Vaccines

New trial data from drugmaker Pfizer shows promising results of a vaccine given to mothers during pregnancy that later protects infants in their first months from the worst effects of respiratory syncytial virus, or RSV.

Pfizer will apply for FDA approval by the end of the year, the company said in a statement Nov. 1.

Trial results are so promising that – after talking with government regulators – the company will stop enrolling new people in the study.

Specifically, the company reported that the vaccine prevented severe illness particularly well during the first 90 days of life, with measurable protection against severe illness continuing through 6 months of age. (That period is when infants are the most fragile if they get sick with RSV.)

RSV is a respiratory illness than can affect anyone, usually resulting in no symptoms or those similar to the common cold. But it can be particularly dangerous – and even deadly – for babies and for people over the age of 65. Pfizer and another drug company, GSK, are developing promising vaccines for older adults, the Washington Post reported.

RSV is the leading cause of hospitalization for infants, the Post noted.

The Pfizer study, called MATISSE, enrolled 7,400 pregnant women in 18 countries worldwide. Those who received the vaccine were given it during the late second to third trimester of pregnancy. Women in the study were monitored for safety through the rest of their pregnancy and 6 months after their children were born. Infants were monitored for at least 1 year for safety and effectiveness; more than half of them were monitored for 2 years.

The Pfizer vaccine works by passing maternal antibodies to the infant during pregnancy, the Post reported, noting that other vaccines transmitted via maternal immunization include those for influenza, diphtheria, tetanus, and pertussis.

Annually, RSV has a devastating impact on young children, hospitalizing tens of thousands and causing up to 300 deaths, data show.

For every 100 children who get RSV under 6 months of age, one or two of them may need to be hospitalized, according to the CDC. Those hospitalized infants may need oxygen, intubation, or even mechanical ventilation to help with breathing.

“Most improve with this type of supportive care and are discharged in a few days,” the CDC said.

“I think this is a big step for protecting babies against RSV and improving overall lung health,” vaccine researcher Barney Graham, PhD, told the Post. “Overall, it’s an exciting time for RSV. It’s also a troubling time, because you see how the patterns of infection have been changed by COVID, and we’re having an earlier, bigger season this year than we have for a couple of years – and it’s causing a lot of hospitalization and misery for people.”

As many as four RSV vaccines may have applications submitted to the FDA in 2022, according to CNN. Also in development is an antibody shot given to infants just after they are born, the news outlet reported.

Pfizer’s data, announced Tuesday, has not yet been published or peer-reviewed, but the company said it is seeking peer-reviewed publication.

“We are thrilled by these data, as this is the first-ever investigational vaccine shown to help protect newborns against severe RSV-related respiratory illness immediately at birth,” Annaliesa Anderson, PhD, Pfizer chief scientific officer for vaccine research & development, said in a statement. “We look forward to working with the FDA and other regulatory agencies to bring this vaccine candidate to expectant mothers to help protect their infants against severe RSV during their most vulnerable first six months of life, which has the highest burden of RSV illness in infants.”

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

New trial data from drugmaker Pfizer shows promising results of a vaccine given to mothers during pregnancy that later protects infants in their first months from the worst effects of respiratory syncytial virus, or RSV.

Pfizer will apply for FDA approval by the end of the year, the company said in a statement Nov. 1.

Trial results are so promising that – after talking with government regulators – the company will stop enrolling new people in the study.

Specifically, the company reported that the vaccine prevented severe illness particularly well during the first 90 days of life, with measurable protection against severe illness continuing through 6 months of age. (That period is when infants are the most fragile if they get sick with RSV.)

RSV is a respiratory illness than can affect anyone, usually resulting in no symptoms or those similar to the common cold. But it can be particularly dangerous – and even deadly – for babies and for people over the age of 65. Pfizer and another drug company, GSK, are developing promising vaccines for older adults, the Washington Post reported.

RSV is the leading cause of hospitalization for infants, the Post noted.

The Pfizer study, called MATISSE, enrolled 7,400 pregnant women in 18 countries worldwide. Those who received the vaccine were given it during the late second to third trimester of pregnancy. Women in the study were monitored for safety through the rest of their pregnancy and 6 months after their children were born. Infants were monitored for at least 1 year for safety and effectiveness; more than half of them were monitored for 2 years.

The Pfizer vaccine works by passing maternal antibodies to the infant during pregnancy, the Post reported, noting that other vaccines transmitted via maternal immunization include those for influenza, diphtheria, tetanus, and pertussis.

Annually, RSV has a devastating impact on young children, hospitalizing tens of thousands and causing up to 300 deaths, data show.

For every 100 children who get RSV under 6 months of age, one or two of them may need to be hospitalized, according to the CDC. Those hospitalized infants may need oxygen, intubation, or even mechanical ventilation to help with breathing.

“Most improve with this type of supportive care and are discharged in a few days,” the CDC said.

“I think this is a big step for protecting babies against RSV and improving overall lung health,” vaccine researcher Barney Graham, PhD, told the Post. “Overall, it’s an exciting time for RSV. It’s also a troubling time, because you see how the patterns of infection have been changed by COVID, and we’re having an earlier, bigger season this year than we have for a couple of years – and it’s causing a lot of hospitalization and misery for people.”

As many as four RSV vaccines may have applications submitted to the FDA in 2022, according to CNN. Also in development is an antibody shot given to infants just after they are born, the news outlet reported.

Pfizer’s data, announced Tuesday, has not yet been published or peer-reviewed, but the company said it is seeking peer-reviewed publication.

“We are thrilled by these data, as this is the first-ever investigational vaccine shown to help protect newborns against severe RSV-related respiratory illness immediately at birth,” Annaliesa Anderson, PhD, Pfizer chief scientific officer for vaccine research & development, said in a statement. “We look forward to working with the FDA and other regulatory agencies to bring this vaccine candidate to expectant mothers to help protect their infants against severe RSV during their most vulnerable first six months of life, which has the highest burden of RSV illness in infants.”

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

New trial data from drugmaker Pfizer shows promising results of a vaccine given to mothers during pregnancy that later protects infants in their first months from the worst effects of respiratory syncytial virus, or RSV.

Pfizer will apply for FDA approval by the end of the year, the company said in a statement Nov. 1.

Trial results are so promising that – after talking with government regulators – the company will stop enrolling new people in the study.

Specifically, the company reported that the vaccine prevented severe illness particularly well during the first 90 days of life, with measurable protection against severe illness continuing through 6 months of age. (That period is when infants are the most fragile if they get sick with RSV.)

RSV is a respiratory illness than can affect anyone, usually resulting in no symptoms or those similar to the common cold. But it can be particularly dangerous – and even deadly – for babies and for people over the age of 65. Pfizer and another drug company, GSK, are developing promising vaccines for older adults, the Washington Post reported.

RSV is the leading cause of hospitalization for infants, the Post noted.

The Pfizer study, called MATISSE, enrolled 7,400 pregnant women in 18 countries worldwide. Those who received the vaccine were given it during the late second to third trimester of pregnancy. Women in the study were monitored for safety through the rest of their pregnancy and 6 months after their children were born. Infants were monitored for at least 1 year for safety and effectiveness; more than half of them were monitored for 2 years.

The Pfizer vaccine works by passing maternal antibodies to the infant during pregnancy, the Post reported, noting that other vaccines transmitted via maternal immunization include those for influenza, diphtheria, tetanus, and pertussis.

Annually, RSV has a devastating impact on young children, hospitalizing tens of thousands and causing up to 300 deaths, data show.

For every 100 children who get RSV under 6 months of age, one or two of them may need to be hospitalized, according to the CDC. Those hospitalized infants may need oxygen, intubation, or even mechanical ventilation to help with breathing.

“Most improve with this type of supportive care and are discharged in a few days,” the CDC said.

“I think this is a big step for protecting babies against RSV and improving overall lung health,” vaccine researcher Barney Graham, PhD, told the Post. “Overall, it’s an exciting time for RSV. It’s also a troubling time, because you see how the patterns of infection have been changed by COVID, and we’re having an earlier, bigger season this year than we have for a couple of years – and it’s causing a lot of hospitalization and misery for people.”

As many as four RSV vaccines may have applications submitted to the FDA in 2022, according to CNN. Also in development is an antibody shot given to infants just after they are born, the news outlet reported.

Pfizer’s data, announced Tuesday, has not yet been published or peer-reviewed, but the company said it is seeking peer-reviewed publication.

“We are thrilled by these data, as this is the first-ever investigational vaccine shown to help protect newborns against severe RSV-related respiratory illness immediately at birth,” Annaliesa Anderson, PhD, Pfizer chief scientific officer for vaccine research & development, said in a statement. “We look forward to working with the FDA and other regulatory agencies to bring this vaccine candidate to expectant mothers to help protect their infants against severe RSV during their most vulnerable first six months of life, which has the highest burden of RSV illness in infants.”

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

The liquid form of the antibiotic amoxicillin often used to treat ear infections and strep throat in children is in short supply, just as Americans head into the season when they use the bacteria-fighting drug the most.

The FDA officially listed the shortage Oct. 28, but pharmacists, hospitals, and a supply tracking database sounded alarms earlier this month.

“The scary part is, we’re coming into the time of the year where you have the greatest need,” independent pharmacy owner Hugh Chancy, PharmD, of Georgia, told NBC News. 

Thus far, reports indicate the impact of the shortages is not widespread but does affect some pharmacies, and at least one hospital has published an algorithm for offering treatment alternatives. 

CVS told Bloomberg News that some stores are experiencing shortages of certain doses of amoxicillin, but a Walmart spokesperson said its diverse supply chain meant none of its pharmacies were affected.

“Hypothetically, if amoxicillin doesn’t come into stock for some time, then we’re potentially having to use less effective antibiotics with more side effects,” said Ohio pediatrician Sean Gallagher, MD, according to Bloomberg.

The shortage impacts three of the four largest amoxicillin manufacturers worldwide, according to the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota. The FDA listed the reason for the shortage as “demand increase for drug,” except in the case of manufacturer Sandoz, for which the reason listed read “information pending.”

A company spokesperson told Bloomberg the reasons were complex.

“The combination in rapid succession of the pandemic impact and consequent demand swings, manufacturing capacity constraints, scarcity of raw materials, and the current energy crisis means we face a uniquely difficult situation in the short term,” Sandoz spokesperson Leslie Pott told Bloomberg.

According to Bloomberg, other major manufacturers are still delivering the product, but limiting new orders.

The American Society of Health-System Pharmacists issued an alert for the shortage last week via its real time drug shortage database.

“Amoxicillin comes in many forms – including capsules, powders and chewable tablets – but the most common type children take is the liquid form, which makes up at least 19 products that are part of the” shortage, Becker’s Hospital Review summarized of the database reports.

The pediatric health system Children’s Minnesota told CIDRAP that supplies are low and that alternatives are being prescribed “when appropriate.”

“As a final step, we temporarily discontinued our standard procedure of dispensing the entire bottle of amoxicillin (which comes in multiple sizes),” a spokesperson told CIDRAP. “We are instead mixing and pouring the exact amount for each course of therapy, to eliminate waste.” 

The Minnesota pediatric clinic and others are particularly on alert because of the surge nationwide of a respiratory virus that particularly impacts children known as RSV.

“We have certainly observed an increase in recent use most likely correlating with the surge in RSV and other respiratory viruses with concern for superimposed bacterial infection in our critically ill and hospitalized patient population,” Laura Bio, PharmD, a clinical pharmacy specialist at Stanford Medicine Children’s Health told CIDRAP.

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

The liquid form of the antibiotic amoxicillin often used to treat ear infections and strep throat in children is in short supply, just as Americans head into the season when they use the bacteria-fighting drug the most.

The FDA officially listed the shortage Oct. 28, but pharmacists, hospitals, and a supply tracking database sounded alarms earlier this month.

“The scary part is, we’re coming into the time of the year where you have the greatest need,” independent pharmacy owner Hugh Chancy, PharmD, of Georgia, told NBC News. 

Thus far, reports indicate the impact of the shortages is not widespread but does affect some pharmacies, and at least one hospital has published an algorithm for offering treatment alternatives. 

CVS told Bloomberg News that some stores are experiencing shortages of certain doses of amoxicillin, but a Walmart spokesperson said its diverse supply chain meant none of its pharmacies were affected.

“Hypothetically, if amoxicillin doesn’t come into stock for some time, then we’re potentially having to use less effective antibiotics with more side effects,” said Ohio pediatrician Sean Gallagher, MD, according to Bloomberg.

The shortage impacts three of the four largest amoxicillin manufacturers worldwide, according to the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota. The FDA listed the reason for the shortage as “demand increase for drug,” except in the case of manufacturer Sandoz, for which the reason listed read “information pending.”

A company spokesperson told Bloomberg the reasons were complex.

“The combination in rapid succession of the pandemic impact and consequent demand swings, manufacturing capacity constraints, scarcity of raw materials, and the current energy crisis means we face a uniquely difficult situation in the short term,” Sandoz spokesperson Leslie Pott told Bloomberg.

According to Bloomberg, other major manufacturers are still delivering the product, but limiting new orders.

