent through electronic health records (EHRs) to patient portals increased rates of scheduling and completion of well-child visits for those overdue for well care, as well as vaccination rates, according to data published today in JAMA Network Open.

Anne E. Berset, BA, with general and community pediatrics at Cincinnati Children’s Hospital, led a randomized clinical trial conducted at three academic primary care practices from July 30 to Oct. 4, 2021.

The practices serve a mostly non-Hispanic Black, low-income population and provide more than 60,000 visits a year to 30,000 patients.

The study population included 945 patients, 62.4% of them non-Hispanic Black and 807 (85.4%) covered by public insurance.
 

Standard message and tailored message compared

The study population was randomized to get either a standard reminder message, a tailored message, or no message (control group).

The standard messages referenced the patient’s first name and reminded parents their child was due for a well-child visit, and asked them to schedule it using the portal or by calling the number provided.

The tailored message added the date of the last well-child check-up “to address distortions of time perception experienced during the pandemic,” the authors write.

The primary outcome was whether the well-child visit was completed within 8 weeks. Other outcomes included whether a well-child visit was scheduled within 2 weeks of the first reminder message and whether the patient received a COVID-19 vaccine within 8 weeks of the reminder.
 

Reminders outperform control group

There was a significant increase in scheduling and completion of appointments after parents received the standard and tailored messages compared with controls.

The results with the COVID reminders were particularly striking. While only 3.7% of the eligible patients got a vaccine when they got no message, 17.3% got the vaccine in that time frame when they got the standard message. Interestingly, only 2.7% received the shot after the tailored message.

J. Howard Smart, MD, with Sharp HealthCare in San Diego, told this publication he was not surprised that a patient portal reminder would increase the rate of scheduling overdue well-child visits. “Parents may indeed have lost track of when their children need to have check-ups” during the pandemic, he said.

Reminders without tailored information more effective

He said he was surprised, just as the investigators were, that the reminders without the tailored information seemed to be more effective for some outcomes.

The authors explained that a focus group found “that families with patient portal accounts prefer straightforward, brief, and user-friendly messages.”

That may help explain why the standard message outperformed the tailored message, the authors write.

“Families may have been distracted by the additional information related to the child’s age and date of last WCC [well-child check-up] in the tailored message,” they write.

Dr. Smart said, “Their discussion of why this might be the case sounds reasonable. Simple, short messages may be better received.”

“Evidence like this should stimulate portal software vendors to make this kind of outgoing messaging easy to set up for providers,” he said.

Simple measure, large effect

Tim Joos, MD, a pediatrician in Seattle, told this publication he “was impressed by how such a simple measure increased rates of well-child care completion.”

Minority and low-income patients have traditionally had more access challenges to completing health care visits and vaccinations on schedule, he noted, so he was glad to see positive results from the intervention in this study population.

The authors note that research on portal messages have largely looked at use in non-Hispanic Whites and the privately insured.

Dr. Joos said the intervention also offers convenience in that once patients get into the portal, they can schedule an appointment there without having to wait on the phone or leave a message.

Funding/support was received from the Center for Clinical and Translational Science and Training at the University of Cincinnati, which is funded by the National Institutes of Health. William B. Brinkman, MD, MEd, MSc, one of the study authors, holds common stock in Pfizer, Merck, Abbott Laboratories, Viatris, and Johnson & Johnson outside the submitted work. No other author disclosures were reported. Dr. Smart and Dr. Joos declared no relevant financial relationships.

Babies born vaginally have a different microbiome to those born by Caesarean section and have heightened responses to childhood vaccinations, according to a new study heralded as “interesting and important” by experts.

The microbiome is known to play a role in immune responses to vaccination. However, the relationship between early-life effects on intestinal microbiota composition and subsequent childhood vaccine responses had remained poorly understood. In the new study, “the findings suggest that vaginal birthing resulted in a microbiota composition associated with an increase in a specific type of antibody response to two routine childhood vaccines in healthy babies, compared with Caesarean section,” the authors said.

Researchers from the University of Edinburgh, with colleagues at Spaarne Hospital and University Medical Centre in Utrecht, and the National Institute for Public Health and the Environment in The Netherlands, tracked the development of the gut microbiome in a cohort of 120 healthy, full-term infants and assessed their antibody levels following two common childhood vaccinations.

The study, published in Nature Communications, found “a clear relationship between microbes in the gut of those babies and levels of antibodies.” Not only was vaginal birth associated with increased levels of Bifidobacterium and Escherichia coli in the gut microbiome in the first months of life but also with higher IgG antibody responses against both pneumococcal and meningococcal vaccines.
 

Antibody responses doubled after vaginal birth

The babies were given pneumococcal and meningococcal vaccinations at 8 and 12 weeks, and saliva was collected at follow-up visits at ages 12 and 18 months for antibody measurement. In the 101 babies tested for pneumococcal antibodies, the researchers found that antibody levels were twice as high among babies delivered naturally, compared with those delivered by C-section. High levels of two gut bacteria in particular – Bifidobacterium and E. coli – were associated with high antibody responses to the pneumococcal vaccine, showing that the microbiome mediated the link between mode of delivery and pneumococcal vaccine responses.

In 66 babies tested for anti-meningococcal antibodies, antibodies were 1.7 times higher for vaginally-born babies than those delivered via C-section, and high antibody levels were particularly associated with high levels of E. coli in the babies’ microbiome.

The results were also influenced by breast-feeding, which even among children born vaginally was linked with 3.5 times higher pneumococcal antibody levels, compared with those of formula-fed children. In contrast, levels of antibodies against meningococcus were unaffected by breast-feeding status.
 

Microbiome ‘sets level of infection protection’

The team said: “The baby acquires Bifidobacterium and E. coli bacteria through natural birth, and human milk is needed to provide the sugars for these bacteria to thrive on.” They explained: “The gut microbiome is seeded at birth, developing rapidly over the first few months of life, and is influenced mostly by delivery mode, breast-feeding, and antibiotic use.” The babies’ microbiome in early life contributes the immune system’s response to vaccines, they said, “and sets the level of protection against certain infections in childhood.”

Study lead Professor Debby Bogaert, chair of pediatric medicine at the University of Edinburgh, said: “I think it is especially interesting that we identified several beneficial microbes to be the link between mode of delivery and vaccine responses. In the future, we may be able to supplement those bacteria to children born by C-section shortly after birth through – for example, mother-to-baby ‘fecal transplants’ or the use of specifically designed probiotics.”

First author Dr. Emma de Koff, a microbiology trainee at the Amsterdam University Medical Center, said: “We expected to find a link between the gut microbiome and the babies’ vaccine responses, however we never thought to find the strongest effects in the first weeks of life.”

The findings “could help to inform conversations about C-sections between expectant mothers and their doctors,” commented the researchers, who said that they could also “shape the design of more tailored vaccination programs.” For example, in the future, vaccination schedules could be adjusted based on the method of delivery or analysis of the baby’s microbiome.
 

Potential to rectify immune system after Caesarean

Responding to the study, Professor Neil Mabbott, personal chair in immunopathology at the Roslin Institute of the University of Edinburgh, told the Science Media Centre: “This is a very interesting and important study. The authors show that infants delivered by a vaginal birth had higher responses to the two different types of vaccines against bacterial diseases, and this was associated with higher abundances of the potentially beneficial bacteria known as Bifidobacterium and E. coli in their intestines.”

He added: “This study raises the possibility that it may be possible to treat infants, especially Caesarean-delivered infants, with a bacterial supplement, or even a product produced by these beneficial bacteria, to help improve their immune systems, enhance their responses to certain vaccines and reduce their susceptibility to infections.”

The study raises important questions, he said, including whether the increased antibody levels from pneumococcal and meningococcal vaccinations following vaginal birth also leads to increased protection of the infants against infection or serious disease. 

Sheena Cruickshank, immunologist and professor in biomedical sciences at the University of Manchester, England, commented: “It is now well established that the microbiome is important in immune development. In turn the mode of delivery and initial method of feeding is important in how the microbiome is first seeded in the baby.”

“However, other factors such as exposure to antibiotics and subsequent diet also play a role in how it then develops, making understanding the way the microbiome develops and changes quite complex. Microbes works as communities, and it can be difficult to determine whether changes in single species are important functionally. Breast milk also plays an important role in protecting the baby via transfer of maternal immunoglobulins, which will wane over a period of 6-12 months in the baby – thus ascertaining whether it’s the baby’s Ig is challenging.

“Given the complexity of the multitude of interactions, it is important that this is accounted for, and group sizes are large enough to ensure data is robust. Whilst this is an interesting study that adds to our knowledge of how the microbiome develops and the possible implications for immune development, it is still very preliminary, and the small group sizes warrant a need for further studies to verify this in larger groups.”

She added: “We will need to understand whether possible impacts of maternal delivery and feeding on immune development or vaccine responses can be restored by, for example, manipulating the microbiome.”

Professor Kim Barrett, vice dean for research at the University of California, Davis School of Medicine, said that, while further research was needed to uncover if and how manipulation of the human microbiome following C-section births might improve vaccine efficacy, “the work should at least lead to prompt additional consideration about an unintended consequence of the ever-increasing use of C-sections that may not be medically-necessary.”

Dr. Marie Lewis, researcher in gut microbiota at the University of Reading, England, said: “We have known for quite some time that the mode of delivery is incredibly important when it comes to the type of bacteria which colonize our guts. We also know that our gut bacteria in early life drive the development of our immune system, and natural births are linked with reduced risks of developing inflammatory conditions, such as asthma. It is therefore perhaps not really surprising that mode of delivery is also linked to responses to vaccinations.”

“The really interesting part here is the extent to which our gut microbiotas are accessible and changeable, and this important work could pave the way for administration of probiotics and prebiotics to improve vaccine responses in Caesarean-born children.”
 

‘Tantalizing data’

Dr. Chrissie Jones, associate professor of pediatric infectious diseases at the University of Southampton, and Southampton UK and education lead for the British Paediatric Allergy, Immunity, and Infection Group, said: “The link between method of delivery of the infant and the bacteria that live in the gut of the young infant has previously been shown. What is really interesting about this study is that, for the first time, the link between method of delivery (vaginal delivery vs. C-section), differences in bacterial communities of the gut, and differences in responses to vaccines is shown.”

“This study may give us fresh insights into the differences that we see in the amount of protective antibodies made after infant vaccination. It also gives us clues as to ways that we might be able to level the playing field for infants in the future – for instance, giving babies a safe cocktail of ‘friendly bacteria’ as a probiotic, or an additional dose of vaccine.”

“This study is the first step – it shows us a link or association but does not prove cause and effect that differences in the way babies are born alters how the immune system responds to vaccines. To prove this link we will need larger studies, but it is tantalizing data.”

The research was funded by Scotland’s Chief Scientist Office and the Netherlands Organisation for Scientific Research. DB received funding from OM pharma and Sanofi. All of the authors declared no other conflicts of interest.

A version of this article first appeared on Medscape.com.

Babies born vaginally have a different microbiome to those born by Caesarean section and have heightened responses to childhood vaccinations, according to a new study heralded as “interesting and important” by experts.

The microbiome is known to play a role in immune responses to vaccination. However, the relationship between early-life effects on intestinal microbiota composition and subsequent childhood vaccine responses had remained poorly understood. In the new study, “the findings suggest that vaginal birthing resulted in a microbiota composition associated with an increase in a specific type of antibody response to two routine childhood vaccines in healthy babies, compared with Caesarean section,” the authors said.

Researchers from the University of Edinburgh, with colleagues at Spaarne Hospital and University Medical Centre in Utrecht, and the National Institute for Public Health and the Environment in The Netherlands, tracked the development of the gut microbiome in a cohort of 120 healthy, full-term infants and assessed their antibody levels following two common childhood vaccinations.

The study, published in Nature Communications, found “a clear relationship between microbes in the gut of those babies and levels of antibodies.” Not only was vaginal birth associated with increased levels of Bifidobacterium and Escherichia coli in the gut microbiome in the first months of life but also with higher IgG antibody responses against both pneumococcal and meningococcal vaccines.
 

Antibody responses doubled after vaginal birth

The babies were given pneumococcal and meningococcal vaccinations at 8 and 12 weeks, and saliva was collected at follow-up visits at ages 12 and 18 months for antibody measurement. In the 101 babies tested for pneumococcal antibodies, the researchers found that antibody levels were twice as high among babies delivered naturally, compared with those delivered by C-section. High levels of two gut bacteria in particular – Bifidobacterium and E. coli – were associated with high antibody responses to the pneumococcal vaccine, showing that the microbiome mediated the link between mode of delivery and pneumococcal vaccine responses.

In 66 babies tested for anti-meningococcal antibodies, antibodies were 1.7 times higher for vaginally-born babies than those delivered via C-section, and high antibody levels were particularly associated with high levels of E. coli in the babies’ microbiome.

The results were also influenced by breast-feeding, which even among children born vaginally was linked with 3.5 times higher pneumococcal antibody levels, compared with those of formula-fed children. In contrast, levels of antibodies against meningococcus were unaffected by breast-feeding status.
 

Microbiome ‘sets level of infection protection’

The team said: “The baby acquires Bifidobacterium and E. coli bacteria through natural birth, and human milk is needed to provide the sugars for these bacteria to thrive on.” They explained: “The gut microbiome is seeded at birth, developing rapidly over the first few months of life, and is influenced mostly by delivery mode, breast-feeding, and antibiotic use.” The babies’ microbiome in early life contributes the immune system’s response to vaccines, they said, “and sets the level of protection against certain infections in childhood.”

Study lead Professor Debby Bogaert, chair of pediatric medicine at the University of Edinburgh, said: “I think it is especially interesting that we identified several beneficial microbes to be the link between mode of delivery and vaccine responses. In the future, we may be able to supplement those bacteria to children born by C-section shortly after birth through – for example, mother-to-baby ‘fecal transplants’ or the use of specifically designed probiotics.”

First author Dr. Emma de Koff, a microbiology trainee at the Amsterdam University Medical Center, said: “We expected to find a link between the gut microbiome and the babies’ vaccine responses, however we never thought to find the strongest effects in the first weeks of life.”

The findings “could help to inform conversations about C-sections between expectant mothers and their doctors,” commented the researchers, who said that they could also “shape the design of more tailored vaccination programs.” For example, in the future, vaccination schedules could be adjusted based on the method of delivery or analysis of the baby’s microbiome.
 

