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Cloth masks should not be considered equivalent to medical masks for the prevention of COVID-19 in clinical settings, according to an evidence review published Jan. 11 in Annals of Family Medicine.

Nevertheless, cloth masks may provide some degree of protection, filtration studies indicate. If clinicians use cloth masks, they should take into account the fit, material, and number of layers, the review authors wrote.

And if cloth masks are used as a last resort, such as during shortages of personal protective equipment (PPE), additional measures may help, such as pairing cloth masks with plastic face shields.

“We recommend frequent cloth mask changes to reduce the risk of moisture retention and washing according to hospital laundry standards to decrease the risk of ineffective cleaning,” review author Ariel Kiyomi Daoud, a researcher at the University of Colorado at Denver, Aurora, and colleagues wrote.

The investigators identified and analyzed nine studies related to cloth masks’ ability to prevent respiratory viral infections among health care clinicians. The studies generally were not specific to SARS-CoV-2. They focused on four nonrandomized trials, three laboratory efficacy studies, one single-case experiment, and one randomized controlled trial.
 

Filtration and fit

“Seven publications addressed the filtration efficacy of commercial cloth masks or materials used to create homemade masks ... in a laboratory setting,” the researchers wrote. These studies found that cloth materials prevent some level of penetration, but generally have “lesser filtration efficiency and greater variability than medical masks” do.

One study found that the materials with the greatest filtration efficacy – vacuum bags and tea towels – had low airflow, which limits their use.

Two studies found that additional layers may increase the viral filtration efficacy of cloth masks.

Several studies that assessed mask fit and airflow found that cloth masks “have worse fit and a greater level of particle leakage, compared to medical masks,” the authors reported. Most studies did not examine cloth masks’ ability to protect wearers from respiratory droplets or contact, which the World Health Organization consider the primary means of SARS-CoV-2 spread, with aerosols playing a smaller role. “Thus, we must interpret these results with caution in the context of COVID-19,” the authors wrote. “For a primary care clinician without access to medical masks, our qualitative synthesis of the literature suggests that it is better to wear a cloth mask than no mask,” as long as other protective measures are considered along with cloth mask use.

Generally consistent guidance

Agencies and researchers have shared similar recommendations about the use of cloth masks in health care settings.

“Health care workers are at the frontline and they need to be protected,” said Abrar Ahmad Chughtai, MBBS, MPH, PhD, an epidemiologist at University of New South Wales, Sydney, in an interview. “Many studies show that respirators are more effective, compared to medical masks, and medical masks are more effective, compared to cloth masks. So ideally, all frontline health care workers should use respirators. If respirators are not available, then medical masks should be used. Cloth masks are not as effective as medical masks and ideally should not be used in health care settings.”

Dr. Chughtai has written about cloth masks for protection against SARS-CoV-2 and was an investigator for a 2015 randomized trial that compared medical masks and cloth masks in health care workers.

In that trial, which was considered in the review, greater rates of influenza-like illness occurred in the cloth mask arm, compared with the medical mask arm.

“Studies show that three or more layers of cloth may reduce the spread of droplets and aerosols from the wearers,” Dr. Chughtai said. “So, cloth masks may be used in community settings to prevent spread of infections from the sick, particularly asymptomatic, people.”

In addition, cloth masks “may be used by health care workers as a last resort, if no other option is available,” he said. In that case, they should have at least three layers, fit to the face, and be washed regularly.
 

Not considered PPE

According to routine infection prevention and control recommendations for health care personnel from the Centers for Disease Control and Prevention, face masks – often referred to as surgical masks or procedure masks – should be worn by workers “at all times while they are in the healthcare facility, including in break rooms or other spaces where they might encounter coworkers.”

Unlike cloth masks, face masks offer “protection for the wearer against exposure to splashes and sprays of infectious material from others,” as well as source control, the agency says. Health care personnel “should remove their respirator or face mask, perform hand hygiene, and put on their cloth mask when leaving the facility at the end of their shift,” according to the CDC.

“Cloth masks are NOT PPE and should not be worn for the care of patients with suspected or confirmed COVID-19 or other situations where use of a respirator or face mask is recommended,” the agency notes.

When respirators or face masks are unavailable, health care personnel “might use cloth masks as a last resort for care of patients with suspected or confirmed diagnosis for which face mask or respirator use is normally recommended,” according to CDC guidance.