The American Society of Health-System Pharmacists issued an alert for the shortage last week via its real time drug shortage database.

“Amoxicillin comes in many forms – including capsules, powders and chewable tablets – but the most common type children take is the liquid form, which makes up at least 19 products that are part of the” shortage, Becker’s Hospital Review summarized of the database reports.

The pediatric health system Children’s Minnesota told CIDRAP that supplies are low and that alternatives are being prescribed “when appropriate.”

“As a final step, we temporarily discontinued our standard procedure of dispensing the entire bottle of amoxicillin (which comes in multiple sizes),” a spokesperson told CIDRAP. “We are instead mixing and pouring the exact amount for each course of therapy, to eliminate waste.” 

The Minnesota pediatric clinic and others are particularly on alert because of the surge nationwide of a respiratory virus that particularly impacts children known as RSV.

“We have certainly observed an increase in recent use most likely correlating with the surge in RSV and other respiratory viruses with concern for superimposed bacterial infection in our critically ill and hospitalized patient population,” Laura Bio, PharmD, a clinical pharmacy specialist at Stanford Medicine Children’s Health told CIDRAP.

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

The liquid form of the antibiotic amoxicillin often used to treat ear infections and strep throat in children is in short supply, just as Americans head into the season when they use the bacteria-fighting drug the most.

The FDA officially listed the shortage Oct. 28, but pharmacists, hospitals, and a supply tracking database sounded alarms earlier this month.

“The scary part is, we’re coming into the time of the year where you have the greatest need,” independent pharmacy owner Hugh Chancy, PharmD, of Georgia, told NBC News. 

Thus far, reports indicate the impact of the shortages is not widespread but does affect some pharmacies, and at least one hospital has published an algorithm for offering treatment alternatives. 

CVS told Bloomberg News that some stores are experiencing shortages of certain doses of amoxicillin, but a Walmart spokesperson said its diverse supply chain meant none of its pharmacies were affected.

“Hypothetically, if amoxicillin doesn’t come into stock for some time, then we’re potentially having to use less effective antibiotics with more side effects,” said Ohio pediatrician Sean Gallagher, MD, according to Bloomberg.

The shortage impacts three of the four largest amoxicillin manufacturers worldwide, according to the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota. The FDA listed the reason for the shortage as “demand increase for drug,” except in the case of manufacturer Sandoz, for which the reason listed read “information pending.”

A company spokesperson told Bloomberg the reasons were complex.

“The combination in rapid succession of the pandemic impact and consequent demand swings, manufacturing capacity constraints, scarcity of raw materials, and the current energy crisis means we face a uniquely difficult situation in the short term,” Sandoz spokesperson Leslie Pott told Bloomberg.

According to Bloomberg, other major manufacturers are still delivering the product, but limiting new orders.

The American Society of Health-System Pharmacists issued an alert for the shortage last week via its real time drug shortage database.

“Amoxicillin comes in many forms – including capsules, powders and chewable tablets – but the most common type children take is the liquid form, which makes up at least 19 products that are part of the” shortage, Becker’s Hospital Review summarized of the database reports.

The pediatric health system Children’s Minnesota told CIDRAP that supplies are low and that alternatives are being prescribed “when appropriate.”

“As a final step, we temporarily discontinued our standard procedure of dispensing the entire bottle of amoxicillin (which comes in multiple sizes),” a spokesperson told CIDRAP. “We are instead mixing and pouring the exact amount for each course of therapy, to eliminate waste.” 

The Minnesota pediatric clinic and others are particularly on alert because of the surge nationwide of a respiratory virus that particularly impacts children known as RSV.

“We have certainly observed an increase in recent use most likely correlating with the surge in RSV and other respiratory viruses with concern for superimposed bacterial infection in our critically ill and hospitalized patient population,” Laura Bio, PharmD, a clinical pharmacy specialist at Stanford Medicine Children’s Health told CIDRAP.

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

The effectiveness of up to three doses of COVID-19 vaccine was moderate overall and significantly lower among individuals with immunocompromising conditions, compared with the general population during the period of Omicron dominance, according to an analysis of data from more than 34,000 hospitalizations.

Previous studies have suggested lower COVID-19 vaccine effectiveness among immunocompromised individuals, compared with healthy individuals from the general population, but data from the period in which Omicron subvariants have been dominant are limited, wrote Amadea Britton, MD, of the Centers for Disease Control and Prevention’s COVID-19 Emergency Response Team, and colleagues.

The CDC currently recommends an expanded primary vaccine series of three doses of an mRNA vaccine, and the Advisory Committee on Immunization Practices has recommended a fourth dose with the new bivalent booster that contains elements of the Omicron variant, the researchers noted.

In a study published in the CDC’s Morbidity and Mortality Weekly Report, the researchers identified 34,220 adults with immunocompromising conditions who were hospitalized for COVID-19–like illness between Dec. 16, 2021, and Aug. 20, 2022. These conditions included solid malignancy (40.5%), hematologic malignancy (14.6%), rheumatologic or inflammatory disorder (24.4%), other intrinsic immune condition or immunodeficiency (38.5%), or organ or stem cell transplant (8.6%). They used data from the CDC’s VISION Network, a multistate database. The data include spring and summer 2022, when the BA.4 and BA.5 Omicron subvariants dominated other strains, and adults with immunocompromising conditions were eligible for a total of four vaccine doses (two primary doses and two boosters). The median age of the study population was 69 years, and 25.7%, 41.7%, and 7.0% had received two, three, and four doses, respectively, of COVID-19 vaccine.

Overall, vaccine effectiveness (VE) among immunocompromised patients was 34% after two vaccine doses, increasing to 71% during days 7-89 after a third dose, then declining to 41% 90 days or more after that dose.

During the full Omicron period, VE was 36% for 14 or more days after dose two, 69% for 7-89 days after dose three, and 44% for 90 or more days after dose three.

When VE was stratified by sublineage period, VE was higher 7 or more days after dose three during the predominance of BA.1 (67%), compared with VE during the dominant periods of BA.2/BA.2.12.1 (32%) and BA.4/BA.5 (35%).

In the later periods when Omicron BA.2/BA.2.12.1 and BA.4/BA.5 variants dominated, and individuals who had received three doses of vaccine were eligible for a fourth, VE against these variants was 32% 90 or more days after dose three and 43% 7 or more days after dose four.

VE was lowest among individuals with potentially more severe immunocompromising conditions, notably solid organ or stem cell transplants, the researchers wrote in their discussion.

The study findings were limited by several factors including the use of ICD-9 and -10 discharge diagnosis codes for immunocompromising conditions, potential confounding in VE models, lack of data on outpatient treatments such as nirmatelvir/ritonavir (Paxlovid), and lack of COVID-19 genomic sequencing data that may have affected which sublineage was identified, the researchers noted.

However, “this study confirms that even with boosters, immunocompromised adults, because of their weakened immune systems, are still at high risk of moderate to severe COVID,” said coauthor Brian Dixon, PhD, of the Regenstrief Institute and Indiana University Richard M. Fairbanks School of Public Health, Indianapolis, in a press release about the study.

“Given the incomplete protection against hospitalization afforded by monovalent COVID-19 vaccines, persons with immunocompromising conditions might benefit from updated bivalent vaccine booster doses that target recently circulating Omicron sublineages, in line with ACIP [Advisory Committee on Immunization Practices] recommendations,” the researchers concluded in the study.

The study was funded by the CDC. The researchers had no financial conflicts to disclose. The VISION Network is a collaboration between the CDC, the Regenstrief Institute, and seven health care systems across the United States: Columbia University Irving Medical Center (New York), HealthPartners (Wisconsin), Intermountain Healthcare (Utah), Kaiser Permanente Northern California, Kaiser Permanente Northwest (Washington State), the University of Colorado, and Paso Del Norte Health Information Exchange (Texas).

The effectiveness of up to three doses of COVID-19 vaccine was moderate overall and significantly lower among individuals with immunocompromising conditions, compared with the general population during the period of Omicron dominance, according to an analysis of data from more than 34,000 hospitalizations.

Previous studies have suggested lower COVID-19 vaccine effectiveness among immunocompromised individuals, compared with healthy individuals from the general population, but data from the period in which Omicron subvariants have been dominant are limited, wrote Amadea Britton, MD, of the Centers for Disease Control and Prevention’s COVID-19 Emergency Response Team, and colleagues.

The CDC currently recommends an expanded primary vaccine series of three doses of an mRNA vaccine, and the Advisory Committee on Immunization Practices has recommended a fourth dose with the new bivalent booster that contains elements of the Omicron variant, the researchers noted.

In a study published in the CDC’s Morbidity and Mortality Weekly Report, the researchers identified 34,220 adults with immunocompromising conditions who were hospitalized for COVID-19–like illness between Dec. 16, 2021, and Aug. 20, 2022. These conditions included solid malignancy (40.5%), hematologic malignancy (14.6%), rheumatologic or inflammatory disorder (24.4%), other intrinsic immune condition or immunodeficiency (38.5%), or organ or stem cell transplant (8.6%). They used data from the CDC’s VISION Network, a multistate database. The data include spring and summer 2022, when the BA.4 and BA.5 Omicron subvariants dominated other strains, and adults with immunocompromising conditions were eligible for a total of four vaccine doses (two primary doses and two boosters). The median age of the study population was 69 years, and 25.7%, 41.7%, and 7.0% had received two, three, and four doses, respectively, of COVID-19 vaccine.

Overall, vaccine effectiveness (VE) among immunocompromised patients was 34% after two vaccine doses, increasing to 71% during days 7-89 after a third dose, then declining to 41% 90 days or more after that dose.

During the full Omicron period, VE was 36% for 14 or more days after dose two, 69% for 7-89 days after dose three, and 44% for 90 or more days after dose three.

When VE was stratified by sublineage period, VE was higher 7 or more days after dose three during the predominance of BA.1 (67%), compared with VE during the dominant periods of BA.2/BA.2.12.1 (32%) and BA.4/BA.5 (35%).

In the later periods when Omicron BA.2/BA.2.12.1 and BA.4/BA.5 variants dominated, and individuals who had received three doses of vaccine were eligible for a fourth, VE against these variants was 32% 90 or more days after dose three and 43% 7 or more days after dose four.

VE was lowest among individuals with potentially more severe immunocompromising conditions, notably solid organ or stem cell transplants, the researchers wrote in their discussion.

The study findings were limited by several factors including the use of ICD-9 and -10 discharge diagnosis codes for immunocompromising conditions, potential confounding in VE models, lack of data on outpatient treatments such as nirmatelvir/ritonavir (Paxlovid), and lack of COVID-19 genomic sequencing data that may have affected which sublineage was identified, the researchers noted.

However, “this study confirms that even with boosters, immunocompromised adults, because of their weakened immune systems, are still at high risk of moderate to severe COVID,” said coauthor Brian Dixon, PhD, of the Regenstrief Institute and Indiana University Richard M. Fairbanks School of Public Health, Indianapolis, in a press release about the study.

“Given the incomplete protection against hospitalization afforded by monovalent COVID-19 vaccines, persons with immunocompromising conditions might benefit from updated bivalent vaccine booster doses that target recently circulating Omicron sublineages, in line with ACIP [Advisory Committee on Immunization Practices] recommendations,” the researchers concluded in the study.

The study was funded by the CDC. The researchers had no financial conflicts to disclose. The VISION Network is a collaboration between the CDC, the Regenstrief Institute, and seven health care systems across the United States: Columbia University Irving Medical Center (New York), HealthPartners (Wisconsin), Intermountain Healthcare (Utah), Kaiser Permanente Northern California, Kaiser Permanente Northwest (Washington State), the University of Colorado, and Paso Del Norte Health Information Exchange (Texas).

The effectiveness of up to three doses of COVID-19 vaccine was moderate overall and significantly lower among individuals with immunocompromising conditions, compared with the general population during the period of Omicron dominance, according to an analysis of data from more than 34,000 hospitalizations.

Previous studies have suggested lower COVID-19 vaccine effectiveness among immunocompromised individuals, compared with healthy individuals from the general population, but data from the period in which Omicron subvariants have been dominant are limited, wrote Amadea Britton, MD, of the Centers for Disease Control and Prevention’s COVID-19 Emergency Response Team, and colleagues.

The CDC currently recommends an expanded primary vaccine series of three doses of an mRNA vaccine, and the Advisory Committee on Immunization Practices has recommended a fourth dose with the new bivalent booster that contains elements of the Omicron variant, the researchers noted.

In a study published in the CDC’s Morbidity and Mortality Weekly Report, the researchers identified 34,220 adults with immunocompromising conditions who were hospitalized for COVID-19–like illness between Dec. 16, 2021, and Aug. 20, 2022. These conditions included solid malignancy (40.5%), hematologic malignancy (14.6%), rheumatologic or inflammatory disorder (24.4%), other intrinsic immune condition or immunodeficiency (38.5%), or organ or stem cell transplant (8.6%). They used data from the CDC’s VISION Network, a multistate database. The data include spring and summer 2022, when the BA.4 and BA.5 Omicron subvariants dominated other strains, and adults with immunocompromising conditions were eligible for a total of four vaccine doses (two primary doses and two boosters). The median age of the study population was 69 years, and 25.7%, 41.7%, and 7.0% had received two, three, and four doses, respectively, of COVID-19 vaccine.