Potential to rectify immune system after Caesarean

Responding to the study, Professor Neil Mabbott, personal chair in immunopathology at the Roslin Institute of the University of Edinburgh, told the Science Media Centre: “This is a very interesting and important study. The authors show that infants delivered by a vaginal birth had higher responses to the two different types of vaccines against bacterial diseases, and this was associated with higher abundances of the potentially beneficial bacteria known as Bifidobacterium and E. coli in their intestines.”

He added: “This study raises the possibility that it may be possible to treat infants, especially Caesarean-delivered infants, with a bacterial supplement, or even a product produced by these beneficial bacteria, to help improve their immune systems, enhance their responses to certain vaccines and reduce their susceptibility to infections.”

The study raises important questions, he said, including whether the increased antibody levels from pneumococcal and meningococcal vaccinations following vaginal birth also leads to increased protection of the infants against infection or serious disease. 

Sheena Cruickshank, immunologist and professor in biomedical sciences at the University of Manchester, England, commented: “It is now well established that the microbiome is important in immune development. In turn the mode of delivery and initial method of feeding is important in how the microbiome is first seeded in the baby.”

“However, other factors such as exposure to antibiotics and subsequent diet also play a role in how it then develops, making understanding the way the microbiome develops and changes quite complex. Microbes works as communities, and it can be difficult to determine whether changes in single species are important functionally. Breast milk also plays an important role in protecting the baby via transfer of maternal immunoglobulins, which will wane over a period of 6-12 months in the baby – thus ascertaining whether it’s the baby’s Ig is challenging.

“Given the complexity of the multitude of interactions, it is important that this is accounted for, and group sizes are large enough to ensure data is robust. Whilst this is an interesting study that adds to our knowledge of how the microbiome develops and the possible implications for immune development, it is still very preliminary, and the small group sizes warrant a need for further studies to verify this in larger groups.”

She added: “We will need to understand whether possible impacts of maternal delivery and feeding on immune development or vaccine responses can be restored by, for example, manipulating the microbiome.”

Professor Kim Barrett, vice dean for research at the University of California, Davis School of Medicine, said that, while further research was needed to uncover if and how manipulation of the human microbiome following C-section births might improve vaccine efficacy, “the work should at least lead to prompt additional consideration about an unintended consequence of the ever-increasing use of C-sections that may not be medically-necessary.”

Dr. Marie Lewis, researcher in gut microbiota at the University of Reading, England, said: “We have known for quite some time that the mode of delivery is incredibly important when it comes to the type of bacteria which colonize our guts. We also know that our gut bacteria in early life drive the development of our immune system, and natural births are linked with reduced risks of developing inflammatory conditions, such as asthma. It is therefore perhaps not really surprising that mode of delivery is also linked to responses to vaccinations.”

“The really interesting part here is the extent to which our gut microbiotas are accessible and changeable, and this important work could pave the way for administration of probiotics and prebiotics to improve vaccine responses in Caesarean-born children.”
 

‘Tantalizing data’

Dr. Chrissie Jones, associate professor of pediatric infectious diseases at the University of Southampton, and Southampton UK and education lead for the British Paediatric Allergy, Immunity, and Infection Group, said: “The link between method of delivery of the infant and the bacteria that live in the gut of the young infant has previously been shown. What is really interesting about this study is that, for the first time, the link between method of delivery (vaginal delivery vs. C-section), differences in bacterial communities of the gut, and differences in responses to vaccines is shown.”

“This study may give us fresh insights into the differences that we see in the amount of protective antibodies made after infant vaccination. It also gives us clues as to ways that we might be able to level the playing field for infants in the future – for instance, giving babies a safe cocktail of ‘friendly bacteria’ as a probiotic, or an additional dose of vaccine.”

“This study is the first step – it shows us a link or association but does not prove cause and effect that differences in the way babies are born alters how the immune system responds to vaccines. To prove this link we will need larger studies, but it is tantalizing data.”

The research was funded by Scotland’s Chief Scientist Office and the Netherlands Organisation for Scientific Research. DB received funding from OM pharma and Sanofi. All of the authors declared no other conflicts of interest.

A version of this article first appeared on Medscape.com.

Babies born vaginally have a different microbiome to those born by Caesarean section and have heightened responses to childhood vaccinations, according to a new study heralded as “interesting and important” by experts.

The microbiome is known to play a role in immune responses to vaccination. However, the relationship between early-life effects on intestinal microbiota composition and subsequent childhood vaccine responses had remained poorly understood. In the new study, “the findings suggest that vaginal birthing resulted in a microbiota composition associated with an increase in a specific type of antibody response to two routine childhood vaccines in healthy babies, compared with Caesarean section,” the authors said.

Researchers from the University of Edinburgh, with colleagues at Spaarne Hospital and University Medical Centre in Utrecht, and the National Institute for Public Health and the Environment in The Netherlands, tracked the development of the gut microbiome in a cohort of 120 healthy, full-term infants and assessed their antibody levels following two common childhood vaccinations.

The study, published in Nature Communications, found “a clear relationship between microbes in the gut of those babies and levels of antibodies.” Not only was vaginal birth associated with increased levels of Bifidobacterium and Escherichia coli in the gut microbiome in the first months of life but also with higher IgG antibody responses against both pneumococcal and meningococcal vaccines.
 

Antibody responses doubled after vaginal birth

The babies were given pneumococcal and meningococcal vaccinations at 8 and 12 weeks, and saliva was collected at follow-up visits at ages 12 and 18 months for antibody measurement. In the 101 babies tested for pneumococcal antibodies, the researchers found that antibody levels were twice as high among babies delivered naturally, compared with those delivered by C-section. High levels of two gut bacteria in particular – Bifidobacterium and E. coli – were associated with high antibody responses to the pneumococcal vaccine, showing that the microbiome mediated the link between mode of delivery and pneumococcal vaccine responses.

In 66 babies tested for anti-meningococcal antibodies, antibodies were 1.7 times higher for vaginally-born babies than those delivered via C-section, and high antibody levels were particularly associated with high levels of E. coli in the babies’ microbiome.

The results were also influenced by breast-feeding, which even among children born vaginally was linked with 3.5 times higher pneumococcal antibody levels, compared with those of formula-fed children. In contrast, levels of antibodies against meningococcus were unaffected by breast-feeding status.
 

Microbiome ‘sets level of infection protection’

The team said: “The baby acquires Bifidobacterium and E. coli bacteria through natural birth, and human milk is needed to provide the sugars for these bacteria to thrive on.” They explained: “The gut microbiome is seeded at birth, developing rapidly over the first few months of life, and is influenced mostly by delivery mode, breast-feeding, and antibiotic use.” The babies’ microbiome in early life contributes the immune system’s response to vaccines, they said, “and sets the level of protection against certain infections in childhood.”

Study lead Professor Debby Bogaert, chair of pediatric medicine at the University of Edinburgh, said: “I think it is especially interesting that we identified several beneficial microbes to be the link between mode of delivery and vaccine responses. In the future, we may be able to supplement those bacteria to children born by C-section shortly after birth through – for example, mother-to-baby ‘fecal transplants’ or the use of specifically designed probiotics.”

First author Dr. Emma de Koff, a microbiology trainee at the Amsterdam University Medical Center, said: “We expected to find a link between the gut microbiome and the babies’ vaccine responses, however we never thought to find the strongest effects in the first weeks of life.”

The findings “could help to inform conversations about C-sections between expectant mothers and their doctors,” commented the researchers, who said that they could also “shape the design of more tailored vaccination programs.” For example, in the future, vaccination schedules could be adjusted based on the method of delivery or analysis of the baby’s microbiome.
 

Potential to rectify immune system after Caesarean

Responding to the study, Professor Neil Mabbott, personal chair in immunopathology at the Roslin Institute of the University of Edinburgh, told the Science Media Centre: “This is a very interesting and important study. The authors show that infants delivered by a vaginal birth had higher responses to the two different types of vaccines against bacterial diseases, and this was associated with higher abundances of the potentially beneficial bacteria known as Bifidobacterium and E. coli in their intestines.”

He added: “This study raises the possibility that it may be possible to treat infants, especially Caesarean-delivered infants, with a bacterial supplement, or even a product produced by these beneficial bacteria, to help improve their immune systems, enhance their responses to certain vaccines and reduce their susceptibility to infections.”

The study raises important questions, he said, including whether the increased antibody levels from pneumococcal and meningococcal vaccinations following vaginal birth also leads to increased protection of the infants against infection or serious disease. 

Sheena Cruickshank, immunologist and professor in biomedical sciences at the University of Manchester, England, commented: “It is now well established that the microbiome is important in immune development. In turn the mode of delivery and initial method of feeding is important in how the microbiome is first seeded in the baby.”

“However, other factors such as exposure to antibiotics and subsequent diet also play a role in how it then develops, making understanding the way the microbiome develops and changes quite complex. Microbes works as communities, and it can be difficult to determine whether changes in single species are important functionally. Breast milk also plays an important role in protecting the baby via transfer of maternal immunoglobulins, which will wane over a period of 6-12 months in the baby – thus ascertaining whether it’s the baby’s Ig is challenging.

“Given the complexity of the multitude of interactions, it is important that this is accounted for, and group sizes are large enough to ensure data is robust. Whilst this is an interesting study that adds to our knowledge of how the microbiome develops and the possible implications for immune development, it is still very preliminary, and the small group sizes warrant a need for further studies to verify this in larger groups.”

She added: “We will need to understand whether possible impacts of maternal delivery and feeding on immune development or vaccine responses can be restored by, for example, manipulating the microbiome.”

Professor Kim Barrett, vice dean for research at the University of California, Davis School of Medicine, said that, while further research was needed to uncover if and how manipulation of the human microbiome following C-section births might improve vaccine efficacy, “the work should at least lead to prompt additional consideration about an unintended consequence of the ever-increasing use of C-sections that may not be medically-necessary.”

Dr. Marie Lewis, researcher in gut microbiota at the University of Reading, England, said: “We have known for quite some time that the mode of delivery is incredibly important when it comes to the type of bacteria which colonize our guts. We also know that our gut bacteria in early life drive the development of our immune system, and natural births are linked with reduced risks of developing inflammatory conditions, such as asthma. It is therefore perhaps not really surprising that mode of delivery is also linked to responses to vaccinations.”

“The really interesting part here is the extent to which our gut microbiotas are accessible and changeable, and this important work could pave the way for administration of probiotics and prebiotics to improve vaccine responses in Caesarean-born children.”
 

‘Tantalizing data’

Dr. Chrissie Jones, associate professor of pediatric infectious diseases at the University of Southampton, and Southampton UK and education lead for the British Paediatric Allergy, Immunity, and Infection Group, said: “The link between method of delivery of the infant and the bacteria that live in the gut of the young infant has previously been shown. What is really interesting about this study is that, for the first time, the link between method of delivery (vaginal delivery vs. C-section), differences in bacterial communities of the gut, and differences in responses to vaccines is shown.”

“This study may give us fresh insights into the differences that we see in the amount of protective antibodies made after infant vaccination. It also gives us clues as to ways that we might be able to level the playing field for infants in the future – for instance, giving babies a safe cocktail of ‘friendly bacteria’ as a probiotic, or an additional dose of vaccine.”

“This study is the first step – it shows us a link or association but does not prove cause and effect that differences in the way babies are born alters how the immune system responds to vaccines. To prove this link we will need larger studies, but it is tantalizing data.”

The research was funded by Scotland’s Chief Scientist Office and the Netherlands Organisation for Scientific Research. DB received funding from OM pharma and Sanofi. All of the authors declared no other conflicts of interest.

A version of this article first appeared on Medscape.com.

Influenza vaccination is associated with a reduced risk of stroke among adults, even if they aren’t at high risk for stroke, according to new research.

The risk of stroke was about 23% lower in the 6 months following a flu shot, regardless of the patient’s age, sex, or underlying health conditions.

“There is an established link between upper respiratory infection and both heart attack and stroke. This has been very salient in the past few years throughout the COVID-19 pandemic,” study author Jessalyn Holodinsky, PhD, a stroke epidemiologist and postdoctoral fellow in clinical neurosciences at the University of Calgary (Alta.) told this news organization.

“It is also known that the flu shot can reduce risk of heart attack and hospitalization for those with heart disease,” she said. “Given both of these [observations], we thought it prudent to study whether there is a link between vaccination for influenza and stroke.”

The study was published in the Lancet Public Health.
 

Large effect size

The investigators analyzed administrative data from 2009 through 2018 from the Alberta Health Care Insurance Plan, which covers all residents of Alberta. The province provides free seasonal influenza vaccines to residents under the insurance plan.

The research team looked for stroke events such as acute ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage, and transient ischemic attack. They then analyzed the risk of stroke events among those with or without a flu shot in the previous 6 months. They accounted for multiple factors, including age, sex, income, location, and factors related to stroke risk, such as anticoagulant use, atrial fibrillation, chronic obstructive pulmonary disease, diabetes, and hypertension.

Among the 4.1 million adults included in the researchers’ analysis, about 1.8 million (43%) received at least one vaccination during the study period. Nearly 97,000 people received a flu vaccine in each year they were in the study, including 29,288 who received a shot in all 10 flu seasons included in the study.

About 38,000 stroke events were recorded, including about 34,000 (90%) first stroke events. Among the 10% of strokes that were recurrent events, the maximum number of stroke events in one person was nine.

Overall, patients who received at least one influenza vaccine were more likely to be older, be women, and have higher rates of comorbidities. The vaccinated group had a slightly higher proportion of people who lived in urban areas, but the income levels were similar between the vaccinated and unvaccinated groups.

The crude incidence of stroke was higher among people who had ever received an influenza vaccination, at 1.25%, compared with 0.52% among those who hadn’t been vaccinated. However, after adjusting for age, sex, underlying conditions, and socioeconomic status, recent flu vaccination (that is, in the previous 6 months) was associated with a 23% reduced risk of stroke.

The significant reduction in risk applied to all stroke types, particularly acute ischemic stroke and intracerebral hemorrhage. In addition, influenza vaccination was associated with a reduced risk across all ages and risk profiles, except patients without hypertension.

“What we were most surprised by was the sheer magnitude of the effect and that it existed across different adult age groups, for both sexes, and for those with and without risk factors for stroke,” said Dr. Holodinsky.

Vaccination was associated with a larger reduction in stroke risk in men than in women, perhaps because unvaccinated men had a significantly higher baseline risk for stroke than unvaccinated women, the study authors write.
 

Promoting cardiovascular health

In addition, vaccination was associated with a greater relative reduction in stroke risk in younger age groups, lower income groups, and those with diabetes, chronic obstructive pulmonary disease, and anticoagulant use.