In that scenario, cloth masks “should ideally be used in combination with a face shield that covers the entire front (that extends to the chin or below) and sides of the face,” the CDC says.
 

Limited data for comparisons

A Dec. 29, 2020, update in Annals of Internal Medicine about masks for prevention of respiratory virus infections highlighted two recent studies in the United States that reported on mask use in health care settings. A study of more than 16,000 health care workers and first responders found that those who used an N95 or surgical mask all of the time were less likely to have SARS-CoV-2 antibodies, compared with workers who did not wear masks all the time. The adjusted odds ratio with consistent N95 use was 0.83, and the aOR with consistent surgical mask use was 0.86.

In the second study, which included more than 20,000 asymptomatic health care workers, risk for infection was reduced with any mask use versus no mask use (OR, 0.58). An N95 mask was associated with decreased risk versus a surgical mask (OR, 0.76). The studies had methodological limitations, however, and “evidence for various comparisons about mask use in health care settings and risk for SARS-CoV-2 remains insufficient,” the authors of the update wrote.

The Annals of Family Medicine review authors had no relevant disclosures. Dr. Chughtai has tested filtration of 3M masks and worked with CleanSpace Technology to research fit testing of respirators, and the 2015 randomized trial was funded by an Australian Research Council Linkage Grant with 3M as a partner on the grant. The Dec. 29, 2020, update was of a review that originally was supported by grants from the Agency for Healthcare Research Quality.

[email protected]

SOURCE: Daoud AK et al. Ann Fam Med. 2020 Jan 11. doi: 10.1370/afm.2640.

Cloth masks should not be considered equivalent to medical masks for the prevention of COVID-19 in clinical settings, according to an evidence review published Jan. 11 in Annals of Family Medicine.

Nevertheless, cloth masks may provide some degree of protection, filtration studies indicate. If clinicians use cloth masks, they should take into account the fit, material, and number of layers, the review authors wrote.

And if cloth masks are used as a last resort, such as during shortages of personal protective equipment (PPE), additional measures may help, such as pairing cloth masks with plastic face shields.

“We recommend frequent cloth mask changes to reduce the risk of moisture retention and washing according to hospital laundry standards to decrease the risk of ineffective cleaning,” review author Ariel Kiyomi Daoud, a researcher at the University of Colorado at Denver, Aurora, and colleagues wrote.

The investigators identified and analyzed nine studies related to cloth masks’ ability to prevent respiratory viral infections among health care clinicians. The studies generally were not specific to SARS-CoV-2. They focused on four nonrandomized trials, three laboratory efficacy studies, one single-case experiment, and one randomized controlled trial.
 

Filtration and fit

“Seven publications addressed the filtration efficacy of commercial cloth masks or materials used to create homemade masks ... in a laboratory setting,” the researchers wrote. These studies found that cloth materials prevent some level of penetration, but generally have “lesser filtration efficiency and greater variability than medical masks” do.

One study found that the materials with the greatest filtration efficacy – vacuum bags and tea towels – had low airflow, which limits their use.

Two studies found that additional layers may increase the viral filtration efficacy of cloth masks.

Several studies that assessed mask fit and airflow found that cloth masks “have worse fit and a greater level of particle leakage, compared to medical masks,” the authors reported. Most studies did not examine cloth masks’ ability to protect wearers from respiratory droplets or contact, which the World Health Organization consider the primary means of SARS-CoV-2 spread, with aerosols playing a smaller role. “Thus, we must interpret these results with caution in the context of COVID-19,” the authors wrote. “For a primary care clinician without access to medical masks, our qualitative synthesis of the literature suggests that it is better to wear a cloth mask than no mask,” as long as other protective measures are considered along with cloth mask use.

Generally consistent guidance

Agencies and researchers have shared similar recommendations about the use of cloth masks in health care settings.

“Health care workers are at the frontline and they need to be protected,” said Abrar Ahmad Chughtai, MBBS, MPH, PhD, an epidemiologist at University of New South Wales, Sydney, in an interview. “Many studies show that respirators are more effective, compared to medical masks, and medical masks are more effective, compared to cloth masks. So ideally, all frontline health care workers should use respirators. If respirators are not available, then medical masks should be used. Cloth masks are not as effective as medical masks and ideally should not be used in health care settings.”

Dr. Chughtai has written about cloth masks for protection against SARS-CoV-2 and was an investigator for a 2015 randomized trial that compared medical masks and cloth masks in health care workers.