Overall, vaccine effectiveness (VE) among immunocompromised patients was 34% after two vaccine doses, increasing to 71% during days 7-89 after a third dose, then declining to 41% 90 days or more after that dose.

During the full Omicron period, VE was 36% for 14 or more days after dose two, 69% for 7-89 days after dose three, and 44% for 90 or more days after dose three.

When VE was stratified by sublineage period, VE was higher 7 or more days after dose three during the predominance of BA.1 (67%), compared with VE during the dominant periods of BA.2/BA.2.12.1 (32%) and BA.4/BA.5 (35%).

In the later periods when Omicron BA.2/BA.2.12.1 and BA.4/BA.5 variants dominated, and individuals who had received three doses of vaccine were eligible for a fourth, VE against these variants was 32% 90 or more days after dose three and 43% 7 or more days after dose four.

VE was lowest among individuals with potentially more severe immunocompromising conditions, notably solid organ or stem cell transplants, the researchers wrote in their discussion.

The study findings were limited by several factors including the use of ICD-9 and -10 discharge diagnosis codes for immunocompromising conditions, potential confounding in VE models, lack of data on outpatient treatments such as nirmatelvir/ritonavir (Paxlovid), and lack of COVID-19 genomic sequencing data that may have affected which sublineage was identified, the researchers noted.

However, “this study confirms that even with boosters, immunocompromised adults, because of their weakened immune systems, are still at high risk of moderate to severe COVID,” said coauthor Brian Dixon, PhD, of the Regenstrief Institute and Indiana University Richard M. Fairbanks School of Public Health, Indianapolis, in a press release about the study.

“Given the incomplete protection against hospitalization afforded by monovalent COVID-19 vaccines, persons with immunocompromising conditions might benefit from updated bivalent vaccine booster doses that target recently circulating Omicron sublineages, in line with ACIP [Advisory Committee on Immunization Practices] recommendations,” the researchers concluded in the study.

The study was funded by the CDC. The researchers had no financial conflicts to disclose. The VISION Network is a collaboration between the CDC, the Regenstrief Institute, and seven health care systems across the United States: Columbia University Irving Medical Center (New York), HealthPartners (Wisconsin), Intermountain Healthcare (Utah), Kaiser Permanente Northern California, Kaiser Permanente Northwest (Washington State), the University of Colorado, and Paso Del Norte Health Information Exchange (Texas).

If you had fever, chills, nausea, or other common side effects to the Pfizer/BioNTech and Moderna COVID-19 vaccines, that’s good news.

It means your body had a greater antibody response than people who had just a little pain or rash at the injection site, or no reaction at all.

That’s according to new research published in the journal JAMA Network Open .

“These findings support reframing postvaccination symptoms as signals of vaccine effectiveness and reinforce guidelines for vaccine boosters in older adults,” researchers from Columbia University in New York, the University of Vermont, and Boston University wrote.

The vaccines provided strong protection regardless of the level of reaction, researchers said. Almost all the study’s 928 adult participants had a positive antibody response after receiving two doses of vaccine.

“I don’t want a patient to tell me that, ‘Golly, I didn’t get any reaction, my arm wasn’t sore, I didn’t have fever. The vaccine didn’t work.’ I don’t want that conclusion to be out there,” William Schaffner, MD, a professor in the division of infectious diseases at Vanderbilt University Medical Center, Nashville, Tenn., told CNN.

“This is more to reassure people who have had a reaction that that’s their immune system responding, actually in a rather good way, to the vaccine, even though it has caused them some discomfort,” said Dr. Schaffner, who was not involved in the study.

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

If you had fever, chills, nausea, or other common side effects to the Pfizer/BioNTech and Moderna COVID-19 vaccines, that’s good news.

It means your body had a greater antibody response than people who had just a little pain or rash at the injection site, or no reaction at all.

That’s according to new research published in the journal JAMA Network Open .

“These findings support reframing postvaccination symptoms as signals of vaccine effectiveness and reinforce guidelines for vaccine boosters in older adults,” researchers from Columbia University in New York, the University of Vermont, and Boston University wrote.

The vaccines provided strong protection regardless of the level of reaction, researchers said. Almost all the study’s 928 adult participants had a positive antibody response after receiving two doses of vaccine.

“I don’t want a patient to tell me that, ‘Golly, I didn’t get any reaction, my arm wasn’t sore, I didn’t have fever. The vaccine didn’t work.’ I don’t want that conclusion to be out there,” William Schaffner, MD, a professor in the division of infectious diseases at Vanderbilt University Medical Center, Nashville, Tenn., told CNN.

“This is more to reassure people who have had a reaction that that’s their immune system responding, actually in a rather good way, to the vaccine, even though it has caused them some discomfort,” said Dr. Schaffner, who was not involved in the study.

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

If you had fever, chills, nausea, or other common side effects to the Pfizer/BioNTech and Moderna COVID-19 vaccines, that’s good news.

It means your body had a greater antibody response than people who had just a little pain or rash at the injection site, or no reaction at all.

That’s according to new research published in the journal JAMA Network Open .

“These findings support reframing postvaccination symptoms as signals of vaccine effectiveness and reinforce guidelines for vaccine boosters in older adults,” researchers from Columbia University in New York, the University of Vermont, and Boston University wrote.

The vaccines provided strong protection regardless of the level of reaction, researchers said. Almost all the study’s 928 adult participants had a positive antibody response after receiving two doses of vaccine.

“I don’t want a patient to tell me that, ‘Golly, I didn’t get any reaction, my arm wasn’t sore, I didn’t have fever. The vaccine didn’t work.’ I don’t want that conclusion to be out there,” William Schaffner, MD, a professor in the division of infectious diseases at Vanderbilt University Medical Center, Nashville, Tenn., told CNN.

“This is more to reassure people who have had a reaction that that’s their immune system responding, actually in a rather good way, to the vaccine, even though it has caused them some discomfort,” said Dr. Schaffner, who was not involved in the study.

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

WASHINGTON – The updated Moderna bivalent COVID-19 vaccine that targets the original virus and the Omicron variant was superior to the original COVID booster in adults aged 18 and older, new results indicate.

The bivalent booster was superior regardless of age and whether a person had previously been infected with SARS-CoV-2.

Additionally, no new safety concerns emerged.

Spyros Chalkias, MD, senior medical director of clinical development at Moderna, presented the data during an annual scientific meeting on infectious diseases.

In the phase 2/3 trial, participants received either 50 mcg of the bivalent vaccine mRNA-1273.214 (25 mcg each of the original Wuhan-Hu-1 and Omicron BA.1 spike mRNAs) or 50 mcg of the standard authorized mRNA-1273. The doses were given as second boosters in adults who had previously received a two-dose primary series and a first booster at least 3 months before.

The model-based geometric mean titers (GMTs) ratio of the enhanced booster compared with the standard booster was 1.74 (1.49-2.04), meeting the prespecified bar for superiority against Omicron BA.1.

In participants without prior SARS-CoV-2 infection who received updated booster doses and those who received standard boosters, the neutralizing antibody GMTs against Omicron BA.1 were 2372.4 and 1473.5, respectively.

Additionally, the updated booster elicited higher GMTs (727.4) than the standard booster (492.1) against Omicron subvariants BA.4/BA.5. Safety and reactogenicity were similar for both vaccine groups.

“By the end of this year, we expect to also have clinical trial data from our BA.4/BA.5 bivalent booster,” Dr. Chalkias said.

In the interim, the U.S. Food and Drug Administration recently granted emergency use authorization for Moderna’s BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine in children and adolescents aged 6-17 years.

Pfizer/BioNTech also has recently issued an announcement that their COVID-19 booster, adapted for the BA.4 and the BA.5 Omicron subvariants, generated a strong immune response and was well tolerated in human tests.

Pfizer/BioNTech said data from roughly 80 adult patients showed that the booster led to a substantial increase in neutralizing antibody levels against the BA.4/BA.5 variants after 1 week.
 

Separate study of causes of severe breakthrough infections in early vaccine formulations

Though COVID vaccines reduce the incidence of severe outcomes, there are reports of breakthrough infections in persons who received the original vaccines, and some of these have been serious.

In a separate study, also presented at the meeting, researchers led by first author Austin D. Vo, BS, with the VA Boston Healthcare System, used data collected from Dec. 15, 2020, through Feb. 28, 2022, in a U.S. veteran population to assess those at highest risk for severe disease despite vaccination.

Results of the large, nationwide retrospective study were simultaneously published in JAMA Network Open.

The primary outcome was development of severe COVID, defined as a hospitalization within 14 days of a confirmed positive SARS-CoV-2 test, receipt of supplemental oxygen, mechanical ventilation, or death within 28 days.

Among 110,760 participants with severe disease after primary vaccination, 13% (14,690) were hospitalized with severe COVID-19 or died.

The strongest risk factor for severe disease despite vaccination was age, the researchers found.

Presenting author Westyn Branch-Elliman, MD, associate professor of medicine with VA Boston Healthcare System, said, “We found that age greater than 50 was associated with an adjusted odds ratio of 1.42 for every 5-year increase.”

To put that in perspective, she said, “compared to patients who are 45 to 50, those over 80 had an adjusted odds ratio of 16 for hospitalization or death following breakthrough infection.”

Priya Nori, MD, an infectious disease specialist at Montefiore Medical Center in New York, said in an interview that the evidence that age is a strong risk factor for severe disease – even after vaccination – confirms that attention should be focused on those in the highest age groups, particularly those 80 years and older.

Other top risk factors included having immunocompromising conditions; having received cytotoxic chemotherapy within 6 months (adjusted odds ratio, 2.69; 95% confidence interval, 2.25-3.21); having leukemias/lymphomas (aOR, 1.84; 95% CI, 1.59-2.14); and having chronic conditions associated with end-organ disease.

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

WASHINGTON – The updated Moderna bivalent COVID-19 vaccine that targets the original virus and the Omicron variant was superior to the original COVID booster in adults aged 18 and older, new results indicate.

The bivalent booster was superior regardless of age and whether a person had previously been infected with SARS-CoV-2.

Additionally, no new safety concerns emerged.

Spyros Chalkias, MD, senior medical director of clinical development at Moderna, presented the data during an annual scientific meeting on infectious diseases.

In the phase 2/3 trial, participants received either 50 mcg of the bivalent vaccine mRNA-1273.214 (25 mcg each of the original Wuhan-Hu-1 and Omicron BA.1 spike mRNAs) or 50 mcg of the standard authorized mRNA-1273. The doses were given as second boosters in adults who had previously received a two-dose primary series and a first booster at least 3 months before.

The model-based geometric mean titers (GMTs) ratio of the enhanced booster compared with the standard booster was 1.74 (1.49-2.04), meeting the prespecified bar for superiority against Omicron BA.1.

In participants without prior SARS-CoV-2 infection who received updated booster doses and those who received standard boosters, the neutralizing antibody GMTs against Omicron BA.1 were 2372.4 and 1473.5, respectively.

Additionally, the updated booster elicited higher GMTs (727.4) than the standard booster (492.1) against Omicron subvariants BA.4/BA.5. Safety and reactogenicity were similar for both vaccine groups.

“By the end of this year, we expect to also have clinical trial data from our BA.4/BA.5 bivalent booster,” Dr. Chalkias said.

In the interim, the U.S. Food and Drug Administration recently granted emergency use authorization for Moderna’s BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine in children and adolescents aged 6-17 years.

Pfizer/BioNTech also has recently issued an announcement that their COVID-19 booster, adapted for the BA.4 and the BA.5 Omicron subvariants, generated a strong immune response and was well tolerated in human tests.

Pfizer/BioNTech said data from roughly 80 adult patients showed that the booster led to a substantial increase in neutralizing antibody levels against the BA.4/BA.5 variants after 1 week.
 

Separate study of causes of severe breakthrough infections in early vaccine formulations

Though COVID vaccines reduce the incidence of severe outcomes, there are reports of breakthrough infections in persons who received the original vaccines, and some of these have been serious.

In a separate study, also presented at the meeting, researchers led by first author Austin D. Vo, BS, with the VA Boston Healthcare System, used data collected from Dec. 15, 2020, through Feb. 28, 2022, in a U.S. veteran population to assess those at highest risk for severe disease despite vaccination.

Results of the large, nationwide retrospective study were simultaneously published in JAMA Network Open.

The primary outcome was development of severe COVID, defined as a hospitalization within 14 days of a confirmed positive SARS-CoV-2 test, receipt of supplemental oxygen, mechanical ventilation, or death within 28 days.

Among 110,760 participants with severe disease after primary vaccination, 13% (14,690) were hospitalized with severe COVID-19 or died.

The strongest risk factor for severe disease despite vaccination was age, the researchers found.

Presenting author Westyn Branch-Elliman, MD, associate professor of medicine with VA Boston Healthcare System, said, “We found that age greater than 50 was associated with an adjusted odds ratio of 1.42 for every 5-year increase.”