Among 2.4 million people observed for the entire study period, vaccination protection increased with the number of vaccines received. People who were vaccinated serially each year had a significantly lower risk of stroke than those who received one shot.

Dr. Holodinsky and colleagues are conducting additional research into influenza vaccination, including stroke risk in children. They’re also investigating whether the reduced risk applies to other vaccinations for respiratory illnesses, such as COVID-19 and pneumonia.

“We hope that this added effect of vaccination encourages more adults to receive the flu shot,” she said. “One day, vaccinations might be considered a key pillar of cardiovascular health, along with diet, exercise, control of hypertension and high cholesterol, and smoking cessation.”

Future research should also investigate the reasons why adults – particularly people at high risk with underlying conditions – don’t receive recommended influenza vaccines, the study authors wrote.
 

‘Call to action’

Bahar Behrouzi, an MD-PhD candidate focused on clinical epidemiology at the Institute of Health Policy, Management, and Evaluation, University of Toronto, said: “There are a variety of observational studies around the world that show that flu vaccine uptake is low among the general population and high-risk persons. In studying these questions, our hope is that we can continue to build confidence in viral respiratory vaccines like the influenza vaccine by continuing to generate rigorous evidence with the latest data.”

Ms. Behrouzi, who wasn’t involved with this study, has researched influenza vaccination and cardiovascular risk. She and her colleagues have found that flu vaccines were associated with a 34% lower risk of major adverse cardiovascular events, including a 45% reduced risk among patients with recent acute coronary syndrome.

“The broader public health message is for people to advocate for themselves and get the seasonal flu vaccine, especially if they are part of an at-risk group,” she said. “In our studies, we have positioned this message as a call to action not only for the public, but also for health care professionals – particularly specialists such as cardiologists or neurologists – to encourage or remind them to engage in conversation about the broad benefits of vaccination beyond just preventing or reducing the severity of flu infection.”

The study was conducted without outside funding. Dr. Holodinsky and Ms. Behrouzi have reported no relevant disclosures.

A version of this article first appeared on Medscape.com.

Influenza vaccination is associated with a reduced risk of stroke among adults, even if they aren’t at high risk for stroke, according to new research.

The risk of stroke was about 23% lower in the 6 months following a flu shot, regardless of the patient’s age, sex, or underlying health conditions.

“There is an established link between upper respiratory infection and both heart attack and stroke. This has been very salient in the past few years throughout the COVID-19 pandemic,” study author Jessalyn Holodinsky, PhD, a stroke epidemiologist and postdoctoral fellow in clinical neurosciences at the University of Calgary (Alta.) told this news organization.

“It is also known that the flu shot can reduce risk of heart attack and hospitalization for those with heart disease,” she said. “Given both of these [observations], we thought it prudent to study whether there is a link between vaccination for influenza and stroke.”

The study was published in the Lancet Public Health.
 

Large effect size

The investigators analyzed administrative data from 2009 through 2018 from the Alberta Health Care Insurance Plan, which covers all residents of Alberta. The province provides free seasonal influenza vaccines to residents under the insurance plan.

The research team looked for stroke events such as acute ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage, and transient ischemic attack. They then analyzed the risk of stroke events among those with or without a flu shot in the previous 6 months. They accounted for multiple factors, including age, sex, income, location, and factors related to stroke risk, such as anticoagulant use, atrial fibrillation, chronic obstructive pulmonary disease, diabetes, and hypertension.

Among the 4.1 million adults included in the researchers’ analysis, about 1.8 million (43%) received at least one vaccination during the study period. Nearly 97,000 people received a flu vaccine in each year they were in the study, including 29,288 who received a shot in all 10 flu seasons included in the study.

About 38,000 stroke events were recorded, including about 34,000 (90%) first stroke events. Among the 10% of strokes that were recurrent events, the maximum number of stroke events in one person was nine.

Overall, patients who received at least one influenza vaccine were more likely to be older, be women, and have higher rates of comorbidities. The vaccinated group had a slightly higher proportion of people who lived in urban areas, but the income levels were similar between the vaccinated and unvaccinated groups.

The crude incidence of stroke was higher among people who had ever received an influenza vaccination, at 1.25%, compared with 0.52% among those who hadn’t been vaccinated. However, after adjusting for age, sex, underlying conditions, and socioeconomic status, recent flu vaccination (that is, in the previous 6 months) was associated with a 23% reduced risk of stroke.

The significant reduction in risk applied to all stroke types, particularly acute ischemic stroke and intracerebral hemorrhage. In addition, influenza vaccination was associated with a reduced risk across all ages and risk profiles, except patients without hypertension.

“What we were most surprised by was the sheer magnitude of the effect and that it existed across different adult age groups, for both sexes, and for those with and without risk factors for stroke,” said Dr. Holodinsky.

Vaccination was associated with a larger reduction in stroke risk in men than in women, perhaps because unvaccinated men had a significantly higher baseline risk for stroke than unvaccinated women, the study authors write.
 

Promoting cardiovascular health

In addition, vaccination was associated with a greater relative reduction in stroke risk in younger age groups, lower income groups, and those with diabetes, chronic obstructive pulmonary disease, and anticoagulant use.

Among 2.4 million people observed for the entire study period, vaccination protection increased with the number of vaccines received. People who were vaccinated serially each year had a significantly lower risk of stroke than those who received one shot.

Dr. Holodinsky and colleagues are conducting additional research into influenza vaccination, including stroke risk in children. They’re also investigating whether the reduced risk applies to other vaccinations for respiratory illnesses, such as COVID-19 and pneumonia.

“We hope that this added effect of vaccination encourages more adults to receive the flu shot,” she said. “One day, vaccinations might be considered a key pillar of cardiovascular health, along with diet, exercise, control of hypertension and high cholesterol, and smoking cessation.”

Future research should also investigate the reasons why adults – particularly people at high risk with underlying conditions – don’t receive recommended influenza vaccines, the study authors wrote.
 

‘Call to action’

Bahar Behrouzi, an MD-PhD candidate focused on clinical epidemiology at the Institute of Health Policy, Management, and Evaluation, University of Toronto, said: “There are a variety of observational studies around the world that show that flu vaccine uptake is low among the general population and high-risk persons. In studying these questions, our hope is that we can continue to build confidence in viral respiratory vaccines like the influenza vaccine by continuing to generate rigorous evidence with the latest data.”

Ms. Behrouzi, who wasn’t involved with this study, has researched influenza vaccination and cardiovascular risk. She and her colleagues have found that flu vaccines were associated with a 34% lower risk of major adverse cardiovascular events, including a 45% reduced risk among patients with recent acute coronary syndrome.

“The broader public health message is for people to advocate for themselves and get the seasonal flu vaccine, especially if they are part of an at-risk group,” she said. “In our studies, we have positioned this message as a call to action not only for the public, but also for health care professionals – particularly specialists such as cardiologists or neurologists – to encourage or remind them to engage in conversation about the broad benefits of vaccination beyond just preventing or reducing the severity of flu infection.”

The study was conducted without outside funding. Dr. Holodinsky and Ms. Behrouzi have reported no relevant disclosures.

A version of this article first appeared on Medscape.com.

Influenza vaccination is associated with a reduced risk of stroke among adults, even if they aren’t at high risk for stroke, according to new research.

The risk of stroke was about 23% lower in the 6 months following a flu shot, regardless of the patient’s age, sex, or underlying health conditions.

“There is an established link between upper respiratory infection and both heart attack and stroke. This has been very salient in the past few years throughout the COVID-19 pandemic,” study author Jessalyn Holodinsky, PhD, a stroke epidemiologist and postdoctoral fellow in clinical neurosciences at the University of Calgary (Alta.) told this news organization.

“It is also known that the flu shot can reduce risk of heart attack and hospitalization for those with heart disease,” she said. “Given both of these [observations], we thought it prudent to study whether there is a link between vaccination for influenza and stroke.”

The study was published in the Lancet Public Health.
 

Large effect size

The investigators analyzed administrative data from 2009 through 2018 from the Alberta Health Care Insurance Plan, which covers all residents of Alberta. The province provides free seasonal influenza vaccines to residents under the insurance plan.

The research team looked for stroke events such as acute ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage, and transient ischemic attack. They then analyzed the risk of stroke events among those with or without a flu shot in the previous 6 months. They accounted for multiple factors, including age, sex, income, location, and factors related to stroke risk, such as anticoagulant use, atrial fibrillation, chronic obstructive pulmonary disease, diabetes, and hypertension.

Among the 4.1 million adults included in the researchers’ analysis, about 1.8 million (43%) received at least one vaccination during the study period. Nearly 97,000 people received a flu vaccine in each year they were in the study, including 29,288 who received a shot in all 10 flu seasons included in the study.

About 38,000 stroke events were recorded, including about 34,000 (90%) first stroke events. Among the 10% of strokes that were recurrent events, the maximum number of stroke events in one person was nine.

Overall, patients who received at least one influenza vaccine were more likely to be older, be women, and have higher rates of comorbidities. The vaccinated group had a slightly higher proportion of people who lived in urban areas, but the income levels were similar between the vaccinated and unvaccinated groups.

The crude incidence of stroke was higher among people who had ever received an influenza vaccination, at 1.25%, compared with 0.52% among those who hadn’t been vaccinated. However, after adjusting for age, sex, underlying conditions, and socioeconomic status, recent flu vaccination (that is, in the previous 6 months) was associated with a 23% reduced risk of stroke.

The significant reduction in risk applied to all stroke types, particularly acute ischemic stroke and intracerebral hemorrhage. In addition, influenza vaccination was associated with a reduced risk across all ages and risk profiles, except patients without hypertension.

“What we were most surprised by was the sheer magnitude of the effect and that it existed across different adult age groups, for both sexes, and for those with and without risk factors for stroke,” said Dr. Holodinsky.

Vaccination was associated with a larger reduction in stroke risk in men than in women, perhaps because unvaccinated men had a significantly higher baseline risk for stroke than unvaccinated women, the study authors write.
 

Promoting cardiovascular health

In addition, vaccination was associated with a greater relative reduction in stroke risk in younger age groups, lower income groups, and those with diabetes, chronic obstructive pulmonary disease, and anticoagulant use.

Among 2.4 million people observed for the entire study period, vaccination protection increased with the number of vaccines received. People who were vaccinated serially each year had a significantly lower risk of stroke than those who received one shot.

Dr. Holodinsky and colleagues are conducting additional research into influenza vaccination, including stroke risk in children. They’re also investigating whether the reduced risk applies to other vaccinations for respiratory illnesses, such as COVID-19 and pneumonia.

“We hope that this added effect of vaccination encourages more adults to receive the flu shot,” she said. “One day, vaccinations might be considered a key pillar of cardiovascular health, along with diet, exercise, control of hypertension and high cholesterol, and smoking cessation.”

Future research should also investigate the reasons why adults – particularly people at high risk with underlying conditions – don’t receive recommended influenza vaccines, the study authors wrote.
 

‘Call to action’

Bahar Behrouzi, an MD-PhD candidate focused on clinical epidemiology at the Institute of Health Policy, Management, and Evaluation, University of Toronto, said: “There are a variety of observational studies around the world that show that flu vaccine uptake is low among the general population and high-risk persons. In studying these questions, our hope is that we can continue to build confidence in viral respiratory vaccines like the influenza vaccine by continuing to generate rigorous evidence with the latest data.”

Ms. Behrouzi, who wasn’t involved with this study, has researched influenza vaccination and cardiovascular risk. She and her colleagues have found that flu vaccines were associated with a 34% lower risk of major adverse cardiovascular events, including a 45% reduced risk among patients with recent acute coronary syndrome.

“The broader public health message is for people to advocate for themselves and get the seasonal flu vaccine, especially if they are part of an at-risk group,” she said. “In our studies, we have positioned this message as a call to action not only for the public, but also for health care professionals – particularly specialists such as cardiologists or neurologists – to encourage or remind them to engage in conversation about the broad benefits of vaccination beyond just preventing or reducing the severity of flu infection.”

The study was conducted without outside funding. Dr. Holodinsky and Ms. Behrouzi have reported no relevant disclosures.

A version of this article first appeared on Medscape.com.

Shortly into the COVID-19 pandemic, Dr. Robert Califf, the commissioner of the US Food and Drug Administration, warned of a coming tsunami of chronic diseases, exacerbated by missed care during the pandemic.¹ According to a Centers for Disease Control and Prevention (CDC) survey, more than 30% of adults reported delaying or avoiding routine medical care in the first 6 months of 2020. This rate was highest in people with comorbidities.² Multiple studies demonstrated declines in hypertension care, hemoglobin A_1c testing, mammography, and colon cancer screening.^3-5 There has been a resultant increase in colon cancer complications, wounds, and amputations.^6,7 The United Kingdom is expected to have a 7.9% to 16.6% increase in future deaths due to breast and colorectal cancer (CRC).⁸ The World Health Organization estimates an excess 14.9 million people died in 2020 and 2021, either directly from or indirectly related to COVID-19.⁹

Due to the large-scale conversion from face-to-face care to telehealth modalities, COVID-19 vaccination events offered a unique opportunity to perform preventive health care that requires in-person visits, since most US adults have sought vaccination. However, vaccine events may not reach people most at risk for COVID-19 or chronic disease. Groups of Americans with lower vaccination rates were concerned about driving times and missing work to get the vaccine.¹⁰

Distance and travel time may be a particular challenge in Hawaii. Oahu is considered rural by the US Department of Veterans Affairs (VA); some communities are 80 minutes away from the VA Pacific Islands Health Care System (VAPIHCS) main facility. Oahu has approximately 150 veterans experiencing homelessness who may not have transportation to vaccine events. Additionally, VAPIHCS serves veterans that may be at higher risk of not receiving COVID-19 vaccination. Racial and ethnic minority residents have lower vaccination rates, yet are at a higher risk of COVID-19 infection and complications, and through the pandemic, this vaccination gap worsened.^11,12 More than 10% of the population of Hawaii is Native Hawaiian or Pacific Islander, and this population is at elevated risk for diabetes mellitus, hypertension, and COVID-19 mortality.^13-16

Health Fair Program

The VA provides clinical reminders in its electronic health record (EHR) that are specified by age, gender assigned at birth, and comorbidities. The clinical reminder program is intended to provide clinically relevant reminders for preventive care at the point of care. Veterans with overdue clinical reminders can be identified by name and address, allowing for the creation of health fair events that were directed towards communities with veterans with clinical reminders, including COVID-19 vaccination need. A team of health care professionals from VAPIHCS conceived of a health fair program to increase the reach of vaccine events and include preventive care in partnership with the VAPIHCS Vet Center Program, local communities, U.S.VETS, and the Hawaii Institute of Health Services (HIHS). We sought to determine which services could be offered in community settings; large vaccine events; and at homeless emergency, transitional, or permanent housing. We tracked veterans who received care in the different locations of the directed health fair.