In that trial, which was considered in the review, greater rates of influenza-like illness occurred in the cloth mask arm, compared with the medical mask arm.

“Studies show that three or more layers of cloth may reduce the spread of droplets and aerosols from the wearers,” Dr. Chughtai said. “So, cloth masks may be used in community settings to prevent spread of infections from the sick, particularly asymptomatic, people.”

In addition, cloth masks “may be used by health care workers as a last resort, if no other option is available,” he said. In that case, they should have at least three layers, fit to the face, and be washed regularly.
 

Not considered PPE

According to routine infection prevention and control recommendations for health care personnel from the Centers for Disease Control and Prevention, face masks – often referred to as surgical masks or procedure masks – should be worn by workers “at all times while they are in the healthcare facility, including in break rooms or other spaces where they might encounter coworkers.”

Unlike cloth masks, face masks offer “protection for the wearer against exposure to splashes and sprays of infectious material from others,” as well as source control, the agency says. Health care personnel “should remove their respirator or face mask, perform hand hygiene, and put on their cloth mask when leaving the facility at the end of their shift,” according to the CDC.

“Cloth masks are NOT PPE and should not be worn for the care of patients with suspected or confirmed COVID-19 or other situations where use of a respirator or face mask is recommended,” the agency notes.

When respirators or face masks are unavailable, health care personnel “might use cloth masks as a last resort for care of patients with suspected or confirmed diagnosis for which face mask or respirator use is normally recommended,” according to CDC guidance.

In that scenario, cloth masks “should ideally be used in combination with a face shield that covers the entire front (that extends to the chin or below) and sides of the face,” the CDC says.
 

Limited data for comparisons

A Dec. 29, 2020, update in Annals of Internal Medicine about masks for prevention of respiratory virus infections highlighted two recent studies in the United States that reported on mask use in health care settings. A study of more than 16,000 health care workers and first responders found that those who used an N95 or surgical mask all of the time were less likely to have SARS-CoV-2 antibodies, compared with workers who did not wear masks all the time. The adjusted odds ratio with consistent N95 use was 0.83, and the aOR with consistent surgical mask use was 0.86.

In the second study, which included more than 20,000 asymptomatic health care workers, risk for infection was reduced with any mask use versus no mask use (OR, 0.58). An N95 mask was associated with decreased risk versus a surgical mask (OR, 0.76). The studies had methodological limitations, however, and “evidence for various comparisons about mask use in health care settings and risk for SARS-CoV-2 remains insufficient,” the authors of the update wrote.

The Annals of Family Medicine review authors had no relevant disclosures. Dr. Chughtai has tested filtration of 3M masks and worked with CleanSpace Technology to research fit testing of respirators, and the 2015 randomized trial was funded by an Australian Research Council Linkage Grant with 3M as a partner on the grant. The Dec. 29, 2020, update was of a review that originally was supported by grants from the Agency for Healthcare Research Quality.

[email protected]

SOURCE: Daoud AK et al. Ann Fam Med. 2020 Jan 11. doi: 10.1370/afm.2640.

Cloth masks should not be considered equivalent to medical masks for the prevention of COVID-19 in clinical settings, according to an evidence review published Jan. 11 in Annals of Family Medicine.

Nevertheless, cloth masks may provide some degree of protection, filtration studies indicate. If clinicians use cloth masks, they should take into account the fit, material, and number of layers, the review authors wrote.

And if cloth masks are used as a last resort, such as during shortages of personal protective equipment (PPE), additional measures may help, such as pairing cloth masks with plastic face shields.

“We recommend frequent cloth mask changes to reduce the risk of moisture retention and washing according to hospital laundry standards to decrease the risk of ineffective cleaning,” review author Ariel Kiyomi Daoud, a researcher at the University of Colorado at Denver, Aurora, and colleagues wrote.

The investigators identified and analyzed nine studies related to cloth masks’ ability to prevent respiratory viral infections among health care clinicians. The studies generally were not specific to SARS-CoV-2. They focused on four nonrandomized trials, three laboratory efficacy studies, one single-case experiment, and one randomized controlled trial.
 

Filtration and fit

“Seven publications addressed the filtration efficacy of commercial cloth masks or materials used to create homemade masks ... in a laboratory setting,” the researchers wrote. These studies found that cloth materials prevent some level of penetration, but generally have “lesser filtration efficiency and greater variability than medical masks” do.