To put that in perspective, she said, “compared to patients who are 45 to 50, those over 80 had an adjusted odds ratio of 16 for hospitalization or death following breakthrough infection.”

Priya Nori, MD, an infectious disease specialist at Montefiore Medical Center in New York, said in an interview that the evidence that age is a strong risk factor for severe disease – even after vaccination – confirms that attention should be focused on those in the highest age groups, particularly those 80 years and older.

Other top risk factors included having immunocompromising conditions; having received cytotoxic chemotherapy within 6 months (adjusted odds ratio, 2.69; 95% confidence interval, 2.25-3.21); having leukemias/lymphomas (aOR, 1.84; 95% CI, 1.59-2.14); and having chronic conditions associated with end-organ disease.

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

WASHINGTON – The updated Moderna bivalent COVID-19 vaccine that targets the original virus and the Omicron variant was superior to the original COVID booster in adults aged 18 and older, new results indicate.

The bivalent booster was superior regardless of age and whether a person had previously been infected with SARS-CoV-2.

Additionally, no new safety concerns emerged.

Spyros Chalkias, MD, senior medical director of clinical development at Moderna, presented the data during an annual scientific meeting on infectious diseases.

In the phase 2/3 trial, participants received either 50 mcg of the bivalent vaccine mRNA-1273.214 (25 mcg each of the original Wuhan-Hu-1 and Omicron BA.1 spike mRNAs) or 50 mcg of the standard authorized mRNA-1273. The doses were given as second boosters in adults who had previously received a two-dose primary series and a first booster at least 3 months before.

The model-based geometric mean titers (GMTs) ratio of the enhanced booster compared with the standard booster was 1.74 (1.49-2.04), meeting the prespecified bar for superiority against Omicron BA.1.

In participants without prior SARS-CoV-2 infection who received updated booster doses and those who received standard boosters, the neutralizing antibody GMTs against Omicron BA.1 were 2372.4 and 1473.5, respectively.

Additionally, the updated booster elicited higher GMTs (727.4) than the standard booster (492.1) against Omicron subvariants BA.4/BA.5. Safety and reactogenicity were similar for both vaccine groups.

“By the end of this year, we expect to also have clinical trial data from our BA.4/BA.5 bivalent booster,” Dr. Chalkias said.

In the interim, the U.S. Food and Drug Administration recently granted emergency use authorization for Moderna’s BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine in children and adolescents aged 6-17 years.

Pfizer/BioNTech also has recently issued an announcement that their COVID-19 booster, adapted for the BA.4 and the BA.5 Omicron subvariants, generated a strong immune response and was well tolerated in human tests.

Pfizer/BioNTech said data from roughly 80 adult patients showed that the booster led to a substantial increase in neutralizing antibody levels against the BA.4/BA.5 variants after 1 week.
 

Separate study of causes of severe breakthrough infections in early vaccine formulations

Though COVID vaccines reduce the incidence of severe outcomes, there are reports of breakthrough infections in persons who received the original vaccines, and some of these have been serious.

In a separate study, also presented at the meeting, researchers led by first author Austin D. Vo, BS, with the VA Boston Healthcare System, used data collected from Dec. 15, 2020, through Feb. 28, 2022, in a U.S. veteran population to assess those at highest risk for severe disease despite vaccination.

Results of the large, nationwide retrospective study were simultaneously published in JAMA Network Open.

The primary outcome was development of severe COVID, defined as a hospitalization within 14 days of a confirmed positive SARS-CoV-2 test, receipt of supplemental oxygen, mechanical ventilation, or death within 28 days.

Among 110,760 participants with severe disease after primary vaccination, 13% (14,690) were hospitalized with severe COVID-19 or died.

The strongest risk factor for severe disease despite vaccination was age, the researchers found.

Presenting author Westyn Branch-Elliman, MD, associate professor of medicine with VA Boston Healthcare System, said, “We found that age greater than 50 was associated with an adjusted odds ratio of 1.42 for every 5-year increase.”

To put that in perspective, she said, “compared to patients who are 45 to 50, those over 80 had an adjusted odds ratio of 16 for hospitalization or death following breakthrough infection.”

Priya Nori, MD, an infectious disease specialist at Montefiore Medical Center in New York, said in an interview that the evidence that age is a strong risk factor for severe disease – even after vaccination – confirms that attention should be focused on those in the highest age groups, particularly those 80 years and older.

Other top risk factors included having immunocompromising conditions; having received cytotoxic chemotherapy within 6 months (adjusted odds ratio, 2.69; 95% confidence interval, 2.25-3.21); having leukemias/lymphomas (aOR, 1.84; 95% CI, 1.59-2.14); and having chronic conditions associated with end-organ disease.

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

WASHINGTON – In the 25 years since the United States first launched its universal vaccinations program to protect children against chickenpox (varicella), the program has seen dramatic results, a data analysis indicates.

Results from 1995 – when universal vaccinations began – through 2019 were presented an annual scientific meeting on infectious diseases by Mona Marin, MD, a medical epidemiologist at the Centers for Disease Control and Prevention. Researchers analyzed published data and surveillance data reported to the CDC.
 

Deaths in under-20 group all but eliminated

It’s now rare for children to be hospitalized with chickenpox, and deaths from the infection in people younger than 20 have largely been eliminated. But benefits extend even further.

Immunocompromised people or pregnant women and infants too young to be vaccinated also benefited from the children’s immunizations.

Each year, about 3.8 million cases, 10,500 hospitalizations, and 100 deaths from chickenpox are prevented in the United States thanks to the vaccination program, Dr. Marin said.

Over 25 years, 91 million cases, 238,000 hospitalizations, and 1,933 – 2,446 deaths have been prevented.

However, chickenpox is still widespread in most of the world.
 

U.S. first with universal program

The disease was thought to be of little consequence, Dr. Marin said, until the mid-1950s after the first cases of fatal varicella in immunocompromised children revealed the virus’ lethal potential.

The United States was the first country to introduce a universal vaccination program, Dr. Marin said. At the time, it was a one-dose vaccine. Within the first 10 years of the one-dose program, declines in chickenpox cases, hospitalization, and death rates went from 71% to 90% in comparison with previous years. But health care leaders wanted to close the remaining gap and target transmission in schools.

“It was a burden the United States considered unacceptable,” Dr. Marin said.

The leaders had seen the control of measles and polio and wanted the same for chickenpox.
 

Two-dose vaccines started in 2007

In 2007, the current two-dose policy was introduced. Administration of the first dose is recommended at age 12–15 months, and the second at age 4–6 years. Vaccination is required before the children enter kindergarten.

Coverage was high – at least 90% – the study authors reported; the two-dose program further reduced the number, size, and duration of outbreaks. Over the 25 years, the proportion of outbreaks with fewer than 10 cases increased from 28% to 73%.

By 2019, incidence had dropped by 97%, hospitalizations were down by 94%, and deaths had dropped by 97%.

The biggest decline was seen in those younger than 20, who were born during the vaccination program. That group saw declines of 97% to 99% in cases, hospitalizations, and incidence compared with rates before vaccinations.

Dr. Marin says one dose of the vaccine is moderately effective in preventing all varicella (82%) and is highly effective in preventing severe varicella (more than 97%).

“The second dose adds 10% or more improved protection against all varicella,” she said.

But there have been gains beyond medical advances.

Researchers calculated the economic benefit and found a net savings of $23 billion in medical costs (which also factored in lost wages from parents staying home to care for sick children).
 

Jaw-dropping results

Jeanne Marrazzo, MD, director of the division of infectious diseases at the University of Alabama at Birmingham, said in an interview that “as someone who is not a vaccinologist, the declines in deaths, let alone hospitalizations, were jaw-dropping. I hadn’t really seen a synthesis of the impact of one and two doses.”

She said the declines in zoster among young people were interesting. The big question, she said, is what impact this may have for shingles infections in middle-aged adults over time, since chickenpox and shingles are caused by the same virus.

Dr. Marrazzo also noted the economic savings calculations.

“It’s such a cheap intervention. It’s one of the best examples of how a simple vaccine can affect a cascade of events that are a result of chronic viral infection,” she said.

There are also messages for the current debates over COVID-19 vaccinations.

“For me, it is further evidence of the profound population-level effect safe vaccines can have,” Dr. Marrazzo said.

The authors and Dr. Marrazzo report no relevant financial relationships.

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

WASHINGTON – In the 25 years since the United States first launched its universal vaccinations program to protect children against chickenpox (varicella), the program has seen dramatic results, a data analysis indicates.

Results from 1995 – when universal vaccinations began – through 2019 were presented an annual scientific meeting on infectious diseases by Mona Marin, MD, a medical epidemiologist at the Centers for Disease Control and Prevention. Researchers analyzed published data and surveillance data reported to the CDC.
 

Deaths in under-20 group all but eliminated

It’s now rare for children to be hospitalized with chickenpox, and deaths from the infection in people younger than 20 have largely been eliminated. But benefits extend even further.

Immunocompromised people or pregnant women and infants too young to be vaccinated also benefited from the children’s immunizations.

Each year, about 3.8 million cases, 10,500 hospitalizations, and 100 deaths from chickenpox are prevented in the United States thanks to the vaccination program, Dr. Marin said.

Over 25 years, 91 million cases, 238,000 hospitalizations, and 1,933 – 2,446 deaths have been prevented.

However, chickenpox is still widespread in most of the world.
 

U.S. first with universal program

The disease was thought to be of little consequence, Dr. Marin said, until the mid-1950s after the first cases of fatal varicella in immunocompromised children revealed the virus’ lethal potential.

The United States was the first country to introduce a universal vaccination program, Dr. Marin said. At the time, it was a one-dose vaccine. Within the first 10 years of the one-dose program, declines in chickenpox cases, hospitalization, and death rates went from 71% to 90% in comparison with previous years. But health care leaders wanted to close the remaining gap and target transmission in schools.

“It was a burden the United States considered unacceptable,” Dr. Marin said.

The leaders had seen the control of measles and polio and wanted the same for chickenpox.
 

Two-dose vaccines started in 2007

In 2007, the current two-dose policy was introduced. Administration of the first dose is recommended at age 12–15 months, and the second at age 4–6 years. Vaccination is required before the children enter kindergarten.

Coverage was high – at least 90% – the study authors reported; the two-dose program further reduced the number, size, and duration of outbreaks. Over the 25 years, the proportion of outbreaks with fewer than 10 cases increased from 28% to 73%.

By 2019, incidence had dropped by 97%, hospitalizations were down by 94%, and deaths had dropped by 97%.

The biggest decline was seen in those younger than 20, who were born during the vaccination program. That group saw declines of 97% to 99% in cases, hospitalizations, and incidence compared with rates before vaccinations.

Dr. Marin says one dose of the vaccine is moderately effective in preventing all varicella (82%) and is highly effective in preventing severe varicella (more than 97%).

“The second dose adds 10% or more improved protection against all varicella,” she said.

But there have been gains beyond medical advances.

Researchers calculated the economic benefit and found a net savings of $23 billion in medical costs (which also factored in lost wages from parents staying home to care for sick children).
 

Jaw-dropping results

Jeanne Marrazzo, MD, director of the division of infectious diseases at the University of Alabama at Birmingham, said in an interview that “as someone who is not a vaccinologist, the declines in deaths, let alone hospitalizations, were jaw-dropping. I hadn’t really seen a synthesis of the impact of one and two doses.”

She said the declines in zoster among young people were interesting. The big question, she said, is what impact this may have for shingles infections in middle-aged adults over time, since chickenpox and shingles are caused by the same virus.

Dr. Marrazzo also noted the economic savings calculations.

“It’s such a cheap intervention. It’s one of the best examples of how a simple vaccine can affect a cascade of events that are a result of chronic viral infection,” she said.

There are also messages for the current debates over COVID-19 vaccinations.

“For me, it is further evidence of the profound population-level effect safe vaccines can have,” Dr. Marrazzo said.

The authors and Dr. Marrazzo report no relevant financial relationships.

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

WASHINGTON – In the 25 years since the United States first launched its universal vaccinations program to protect children against chickenpox (varicella), the program has seen dramatic results, a data analysis indicates.

Results from 1995 – when universal vaccinations began – through 2019 were presented an annual scientific meeting on infectious diseases by Mona Marin, MD, a medical epidemiologist at the Centers for Disease Control and Prevention. Researchers analyzed published data and surveillance data reported to the CDC.
 

Deaths in under-20 group all but eliminated

It’s now rare for children to be hospitalized with chickenpox, and deaths from the infection in people younger than 20 have largely been eliminated. But benefits extend even further.

Immunocompromised people or pregnant women and infants too young to be vaccinated also benefited from the children’s immunizations.

Each year, about 3.8 million cases, 10,500 hospitalizations, and 100 deaths from chickenpox are prevented in the United States thanks to the vaccination program, Dr. Marin said.

Over 25 years, 91 million cases, 238,000 hospitalizations, and 1,933 – 2,446 deaths have been prevented.

However, chickenpox is still widespread in most of the world.
 

U.S. first with universal program

The disease was thought to be of little consequence, Dr. Marin said, until the mid-1950s after the first cases of fatal varicella in immunocompromised children revealed the virus’ lethal potential.