This project was determined to be a quality improvement initiative by the VAPIHCS Office of Research and Development. It was jointly planned by the VAPIHCS pharmacy, infectious diseases, Vet Center Program, and homeless team to make the COVID-19 vaccines available to more rural and to veterans experiencing homelessness, and in response to a decline in facility face-to-face visits. Monthly meetings were held to select sites within zip codes with higher numbers of open clinical reminders and lower vaccination uptake. Informatics developed a list of clinical reminders by zip code for care performed at face-to-face visits.

Partners

The Vet Center Program, suicide prevention coordinator, and the homeless outreach team have a mandate to perform outreach events.^17,18 These services collaborate with community partners to locate sites for events. The team was able to leverage these contacts to set up sites for events. The Vet Center Program readjustment counselor and the suicide prevention coordinator provide mental health counseling. The Vet Center counsels on veteran benefits. They supplied a mobile van with WiFi, counseling and examination spaces, and refrigeration, which became the mobile clinic for the preventive care offered at events. The homeless program works with multiple community partners. They contract with HIHS and U.S.VETS to provide emergency and permanent housing for veterans. Each event is reviewed with HIHS and U.S.VETS staff for permission to be on site. The suicide prevention coordinator or the Vet Center readjustment counselor and the homeless team became regular attendees of events. The homeless team provided resources for housing or food insecurity.

Preventive Health Measures

The VA clinical reminder system supports caregivers for both preventive health care and chronic condition management.¹⁹ Clinical reminders appear as due in the EHR, and reminder reports can be run by clinical informatics to determine groups of patients who have not had a reminder completed. The following reminders were completed: vaccinations (including COVID-19), CRC screening, diabetic foot check and teaching of foot care, diabetic retinal consultations, laboratory studies (lipids, hemoglobin A_1c, microalbumin), mammogram and pap smear referrals, mental health reminders, homeless and food insecurity screening, HIV and hepatitis C testing, and blood pressure (BP) measurement. Health records were reviewed 3 months after each event to determine whether they were completed by the veteran. Additionally, we determined whether BP was controlled (< 130/80 mm Hg).

Settings

Large urban event. The first setting for the health fair was a large vaccination event near the VAPIHCS center in April 2021. Attendance was solicited by VEText, phone calls, and social media advertisements. At check-in, veterans with relevant open clinical reminders were invited to receive preventive health care during the 15-minute monitoring period after the COVID-19 vaccine. The Vet Center Program stationed the mobile van outside the vaccination event, where a physician and a clinical pharmacy specialist (CPS) did assessments, completed reminders, and entered follow-up requests for about 4 hours. A medical support assistant registered veterans who had never signed up for VA health care.

Community Settings. Nine events occurred at least monthly between March and September 2021 at 4 different sites in Oahu. Texts and phone calls were used to solicit attendance; there was no prior publicity on social media. Community events required scheduling resources; this required about 30 hours of medical staff assistant time. Seven sites were visited for about 3 hours each. A physician, pharmacy technician, and CPS conducted assessments, completed reminders, and entered follow-up requests. A medical support assistant registered veterans who had never signed up for VA health care.

Homeless veteran outreach. Five events occurred at 2 homeless veteran housing sites between August 2021 and January 2022. These sites were emergency housing sites (2 events) and transitional and permanent housing (2 events). U.S.VETS and HIHS contacted veterans living in those settings to promote the event. A physician, registered nurse, licensed practical nurse, and CPS conducted assessments, completed reminders, and entered follow-up requests. A medical support assistant registered veterans that had never signed up for VA health care. Each event lasted approximate 3 hours.

Process Quality Improvement

After the CDC changed recommendations to allow concurrent vaccination with the COVID-19 vaccine, we added other vaccinations to the events. This occurred during the course of community events. In June of 2021, there was a health advisory concerning hepatitis A among people experiencing homelessness in Oahu, so hepatitis vaccinations were added for events for veterans.²⁰

Veterans Served

The EHR was used to determine demographics, open clinical reminders, and attendance at follow-up. Simple descriptive statistics were performed in Microsoft Excel. A total of 115 veterans were seen for preventive health visits, and 404 clinical reminders were completed. Seven hundred veterans attended the large centrally located vaccine event and 43 agreed to have a preventive health visit. Thirty-eight veterans had a preventive health visit at homeless outreach events and 34 veterans had a preventive health visit at the community events. Veterans at community

Of the 166 vaccines given, 73 were for COVID-19. Besides vaccination,

Discussion

This program provided evidence that adding preventive screenings to vaccine events may help reach veterans who may have missed important preventive care due to the COVID-19 pandemic. The involvement of clinical informatics service allowed the outreach to be targeted to communities with incomplete clinical reminders. Interventions that could not be completed at the event had high levels of follow-up by veterans with important findings. The presence of a physician or nurse and a CPS allowed for point-of-care testing, as well as entering orders for medication, laboratory tests, and consultations. The attendance by representatives from the Vet Center, suicide prevention, and homeless services allowed counseling regarding benefits, and mental health follow-up. We believe that we were able to reach communities of veterans with unmet preventive needs and had higher risk of severe COVID-19, given the high numbers with open clinical reminders, the number of vaccines provided, and the high percentage of racial and ethnic minority veterans at events in the community. Our program experience provides some evidence that mobile and pop-up vaccination clinics may be beneficial for screening and managing chronic diseases, as proposed elsewhere.^21-24

Strengths of this intervention include that we were able to show a high level of follow-up for recommended medical care as well as the results of our interventions. We have found no similar articles that provide data on completion of follow-up appointments after a health fair. A prior study showed only 23% to 63% of participants at a health fair reported having a recommended follow-up discussion with doctors, but the study reported no outcome of completed cancer screenings.²⁵

Limitations

Weaknesses include the fact that health fair events may reach only healthy people, since attendees generally report better health and better health behaviors than nonattendees.^26,27 We felt this was more problematic for the large-scale urban event and that offering rural events and events in homeless housing improved the reach. Future efforts will involve the use of social media and mailings to solicit attendance. To improve follow-up, future work will include adding to the events: phlebotomy or expanded point-of-care testing; specialty care telehealth capability; cervical cancer screen self-collection; and tele-retinal services.

Conclusions

This program provided evidence that directed, preventive screening can be performed in outreach settings paired with vaccine events. These vaccination events in rural and homeless settings reached communities with demonstrable COVID-19 vaccination and other preventive care needs. This approach could be used to help veterans catch up on needed preventive care.

Acknowledgments

Veterans Affairs Pacific Islands Health Care System: Anthony Chance, LCSW; Nicholas Chang, PharmD; Andrew Dahlburg, LCSW; Wilminia G. Ellorimo-Gil, RN; Paul Guillory, RN; Wendy D. Joy; Arthur Minor, LCSW; Avalua Smith; Jessica Spurrier, RN. Veterans Health Administration Vet Center Program: Rolly O. Alvarado; Edmond G. DeGuzman; Richard T. Teel. Hawaii Institute for Human Services. U.S.VETS.

Shortly into the COVID-19 pandemic, Dr. Robert Califf, the commissioner of the US Food and Drug Administration, warned of a coming tsunami of chronic diseases, exacerbated by missed care during the pandemic.¹ According to a Centers for Disease Control and Prevention (CDC) survey, more than 30% of adults reported delaying or avoiding routine medical care in the first 6 months of 2020. This rate was highest in people with comorbidities.² Multiple studies demonstrated declines in hypertension care, hemoglobin A_1c testing, mammography, and colon cancer screening.^3-5 There has been a resultant increase in colon cancer complications, wounds, and amputations.^6,7 The United Kingdom is expected to have a 7.9% to 16.6% increase in future deaths due to breast and colorectal cancer (CRC).⁸ The World Health Organization estimates an excess 14.9 million people died in 2020 and 2021, either directly from or indirectly related to COVID-19.⁹

Due to the large-scale conversion from face-to-face care to telehealth modalities, COVID-19 vaccination events offered a unique opportunity to perform preventive health care that requires in-person visits, since most US adults have sought vaccination. However, vaccine events may not reach people most at risk for COVID-19 or chronic disease. Groups of Americans with lower vaccination rates were concerned about driving times and missing work to get the vaccine.¹⁰

Distance and travel time may be a particular challenge in Hawaii. Oahu is considered rural by the US Department of Veterans Affairs (VA); some communities are 80 minutes away from the VA Pacific Islands Health Care System (VAPIHCS) main facility. Oahu has approximately 150 veterans experiencing homelessness who may not have transportation to vaccine events. Additionally, VAPIHCS serves veterans that may be at higher risk of not receiving COVID-19 vaccination. Racial and ethnic minority residents have lower vaccination rates, yet are at a higher risk of COVID-19 infection and complications, and through the pandemic, this vaccination gap worsened.^11,12 More than 10% of the population of Hawaii is Native Hawaiian or Pacific Islander, and this population is at elevated risk for diabetes mellitus, hypertension, and COVID-19 mortality.^13-16

Health Fair Program

The VA provides clinical reminders in its electronic health record (EHR) that are specified by age, gender assigned at birth, and comorbidities. The clinical reminder program is intended to provide clinically relevant reminders for preventive care at the point of care. Veterans with overdue clinical reminders can be identified by name and address, allowing for the creation of health fair events that were directed towards communities with veterans with clinical reminders, including COVID-19 vaccination need. A team of health care professionals from VAPIHCS conceived of a health fair program to increase the reach of vaccine events and include preventive care in partnership with the VAPIHCS Vet Center Program, local communities, U.S.VETS, and the Hawaii Institute of Health Services (HIHS). We sought to determine which services could be offered in community settings; large vaccine events; and at homeless emergency, transitional, or permanent housing. We tracked veterans who received care in the different locations of the directed health fair.

This project was determined to be a quality improvement initiative by the VAPIHCS Office of Research and Development. It was jointly planned by the VAPIHCS pharmacy, infectious diseases, Vet Center Program, and homeless team to make the COVID-19 vaccines available to more rural and to veterans experiencing homelessness, and in response to a decline in facility face-to-face visits. Monthly meetings were held to select sites within zip codes with higher numbers of open clinical reminders and lower vaccination uptake. Informatics developed a list of clinical reminders by zip code for care performed at face-to-face visits.

Partners

The Vet Center Program, suicide prevention coordinator, and the homeless outreach team have a mandate to perform outreach events.^17,18 These services collaborate with community partners to locate sites for events. The team was able to leverage these contacts to set up sites for events. The Vet Center Program readjustment counselor and the suicide prevention coordinator provide mental health counseling. The Vet Center counsels on veteran benefits. They supplied a mobile van with WiFi, counseling and examination spaces, and refrigeration, which became the mobile clinic for the preventive care offered at events. The homeless program works with multiple community partners. They contract with HIHS and U.S.VETS to provide emergency and permanent housing for veterans. Each event is reviewed with HIHS and U.S.VETS staff for permission to be on site. The suicide prevention coordinator or the Vet Center readjustment counselor and the homeless team became regular attendees of events. The homeless team provided resources for housing or food insecurity.

Preventive Health Measures

The VA clinical reminder system supports caregivers for both preventive health care and chronic condition management.¹⁹ Clinical reminders appear as due in the EHR, and reminder reports can be run by clinical informatics to determine groups of patients who have not had a reminder completed. The following reminders were completed: vaccinations (including COVID-19), CRC screening, diabetic foot check and teaching of foot care, diabetic retinal consultations, laboratory studies (lipids, hemoglobin A_1c, microalbumin), mammogram and pap smear referrals, mental health reminders, homeless and food insecurity screening, HIV and hepatitis C testing, and blood pressure (BP) measurement. Health records were reviewed 3 months after each event to determine whether they were completed by the veteran. Additionally, we determined whether BP was controlled (< 130/80 mm Hg).

Settings

Large urban event. The first setting for the health fair was a large vaccination event near the VAPIHCS center in April 2021. Attendance was solicited by VEText, phone calls, and social media advertisements. At check-in, veterans with relevant open clinical reminders were invited to receive preventive health care during the 15-minute monitoring period after the COVID-19 vaccine. The Vet Center Program stationed the mobile van outside the vaccination event, where a physician and a clinical pharmacy specialist (CPS) did assessments, completed reminders, and entered follow-up requests for about 4 hours. A medical support assistant registered veterans who had never signed up for VA health care.

Community Settings. Nine events occurred at least monthly between March and September 2021 at 4 different sites in Oahu. Texts and phone calls were used to solicit attendance; there was no prior publicity on social media. Community events required scheduling resources; this required about 30 hours of medical staff assistant time. Seven sites were visited for about 3 hours each. A physician, pharmacy technician, and CPS conducted assessments, completed reminders, and entered follow-up requests. A medical support assistant registered veterans who had never signed up for VA health care.

Homeless veteran outreach. Five events occurred at 2 homeless veteran housing sites between August 2021 and January 2022. These sites were emergency housing sites (2 events) and transitional and permanent housing (2 events). U.S.VETS and HIHS contacted veterans living in those settings to promote the event. A physician, registered nurse, licensed practical nurse, and CPS conducted assessments, completed reminders, and entered follow-up requests. A medical support assistant registered veterans that had never signed up for VA health care. Each event lasted approximate 3 hours.