One study found that the materials with the greatest filtration efficacy – vacuum bags and tea towels – had low airflow, which limits their use.

Two studies found that additional layers may increase the viral filtration efficacy of cloth masks.

Several studies that assessed mask fit and airflow found that cloth masks “have worse fit and a greater level of particle leakage, compared to medical masks,” the authors reported. Most studies did not examine cloth masks’ ability to protect wearers from respiratory droplets or contact, which the World Health Organization consider the primary means of SARS-CoV-2 spread, with aerosols playing a smaller role. “Thus, we must interpret these results with caution in the context of COVID-19,” the authors wrote. “For a primary care clinician without access to medical masks, our qualitative synthesis of the literature suggests that it is better to wear a cloth mask than no mask,” as long as other protective measures are considered along with cloth mask use.

Generally consistent guidance

Agencies and researchers have shared similar recommendations about the use of cloth masks in health care settings.

“Health care workers are at the frontline and they need to be protected,” said Abrar Ahmad Chughtai, MBBS, MPH, PhD, an epidemiologist at University of New South Wales, Sydney, in an interview. “Many studies show that respirators are more effective, compared to medical masks, and medical masks are more effective, compared to cloth masks. So ideally, all frontline health care workers should use respirators. If respirators are not available, then medical masks should be used. Cloth masks are not as effective as medical masks and ideally should not be used in health care settings.”

Dr. Chughtai has written about cloth masks for protection against SARS-CoV-2 and was an investigator for a 2015 randomized trial that compared medical masks and cloth masks in health care workers.

In that trial, which was considered in the review, greater rates of influenza-like illness occurred in the cloth mask arm, compared with the medical mask arm.

“Studies show that three or more layers of cloth may reduce the spread of droplets and aerosols from the wearers,” Dr. Chughtai said. “So, cloth masks may be used in community settings to prevent spread of infections from the sick, particularly asymptomatic, people.”

In addition, cloth masks “may be used by health care workers as a last resort, if no other option is available,” he said. In that case, they should have at least three layers, fit to the face, and be washed regularly.
 

Not considered PPE

According to routine infection prevention and control recommendations for health care personnel from the Centers for Disease Control and Prevention, face masks – often referred to as surgical masks or procedure masks – should be worn by workers “at all times while they are in the healthcare facility, including in break rooms or other spaces where they might encounter coworkers.”

Unlike cloth masks, face masks offer “protection for the wearer against exposure to splashes and sprays of infectious material from others,” as well as source control, the agency says. Health care personnel “should remove their respirator or face mask, perform hand hygiene, and put on their cloth mask when leaving the facility at the end of their shift,” according to the CDC.

“Cloth masks are NOT PPE and should not be worn for the care of patients with suspected or confirmed COVID-19 or other situations where use of a respirator or face mask is recommended,” the agency notes.

When respirators or face masks are unavailable, health care personnel “might use cloth masks as a last resort for care of patients with suspected or confirmed diagnosis for which face mask or respirator use is normally recommended,” according to CDC guidance.

In that scenario, cloth masks “should ideally be used in combination with a face shield that covers the entire front (that extends to the chin or below) and sides of the face,” the CDC says.
 

Limited data for comparisons

A Dec. 29, 2020, update in Annals of Internal Medicine about masks for prevention of respiratory virus infections highlighted two recent studies in the United States that reported on mask use in health care settings. A study of more than 16,000 health care workers and first responders found that those who used an N95 or surgical mask all of the time were less likely to have SARS-CoV-2 antibodies, compared with workers who did not wear masks all the time. The adjusted odds ratio with consistent N95 use was 0.83, and the aOR with consistent surgical mask use was 0.86.

In the second study, which included more than 20,000 asymptomatic health care workers, risk for infection was reduced with any mask use versus no mask use (OR, 0.58). An N95 mask was associated with decreased risk versus a surgical mask (OR, 0.76). The studies had methodological limitations, however, and “evidence for various comparisons about mask use in health care settings and risk for SARS-CoV-2 remains insufficient,” the authors of the update wrote.

The Annals of Family Medicine review authors had no relevant disclosures. Dr. Chughtai has tested filtration of 3M masks and worked with CleanSpace Technology to research fit testing of respirators, and the 2015 randomized trial was funded by an Australian Research Council Linkage Grant with 3M as a partner on the grant. The Dec. 29, 2020, update was of a review that originally was supported by grants from the Agency for Healthcare Research Quality.