The United States was the first country to introduce a universal vaccination program, Dr. Marin said. At the time, it was a one-dose vaccine. Within the first 10 years of the one-dose program, declines in chickenpox cases, hospitalization, and death rates went from 71% to 90% in comparison with previous years. But health care leaders wanted to close the remaining gap and target transmission in schools.

“It was a burden the United States considered unacceptable,” Dr. Marin said.

The leaders had seen the control of measles and polio and wanted the same for chickenpox.
 

Two-dose vaccines started in 2007

In 2007, the current two-dose policy was introduced. Administration of the first dose is recommended at age 12–15 months, and the second at age 4–6 years. Vaccination is required before the children enter kindergarten.

Coverage was high – at least 90% – the study authors reported; the two-dose program further reduced the number, size, and duration of outbreaks. Over the 25 years, the proportion of outbreaks with fewer than 10 cases increased from 28% to 73%.

By 2019, incidence had dropped by 97%, hospitalizations were down by 94%, and deaths had dropped by 97%.

The biggest decline was seen in those younger than 20, who were born during the vaccination program. That group saw declines of 97% to 99% in cases, hospitalizations, and incidence compared with rates before vaccinations.

Dr. Marin says one dose of the vaccine is moderately effective in preventing all varicella (82%) and is highly effective in preventing severe varicella (more than 97%).

“The second dose adds 10% or more improved protection against all varicella,” she said.

But there have been gains beyond medical advances.

Researchers calculated the economic benefit and found a net savings of $23 billion in medical costs (which also factored in lost wages from parents staying home to care for sick children).
 

Jaw-dropping results

Jeanne Marrazzo, MD, director of the division of infectious diseases at the University of Alabama at Birmingham, said in an interview that “as someone who is not a vaccinologist, the declines in deaths, let alone hospitalizations, were jaw-dropping. I hadn’t really seen a synthesis of the impact of one and two doses.”

She said the declines in zoster among young people were interesting. The big question, she said, is what impact this may have for shingles infections in middle-aged adults over time, since chickenpox and shingles are caused by the same virus.

Dr. Marrazzo also noted the economic savings calculations.

“It’s such a cheap intervention. It’s one of the best examples of how a simple vaccine can affect a cascade of events that are a result of chronic viral infection,” she said.

There are also messages for the current debates over COVID-19 vaccinations.

“For me, it is further evidence of the profound population-level effect safe vaccines can have,” Dr. Marrazzo said.

The authors and Dr. Marrazzo report no relevant financial relationships.

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

People taking methotrexate for immunomodulatory diseases can skip one or two scheduled doses after they get an mRNA-based vaccine booster for COVID-19 and achieve a level of immunity against Omicron variants that’s comparable to people who aren’t immunosuppressed, a small observational cohort study from Germany reported.

Kmatta/Moment/Getty Images

“In general, the data suggest that pausing methotrexate is feasible, and it’s sufficient if the last dose occurs 1-3 days before the vaccination,” study coauthor Gerd Burmester, MD, a senior professor of rheumatology and immunology at the University of Medicine Berlin, told this news organization. “In pragmatic terms: pausing the methotrexate injection just twice after the vaccine is finished and, interestingly, not prior to the vaccination.”

Study results

The study found that serum neutralizing activity against the Omicron BA.1 variant, measured as geometric mean 50% inhibitory serum dilution (ID50s), wasn’t significantly different between the methotrexate and the nonimmunosuppressed groups before getting their mRNA booster (P = .657). However, 4 weeks after getting the booster, the nonimmunosuppressed group had a 68-fold increase in antibody activity versus a 20-fold increase in the methotrexate patients. After 12 weeks, ID50s in both groups decreased by about half (P = .001).

The methotrexate patients who continued therapy after the booster had significantly lower neutralization against Omicron BA.1 at both 4 weeks and 12 weeks than did their counterparts who paused therapy, as well as control patients.

The results were very similar in the same group comparisons of the serum neutralizing activity against the Omicron BA.2 variant at 4 and 12 weeks after booster vaccination.
 

Expert commentary

This study is noteworthy because it used SARS-CoV-2 pseudovirus neutralization assays to evaluate antibody levels, Kevin Winthrop, MD, MPH, professor of infectious disease and public health at Oregon Health & Science University, Portland, who was not involved in the study, said. “A lot of studies don’t look at neutralizing antibody titers, and that’s really what we care about,” Dr. Winthrop said. “What we want are functional antibodies that are doing something, and the only way to do that is to test them.”

The study is “confirmatory” of other studies that call for pausing methotrexate after vaccination, Dr. Winthrop said, including a study he coauthored, and which the German researchers cited, that found pausing methotrexate for a week or so after the influenza vaccination in RA patients improved vaccine immunogenicity. He added that the findings with the early Omicron variants are important because the newest boosters target the later Omicron variants, BA.4 and BA.5.

“The bottom line is that when someone comes in for a COVID-19 vaccination, tell them to be off of methotrexate for 7-10 days,” Dr. Winthrop said. “This is for the booster, but it raises the question: If you go out to three, four, or five vaccinations, does this matter anymore? With the flu vaccine, most people are out to 10 or 15 boosters, and we haven’t seen any significant increase in disease flares.”

The study received funding from Medac, Gilead/Galapagos, and Friends and Sponsors of Berlin Charity. Dr. Burmester reported no relevant disclosures. Dr. Winthrop is a research consultant to Pfizer.

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

People taking methotrexate for immunomodulatory diseases can skip one or two scheduled doses after they get an mRNA-based vaccine booster for COVID-19 and achieve a level of immunity against Omicron variants that’s comparable to people who aren’t immunosuppressed, a small observational cohort study from Germany reported.

Kmatta/Moment/Getty Images

“In general, the data suggest that pausing methotrexate is feasible, and it’s sufficient if the last dose occurs 1-3 days before the vaccination,” study coauthor Gerd Burmester, MD, a senior professor of rheumatology and immunology at the University of Medicine Berlin, told this news organization. “In pragmatic terms: pausing the methotrexate injection just twice after the vaccine is finished and, interestingly, not prior to the vaccination.”

Study results

The study found that serum neutralizing activity against the Omicron BA.1 variant, measured as geometric mean 50% inhibitory serum dilution (ID50s), wasn’t significantly different between the methotrexate and the nonimmunosuppressed groups before getting their mRNA booster (P = .657). However, 4 weeks after getting the booster, the nonimmunosuppressed group had a 68-fold increase in antibody activity versus a 20-fold increase in the methotrexate patients. After 12 weeks, ID50s in both groups decreased by about half (P = .001).

The methotrexate patients who continued therapy after the booster had significantly lower neutralization against Omicron BA.1 at both 4 weeks and 12 weeks than did their counterparts who paused therapy, as well as control patients.

The results were very similar in the same group comparisons of the serum neutralizing activity against the Omicron BA.2 variant at 4 and 12 weeks after booster vaccination.
 

Expert commentary

This study is noteworthy because it used SARS-CoV-2 pseudovirus neutralization assays to evaluate antibody levels, Kevin Winthrop, MD, MPH, professor of infectious disease and public health at Oregon Health & Science University, Portland, who was not involved in the study, said. “A lot of studies don’t look at neutralizing antibody titers, and that’s really what we care about,” Dr. Winthrop said. “What we want are functional antibodies that are doing something, and the only way to do that is to test them.”

The study is “confirmatory” of other studies that call for pausing methotrexate after vaccination, Dr. Winthrop said, including a study he coauthored, and which the German researchers cited, that found pausing methotrexate for a week or so after the influenza vaccination in RA patients improved vaccine immunogenicity. He added that the findings with the early Omicron variants are important because the newest boosters target the later Omicron variants, BA.4 and BA.5.

“The bottom line is that when someone comes in for a COVID-19 vaccination, tell them to be off of methotrexate for 7-10 days,” Dr. Winthrop said. “This is for the booster, but it raises the question: If you go out to three, four, or five vaccinations, does this matter anymore? With the flu vaccine, most people are out to 10 or 15 boosters, and we haven’t seen any significant increase in disease flares.”

The study received funding from Medac, Gilead/Galapagos, and Friends and Sponsors of Berlin Charity. Dr. Burmester reported no relevant disclosures. Dr. Winthrop is a research consultant to Pfizer.

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

People taking methotrexate for immunomodulatory diseases can skip one or two scheduled doses after they get an mRNA-based vaccine booster for COVID-19 and achieve a level of immunity against Omicron variants that’s comparable to people who aren’t immunosuppressed, a small observational cohort study from Germany reported.

Kmatta/Moment/Getty Images

“In general, the data suggest that pausing methotrexate is feasible, and it’s sufficient if the last dose occurs 1-3 days before the vaccination,” study coauthor Gerd Burmester, MD, a senior professor of rheumatology and immunology at the University of Medicine Berlin, told this news organization. “In pragmatic terms: pausing the methotrexate injection just twice after the vaccine is finished and, interestingly, not prior to the vaccination.”

Study results

The study found that serum neutralizing activity against the Omicron BA.1 variant, measured as geometric mean 50% inhibitory serum dilution (ID50s), wasn’t significantly different between the methotrexate and the nonimmunosuppressed groups before getting their mRNA booster (P = .657). However, 4 weeks after getting the booster, the nonimmunosuppressed group had a 68-fold increase in antibody activity versus a 20-fold increase in the methotrexate patients. After 12 weeks, ID50s in both groups decreased by about half (P = .001).

The methotrexate patients who continued therapy after the booster had significantly lower neutralization against Omicron BA.1 at both 4 weeks and 12 weeks than did their counterparts who paused therapy, as well as control patients.

The results were very similar in the same group comparisons of the serum neutralizing activity against the Omicron BA.2 variant at 4 and 12 weeks after booster vaccination.
 

Expert commentary

This study is noteworthy because it used SARS-CoV-2 pseudovirus neutralization assays to evaluate antibody levels, Kevin Winthrop, MD, MPH, professor of infectious disease and public health at Oregon Health & Science University, Portland, who was not involved in the study, said. “A lot of studies don’t look at neutralizing antibody titers, and that’s really what we care about,” Dr. Winthrop said. “What we want are functional antibodies that are doing something, and the only way to do that is to test them.”

The study is “confirmatory” of other studies that call for pausing methotrexate after vaccination, Dr. Winthrop said, including a study he coauthored, and which the German researchers cited, that found pausing methotrexate for a week or so after the influenza vaccination in RA patients improved vaccine immunogenicity. He added that the findings with the early Omicron variants are important because the newest boosters target the later Omicron variants, BA.4 and BA.5.

“The bottom line is that when someone comes in for a COVID-19 vaccination, tell them to be off of methotrexate for 7-10 days,” Dr. Winthrop said. “This is for the booster, but it raises the question: If you go out to three, four, or five vaccinations, does this matter anymore? With the flu vaccine, most people are out to 10 or 15 boosters, and we haven’t seen any significant increase in disease flares.”

The study received funding from Medac, Gilead/Galapagos, and Friends and Sponsors of Berlin Charity. Dr. Burmester reported no relevant disclosures. Dr. Winthrop is a research consultant to Pfizer.

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

“I’m not getting the vaccine. Nobody knows the long-term effects, and I heard that people are getting clots.”

We were screening patients at a low-cost clinic in Philadelphia for concerns surrounding social determinants of health. During one patient visit, in addition to concerns including housing, medication affordability, and transportation, we found that she had not received the COVID-19 vaccine, and we asked if she was interested in being immunized.

News reports have endlessly covered antivaccine sentiment, but this personal encounter hit home. From simple face masks to groundbreaking vaccines, we failed as physicians to encourage widespread uptake of health-protective measures despite strong scientific backing.

Large swaths of the public deny these tools’ importance or question their safety. This is ultimately rooted in the inability of community leaders and health care professionals to communicate with the public.

Science communication is inherently difficult. Scientists use complex language, and it is hard to evaluate the lay public’s baseline knowledge. Moreover, we are trained to speak with qualifications, encourage doubt, and accept change and evolution of fact. These qualities contrast the definitive messaging necessary in public settings. COVID-19 highlighted these gaps, where regardless of novel scientific solutions, poor communication led to a resistance to accept the tested scientific solution, which ultimately was the rate-limiting factor for overcoming the virus.

As directors of Physician Executive Leadership, an organization that trains future physicians at Thomas Jefferson University to tackle emerging health care issues, we hosted Paul Offit, MD, a national media figure and vaccine advocate. Dr. Offit shared his personal growth during the pandemic, from being abruptly thrown into the spotlight to eventually honing his communication skills. Dr. Offit discussed the challenges of sharing medical knowledge with laypeople and adaptations that are necessary. We found this transformative, realizing the importance of science communication training early in medical education.

Emphasizing the humanities and building soft skills will improve outcomes and benefit broader society by producing physician-leaders in public health and policy. We hope to improve our own communication skills and work in medical education to incorporate similar training into education paradigms for future students.

As seen in our patient interaction, strong science alone will not drive patient adherence; instead, we must work at personal and system levels to induce change. Physicians have a unique opportunity to generate trust and guide evidence-based policy. We must communicate, whether one-on-one with patients, or to millions of viewers via media or policymaker settings. We hope to not only be doctors, but to be advocates, leaders, and trusted advisers for the public.