Process Quality Improvement

After the CDC changed recommendations to allow concurrent vaccination with the COVID-19 vaccine, we added other vaccinations to the events. This occurred during the course of community events. In June of 2021, there was a health advisory concerning hepatitis A among people experiencing homelessness in Oahu, so hepatitis vaccinations were added for events for veterans.²⁰

Veterans Served

The EHR was used to determine demographics, open clinical reminders, and attendance at follow-up. Simple descriptive statistics were performed in Microsoft Excel. A total of 115 veterans were seen for preventive health visits, and 404 clinical reminders were completed. Seven hundred veterans attended the large centrally located vaccine event and 43 agreed to have a preventive health visit. Thirty-eight veterans had a preventive health visit at homeless outreach events and 34 veterans had a preventive health visit at the community events. Veterans at community

Of the 166 vaccines given, 73 were for COVID-19. Besides vaccination,

Discussion

This program provided evidence that adding preventive screenings to vaccine events may help reach veterans who may have missed important preventive care due to the COVID-19 pandemic. The involvement of clinical informatics service allowed the outreach to be targeted to communities with incomplete clinical reminders. Interventions that could not be completed at the event had high levels of follow-up by veterans with important findings. The presence of a physician or nurse and a CPS allowed for point-of-care testing, as well as entering orders for medication, laboratory tests, and consultations. The attendance by representatives from the Vet Center, suicide prevention, and homeless services allowed counseling regarding benefits, and mental health follow-up. We believe that we were able to reach communities of veterans with unmet preventive needs and had higher risk of severe COVID-19, given the high numbers with open clinical reminders, the number of vaccines provided, and the high percentage of racial and ethnic minority veterans at events in the community. Our program experience provides some evidence that mobile and pop-up vaccination clinics may be beneficial for screening and managing chronic diseases, as proposed elsewhere.^21-24

Strengths of this intervention include that we were able to show a high level of follow-up for recommended medical care as well as the results of our interventions. We have found no similar articles that provide data on completion of follow-up appointments after a health fair. A prior study showed only 23% to 63% of participants at a health fair reported having a recommended follow-up discussion with doctors, but the study reported no outcome of completed cancer screenings.²⁵

Limitations

Weaknesses include the fact that health fair events may reach only healthy people, since attendees generally report better health and better health behaviors than nonattendees.^26,27 We felt this was more problematic for the large-scale urban event and that offering rural events and events in homeless housing improved the reach. Future efforts will involve the use of social media and mailings to solicit attendance. To improve follow-up, future work will include adding to the events: phlebotomy or expanded point-of-care testing; specialty care telehealth capability; cervical cancer screen self-collection; and tele-retinal services.

Conclusions

This program provided evidence that directed, preventive screening can be performed in outreach settings paired with vaccine events. These vaccination events in rural and homeless settings reached communities with demonstrable COVID-19 vaccination and other preventive care needs. This approach could be used to help veterans catch up on needed preventive care.

Acknowledgments

Veterans Affairs Pacific Islands Health Care System: Anthony Chance, LCSW; Nicholas Chang, PharmD; Andrew Dahlburg, LCSW; Wilminia G. Ellorimo-Gil, RN; Paul Guillory, RN; Wendy D. Joy; Arthur Minor, LCSW; Avalua Smith; Jessica Spurrier, RN. Veterans Health Administration Vet Center Program: Rolly O. Alvarado; Edmond G. DeGuzman; Richard T. Teel. Hawaii Institute for Human Services. U.S.VETS.

Shortly into the COVID-19 pandemic, Dr. Robert Califf, the commissioner of the US Food and Drug Administration, warned of a coming tsunami of chronic diseases, exacerbated by missed care during the pandemic.¹ According to a Centers for Disease Control and Prevention (CDC) survey, more than 30% of adults reported delaying or avoiding routine medical care in the first 6 months of 2020. This rate was highest in people with comorbidities.² Multiple studies demonstrated declines in hypertension care, hemoglobin A_1c testing, mammography, and colon cancer screening.^3-5 There has been a resultant increase in colon cancer complications, wounds, and amputations.^6,7 The United Kingdom is expected to have a 7.9% to 16.6% increase in future deaths due to breast and colorectal cancer (CRC).⁸ The World Health Organization estimates an excess 14.9 million people died in 2020 and 2021, either directly from or indirectly related to COVID-19.⁹

Due to the large-scale conversion from face-to-face care to telehealth modalities, COVID-19 vaccination events offered a unique opportunity to perform preventive health care that requires in-person visits, since most US adults have sought vaccination. However, vaccine events may not reach people most at risk for COVID-19 or chronic disease. Groups of Americans with lower vaccination rates were concerned about driving times and missing work to get the vaccine.¹⁰

Distance and travel time may be a particular challenge in Hawaii. Oahu is considered rural by the US Department of Veterans Affairs (VA); some communities are 80 minutes away from the VA Pacific Islands Health Care System (VAPIHCS) main facility. Oahu has approximately 150 veterans experiencing homelessness who may not have transportation to vaccine events. Additionally, VAPIHCS serves veterans that may be at higher risk of not receiving COVID-19 vaccination. Racial and ethnic minority residents have lower vaccination rates, yet are at a higher risk of COVID-19 infection and complications, and through the pandemic, this vaccination gap worsened.^11,12 More than 10% of the population of Hawaii is Native Hawaiian or Pacific Islander, and this population is at elevated risk for diabetes mellitus, hypertension, and COVID-19 mortality.^13-16

Health Fair Program

The VA provides clinical reminders in its electronic health record (EHR) that are specified by age, gender assigned at birth, and comorbidities. The clinical reminder program is intended to provide clinically relevant reminders for preventive care at the point of care. Veterans with overdue clinical reminders can be identified by name and address, allowing for the creation of health fair events that were directed towards communities with veterans with clinical reminders, including COVID-19 vaccination need. A team of health care professionals from VAPIHCS conceived of a health fair program to increase the reach of vaccine events and include preventive care in partnership with the VAPIHCS Vet Center Program, local communities, U.S.VETS, and the Hawaii Institute of Health Services (HIHS). We sought to determine which services could be offered in community settings; large vaccine events; and at homeless emergency, transitional, or permanent housing. We tracked veterans who received care in the different locations of the directed health fair.

This project was determined to be a quality improvement initiative by the VAPIHCS Office of Research and Development. It was jointly planned by the VAPIHCS pharmacy, infectious diseases, Vet Center Program, and homeless team to make the COVID-19 vaccines available to more rural and to veterans experiencing homelessness, and in response to a decline in facility face-to-face visits. Monthly meetings were held to select sites within zip codes with higher numbers of open clinical reminders and lower vaccination uptake. Informatics developed a list of clinical reminders by zip code for care performed at face-to-face visits.

Partners

The Vet Center Program, suicide prevention coordinator, and the homeless outreach team have a mandate to perform outreach events.^17,18 These services collaborate with community partners to locate sites for events. The team was able to leverage these contacts to set up sites for events. The Vet Center Program readjustment counselor and the suicide prevention coordinator provide mental health counseling. The Vet Center counsels on veteran benefits. They supplied a mobile van with WiFi, counseling and examination spaces, and refrigeration, which became the mobile clinic for the preventive care offered at events. The homeless program works with multiple community partners. They contract with HIHS and U.S.VETS to provide emergency and permanent housing for veterans. Each event is reviewed with HIHS and U.S.VETS staff for permission to be on site. The suicide prevention coordinator or the Vet Center readjustment counselor and the homeless team became regular attendees of events. The homeless team provided resources for housing or food insecurity.

Preventive Health Measures

The VA clinical reminder system supports caregivers for both preventive health care and chronic condition management.¹⁹ Clinical reminders appear as due in the EHR, and reminder reports can be run by clinical informatics to determine groups of patients who have not had a reminder completed. The following reminders were completed: vaccinations (including COVID-19), CRC screening, diabetic foot check and teaching of foot care, diabetic retinal consultations, laboratory studies (lipids, hemoglobin A_1c, microalbumin), mammogram and pap smear referrals, mental health reminders, homeless and food insecurity screening, HIV and hepatitis C testing, and blood pressure (BP) measurement. Health records were reviewed 3 months after each event to determine whether they were completed by the veteran. Additionally, we determined whether BP was controlled (< 130/80 mm Hg).

Settings

Large urban event. The first setting for the health fair was a large vaccination event near the VAPIHCS center in April 2021. Attendance was solicited by VEText, phone calls, and social media advertisements. At check-in, veterans with relevant open clinical reminders were invited to receive preventive health care during the 15-minute monitoring period after the COVID-19 vaccine. The Vet Center Program stationed the mobile van outside the vaccination event, where a physician and a clinical pharmacy specialist (CPS) did assessments, completed reminders, and entered follow-up requests for about 4 hours. A medical support assistant registered veterans who had never signed up for VA health care.

Community Settings. Nine events occurred at least monthly between March and September 2021 at 4 different sites in Oahu. Texts and phone calls were used to solicit attendance; there was no prior publicity on social media. Community events required scheduling resources; this required about 30 hours of medical staff assistant time. Seven sites were visited for about 3 hours each. A physician, pharmacy technician, and CPS conducted assessments, completed reminders, and entered follow-up requests. A medical support assistant registered veterans who had never signed up for VA health care.

Homeless veteran outreach. Five events occurred at 2 homeless veteran housing sites between August 2021 and January 2022. These sites were emergency housing sites (2 events) and transitional and permanent housing (2 events). U.S.VETS and HIHS contacted veterans living in those settings to promote the event. A physician, registered nurse, licensed practical nurse, and CPS conducted assessments, completed reminders, and entered follow-up requests. A medical support assistant registered veterans that had never signed up for VA health care. Each event lasted approximate 3 hours.

Process Quality Improvement

After the CDC changed recommendations to allow concurrent vaccination with the COVID-19 vaccine, we added other vaccinations to the events. This occurred during the course of community events. In June of 2021, there was a health advisory concerning hepatitis A among people experiencing homelessness in Oahu, so hepatitis vaccinations were added for events for veterans.²⁰

Veterans Served

The EHR was used to determine demographics, open clinical reminders, and attendance at follow-up. Simple descriptive statistics were performed in Microsoft Excel. A total of 115 veterans were seen for preventive health visits, and 404 clinical reminders were completed. Seven hundred veterans attended the large centrally located vaccine event and 43 agreed to have a preventive health visit. Thirty-eight veterans had a preventive health visit at homeless outreach events and 34 veterans had a preventive health visit at the community events. Veterans at community

Of the 166 vaccines given, 73 were for COVID-19. Besides vaccination,

Discussion

This program provided evidence that adding preventive screenings to vaccine events may help reach veterans who may have missed important preventive care due to the COVID-19 pandemic. The involvement of clinical informatics service allowed the outreach to be targeted to communities with incomplete clinical reminders. Interventions that could not be completed at the event had high levels of follow-up by veterans with important findings. The presence of a physician or nurse and a CPS allowed for point-of-care testing, as well as entering orders for medication, laboratory tests, and consultations. The attendance by representatives from the Vet Center, suicide prevention, and homeless services allowed counseling regarding benefits, and mental health follow-up. We believe that we were able to reach communities of veterans with unmet preventive needs and had higher risk of severe COVID-19, given the high numbers with open clinical reminders, the number of vaccines provided, and the high percentage of racial and ethnic minority veterans at events in the community. Our program experience provides some evidence that mobile and pop-up vaccination clinics may be beneficial for screening and managing chronic diseases, as proposed elsewhere.^21-24

Strengths of this intervention include that we were able to show a high level of follow-up for recommended medical care as well as the results of our interventions. We have found no similar articles that provide data on completion of follow-up appointments after a health fair. A prior study showed only 23% to 63% of participants at a health fair reported having a recommended follow-up discussion with doctors, but the study reported no outcome of completed cancer screenings.²⁵

Limitations

Weaknesses include the fact that health fair events may reach only healthy people, since attendees generally report better health and better health behaviors than nonattendees.^26,27 We felt this was more problematic for the large-scale urban event and that offering rural events and events in homeless housing improved the reach. Future efforts will involve the use of social media and mailings to solicit attendance. To improve follow-up, future work will include adding to the events: phlebotomy or expanded point-of-care testing; specialty care telehealth capability; cervical cancer screen self-collection; and tele-retinal services.

Conclusions

This program provided evidence that directed, preventive screening can be performed in outreach settings paired with vaccine events. These vaccination events in rural and homeless settings reached communities with demonstrable COVID-19 vaccination and other preventive care needs. This approach could be used to help veterans catch up on needed preventive care.

Acknowledgments

Veterans Affairs Pacific Islands Health Care System: Anthony Chance, LCSW; Nicholas Chang, PharmD; Andrew Dahlburg, LCSW; Wilminia G. Ellorimo-Gil, RN; Paul Guillory, RN; Wendy D. Joy; Arthur Minor, LCSW; Avalua Smith; Jessica Spurrier, RN. Veterans Health Administration Vet Center Program: Rolly O. Alvarado; Edmond G. DeGuzman; Richard T. Teel. Hawaii Institute for Human Services. U.S.VETS.

Cold and flu season came early in 2022.

On Nov. 4, 2022, the Centers for Disease Control and Prevention issued a Health Alert Network Health Advisory about early, elevated respiratory disease incidence caused by multiple viruses other than SARS-CoV-2.

Interseasonal spread of respiratory syncytial virus has continued in 2022, with RSV-associated hospitalizations increasing in the late spring and continuing throughout the summer and into the fall. In October, some regions of the country were seeing RSV activity near the peak seasonal levels typically observed in December and January.

Cases of severe respiratory infection in children who tested positive for rhinovirus or enterovirus spiked in August; further testing confirmed the presence of EV-D68 in some children. Rhinovirus and enterovirus continue to circulate and are isolated in hospitalized children with respiratory illness.

In some parts of the country, influenza cases have rapidly increased ahead of what we normally anticipate. According to preliminary estimates from the CDC, between Oct. 1 and Oct. 22, 880,000 people were sickened with flu, 420,000 people visited a health care provider for flu illness, and 6,900 people were hospitalized for flu. The cumulative hospitalization rate is higher than observed at this time of year in every previous flu season since 2010-2011. Hospitalization rates are highest in children aged 0-4 years and adults 65 years and older.

Of course, this report came as no surprise to pediatric health care providers. Many children’s hospitals had been operating at or over capacity for weeks. While a systematic assessment of the surge on children’s hospitals has not been published, anecdotally, hospitals from around the country have described record emergency department visits and inpatient census numbers. Some have set up tents or other temporary facilities to see ambulatory patients and have canceled elective surgeries because of a lack of beds.

There is no quick or easy solution to stem the tide of RSV-related or enterovirus/rhinovirus admissions, but many flu-related hospitalizations are vaccine preventable. Unfortunately, too few children are receiving influenza vaccine. As of the week ending Oct. 15, only about 22.1% of eligible children had been immunized. The American Academy of Pediatrics and the CDC recommend that all children are vaccinated, preferably by the end of October so they have time to develop immunity before influenza starts circulating. As it stands now, the majority of the nation’s children are facing a flu season without the benefits of vaccine.

There is still time to take steps to prevent this flu season from becoming one of the worst in recent memory. A strong provider recommendation for influenza vaccine is consistently associated with higher rates of vaccine acceptance. We need to recommend influenza vaccine to all eligible patients at every visit and in every setting. It will help if we can say it like we mean it. Some of us are tired of debating the merits of COVID-19 vaccine with families and may be leery of additional debates about flu. Some of us may just be tired, as many practices have already expanded office hours to care for the influx of kids with respiratory illness. On the heels of two atypical flu seasons, a few of us may be quietly complacent about the importance of flu vaccines for children.