[email protected]

SOURCE: Daoud AK et al. Ann Fam Med. 2020 Jan 11. doi: 10.1370/afm.2640.

Evidence that a SARS-CoV-2 vaccine is associated with inflammatory reactions in patients with dermal fillers has led the American Society for Dermatologic Surgery to issue a guidance outlining the potential risk and clinical relevance.

The association is not surprising, since other vaccines, including the influenza vaccine, have also been associated with inflammatory reactions in patients with dermal fillers. A warning about inflammatory events from these and other immunologic triggers should be part of routine informed consent, according to Sue Ellen Cox, MD, a coauthor of the guidance and the ASDS president-elect.

“Patients who have had dermal filler should not be discouraged from receiving the vaccine, and those who have received the vaccine should not be discouraged from receiving dermal filler,” Dr. Cox, who practices in Chapel Hill, N.C., said in an interview.

The only available data to assess the risk came from the trial of the Moderna vaccine. Of a total of 15,184 participants who received at least one dose of mRNA-1273, three developed facial or lip swelling that was presumably related to dermal filler. In the placebo group, there were no comparable inflammatory events.

“This is a very small number, but there is no reliable information about the number of patients in either group who had dermal filler, so we do not know the denominator,” Dr. Cox said.

In all three cases, the swelling at the site of dermal filler was observed within 2 days of the vaccination. None were considered a serious adverse event and all resolved. The filler had been administered 2 weeks prior to vaccination in one case, 6 months prior in a second, and time of administration was unknown in the third.

The resolution of the inflammatory reactions associated with the SARS-CoV-2 vaccine is similar to those related to dermal fillers following other immunologic triggers, which not only include other vaccines, but viral or bacterial illnesses and dental procedures. Typically, they are readily controlled with oral corticosteroids, but also typically resolve even in the absence of treatment, according to Dr. Cox.

“The good news is that these will go away,” Dr. Cox said.

The ASDS guidance is meant to alert clinicians and patients to the potential association between inflammatory events and SARS-CoV-2 vaccination in patients with dermal filler, but Dr. Cox said that it will ultimately have very little effect on her own practice. She already employs an informed consent that includes language warning about the potential risk of local reactions to immunological triggers that include vaccines. SARS-CoV-2 vaccination can now be added to examples of potential triggers, but it does not change the importance of informing patients of such triggers, Dr. Cox explained.

Asked if patients should be informed specifically about the association between dermal filler inflammatory reactions and SARS-CoV-2 vaccine, the current ASDS president and first author of the guidance, Mathew Avram, MD, JD, suggested that they should. Although he emphasized that the side effect is clearly rare, he believes it deserves attention.

“We wanted dermatologists and other physicians to be aware of the potential. We focused on the available data but specifically decided not to provide any treatment recommendations at this time,” he said in an interview.

As new data become available, the Soft-Tissue Fillers Guideline Task Force of the ASDS, which provided the guidance, will continue to monitor the relationship between SARS-CoV-2 vaccinations and dermal filler reactions, including other SARS-CoV-2 vaccines and the relative risks for hyaluronic acid and non–hyaluronic acid types of fillers.

“Our guidance was based only on the trial data, but there will soon be tens of millions of patients exposed to several different SARS-CoV-2 vaccines. We may learn things we do not know now, and we plan to communicate to our membership and others any new information as events unfold,” said Dr. Avram, who is director of dermatologic surgery, Massachusetts General Hospital, Boston,

Based on her own expertise in the field, Dr. Cox suggested that administration of SARS-CoV-2 vaccine and administration of dermal filler should be separated by at least 2 weeks regardless of which comes first. Her recommendation is not based on controlled data, but she considers this a prudent interval even if it has not been tested in a controlled study.

The full ASDS guidance is scheduled to appear in an upcoming issue of Dermatologic Surgery.

As new data become available, the Soft-tissue Fillers Guideline Task Force of the ASDS, which provided the guidance, will continue to monitor the relationship between SARS-CoV-2 vaccinations and dermal filler reactions, including other types of vaccines and the relative risks for hyaluronic acid and non–hyaluronic acid types of fillers.

This article was updated 1/7/21.

Evidence that a SARS-CoV-2 vaccine is associated with inflammatory reactions in patients with dermal fillers has led the American Society for Dermatologic Surgery to issue a guidance outlining the potential risk and clinical relevance.