Mr. Kieran and Mr. Shah are second-year medical students at Sidney Kimmel Medical College, Philadelphia. Neither disclosed any relevant conflicts of interest. A version of this article first appeared on Medscape.com.

“I’m not getting the vaccine. Nobody knows the long-term effects, and I heard that people are getting clots.”

We were screening patients at a low-cost clinic in Philadelphia for concerns surrounding social determinants of health. During one patient visit, in addition to concerns including housing, medication affordability, and transportation, we found that she had not received the COVID-19 vaccine, and we asked if she was interested in being immunized.

News reports have endlessly covered antivaccine sentiment, but this personal encounter hit home. From simple face masks to groundbreaking vaccines, we failed as physicians to encourage widespread uptake of health-protective measures despite strong scientific backing.

Large swaths of the public deny these tools’ importance or question their safety. This is ultimately rooted in the inability of community leaders and health care professionals to communicate with the public.

Science communication is inherently difficult. Scientists use complex language, and it is hard to evaluate the lay public’s baseline knowledge. Moreover, we are trained to speak with qualifications, encourage doubt, and accept change and evolution of fact. These qualities contrast the definitive messaging necessary in public settings. COVID-19 highlighted these gaps, where regardless of novel scientific solutions, poor communication led to a resistance to accept the tested scientific solution, which ultimately was the rate-limiting factor for overcoming the virus.

As directors of Physician Executive Leadership, an organization that trains future physicians at Thomas Jefferson University to tackle emerging health care issues, we hosted Paul Offit, MD, a national media figure and vaccine advocate. Dr. Offit shared his personal growth during the pandemic, from being abruptly thrown into the spotlight to eventually honing his communication skills. Dr. Offit discussed the challenges of sharing medical knowledge with laypeople and adaptations that are necessary. We found this transformative, realizing the importance of science communication training early in medical education.

Emphasizing the humanities and building soft skills will improve outcomes and benefit broader society by producing physician-leaders in public health and policy. We hope to improve our own communication skills and work in medical education to incorporate similar training into education paradigms for future students.

As seen in our patient interaction, strong science alone will not drive patient adherence; instead, we must work at personal and system levels to induce change. Physicians have a unique opportunity to generate trust and guide evidence-based policy. We must communicate, whether one-on-one with patients, or to millions of viewers via media or policymaker settings. We hope to not only be doctors, but to be advocates, leaders, and trusted advisers for the public.

Mr. Kieran and Mr. Shah are second-year medical students at Sidney Kimmel Medical College, Philadelphia. Neither disclosed any relevant conflicts of interest. A version of this article first appeared on Medscape.com.

“I’m not getting the vaccine. Nobody knows the long-term effects, and I heard that people are getting clots.”

We were screening patients at a low-cost clinic in Philadelphia for concerns surrounding social determinants of health. During one patient visit, in addition to concerns including housing, medication affordability, and transportation, we found that she had not received the COVID-19 vaccine, and we asked if she was interested in being immunized.

News reports have endlessly covered antivaccine sentiment, but this personal encounter hit home. From simple face masks to groundbreaking vaccines, we failed as physicians to encourage widespread uptake of health-protective measures despite strong scientific backing.

Large swaths of the public deny these tools’ importance or question their safety. This is ultimately rooted in the inability of community leaders and health care professionals to communicate with the public.

Science communication is inherently difficult. Scientists use complex language, and it is hard to evaluate the lay public’s baseline knowledge. Moreover, we are trained to speak with qualifications, encourage doubt, and accept change and evolution of fact. These qualities contrast the definitive messaging necessary in public settings. COVID-19 highlighted these gaps, where regardless of novel scientific solutions, poor communication led to a resistance to accept the tested scientific solution, which ultimately was the rate-limiting factor for overcoming the virus.

As directors of Physician Executive Leadership, an organization that trains future physicians at Thomas Jefferson University to tackle emerging health care issues, we hosted Paul Offit, MD, a national media figure and vaccine advocate. Dr. Offit shared his personal growth during the pandemic, from being abruptly thrown into the spotlight to eventually honing his communication skills. Dr. Offit discussed the challenges of sharing medical knowledge with laypeople and adaptations that are necessary. We found this transformative, realizing the importance of science communication training early in medical education.

Emphasizing the humanities and building soft skills will improve outcomes and benefit broader society by producing physician-leaders in public health and policy. We hope to improve our own communication skills and work in medical education to incorporate similar training into education paradigms for future students.

As seen in our patient interaction, strong science alone will not drive patient adherence; instead, we must work at personal and system levels to induce change. Physicians have a unique opportunity to generate trust and guide evidence-based policy. We must communicate, whether one-on-one with patients, or to millions of viewers via media or policymaker settings. We hope to not only be doctors, but to be advocates, leaders, and trusted advisers for the public.

Mr. Kieran and Mr. Shah are second-year medical students at Sidney Kimmel Medical College, Philadelphia. Neither disclosed any relevant conflicts of interest. A version of this article first appeared on Medscape.com.

Gregory A. Hood, MD, remembers a patient of his who was perpetually dubious about COVID-19 – and then couldn’t be saved.

“I spoke to him on many occasions about the dangers of COVID, but he just didn’t believe me,” said Dr. Hood, an internist in Lexington, Ky. “He just didn’t give me enough time to help him. He waited to let me know he was ill with COVID and took days to pick up the medicine. Unfortunately, he then passed away.”
 

The rise of the skeptical patient

It can be extremely frustrating for doctors when patients question or disbelieve their physician’s medical advice and explanations. And many physicians resent the amount of time they spend trying to explain or make their case, especially during a busy day. But patients’ skepticism about the validity of some treatments seems to be increasing.

“Patients are now more likely to have their own medical explanation for their complaint than they used to, and that can be bad for their health,” Dr. Hood said.

Dr. Hood sees medical cynicism as part of Americans’ growing distrust of experts, leveraged by easy access to the internet. “When people Google, they tend to look for support of their opinions, rather than arrive at a fully educated decision.”

Only about half of patients believe their physicians “provide fair and accurate treatment information all or most of the time,” according to a 2019 survey by the Pew Research Center.

Patients’ distrust has become more obvious during the COVID-19 pandemic, said John Schumann, MD, an internist with Oak Street Health, a practice with more than 500 physicians and other providers in 20 states, treating almost exclusively Medicare patients.

“The skeptics became more entrenched during the pandemic,” said Dr. Schumann, who is based in Tulsa, Okla. “They may think the COVID vaccines were approved too quickly, or believe the pandemic itself is a hoax.”

“There’s a lot of antiscience rhetoric now,” Dr. Schumann added. “I’d say about half of my patients are comfortable with science-based decisions and the other half are not.”
 

What are patients mistrustful about?

Patients’ suspicions of certain therapies began long before the pandemic. In dermatology, for example, some patients refuse to take topical steroids, said Steven R. Feldman, MD, a dermatologist in Winston-Salem, N.C.

“Their distrust is usually based on anecdotal stories they read about,” he noted. “Patients in other specialties are dead set against vaccinations.”

In addition to refusing treatments and inoculations, some patients ask for questionable regimens mentioned in the news. “Some patients have demanded hydroxychloroquine or Noromectin, drugs that are unproven in the treatment of COVID,” Dr. Schumann said. “We refuse to prescribe them.”

Dr. Hood said patients’ reluctance to follow medical advice can often be based on cost. “I have a patient who was more willing to save $20 than to save his life. But when the progression of his test results fit my predictions, he became more willing to take treatments. I had to wait for the opportune moment to convince him.”

Many naysayer patients keep their views to themselves, and physicians may be unaware that the patients are stonewalling. A 2006 study estimated that about 10%-16% of primary care patients actively resist medical authority.

Dr. Schumann cited patients who don’t want to hear an upsetting diagnosis. “Some patients might refuse to take a biopsy to see if they have cancer because they don’t want to know,” he said. “In many cases, they simply won’t get the biopsy and won’t tell the doctor that they didn’t.”
 

Sometimes skeptics’ arguments have merit

Some patients’ concerns can be valid, such as when they refuse to go on statins, said Zain Hakeem, DO, a physician in Austin, Tex.

“In some cases, I feel that statins are not necessary,” he said. “The science on statins for primary prevention is not strong, although they should be used for exceedingly high-risk patients.”

Certain patients, especially those with chronic conditions, do a great deal of research, using legitimate sources on the Web, and their research is well supported.

However, these patients can be overconfident in their conclusions. Several studies have shown that with just a little experience, people can replace beginners’ caution with a false sense of competence.

For example, “Patients may not weigh the risks correctly,” Dr. Hakeem said. “They can be more concerned about the risk of having their colon perforated during a colonoscopy, while the risk of cancer if they don’t have a colonoscopy is much higher.”

Some highly successful people may be more likely to trust their own medical instincts. When Steve Jobs, the founder of Apple, was diagnosed with pancreatic cancer in 2003, he put off surgery for 9 months while he tried to cure his disease with a vegan diet, acupuncture, herbs, bowel cleansings, and other remedies he read about. He died in 2011. Some experts believe that delay hastened his death.

Of course, not all physicians’ diagnoses or treatments are correct. One study indicated doctors’ diagnostic error rate could be as high as 15%. And just as patients can be overconfident in their conclusions, so can doctors. Another study found that physicians’ stated confidence in their diagnosis was only slightly affected by the inaccuracy of that diagnosis or the difficulty of the case.
 

Best ways to deal with cynical patients

Patients’ skepticism can frustrate doctors, reduce the efficiency of care delivery, and interfere with recovery. What can doctors do to deal with these problems?

1. Build the patient’s trust in you. “Getting patients to adhere to your advice involves making sure they feel they have a caring doctor whom they trust,” Dr. Feldman said.

“I want to show patients that I am entirely focused on them,” he added. “For example, I may rush to the door of the exam room from my last appointment, but I open the door very slowly and deliberately, because I want the patient to see that I won’t hurry with them.”

2. Spend time with the patient. Familiarity builds trust. Dr. Schumann said doctors at Oak Street Health see their patients an average of six to eight times a year, an unusually high number. “The more patients see their physicians, the more likely they are to trust them.”

3. Keep up to date. “I make sure I’m up to date with the literature, and I try to present a truthful message,” Dr. Hood said. “For instance, my research showed that inflammation played a strong role in developing complications from COVID, so I wrote a detailed treatment protocol aimed at the inflammation and the immune response, which has been very effective.”

4. Confront patients tactfully. Patients who do research on the Web don’t want to be scolded, Dr. Feldman said. In fact, he praises them, even if he doesn’t agree with their findings. “I might say: ‘What a relief to finally find patients who’ve taken the time to educate themselves before coming here.’ ”

Dr. Feldman is careful not to dispute patients’ conclusions. “Debating the issues is not an effective approach to get patients to trust you. The last thing you want to tell a patient is: ‘Listen to me! I’m an expert.’ People just dig in.”

However, it does help to give patients feedback. “I’m a big fan of patients arguing with me,” Dr. Hakeem said. “It means you can straighten out misunderstandings and improve decision-making.”

5. Explain your reasoning. “You need to communicate clearly and show them your thinking,” Dr. Hood said. “For instance, I’ll explain why a patient has a strong risk for heart attack.”

6. Acknowledge uncertainties. “The doctor may present the science as far more certain than it is,” Dr. Hakeem said. “If you don’t acknowledge the uncertainties, you could break the patient’s trust in you.”

7. Don’t use a lot of numbers. “Data is not a good tool to convince patients,” Dr. Feldman said. “The human brain isn’t designed to work that way.”

If you want to use numbers to show clinical risk, Dr. Hakeem advisd using natural frequencies, such as 10 out of 10,000, which is less confusing to the patient than the equivalent percentage of 0.1%.

It can be helpful to refer to familiar concepts. One way to understand a risk is to compare it with risks in daily life, such as the dangers of driving or falling in the shower, Dr. Hakeem added.

Dr. Feldman often refers to another person’s experience when presenting his medical advice. “I might say to the patient: ‘You remind me of another patient I had. They were sitting in the same chair you’re sitting in. They did really well on this drug, and I think it’s probably the best choice for you, too.’ ”

8. Adopt shared decision-making. This approach involves empowering the patient to become an equal partner in medical decisions. The patient is given information through portals and is encouraged to do research. Critics, however, say that most patients don’t want this degree of empowerment and would rather depend on the doctor’s advice.

Conclusion

It’s often impossible to get through to a skeptical patient, which can be disheartening for doctors. “Physicians want to do what is best for the patient, so when the patient doesn’t listen, they may take it personally,” Dr. Hood said. “But you always have to remember, the patient is the one with disease, and it’s up to the patient to open the door.”

Still, some skeptical patients ultimately change their minds. Dr. Schumann said patients who initially declined the COVID vaccine eventually decided to get it. “It often took them more than a year. but it’s never too late.”

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

Gregory A. Hood, MD, remembers a patient of his who was perpetually dubious about COVID-19 – and then couldn’t be saved.