Anyone in need of a little motivation should check out a paper recently published in Clinical Infectious Diseases that reinforces the value of flu vaccine, even in a year when there is a poor match between the vaccine and circulating viruses.

The 2019-2020 flu season was a bad flu season for children. Two antigenically drifted influenza viruses predominated and cases of influenza soared, resulting in the largest influenza epidemic in children in the United States since 1992. Pediatric Intensive Care Influenza Study investigators used a test-negative design to estimate the effectiveness of influenza vaccine in preventing critical and life-threatening influenza in children during that season. The good news: vaccination reduced the risk of critical influenza by 78% against H1N1pdm09 viruses that were well-matched to vaccine and by 47% against mismatched viruses. Vaccination was estimated to be 75% protective against antigenically drifted B-Victoria viruses. Overall vaccine effectiveness against critical illness from any influenza virus was 63% (95% confidence interval, 38%-78%).

While it might be tempting to attribute suboptimal immunization rates to vaccine hesitancy, ready availability remains an issue for some families. We need to eliminate barriers to access. While the AAP continues to emphasize immunization in the medical home, especially for the youngest infants, the 2022 policy statement suggests that vaccinating children in schools, pharmacies, and other nontraditional settings could improve immunization rates. To the extent feasible, we need to work with partners to support community-based initiatives and promote these to families who struggle to make it into the office.

Improving access is just one potential way to reduce health disparities related to influenza and influenza vaccination. Over 10 influenza seasons, higher rates of influenza-associated hospitalizations and intensive care unit admissions were observed in Black, Hispanic, and American Indian/Alaska Native people. These disparities were highest in children aged younger than 4 years and influenza-associated in-hospital deaths were three- to fourfold higher in Black, Hispanic, and Asian/Pacific Islander children, compared with White children. The reason for the disparities isn’t completely clear but increasing immunization rates may be part of the solution. During the 2020-2021 influenza season, flu immunization rates in Black children (51.6%) were lower than those seen in White (57.4%) and Hispanic children (58.9%).

The AAP’s Recommendations for Prevention and Control of Influenza in Children, 2022–2023, highlight a variety of evidence-based strategies to increase influenza immunization rates. These may provide a little inspiration for clinicians looking to try a new approach. If you wish to share your experience with increasing influenza immunization rates in your practice setting, please email me at [email protected].

Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She is a member of the AAP’s Committee on Infectious Diseases and one of the lead authors of the AAP’s Recommendations for Prevention and Control of Influenza in Children, 2022–2023. The opinions expressed in this article are her own. Dr. Bryant discloses that she has served as an investigator on clinical trials funded by Pfizer, Enanta, and Gilead.

Cold and flu season came early in 2022.

On Nov. 4, 2022, the Centers for Disease Control and Prevention issued a Health Alert Network Health Advisory about early, elevated respiratory disease incidence caused by multiple viruses other than SARS-CoV-2.

Interseasonal spread of respiratory syncytial virus has continued in 2022, with RSV-associated hospitalizations increasing in the late spring and continuing throughout the summer and into the fall. In October, some regions of the country were seeing RSV activity near the peak seasonal levels typically observed in December and January.

Cases of severe respiratory infection in children who tested positive for rhinovirus or enterovirus spiked in August; further testing confirmed the presence of EV-D68 in some children. Rhinovirus and enterovirus continue to circulate and are isolated in hospitalized children with respiratory illness.

In some parts of the country, influenza cases have rapidly increased ahead of what we normally anticipate. According to preliminary estimates from the CDC, between Oct. 1 and Oct. 22, 880,000 people were sickened with flu, 420,000 people visited a health care provider for flu illness, and 6,900 people were hospitalized for flu. The cumulative hospitalization rate is higher than observed at this time of year in every previous flu season since 2010-2011. Hospitalization rates are highest in children aged 0-4 years and adults 65 years and older.

Of course, this report came as no surprise to pediatric health care providers. Many children’s hospitals had been operating at or over capacity for weeks. While a systematic assessment of the surge on children’s hospitals has not been published, anecdotally, hospitals from around the country have described record emergency department visits and inpatient census numbers. Some have set up tents or other temporary facilities to see ambulatory patients and have canceled elective surgeries because of a lack of beds.

There is no quick or easy solution to stem the tide of RSV-related or enterovirus/rhinovirus admissions, but many flu-related hospitalizations are vaccine preventable. Unfortunately, too few children are receiving influenza vaccine. As of the week ending Oct. 15, only about 22.1% of eligible children had been immunized. The American Academy of Pediatrics and the CDC recommend that all children are vaccinated, preferably by the end of October so they have time to develop immunity before influenza starts circulating. As it stands now, the majority of the nation’s children are facing a flu season without the benefits of vaccine.

There is still time to take steps to prevent this flu season from becoming one of the worst in recent memory. A strong provider recommendation for influenza vaccine is consistently associated with higher rates of vaccine acceptance. We need to recommend influenza vaccine to all eligible patients at every visit and in every setting. It will help if we can say it like we mean it. Some of us are tired of debating the merits of COVID-19 vaccine with families and may be leery of additional debates about flu. Some of us may just be tired, as many practices have already expanded office hours to care for the influx of kids with respiratory illness. On the heels of two atypical flu seasons, a few of us may be quietly complacent about the importance of flu vaccines for children.

Anyone in need of a little motivation should check out a paper recently published in Clinical Infectious Diseases that reinforces the value of flu vaccine, even in a year when there is a poor match between the vaccine and circulating viruses.

The 2019-2020 flu season was a bad flu season for children. Two antigenically drifted influenza viruses predominated and cases of influenza soared, resulting in the largest influenza epidemic in children in the United States since 1992. Pediatric Intensive Care Influenza Study investigators used a test-negative design to estimate the effectiveness of influenza vaccine in preventing critical and life-threatening influenza in children during that season. The good news: vaccination reduced the risk of critical influenza by 78% against H1N1pdm09 viruses that were well-matched to vaccine and by 47% against mismatched viruses. Vaccination was estimated to be 75% protective against antigenically drifted B-Victoria viruses. Overall vaccine effectiveness against critical illness from any influenza virus was 63% (95% confidence interval, 38%-78%).

While it might be tempting to attribute suboptimal immunization rates to vaccine hesitancy, ready availability remains an issue for some families. We need to eliminate barriers to access. While the AAP continues to emphasize immunization in the medical home, especially for the youngest infants, the 2022 policy statement suggests that vaccinating children in schools, pharmacies, and other nontraditional settings could improve immunization rates. To the extent feasible, we need to work with partners to support community-based initiatives and promote these to families who struggle to make it into the office.

Improving access is just one potential way to reduce health disparities related to influenza and influenza vaccination. Over 10 influenza seasons, higher rates of influenza-associated hospitalizations and intensive care unit admissions were observed in Black, Hispanic, and American Indian/Alaska Native people. These disparities were highest in children aged younger than 4 years and influenza-associated in-hospital deaths were three- to fourfold higher in Black, Hispanic, and Asian/Pacific Islander children, compared with White children. The reason for the disparities isn’t completely clear but increasing immunization rates may be part of the solution. During the 2020-2021 influenza season, flu immunization rates in Black children (51.6%) were lower than those seen in White (57.4%) and Hispanic children (58.9%).

The AAP’s Recommendations for Prevention and Control of Influenza in Children, 2022–2023, highlight a variety of evidence-based strategies to increase influenza immunization rates. These may provide a little inspiration for clinicians looking to try a new approach. If you wish to share your experience with increasing influenza immunization rates in your practice setting, please email me at [email protected].

Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She is a member of the AAP’s Committee on Infectious Diseases and one of the lead authors of the AAP’s Recommendations for Prevention and Control of Influenza in Children, 2022–2023. The opinions expressed in this article are her own. Dr. Bryant discloses that she has served as an investigator on clinical trials funded by Pfizer, Enanta, and Gilead.

Cold and flu season came early in 2022.

On Nov. 4, 2022, the Centers for Disease Control and Prevention issued a Health Alert Network Health Advisory about early, elevated respiratory disease incidence caused by multiple viruses other than SARS-CoV-2.

Interseasonal spread of respiratory syncytial virus has continued in 2022, with RSV-associated hospitalizations increasing in the late spring and continuing throughout the summer and into the fall. In October, some regions of the country were seeing RSV activity near the peak seasonal levels typically observed in December and January.

Cases of severe respiratory infection in children who tested positive for rhinovirus or enterovirus spiked in August; further testing confirmed the presence of EV-D68 in some children. Rhinovirus and enterovirus continue to circulate and are isolated in hospitalized children with respiratory illness.

In some parts of the country, influenza cases have rapidly increased ahead of what we normally anticipate. According to preliminary estimates from the CDC, between Oct. 1 and Oct. 22, 880,000 people were sickened with flu, 420,000 people visited a health care provider for flu illness, and 6,900 people were hospitalized for flu. The cumulative hospitalization rate is higher than observed at this time of year in every previous flu season since 2010-2011. Hospitalization rates are highest in children aged 0-4 years and adults 65 years and older.

Of course, this report came as no surprise to pediatric health care providers. Many children’s hospitals had been operating at or over capacity for weeks. While a systematic assessment of the surge on children’s hospitals has not been published, anecdotally, hospitals from around the country have described record emergency department visits and inpatient census numbers. Some have set up tents or other temporary facilities to see ambulatory patients and have canceled elective surgeries because of a lack of beds.

There is no quick or easy solution to stem the tide of RSV-related or enterovirus/rhinovirus admissions, but many flu-related hospitalizations are vaccine preventable. Unfortunately, too few children are receiving influenza vaccine. As of the week ending Oct. 15, only about 22.1% of eligible children had been immunized. The American Academy of Pediatrics and the CDC recommend that all children are vaccinated, preferably by the end of October so they have time to develop immunity before influenza starts circulating. As it stands now, the majority of the nation’s children are facing a flu season without the benefits of vaccine.

There is still time to take steps to prevent this flu season from becoming one of the worst in recent memory. A strong provider recommendation for influenza vaccine is consistently associated with higher rates of vaccine acceptance. We need to recommend influenza vaccine to all eligible patients at every visit and in every setting. It will help if we can say it like we mean it. Some of us are tired of debating the merits of COVID-19 vaccine with families and may be leery of additional debates about flu. Some of us may just be tired, as many practices have already expanded office hours to care for the influx of kids with respiratory illness. On the heels of two atypical flu seasons, a few of us may be quietly complacent about the importance of flu vaccines for children.

Anyone in need of a little motivation should check out a paper recently published in Clinical Infectious Diseases that reinforces the value of flu vaccine, even in a year when there is a poor match between the vaccine and circulating viruses.

The 2019-2020 flu season was a bad flu season for children. Two antigenically drifted influenza viruses predominated and cases of influenza soared, resulting in the largest influenza epidemic in children in the United States since 1992. Pediatric Intensive Care Influenza Study investigators used a test-negative design to estimate the effectiveness of influenza vaccine in preventing critical and life-threatening influenza in children during that season. The good news: vaccination reduced the risk of critical influenza by 78% against H1N1pdm09 viruses that were well-matched to vaccine and by 47% against mismatched viruses. Vaccination was estimated to be 75% protective against antigenically drifted B-Victoria viruses. Overall vaccine effectiveness against critical illness from any influenza virus was 63% (95% confidence interval, 38%-78%).

While it might be tempting to attribute suboptimal immunization rates to vaccine hesitancy, ready availability remains an issue for some families. We need to eliminate barriers to access. While the AAP continues to emphasize immunization in the medical home, especially for the youngest infants, the 2022 policy statement suggests that vaccinating children in schools, pharmacies, and other nontraditional settings could improve immunization rates. To the extent feasible, we need to work with partners to support community-based initiatives and promote these to families who struggle to make it into the office.

Improving access is just one potential way to reduce health disparities related to influenza and influenza vaccination. Over 10 influenza seasons, higher rates of influenza-associated hospitalizations and intensive care unit admissions were observed in Black, Hispanic, and American Indian/Alaska Native people. These disparities were highest in children aged younger than 4 years and influenza-associated in-hospital deaths were three- to fourfold higher in Black, Hispanic, and Asian/Pacific Islander children, compared with White children. The reason for the disparities isn’t completely clear but increasing immunization rates may be part of the solution. During the 2020-2021 influenza season, flu immunization rates in Black children (51.6%) were lower than those seen in White (57.4%) and Hispanic children (58.9%).

The AAP’s Recommendations for Prevention and Control of Influenza in Children, 2022–2023, highlight a variety of evidence-based strategies to increase influenza immunization rates. These may provide a little inspiration for clinicians looking to try a new approach. If you wish to share your experience with increasing influenza immunization rates in your practice setting, please email me at [email protected].

Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She is a member of the AAP’s Committee on Infectious Diseases and one of the lead authors of the AAP’s Recommendations for Prevention and Control of Influenza in Children, 2022–2023. The opinions expressed in this article are her own. Dr. Bryant discloses that she has served as an investigator on clinical trials funded by Pfizer, Enanta, and Gilead.

A majority of states cover human papillomavirus vaccination through age 45 years with no need for prior authorization, which has implications for adults with certain dermatologic diseases, according to the authors of a review of Medicaid policies across all 50 states.

The human papillomavirus (HPV) vaccine is approved for people aged 9-45 years, for preventing genital, cervical, anal, and oropharyngeal cancers, and genital warts. And the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices recommends routine vaccination with the HPV vaccine for individuals aged 9-26 years, with “shared clinical decision-making” recommended for vaccination of those aged 27-45 years, wrote Nathaniel Goldman of New York Medical College, Valhalla, and coauthors, from the University of Missouri–Kansas City and Harvard Medical School, Boston.

xrender/Thinkstock

Vaccine discussions are important in dermatology

“Dermatologists care for patients who may be an increased risk of vaccine-preventable illnesses, either from a skin disease or a dermatology medication,” corresponding author Megan H. Noe, MD, a dermatologist at Brigham and Women’s Hospital, and assistant professor of dermatology, Harvard Medical School, Boston, said in an interview. “Over the last several years, we have seen that all physicians, whether they provide vaccinations or not, can play an important role in discussing vaccines with their patients,” she said.  

“Vaccines can be cost-prohibitive for patients without insurance coverage, so we hope that dermatologists will be more likely to recommend the HPV vaccine to patients 27-45 years of age if they know that it is likely covered by insurance,” Dr. Noe noted.