The association is not surprising, since other vaccines, including the influenza vaccine, have also been associated with inflammatory reactions in patients with dermal fillers. A warning about inflammatory events from these and other immunologic triggers should be part of routine informed consent, according to Sue Ellen Cox, MD, a coauthor of the guidance and the ASDS president-elect.

“Patients who have had dermal filler should not be discouraged from receiving the vaccine, and those who have received the vaccine should not be discouraged from receiving dermal filler,” Dr. Cox, who practices in Chapel Hill, N.C., said in an interview.

The only available data to assess the risk came from the trial of the Moderna vaccine. Of a total of 15,184 participants who received at least one dose of mRNA-1273, three developed facial or lip swelling that was presumably related to dermal filler. In the placebo group, there were no comparable inflammatory events.

“This is a very small number, but there is no reliable information about the number of patients in either group who had dermal filler, so we do not know the denominator,” Dr. Cox said.

In all three cases, the swelling at the site of dermal filler was observed within 2 days of the vaccination. None were considered a serious adverse event and all resolved. The filler had been administered 2 weeks prior to vaccination in one case, 6 months prior in a second, and time of administration was unknown in the third.

The resolution of the inflammatory reactions associated with the SARS-CoV-2 vaccine is similar to those related to dermal fillers following other immunologic triggers, which not only include other vaccines, but viral or bacterial illnesses and dental procedures. Typically, they are readily controlled with oral corticosteroids, but also typically resolve even in the absence of treatment, according to Dr. Cox.

“The good news is that these will go away,” Dr. Cox said.

The ASDS guidance is meant to alert clinicians and patients to the potential association between inflammatory events and SARS-CoV-2 vaccination in patients with dermal filler, but Dr. Cox said that it will ultimately have very little effect on her own practice. She already employs an informed consent that includes language warning about the potential risk of local reactions to immunological triggers that include vaccines. SARS-CoV-2 vaccination can now be added to examples of potential triggers, but it does not change the importance of informing patients of such triggers, Dr. Cox explained.

Asked if patients should be informed specifically about the association between dermal filler inflammatory reactions and SARS-CoV-2 vaccine, the current ASDS president and first author of the guidance, Mathew Avram, MD, JD, suggested that they should. Although he emphasized that the side effect is clearly rare, he believes it deserves attention.

“We wanted dermatologists and other physicians to be aware of the potential. We focused on the available data but specifically decided not to provide any treatment recommendations at this time,” he said in an interview.

As new data become available, the Soft-Tissue Fillers Guideline Task Force of the ASDS, which provided the guidance, will continue to monitor the relationship between SARS-CoV-2 vaccinations and dermal filler reactions, including other SARS-CoV-2 vaccines and the relative risks for hyaluronic acid and non–hyaluronic acid types of fillers.

“Our guidance was based only on the trial data, but there will soon be tens of millions of patients exposed to several different SARS-CoV-2 vaccines. We may learn things we do not know now, and we plan to communicate to our membership and others any new information as events unfold,” said Dr. Avram, who is director of dermatologic surgery, Massachusetts General Hospital, Boston,

Based on her own expertise in the field, Dr. Cox suggested that administration of SARS-CoV-2 vaccine and administration of dermal filler should be separated by at least 2 weeks regardless of which comes first. Her recommendation is not based on controlled data, but she considers this a prudent interval even if it has not been tested in a controlled study.

The full ASDS guidance is scheduled to appear in an upcoming issue of Dermatologic Surgery.

As new data become available, the Soft-tissue Fillers Guideline Task Force of the ASDS, which provided the guidance, will continue to monitor the relationship between SARS-CoV-2 vaccinations and dermal filler reactions, including other types of vaccines and the relative risks for hyaluronic acid and non–hyaluronic acid types of fillers.

This article was updated 1/7/21.

Evidence that a SARS-CoV-2 vaccine is associated with inflammatory reactions in patients with dermal fillers has led the American Society for Dermatologic Surgery to issue a guidance outlining the potential risk and clinical relevance.

The association is not surprising, since other vaccines, including the influenza vaccine, have also been associated with inflammatory reactions in patients with dermal fillers. A warning about inflammatory events from these and other immunologic triggers should be part of routine informed consent, according to Sue Ellen Cox, MD, a coauthor of the guidance and the ASDS president-elect.