“I spoke to him on many occasions about the dangers of COVID, but he just didn’t believe me,” said Dr. Hood, an internist in Lexington, Ky. “He just didn’t give me enough time to help him. He waited to let me know he was ill with COVID and took days to pick up the medicine. Unfortunately, he then passed away.”
 

The rise of the skeptical patient

It can be extremely frustrating for doctors when patients question or disbelieve their physician’s medical advice and explanations. And many physicians resent the amount of time they spend trying to explain or make their case, especially during a busy day. But patients’ skepticism about the validity of some treatments seems to be increasing.

“Patients are now more likely to have their own medical explanation for their complaint than they used to, and that can be bad for their health,” Dr. Hood said.

Dr. Hood sees medical cynicism as part of Americans’ growing distrust of experts, leveraged by easy access to the internet. “When people Google, they tend to look for support of their opinions, rather than arrive at a fully educated decision.”

Only about half of patients believe their physicians “provide fair and accurate treatment information all or most of the time,” according to a 2019 survey by the Pew Research Center.

Patients’ distrust has become more obvious during the COVID-19 pandemic, said John Schumann, MD, an internist with Oak Street Health, a practice with more than 500 physicians and other providers in 20 states, treating almost exclusively Medicare patients.

“The skeptics became more entrenched during the pandemic,” said Dr. Schumann, who is based in Tulsa, Okla. “They may think the COVID vaccines were approved too quickly, or believe the pandemic itself is a hoax.”

“There’s a lot of antiscience rhetoric now,” Dr. Schumann added. “I’d say about half of my patients are comfortable with science-based decisions and the other half are not.”
 

What are patients mistrustful about?

Patients’ suspicions of certain therapies began long before the pandemic. In dermatology, for example, some patients refuse to take topical steroids, said Steven R. Feldman, MD, a dermatologist in Winston-Salem, N.C.

“Their distrust is usually based on anecdotal stories they read about,” he noted. “Patients in other specialties are dead set against vaccinations.”

In addition to refusing treatments and inoculations, some patients ask for questionable regimens mentioned in the news. “Some patients have demanded hydroxychloroquine or Noromectin, drugs that are unproven in the treatment of COVID,” Dr. Schumann said. “We refuse to prescribe them.”

Dr. Hood said patients’ reluctance to follow medical advice can often be based on cost. “I have a patient who was more willing to save $20 than to save his life. But when the progression of his test results fit my predictions, he became more willing to take treatments. I had to wait for the opportune moment to convince him.”

Many naysayer patients keep their views to themselves, and physicians may be unaware that the patients are stonewalling. A 2006 study estimated that about 10%-16% of primary care patients actively resist medical authority.

Dr. Schumann cited patients who don’t want to hear an upsetting diagnosis. “Some patients might refuse to take a biopsy to see if they have cancer because they don’t want to know,” he said. “In many cases, they simply won’t get the biopsy and won’t tell the doctor that they didn’t.”
 

Sometimes skeptics’ arguments have merit

Some patients’ concerns can be valid, such as when they refuse to go on statins, said Zain Hakeem, DO, a physician in Austin, Tex.

“In some cases, I feel that statins are not necessary,” he said. “The science on statins for primary prevention is not strong, although they should be used for exceedingly high-risk patients.”

Certain patients, especially those with chronic conditions, do a great deal of research, using legitimate sources on the Web, and their research is well supported.

However, these patients can be overconfident in their conclusions. Several studies have shown that with just a little experience, people can replace beginners’ caution with a false sense of competence.

For example, “Patients may not weigh the risks correctly,” Dr. Hakeem said. “They can be more concerned about the risk of having their colon perforated during a colonoscopy, while the risk of cancer if they don’t have a colonoscopy is much higher.”

Some highly successful people may be more likely to trust their own medical instincts. When Steve Jobs, the founder of Apple, was diagnosed with pancreatic cancer in 2003, he put off surgery for 9 months while he tried to cure his disease with a vegan diet, acupuncture, herbs, bowel cleansings, and other remedies he read about. He died in 2011. Some experts believe that delay hastened his death.

Of course, not all physicians’ diagnoses or treatments are correct. One study indicated doctors’ diagnostic error rate could be as high as 15%. And just as patients can be overconfident in their conclusions, so can doctors. Another study found that physicians’ stated confidence in their diagnosis was only slightly affected by the inaccuracy of that diagnosis or the difficulty of the case.
 

Best ways to deal with cynical patients

Patients’ skepticism can frustrate doctors, reduce the efficiency of care delivery, and interfere with recovery. What can doctors do to deal with these problems?

1. Build the patient’s trust in you. “Getting patients to adhere to your advice involves making sure they feel they have a caring doctor whom they trust,” Dr. Feldman said.

“I want to show patients that I am entirely focused on them,” he added. “For example, I may rush to the door of the exam room from my last appointment, but I open the door very slowly and deliberately, because I want the patient to see that I won’t hurry with them.”

2. Spend time with the patient. Familiarity builds trust. Dr. Schumann said doctors at Oak Street Health see their patients an average of six to eight times a year, an unusually high number. “The more patients see their physicians, the more likely they are to trust them.”

3. Keep up to date. “I make sure I’m up to date with the literature, and I try to present a truthful message,” Dr. Hood said. “For instance, my research showed that inflammation played a strong role in developing complications from COVID, so I wrote a detailed treatment protocol aimed at the inflammation and the immune response, which has been very effective.”

4. Confront patients tactfully. Patients who do research on the Web don’t want to be scolded, Dr. Feldman said. In fact, he praises them, even if he doesn’t agree with their findings. “I might say: ‘What a relief to finally find patients who’ve taken the time to educate themselves before coming here.’ ”

Dr. Feldman is careful not to dispute patients’ conclusions. “Debating the issues is not an effective approach to get patients to trust you. The last thing you want to tell a patient is: ‘Listen to me! I’m an expert.’ People just dig in.”

However, it does help to give patients feedback. “I’m a big fan of patients arguing with me,” Dr. Hakeem said. “It means you can straighten out misunderstandings and improve decision-making.”

5. Explain your reasoning. “You need to communicate clearly and show them your thinking,” Dr. Hood said. “For instance, I’ll explain why a patient has a strong risk for heart attack.”

6. Acknowledge uncertainties. “The doctor may present the science as far more certain than it is,” Dr. Hakeem said. “If you don’t acknowledge the uncertainties, you could break the patient’s trust in you.”

7. Don’t use a lot of numbers. “Data is not a good tool to convince patients,” Dr. Feldman said. “The human brain isn’t designed to work that way.”

If you want to use numbers to show clinical risk, Dr. Hakeem advisd using natural frequencies, such as 10 out of 10,000, which is less confusing to the patient than the equivalent percentage of 0.1%.

It can be helpful to refer to familiar concepts. One way to understand a risk is to compare it with risks in daily life, such as the dangers of driving or falling in the shower, Dr. Hakeem added.

Dr. Feldman often refers to another person’s experience when presenting his medical advice. “I might say to the patient: ‘You remind me of another patient I had. They were sitting in the same chair you’re sitting in. They did really well on this drug, and I think it’s probably the best choice for you, too.’ ”

8. Adopt shared decision-making. This approach involves empowering the patient to become an equal partner in medical decisions. The patient is given information through portals and is encouraged to do research. Critics, however, say that most patients don’t want this degree of empowerment and would rather depend on the doctor’s advice.

Conclusion

It’s often impossible to get through to a skeptical patient, which can be disheartening for doctors. “Physicians want to do what is best for the patient, so when the patient doesn’t listen, they may take it personally,” Dr. Hood said. “But you always have to remember, the patient is the one with disease, and it’s up to the patient to open the door.”

Still, some skeptical patients ultimately change their minds. Dr. Schumann said patients who initially declined the COVID vaccine eventually decided to get it. “It often took them more than a year. but it’s never too late.”

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

Gregory A. Hood, MD, remembers a patient of his who was perpetually dubious about COVID-19 – and then couldn’t be saved.

“I spoke to him on many occasions about the dangers of COVID, but he just didn’t believe me,” said Dr. Hood, an internist in Lexington, Ky. “He just didn’t give me enough time to help him. He waited to let me know he was ill with COVID and took days to pick up the medicine. Unfortunately, he then passed away.”
 

The rise of the skeptical patient

It can be extremely frustrating for doctors when patients question or disbelieve their physician’s medical advice and explanations. And many physicians resent the amount of time they spend trying to explain or make their case, especially during a busy day. But patients’ skepticism about the validity of some treatments seems to be increasing.

“Patients are now more likely to have their own medical explanation for their complaint than they used to, and that can be bad for their health,” Dr. Hood said.

Dr. Hood sees medical cynicism as part of Americans’ growing distrust of experts, leveraged by easy access to the internet. “When people Google, they tend to look for support of their opinions, rather than arrive at a fully educated decision.”

Only about half of patients believe their physicians “provide fair and accurate treatment information all or most of the time,” according to a 2019 survey by the Pew Research Center.

Patients’ distrust has become more obvious during the COVID-19 pandemic, said John Schumann, MD, an internist with Oak Street Health, a practice with more than 500 physicians and other providers in 20 states, treating almost exclusively Medicare patients.

“The skeptics became more entrenched during the pandemic,” said Dr. Schumann, who is based in Tulsa, Okla. “They may think the COVID vaccines were approved too quickly, or believe the pandemic itself is a hoax.”

“There’s a lot of antiscience rhetoric now,” Dr. Schumann added. “I’d say about half of my patients are comfortable with science-based decisions and the other half are not.”
 

What are patients mistrustful about?

Patients’ suspicions of certain therapies began long before the pandemic. In dermatology, for example, some patients refuse to take topical steroids, said Steven R. Feldman, MD, a dermatologist in Winston-Salem, N.C.

“Their distrust is usually based on anecdotal stories they read about,” he noted. “Patients in other specialties are dead set against vaccinations.”

In addition to refusing treatments and inoculations, some patients ask for questionable regimens mentioned in the news. “Some patients have demanded hydroxychloroquine or Noromectin, drugs that are unproven in the treatment of COVID,” Dr. Schumann said. “We refuse to prescribe them.”

Dr. Hood said patients’ reluctance to follow medical advice can often be based on cost. “I have a patient who was more willing to save $20 than to save his life. But when the progression of his test results fit my predictions, he became more willing to take treatments. I had to wait for the opportune moment to convince him.”

Many naysayer patients keep their views to themselves, and physicians may be unaware that the patients are stonewalling. A 2006 study estimated that about 10%-16% of primary care patients actively resist medical authority.

Dr. Schumann cited patients who don’t want to hear an upsetting diagnosis. “Some patients might refuse to take a biopsy to see if they have cancer because they don’t want to know,” he said. “In many cases, they simply won’t get the biopsy and won’t tell the doctor that they didn’t.”
 

Sometimes skeptics’ arguments have merit

Some patients’ concerns can be valid, such as when they refuse to go on statins, said Zain Hakeem, DO, a physician in Austin, Tex.

“In some cases, I feel that statins are not necessary,” he said. “The science on statins for primary prevention is not strong, although they should be used for exceedingly high-risk patients.”

Certain patients, especially those with chronic conditions, do a great deal of research, using legitimate sources on the Web, and their research is well supported.

However, these patients can be overconfident in their conclusions. Several studies have shown that with just a little experience, people can replace beginners’ caution with a false sense of competence.

For example, “Patients may not weigh the risks correctly,” Dr. Hakeem said. “They can be more concerned about the risk of having their colon perforated during a colonoscopy, while the risk of cancer if they don’t have a colonoscopy is much higher.”

Some highly successful people may be more likely to trust their own medical instincts. When Steve Jobs, the founder of Apple, was diagnosed with pancreatic cancer in 2003, he put off surgery for 9 months while he tried to cure his disease with a vegan diet, acupuncture, herbs, bowel cleansings, and other remedies he read about. He died in 2011. Some experts believe that delay hastened his death.

Of course, not all physicians’ diagnoses or treatments are correct. One study indicated doctors’ diagnostic error rate could be as high as 15%. And just as patients can be overconfident in their conclusions, so can doctors. Another study found that physicians’ stated confidence in their diagnosis was only slightly affected by the inaccuracy of that diagnosis or the difficulty of the case.
 

Best ways to deal with cynical patients

Patients’ skepticism can frustrate doctors, reduce the efficiency of care delivery, and interfere with recovery. What can doctors do to deal with these problems?

1. Build the patient’s trust in you. “Getting patients to adhere to your advice involves making sure they feel they have a caring doctor whom they trust,” Dr. Feldman said.

“I want to show patients that I am entirely focused on them,” he added. “For example, I may rush to the door of the exam room from my last appointment, but I open the door very slowly and deliberately, because I want the patient to see that I won’t hurry with them.”

2. Spend time with the patient. Familiarity builds trust. Dr. Schumann said doctors at Oak Street Health see their patients an average of six to eight times a year, an unusually high number. “The more patients see their physicians, the more likely they are to trust them.”

3. Keep up to date. “I make sure I’m up to date with the literature, and I try to present a truthful message,” Dr. Hood said. “For instance, my research showed that inflammation played a strong role in developing complications from COVID, so I wrote a detailed treatment protocol aimed at the inflammation and the immune response, which has been very effective.”