Vaccine discussions

“I think it’s great that many Medicaid plans are covering HPV vaccination,” said Karl Saardi, MD, of the department of dermatology, George Washington University, Washington, who was asked to comment on the study. “I routinely recommend [vaccination] for patients who have viral warts, since it does lead to improvement in some cases,” Dr. Saardi, who was not involved in the current study, said in an interview. “Although we don’t have the HPV vaccines in our clinic for administration, my experience has been that patients are very open to discussing it with their primary care doctors.”

Although the upper age range continues to rise, “I think getting younger people vaccinated will also prove to be important,” said Dr. Saardi, director of the inpatient dermatology service at the George Washington University Hospital.

The point made in the current study about the importance of HPV vaccination in patients with hidradenitis suppurativa is also crucial, he added. “Since chronic skin inflammation in hidradenitis drives squamous cell carcinoma, reducing the impact of HPV on such cancers makes perfect sense.”

The study received no outside funding. Dr. Noe disclosed grants from Boehringer Ingelheim unrelated to the current study. Dr. Saardi had no financial conflicts to disclose.

A majority of states cover human papillomavirus vaccination through age 45 years with no need for prior authorization, which has implications for adults with certain dermatologic diseases, according to the authors of a review of Medicaid policies across all 50 states.

The human papillomavirus (HPV) vaccine is approved for people aged 9-45 years, for preventing genital, cervical, anal, and oropharyngeal cancers, and genital warts. And the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices recommends routine vaccination with the HPV vaccine for individuals aged 9-26 years, with “shared clinical decision-making” recommended for vaccination of those aged 27-45 years, wrote Nathaniel Goldman of New York Medical College, Valhalla, and coauthors, from the University of Missouri–Kansas City and Harvard Medical School, Boston.

xrender/Thinkstock

Vaccine discussions are important in dermatology

“Dermatologists care for patients who may be an increased risk of vaccine-preventable illnesses, either from a skin disease or a dermatology medication,” corresponding author Megan H. Noe, MD, a dermatologist at Brigham and Women’s Hospital, and assistant professor of dermatology, Harvard Medical School, Boston, said in an interview. “Over the last several years, we have seen that all physicians, whether they provide vaccinations or not, can play an important role in discussing vaccines with their patients,” she said.  

“Vaccines can be cost-prohibitive for patients without insurance coverage, so we hope that dermatologists will be more likely to recommend the HPV vaccine to patients 27-45 years of age if they know that it is likely covered by insurance,” Dr. Noe noted.

Vaccine discussions

“I think it’s great that many Medicaid plans are covering HPV vaccination,” said Karl Saardi, MD, of the department of dermatology, George Washington University, Washington, who was asked to comment on the study. “I routinely recommend [vaccination] for patients who have viral warts, since it does lead to improvement in some cases,” Dr. Saardi, who was not involved in the current study, said in an interview. “Although we don’t have the HPV vaccines in our clinic for administration, my experience has been that patients are very open to discussing it with their primary care doctors.”

Although the upper age range continues to rise, “I think getting younger people vaccinated will also prove to be important,” said Dr. Saardi, director of the inpatient dermatology service at the George Washington University Hospital.

The point made in the current study about the importance of HPV vaccination in patients with hidradenitis suppurativa is also crucial, he added. “Since chronic skin inflammation in hidradenitis drives squamous cell carcinoma, reducing the impact of HPV on such cancers makes perfect sense.”

The study received no outside funding. Dr. Noe disclosed grants from Boehringer Ingelheim unrelated to the current study. Dr. Saardi had no financial conflicts to disclose.

A majority of states cover human papillomavirus vaccination through age 45 years with no need for prior authorization, which has implications for adults with certain dermatologic diseases, according to the authors of a review of Medicaid policies across all 50 states.

The human papillomavirus (HPV) vaccine is approved for people aged 9-45 years, for preventing genital, cervical, anal, and oropharyngeal cancers, and genital warts. And the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices recommends routine vaccination with the HPV vaccine for individuals aged 9-26 years, with “shared clinical decision-making” recommended for vaccination of those aged 27-45 years, wrote Nathaniel Goldman of New York Medical College, Valhalla, and coauthors, from the University of Missouri–Kansas City and Harvard Medical School, Boston.

xrender/Thinkstock

Vaccine discussions are important in dermatology

“Dermatologists care for patients who may be an increased risk of vaccine-preventable illnesses, either from a skin disease or a dermatology medication,” corresponding author Megan H. Noe, MD, a dermatologist at Brigham and Women’s Hospital, and assistant professor of dermatology, Harvard Medical School, Boston, said in an interview. “Over the last several years, we have seen that all physicians, whether they provide vaccinations or not, can play an important role in discussing vaccines with their patients,” she said.  

“Vaccines can be cost-prohibitive for patients without insurance coverage, so we hope that dermatologists will be more likely to recommend the HPV vaccine to patients 27-45 years of age if they know that it is likely covered by insurance,” Dr. Noe noted.

Vaccine discussions

“I think it’s great that many Medicaid plans are covering HPV vaccination,” said Karl Saardi, MD, of the department of dermatology, George Washington University, Washington, who was asked to comment on the study. “I routinely recommend [vaccination] for patients who have viral warts, since it does lead to improvement in some cases,” Dr. Saardi, who was not involved in the current study, said in an interview. “Although we don’t have the HPV vaccines in our clinic for administration, my experience has been that patients are very open to discussing it with their primary care doctors.”

Although the upper age range continues to rise, “I think getting younger people vaccinated will also prove to be important,” said Dr. Saardi, director of the inpatient dermatology service at the George Washington University Hospital.

The point made in the current study about the importance of HPV vaccination in patients with hidradenitis suppurativa is also crucial, he added. “Since chronic skin inflammation in hidradenitis drives squamous cell carcinoma, reducing the impact of HPV on such cancers makes perfect sense.”

The study received no outside funding. Dr. Noe disclosed grants from Boehringer Ingelheim unrelated to the current study. Dr. Saardi had no financial conflicts to disclose.

The effectiveness of the human papillomavirus (HPV) vaccine against HPV types 16 and 18 is highly dependent on the age at which it is given. Prevalence rates have been shown to be significantly lower among girls who are vaccinated at the recommended ages of 9-12 years, compared with those who are vaccinated after their sexual debut, data from the National Health and Nutrition Examination Survey (NHANES) indicate.

“HPV vaccination does not have any therapeutic effect on HPV infections already acquired, which is more likely to explain the difference in prevalence between predebut versus postdebut recipients than a lower immune response [among older recipients],” lead study author Didem Egemen, PhD, National Cancer Institute, Rockville, Md., told this news organization in an email.

“Still, among older females, the immune response of the vaccine is likely to still be quite strong, and we would encourage vaccination [of female patients] if unvaccinated, as our paper showed that vaccination post debut will still reduce HPV 16/18 prevalence by half,” she added.

The research letter was published online in JAMA Network Open.
 

National sample evaluated

Using data from NHANES, a biennial, cross-sectional sample (cycles 2011 through 2018), the researchers identified female persons who were aged 26 years or younger in 2006, when HPV vaccination was introduced, and who were eligible for routine vaccination or “catch-up” vaccination (given between the ages of 13 and 26 years), as per recommendations from the Advisory Committee on Immunization Practices. The investigators then compared the prevalence of HPV types 16 and 18 among unvaccinated female patients, female patients who had been vaccinated prior to their sexual debut (predebut group), and those who had been vaccinated after their sexual debut (postdebut group).

They also estimated vaccine uptake among those who were eligible for routine vaccination, as well as the proportion of vaccinated female patients with respect to racial and ethnic subgroups.

In the overall cohort, the prevalence of HPV types 16 and 18 decreased by 6% (95% confidence interval, 4%-7%) in the unvaccinated group to 3% (95% CI, 1%-6%) in the postdebut group and to less than 1% (95% CI, <1%-1%) in the predebut group, Dr. Egemen and colleagues report.

In real percentages, the prevalence of HPV 16 and 18 was 89% lower in the predebut group (P < .001) but only 41% lower in the postdebut group (P = .29) compared with unvaccinated female patients. And compared with female patients who were vaccinated after their sexual debut, the prevalence of HPV 16 and 18 was reduced by 82% among those who had received the vaccine at the recommended ages of 9-12 years (P = .08).

In the current study, Dr. Egeman acknowledged that only 38% of ever-eligible female patients received the vaccine, although the prevalence increased to 56% when only female patients who were eligible for routine vaccination were taken into account. On the other hand, only 21% (95% CI, 14%-28%) of female patients eligible for routine vaccination received their first dose by age 12 years.

Indeed, the mean age on receipt of the first vaccination dose was 14.5 years (95% CI, 14.1-14.8 years), the authors note, and only 59% of girls received their first dose prior to their sexual debut. Additionally, among routine vaccination–eligible girls aged 12 years or younger in 2006, 33% were vaccinated before and 23% after their sexual debut, and the rest were not vaccinated.

Interestingly, differences in the age at which the HPV vaccine was received by race and ethnicity were negligible, the investigators point out.
 

Vaccination rates increasing

Asked to comment on the findings, Rebecca Perkins, MD, professor of obstetrics and gynecology at Boston University, Boston Medical Center, pointed out that the investigators evaluated data from 2011 to 2018. “We know that HPV vaccination rates have increased over that period and continue to increase,” she emphasized in an email to this news organization.

Physicians also know that more persons are being vaccinated between the ages of 9 and 12 than was the case at the beginning of this study. “This is good news,” she said, “as it means that more adolescents now in 2022 are benefiting fully from vaccination than they were in 2011,” she added.

At the same time, Dr. Perkins acknowledged that many persons are still missing out on the chance to receive the vaccine on time – which means they are missing out on the chance to prevent cancer.

“Making sure that all adolescents receive vaccination between the ages of 9 to 12 has the potential to prevent up to 40,000 cancers every year in the U.S., [including] the most common HPV-related cancers, such as cervical cancer in women and tongue and tonsillar cancer in men,” Dr. Perkins noted.

“Thus, it’s critical that doctors and parents get the message that you can’t vaccinate too early, only too late,” she emphasized.

Dr. Edgman and Dr. Perkins report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The effectiveness of the human papillomavirus (HPV) vaccine against HPV types 16 and 18 is highly dependent on the age at which it is given. Prevalence rates have been shown to be significantly lower among girls who are vaccinated at the recommended ages of 9-12 years, compared with those who are vaccinated after their sexual debut, data from the National Health and Nutrition Examination Survey (NHANES) indicate.

“HPV vaccination does not have any therapeutic effect on HPV infections already acquired, which is more likely to explain the difference in prevalence between predebut versus postdebut recipients than a lower immune response [among older recipients],” lead study author Didem Egemen, PhD, National Cancer Institute, Rockville, Md., told this news organization in an email.

“Still, among older females, the immune response of the vaccine is likely to still be quite strong, and we would encourage vaccination [of female patients] if unvaccinated, as our paper showed that vaccination post debut will still reduce HPV 16/18 prevalence by half,” she added.

The research letter was published online in JAMA Network Open.
 

National sample evaluated

Using data from NHANES, a biennial, cross-sectional sample (cycles 2011 through 2018), the researchers identified female persons who were aged 26 years or younger in 2006, when HPV vaccination was introduced, and who were eligible for routine vaccination or “catch-up” vaccination (given between the ages of 13 and 26 years), as per recommendations from the Advisory Committee on Immunization Practices. The investigators then compared the prevalence of HPV types 16 and 18 among unvaccinated female patients, female patients who had been vaccinated prior to their sexual debut (predebut group), and those who had been vaccinated after their sexual debut (postdebut group).

They also estimated vaccine uptake among those who were eligible for routine vaccination, as well as the proportion of vaccinated female patients with respect to racial and ethnic subgroups.

In the overall cohort, the prevalence of HPV types 16 and 18 decreased by 6% (95% confidence interval, 4%-7%) in the unvaccinated group to 3% (95% CI, 1%-6%) in the postdebut group and to less than 1% (95% CI, <1%-1%) in the predebut group, Dr. Egemen and colleagues report.

In real percentages, the prevalence of HPV 16 and 18 was 89% lower in the predebut group (P < .001) but only 41% lower in the postdebut group (P = .29) compared with unvaccinated female patients. And compared with female patients who were vaccinated after their sexual debut, the prevalence of HPV 16 and 18 was reduced by 82% among those who had received the vaccine at the recommended ages of 9-12 years (P = .08).

In the current study, Dr. Egeman acknowledged that only 38% of ever-eligible female patients received the vaccine, although the prevalence increased to 56% when only female patients who were eligible for routine vaccination were taken into account. On the other hand, only 21% (95% CI, 14%-28%) of female patients eligible for routine vaccination received their first dose by age 12 years.

Indeed, the mean age on receipt of the first vaccination dose was 14.5 years (95% CI, 14.1-14.8 years), the authors note, and only 59% of girls received their first dose prior to their sexual debut. Additionally, among routine vaccination–eligible girls aged 12 years or younger in 2006, 33% were vaccinated before and 23% after their sexual debut, and the rest were not vaccinated.

Interestingly, differences in the age at which the HPV vaccine was received by race and ethnicity were negligible, the investigators point out.
 

Vaccination rates increasing

Asked to comment on the findings, Rebecca Perkins, MD, professor of obstetrics and gynecology at Boston University, Boston Medical Center, pointed out that the investigators evaluated data from 2011 to 2018. “We know that HPV vaccination rates have increased over that period and continue to increase,” she emphasized in an email to this news organization.

Physicians also know that more persons are being vaccinated between the ages of 9 and 12 than was the case at the beginning of this study. “This is good news,” she said, “as it means that more adolescents now in 2022 are benefiting fully from vaccination than they were in 2011,” she added.

At the same time, Dr. Perkins acknowledged that many persons are still missing out on the chance to receive the vaccine on time – which means they are missing out on the chance to prevent cancer.

“Making sure that all adolescents receive vaccination between the ages of 9 to 12 has the potential to prevent up to 40,000 cancers every year in the U.S., [including] the most common HPV-related cancers, such as cervical cancer in women and tongue and tonsillar cancer in men,” Dr. Perkins noted.

“Thus, it’s critical that doctors and parents get the message that you can’t vaccinate too early, only too late,” she emphasized.

Dr. Edgman and Dr. Perkins report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The effectiveness of the human papillomavirus (HPV) vaccine against HPV types 16 and 18 is highly dependent on the age at which it is given. Prevalence rates have been shown to be significantly lower among girls who are vaccinated at the recommended ages of 9-12 years, compared with those who are vaccinated after their sexual debut, data from the National Health and Nutrition Examination Survey (NHANES) indicate.