4. Confront patients tactfully. Patients who do research on the Web don’t want to be scolded, Dr. Feldman said. In fact, he praises them, even if he doesn’t agree with their findings. “I might say: ‘What a relief to finally find patients who’ve taken the time to educate themselves before coming here.’ ”

Dr. Feldman is careful not to dispute patients’ conclusions. “Debating the issues is not an effective approach to get patients to trust you. The last thing you want to tell a patient is: ‘Listen to me! I’m an expert.’ People just dig in.”

However, it does help to give patients feedback. “I’m a big fan of patients arguing with me,” Dr. Hakeem said. “It means you can straighten out misunderstandings and improve decision-making.”

5. Explain your reasoning. “You need to communicate clearly and show them your thinking,” Dr. Hood said. “For instance, I’ll explain why a patient has a strong risk for heart attack.”

6. Acknowledge uncertainties. “The doctor may present the science as far more certain than it is,” Dr. Hakeem said. “If you don’t acknowledge the uncertainties, you could break the patient’s trust in you.”

7. Don’t use a lot of numbers. “Data is not a good tool to convince patients,” Dr. Feldman said. “The human brain isn’t designed to work that way.”

If you want to use numbers to show clinical risk, Dr. Hakeem advisd using natural frequencies, such as 10 out of 10,000, which is less confusing to the patient than the equivalent percentage of 0.1%.

It can be helpful to refer to familiar concepts. One way to understand a risk is to compare it with risks in daily life, such as the dangers of driving or falling in the shower, Dr. Hakeem added.

Dr. Feldman often refers to another person’s experience when presenting his medical advice. “I might say to the patient: ‘You remind me of another patient I had. They were sitting in the same chair you’re sitting in. They did really well on this drug, and I think it’s probably the best choice for you, too.’ ”

8. Adopt shared decision-making. This approach involves empowering the patient to become an equal partner in medical decisions. The patient is given information through portals and is encouraged to do research. Critics, however, say that most patients don’t want this degree of empowerment and would rather depend on the doctor’s advice.

Conclusion

It’s often impossible to get through to a skeptical patient, which can be disheartening for doctors. “Physicians want to do what is best for the patient, so when the patient doesn’t listen, they may take it personally,” Dr. Hood said. “But you always have to remember, the patient is the one with disease, and it’s up to the patient to open the door.”

Still, some skeptical patients ultimately change their minds. Dr. Schumann said patients who initially declined the COVID vaccine eventually decided to get it. “It often took them more than a year. but it’s never too late.”

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

Full vaccination status against COVID-19 was associated with significantly reduced mortality among critically ill patients with COVID-19 who needed mechanical ventilation, according to results of a study that involved 265 adults.

Although COVID-19 vaccination has been demonstrated to be effective at preventing infection, breakthrough infections occur, write Eirini Grapsa, RN, of Kapodistrian University of Athens Medical School, Greece, and colleagues. The potential protective benefits of vaccination for patients who experience these breakthrough infections, especially cases severe enough to require hospitalization and the need for mechanical ventilation, have not been well studied, the investigators say.

In a study published in JAMA Network Open, the researchers reviewed data from 265 consecutive patients older than 18 years who were admitted to intensive care units at three tertiary care centers with confirmed SARS-CoV-2 infections between June 7, 2021, and Feb. 1, 2022. All patients in the study received invasive mechanical ventilation because of acute respiratory distress syndrome (ARDS). The patients were divided into two groups: 26 patients were in the full vaccination group, and 239 served as control patients. Full vaccination was defined as having completed the primary COVID-19 series more than 14 days but less than 5 months before intubation. The control group included patients who had been fully vaccinated for less than 14 days or more than 5 months, were partially vaccinated, or were not vaccinated. A total of 20 of 26 patients in the full vaccination group received the Pfizer BioNTech BNT162b2 vaccine, as did 25 of the 33 vaccinated patients in the control group.

The median age of the patients overall was 66 years; 36% were women, and 99% were White. Patients in the full vaccination group were more likely to be older and to have comorbidities. The primary outcome was the time from intubation to all-cause mortality.

Overall, mortality was lower among the patients with full vaccination status than among those in the control group (61.5% vs. 68.2%; P = .03). Full vaccination also was associated with lower mortality in sensitivity analyses that included (a) only patients who received an mRNA vaccine in the full vaccination group, and (b) only unvaccinated patients in the control group (hazard ratios, 0.47 and 0.54, respectively).

In a regression model that examined secondary outcomes, the HR was 0.40 for the association between full vaccination and 28-day mortality. No significant differences were seen in length of stay in the intensive care unit (ICU) or length of hospital stay among survivors, nor in the occurrence of bacteremia, use of vasopressors, number of vasopressor-free days, use of continuous kidney replacement therapy (CKRT), number of CKRT-free days, and the number of ventilator-free and ICU-free days.

“Our choice to take time since vaccination into consideration was based on several previous studies indicating that protection against infection from vaccination (specifically with mRNA vaccines, such as BNT162b2, which was administered to 76.9% of patients in the full vaccination group) may decrease over time,” the researchers write.

Oxygenation was higher in the full vaccination group than in the control group on the third day after intubation. Previous studies conducted before the COVID-19 pandemic have shown that oxygenation on the third day after intubation may be more strongly associated with mortality than oxygenation on the day of intubation, the researchers note. Bacteremia was higher among the control patients and could have affected mortality, although the difference between vaccinated patients and control patients was not significant, the researchers add.

The study findings were limited by several factors, including small sample size, which prevented direct comparisons of the effectiveness of different numbers of vaccine doses or vaccine types, the researchers note. Other limitations include selection bias and residual confounding variables, they say.

The results demonstrate an association between full vaccination and lower mortality and suggest that vaccination may benefit patients with COVID-19–related ARDS, beyond the need for mechanical ventilation alone, they say. “These results expand our understanding of the outcomes of patients with breakthrough infections,” they conclude.

The study was supported by a grant to corresponding author Ilias I. Siempos, MD, from the Hellenic Foundation for Research and Innovation. The researchers have disclosed no relevant financial relationships.

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

Full vaccination status against COVID-19 was associated with significantly reduced mortality among critically ill patients with COVID-19 who needed mechanical ventilation, according to results of a study that involved 265 adults.

Although COVID-19 vaccination has been demonstrated to be effective at preventing infection, breakthrough infections occur, write Eirini Grapsa, RN, of Kapodistrian University of Athens Medical School, Greece, and colleagues. The potential protective benefits of vaccination for patients who experience these breakthrough infections, especially cases severe enough to require hospitalization and the need for mechanical ventilation, have not been well studied, the investigators say.

In a study published in JAMA Network Open, the researchers reviewed data from 265 consecutive patients older than 18 years who were admitted to intensive care units at three tertiary care centers with confirmed SARS-CoV-2 infections between June 7, 2021, and Feb. 1, 2022. All patients in the study received invasive mechanical ventilation because of acute respiratory distress syndrome (ARDS). The patients were divided into two groups: 26 patients were in the full vaccination group, and 239 served as control patients. Full vaccination was defined as having completed the primary COVID-19 series more than 14 days but less than 5 months before intubation. The control group included patients who had been fully vaccinated for less than 14 days or more than 5 months, were partially vaccinated, or were not vaccinated. A total of 20 of 26 patients in the full vaccination group received the Pfizer BioNTech BNT162b2 vaccine, as did 25 of the 33 vaccinated patients in the control group.

The median age of the patients overall was 66 years; 36% were women, and 99% were White. Patients in the full vaccination group were more likely to be older and to have comorbidities. The primary outcome was the time from intubation to all-cause mortality.

Overall, mortality was lower among the patients with full vaccination status than among those in the control group (61.5% vs. 68.2%; P = .03). Full vaccination also was associated with lower mortality in sensitivity analyses that included (a) only patients who received an mRNA vaccine in the full vaccination group, and (b) only unvaccinated patients in the control group (hazard ratios, 0.47 and 0.54, respectively).

In a regression model that examined secondary outcomes, the HR was 0.40 for the association between full vaccination and 28-day mortality. No significant differences were seen in length of stay in the intensive care unit (ICU) or length of hospital stay among survivors, nor in the occurrence of bacteremia, use of vasopressors, number of vasopressor-free days, use of continuous kidney replacement therapy (CKRT), number of CKRT-free days, and the number of ventilator-free and ICU-free days.

“Our choice to take time since vaccination into consideration was based on several previous studies indicating that protection against infection from vaccination (specifically with mRNA vaccines, such as BNT162b2, which was administered to 76.9% of patients in the full vaccination group) may decrease over time,” the researchers write.

Oxygenation was higher in the full vaccination group than in the control group on the third day after intubation. Previous studies conducted before the COVID-19 pandemic have shown that oxygenation on the third day after intubation may be more strongly associated with mortality than oxygenation on the day of intubation, the researchers note. Bacteremia was higher among the control patients and could have affected mortality, although the difference between vaccinated patients and control patients was not significant, the researchers add.

The study findings were limited by several factors, including small sample size, which prevented direct comparisons of the effectiveness of different numbers of vaccine doses or vaccine types, the researchers note. Other limitations include selection bias and residual confounding variables, they say.

The results demonstrate an association between full vaccination and lower mortality and suggest that vaccination may benefit patients with COVID-19–related ARDS, beyond the need for mechanical ventilation alone, they say. “These results expand our understanding of the outcomes of patients with breakthrough infections,” they conclude.

The study was supported by a grant to corresponding author Ilias I. Siempos, MD, from the Hellenic Foundation for Research and Innovation. The researchers have disclosed no relevant financial relationships.

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

Full vaccination status against COVID-19 was associated with significantly reduced mortality among critically ill patients with COVID-19 who needed mechanical ventilation, according to results of a study that involved 265 adults.

Although COVID-19 vaccination has been demonstrated to be effective at preventing infection, breakthrough infections occur, write Eirini Grapsa, RN, of Kapodistrian University of Athens Medical School, Greece, and colleagues. The potential protective benefits of vaccination for patients who experience these breakthrough infections, especially cases severe enough to require hospitalization and the need for mechanical ventilation, have not been well studied, the investigators say.

In a study published in JAMA Network Open, the researchers reviewed data from 265 consecutive patients older than 18 years who were admitted to intensive care units at three tertiary care centers with confirmed SARS-CoV-2 infections between June 7, 2021, and Feb. 1, 2022. All patients in the study received invasive mechanical ventilation because of acute respiratory distress syndrome (ARDS). The patients were divided into two groups: 26 patients were in the full vaccination group, and 239 served as control patients. Full vaccination was defined as having completed the primary COVID-19 series more than 14 days but less than 5 months before intubation. The control group included patients who had been fully vaccinated for less than 14 days or more than 5 months, were partially vaccinated, or were not vaccinated. A total of 20 of 26 patients in the full vaccination group received the Pfizer BioNTech BNT162b2 vaccine, as did 25 of the 33 vaccinated patients in the control group.

The median age of the patients overall was 66 years; 36% were women, and 99% were White. Patients in the full vaccination group were more likely to be older and to have comorbidities. The primary outcome was the time from intubation to all-cause mortality.

Overall, mortality was lower among the patients with full vaccination status than among those in the control group (61.5% vs. 68.2%; P = .03). Full vaccination also was associated with lower mortality in sensitivity analyses that included (a) only patients who received an mRNA vaccine in the full vaccination group, and (b) only unvaccinated patients in the control group (hazard ratios, 0.47 and 0.54, respectively).

In a regression model that examined secondary outcomes, the HR was 0.40 for the association between full vaccination and 28-day mortality. No significant differences were seen in length of stay in the intensive care unit (ICU) or length of hospital stay among survivors, nor in the occurrence of bacteremia, use of vasopressors, number of vasopressor-free days, use of continuous kidney replacement therapy (CKRT), number of CKRT-free days, and the number of ventilator-free and ICU-free days.

“Our choice to take time since vaccination into consideration was based on several previous studies indicating that protection against infection from vaccination (specifically with mRNA vaccines, such as BNT162b2, which was administered to 76.9% of patients in the full vaccination group) may decrease over time,” the researchers write.

Oxygenation was higher in the full vaccination group than in the control group on the third day after intubation. Previous studies conducted before the COVID-19 pandemic have shown that oxygenation on the third day after intubation may be more strongly associated with mortality than oxygenation on the day of intubation, the researchers note. Bacteremia was higher among the control patients and could have affected mortality, although the difference between vaccinated patients and control patients was not significant, the researchers add.

The study findings were limited by several factors, including small sample size, which prevented direct comparisons of the effectiveness of different numbers of vaccine doses or vaccine types, the researchers note. Other limitations include selection bias and residual confounding variables, they say.

The results demonstrate an association between full vaccination and lower mortality and suggest that vaccination may benefit patients with COVID-19–related ARDS, beyond the need for mechanical ventilation alone, they say. “These results expand our understanding of the outcomes of patients with breakthrough infections,” they conclude.

The study was supported by a grant to corresponding author Ilias I. Siempos, MD, from the Hellenic Foundation for Research and Innovation. The researchers have disclosed no relevant financial relationships.

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