“HPV vaccination does not have any therapeutic effect on HPV infections already acquired, which is more likely to explain the difference in prevalence between predebut versus postdebut recipients than a lower immune response [among older recipients],” lead study author Didem Egemen, PhD, National Cancer Institute, Rockville, Md., told this news organization in an email.

“Still, among older females, the immune response of the vaccine is likely to still be quite strong, and we would encourage vaccination [of female patients] if unvaccinated, as our paper showed that vaccination post debut will still reduce HPV 16/18 prevalence by half,” she added.

The research letter was published online in JAMA Network Open.
 

National sample evaluated

Using data from NHANES, a biennial, cross-sectional sample (cycles 2011 through 2018), the researchers identified female persons who were aged 26 years or younger in 2006, when HPV vaccination was introduced, and who were eligible for routine vaccination or “catch-up” vaccination (given between the ages of 13 and 26 years), as per recommendations from the Advisory Committee on Immunization Practices. The investigators then compared the prevalence of HPV types 16 and 18 among unvaccinated female patients, female patients who had been vaccinated prior to their sexual debut (predebut group), and those who had been vaccinated after their sexual debut (postdebut group).

They also estimated vaccine uptake among those who were eligible for routine vaccination, as well as the proportion of vaccinated female patients with respect to racial and ethnic subgroups.

In the overall cohort, the prevalence of HPV types 16 and 18 decreased by 6% (95% confidence interval, 4%-7%) in the unvaccinated group to 3% (95% CI, 1%-6%) in the postdebut group and to less than 1% (95% CI, <1%-1%) in the predebut group, Dr. Egemen and colleagues report.

In real percentages, the prevalence of HPV 16 and 18 was 89% lower in the predebut group (P < .001) but only 41% lower in the postdebut group (P = .29) compared with unvaccinated female patients. And compared with female patients who were vaccinated after their sexual debut, the prevalence of HPV 16 and 18 was reduced by 82% among those who had received the vaccine at the recommended ages of 9-12 years (P = .08).

In the current study, Dr. Egeman acknowledged that only 38% of ever-eligible female patients received the vaccine, although the prevalence increased to 56% when only female patients who were eligible for routine vaccination were taken into account. On the other hand, only 21% (95% CI, 14%-28%) of female patients eligible for routine vaccination received their first dose by age 12 years.

Indeed, the mean age on receipt of the first vaccination dose was 14.5 years (95% CI, 14.1-14.8 years), the authors note, and only 59% of girls received their first dose prior to their sexual debut. Additionally, among routine vaccination–eligible girls aged 12 years or younger in 2006, 33% were vaccinated before and 23% after their sexual debut, and the rest were not vaccinated.

Interestingly, differences in the age at which the HPV vaccine was received by race and ethnicity were negligible, the investigators point out.
 

Vaccination rates increasing

Asked to comment on the findings, Rebecca Perkins, MD, professor of obstetrics and gynecology at Boston University, Boston Medical Center, pointed out that the investigators evaluated data from 2011 to 2018. “We know that HPV vaccination rates have increased over that period and continue to increase,” she emphasized in an email to this news organization.

Physicians also know that more persons are being vaccinated between the ages of 9 and 12 than was the case at the beginning of this study. “This is good news,” she said, “as it means that more adolescents now in 2022 are benefiting fully from vaccination than they were in 2011,” she added.

At the same time, Dr. Perkins acknowledged that many persons are still missing out on the chance to receive the vaccine on time – which means they are missing out on the chance to prevent cancer.

“Making sure that all adolescents receive vaccination between the ages of 9 to 12 has the potential to prevent up to 40,000 cancers every year in the U.S., [including] the most common HPV-related cancers, such as cervical cancer in women and tongue and tonsillar cancer in men,” Dr. Perkins noted.

“Thus, it’s critical that doctors and parents get the message that you can’t vaccinate too early, only too late,” she emphasized.

Dr. Edgman and Dr. Perkins report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The COVID-19 bivalent Pfizer/BioNTech vaccine triggers a stronger immune response than a fourth dose of the original vaccine, the company reported on Nov. 4, supporting calls by public health officials for eligible people to get this booster before a potential COVID-19 surge this winter.

The company’s ongoing phase 2/3 study of their Omicron BA.4 and BA.5 bivalent – which targets both the virus’ original strain and the two subvariants – shows that the vaccine offered the strongest protection in people older than 55 years.

One month after receiving a 30-mcg booster with the bivalent vaccine, those older than 55 had four times more neutralizing antibodies against these Omicron subvariants, compared with people who received the original monovalent vaccine as a booster in the study.

Researchers compared the geometric mean titer (GMT) levels of these antibodies in three groups before and 1 month after boosting. The 36 people older than 55 years in the released study findings had an GMT level of 896 with the bivalent booster, a level 13 times higher than before this immunization.

For the 38 adults ages 18-55 in the study, the GMT level increased to 606 at 1 month after the bivalent booster, an increase of almost 10-fold, compared with baseline. In a comparator group of 40 people receiving the original vaccine as a fourth dose, the GMT level was 236, or threefold higher than before their booster shot.

The newly released data is “very encouraging and consistent now with three studies all showing a substantial 3-4 fold increased level of neutralizing antibodies versus BA.5 as compared with the original booster,” said Eric Topol, MD, director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape Medical News.

Pfizer and BioNTech announced the updated findings in a Nov. 4 press release.

A booster dose of the BA.4/BA.5-adapted bivalent vaccine is authorized for emergency use by the Food and Drug Administration for ages 5 years and older. The safety and tolerability profile of the Pfizer/BioNTech bivalent booster remains favorable and similar to the original COVID-19 vaccine, the company reported.

Until recently, the BA.5 Omicron variant was the dominant strain in the United States, but is now getting elbowed out by the subvariants BQ.1.1, BQ.1, and BA.4.6, which together make up almost 45% of the circulating virus.
 

Some skepticism

“It is important to note that these data are press-release level, which does not allow a view of the data totality,” Hana El Sahly, MD, professor of molecular virology and microbiology, Baylor College of Medicine, Houston, said in an interview.

“For example, there may be significant differences between the groups, and the release mentions at least one difference that is of importance: the interval since the last vaccination which often affects the response to subsequent boosting,” she said.

Dr. El Sahly added that the findings are not surprising. “In the short term, a variant-specific vaccine produces a higher level of antibody against the variant in the vaccine than the vaccines based on the ancestral strains.”

More researcher results are warranted. “These data do not indicate that these differences between the two vaccines translate into a meaningful clinical benefit at a population level,” Dr. El Sahly said.
 

An uncertain winter ahead

“As we head into the holiday season, we hope these updated data will encourage people to seek out a COVID-19 bivalent booster as soon as they are eligible in order to maintain high levels of protection against the widely circulating Omicron BA.4 and BA.5 sublineages,” Albert Bourla, Pfizer chairman and CEO, stated in the release.

The updated data from the Pfizer/BioNTech study are “all the more reason to get a booster, with added protection also versus BQ.1.1, which will soon become dominant in the U.S.,” Dr. Topol predicted.

It is unclear when the next surge will happen, as COVID-19 does not always follow a seasonal pattern, at least not yet, Dr. El Sahly said. “Regardless, it is reasonable to recommend additional vaccine doses to immunocompromised and frail or older persons. More importantly, influenza vaccination and being up to date on pneumococcal vaccines are highly recommended as soon as feasible, given the early and intense flu season.”

A version of this article first appeared on Medscape.com.

The COVID-19 bivalent Pfizer/BioNTech vaccine triggers a stronger immune response than a fourth dose of the original vaccine, the company reported on Nov. 4, supporting calls by public health officials for eligible people to get this booster before a potential COVID-19 surge this winter.

The company’s ongoing phase 2/3 study of their Omicron BA.4 and BA.5 bivalent – which targets both the virus’ original strain and the two subvariants – shows that the vaccine offered the strongest protection in people older than 55 years.

One month after receiving a 30-mcg booster with the bivalent vaccine, those older than 55 had four times more neutralizing antibodies against these Omicron subvariants, compared with people who received the original monovalent vaccine as a booster in the study.

Researchers compared the geometric mean titer (GMT) levels of these antibodies in three groups before and 1 month after boosting. The 36 people older than 55 years in the released study findings had an GMT level of 896 with the bivalent booster, a level 13 times higher than before this immunization.

For the 38 adults ages 18-55 in the study, the GMT level increased to 606 at 1 month after the bivalent booster, an increase of almost 10-fold, compared with baseline. In a comparator group of 40 people receiving the original vaccine as a fourth dose, the GMT level was 236, or threefold higher than before their booster shot.

The newly released data is “very encouraging and consistent now with three studies all showing a substantial 3-4 fold increased level of neutralizing antibodies versus BA.5 as compared with the original booster,” said Eric Topol, MD, director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape Medical News.

Pfizer and BioNTech announced the updated findings in a Nov. 4 press release.

A booster dose of the BA.4/BA.5-adapted bivalent vaccine is authorized for emergency use by the Food and Drug Administration for ages 5 years and older. The safety and tolerability profile of the Pfizer/BioNTech bivalent booster remains favorable and similar to the original COVID-19 vaccine, the company reported.

Until recently, the BA.5 Omicron variant was the dominant strain in the United States, but is now getting elbowed out by the subvariants BQ.1.1, BQ.1, and BA.4.6, which together make up almost 45% of the circulating virus.
 

Some skepticism

“It is important to note that these data are press-release level, which does not allow a view of the data totality,” Hana El Sahly, MD, professor of molecular virology and microbiology, Baylor College of Medicine, Houston, said in an interview.

“For example, there may be significant differences between the groups, and the release mentions at least one difference that is of importance: the interval since the last vaccination which often affects the response to subsequent boosting,” she said.

Dr. El Sahly added that the findings are not surprising. “In the short term, a variant-specific vaccine produces a higher level of antibody against the variant in the vaccine than the vaccines based on the ancestral strains.”

More researcher results are warranted. “These data do not indicate that these differences between the two vaccines translate into a meaningful clinical benefit at a population level,” Dr. El Sahly said.
 

An uncertain winter ahead

“As we head into the holiday season, we hope these updated data will encourage people to seek out a COVID-19 bivalent booster as soon as they are eligible in order to maintain high levels of protection against the widely circulating Omicron BA.4 and BA.5 sublineages,” Albert Bourla, Pfizer chairman and CEO, stated in the release.

The updated data from the Pfizer/BioNTech study are “all the more reason to get a booster, with added protection also versus BQ.1.1, which will soon become dominant in the U.S.,” Dr. Topol predicted.

It is unclear when the next surge will happen, as COVID-19 does not always follow a seasonal pattern, at least not yet, Dr. El Sahly said. “Regardless, it is reasonable to recommend additional vaccine doses to immunocompromised and frail or older persons. More importantly, influenza vaccination and being up to date on pneumococcal vaccines are highly recommended as soon as feasible, given the early and intense flu season.”

A version of this article first appeared on Medscape.com.

The COVID-19 bivalent Pfizer/BioNTech vaccine triggers a stronger immune response than a fourth dose of the original vaccine, the company reported on Nov. 4, supporting calls by public health officials for eligible people to get this booster before a potential COVID-19 surge this winter.

The company’s ongoing phase 2/3 study of their Omicron BA.4 and BA.5 bivalent – which targets both the virus’ original strain and the two subvariants – shows that the vaccine offered the strongest protection in people older than 55 years.

One month after receiving a 30-mcg booster with the bivalent vaccine, those older than 55 had four times more neutralizing antibodies against these Omicron subvariants, compared with people who received the original monovalent vaccine as a booster in the study.

Researchers compared the geometric mean titer (GMT) levels of these antibodies in three groups before and 1 month after boosting. The 36 people older than 55 years in the released study findings had an GMT level of 896 with the bivalent booster, a level 13 times higher than before this immunization.

For the 38 adults ages 18-55 in the study, the GMT level increased to 606 at 1 month after the bivalent booster, an increase of almost 10-fold, compared with baseline. In a comparator group of 40 people receiving the original vaccine as a fourth dose, the GMT level was 236, or threefold higher than before their booster shot.

The newly released data is “very encouraging and consistent now with three studies all showing a substantial 3-4 fold increased level of neutralizing antibodies versus BA.5 as compared with the original booster,” said Eric Topol, MD, director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape Medical News.

Pfizer and BioNTech announced the updated findings in a Nov. 4 press release.

A booster dose of the BA.4/BA.5-adapted bivalent vaccine is authorized for emergency use by the Food and Drug Administration for ages 5 years and older. The safety and tolerability profile of the Pfizer/BioNTech bivalent booster remains favorable and similar to the original COVID-19 vaccine, the company reported.

Until recently, the BA.5 Omicron variant was the dominant strain in the United States, but is now getting elbowed out by the subvariants BQ.1.1, BQ.1, and BA.4.6, which together make up almost 45% of the circulating virus.
 

Some skepticism

“It is important to note that these data are press-release level, which does not allow a view of the data totality,” Hana El Sahly, MD, professor of molecular virology and microbiology, Baylor College of Medicine, Houston, said in an interview.

“For example, there may be significant differences between the groups, and the release mentions at least one difference that is of importance: the interval since the last vaccination which often affects the response to subsequent boosting,” she said.

Dr. El Sahly added that the findings are not surprising. “In the short term, a variant-specific vaccine produces a higher level of antibody against the variant in the vaccine than the vaccines based on the ancestral strains.”

More researcher results are warranted. “These data do not indicate that these differences between the two vaccines translate into a meaningful clinical benefit at a population level,” Dr. El Sahly said.
 

An uncertain winter ahead

“As we head into the holiday season, we hope these updated data will encourage people to seek out a COVID-19 bivalent booster as soon as they are eligible in order to maintain high levels of protection against the widely circulating Omicron BA.4 and BA.5 sublineages,” Albert Bourla, Pfizer chairman and CEO, stated in the release.

The updated data from the Pfizer/BioNTech study are “all the more reason to get a booster, with added protection also versus BQ.1.1, which will soon become dominant in the U.S.,” Dr. Topol predicted.

It is unclear when the next surge will happen, as COVID-19 does not always follow a seasonal pattern, at least not yet, Dr. El Sahly said. “Regardless, it is reasonable to recommend additional vaccine doses to immunocompromised and frail or older persons. More importantly, influenza vaccination and being up to date on pneumococcal vaccines are highly recommended as soon as feasible, given the early and intense flu season.”

A version of this article first appeared on Medscape.com.