“Patients who have had dermal filler should not be discouraged from receiving the vaccine, and those who have received the vaccine should not be discouraged from receiving dermal filler,” Dr. Cox, who practices in Chapel Hill, N.C., said in an interview.

The only available data to assess the risk came from the trial of the Moderna vaccine. Of a total of 15,184 participants who received at least one dose of mRNA-1273, three developed facial or lip swelling that was presumably related to dermal filler. In the placebo group, there were no comparable inflammatory events.

“This is a very small number, but there is no reliable information about the number of patients in either group who had dermal filler, so we do not know the denominator,” Dr. Cox said.

In all three cases, the swelling at the site of dermal filler was observed within 2 days of the vaccination. None were considered a serious adverse event and all resolved. The filler had been administered 2 weeks prior to vaccination in one case, 6 months prior in a second, and time of administration was unknown in the third.

The resolution of the inflammatory reactions associated with the SARS-CoV-2 vaccine is similar to those related to dermal fillers following other immunologic triggers, which not only include other vaccines, but viral or bacterial illnesses and dental procedures. Typically, they are readily controlled with oral corticosteroids, but also typically resolve even in the absence of treatment, according to Dr. Cox.

“The good news is that these will go away,” Dr. Cox said.

The ASDS guidance is meant to alert clinicians and patients to the potential association between inflammatory events and SARS-CoV-2 vaccination in patients with dermal filler, but Dr. Cox said that it will ultimately have very little effect on her own practice. She already employs an informed consent that includes language warning about the potential risk of local reactions to immunological triggers that include vaccines. SARS-CoV-2 vaccination can now be added to examples of potential triggers, but it does not change the importance of informing patients of such triggers, Dr. Cox explained.

Asked if patients should be informed specifically about the association between dermal filler inflammatory reactions and SARS-CoV-2 vaccine, the current ASDS president and first author of the guidance, Mathew Avram, MD, JD, suggested that they should. Although he emphasized that the side effect is clearly rare, he believes it deserves attention.

“We wanted dermatologists and other physicians to be aware of the potential. We focused on the available data but specifically decided not to provide any treatment recommendations at this time,” he said in an interview.

As new data become available, the Soft-Tissue Fillers Guideline Task Force of the ASDS, which provided the guidance, will continue to monitor the relationship between SARS-CoV-2 vaccinations and dermal filler reactions, including other SARS-CoV-2 vaccines and the relative risks for hyaluronic acid and non–hyaluronic acid types of fillers.

“Our guidance was based only on the trial data, but there will soon be tens of millions of patients exposed to several different SARS-CoV-2 vaccines. We may learn things we do not know now, and we plan to communicate to our membership and others any new information as events unfold,” said Dr. Avram, who is director of dermatologic surgery, Massachusetts General Hospital, Boston,

Based on her own expertise in the field, Dr. Cox suggested that administration of SARS-CoV-2 vaccine and administration of dermal filler should be separated by at least 2 weeks regardless of which comes first. Her recommendation is not based on controlled data, but she considers this a prudent interval even if it has not been tested in a controlled study.

The full ASDS guidance is scheduled to appear in an upcoming issue of Dermatologic Surgery.

As new data become available, the Soft-tissue Fillers Guideline Task Force of the ASDS, which provided the guidance, will continue to monitor the relationship between SARS-CoV-2 vaccinations and dermal filler reactions, including other types of vaccines and the relative risks for hyaluronic acid and non–hyaluronic acid types of fillers.

This article was updated 1/7/21.

In patients who undergo resection of pancreatic ductal adenocarcinoma (PDAC) after neoadjuvant therapy, reduction in tumor size between diagnosis and surgery is associated with improved survival, according to a new single-center, retrospective analysis. The researchers compared tumor size as measured by endoscopic ultrasound (EUS) and found that a threshold of 47% or greater reduction in tumor size at resection was associated with a doubling in the 3-year survival rate.

The study, led by Rohit Das, MD, of the University of Pittsburgh Medical Center, was published in Clinical Gastroenterology and Hepatology.

The research represents only a small percentage of patients since most diagnosed with PDAC have locally advanced or metastatic disease that rules out surgery. Still, the work puts more emphasis on measuring tumor size while performing EUS, according to Robert Jay Sealock, MD, who is an assistant professor of medicine at Baylor College of Medicine, Houston.

“This is some helpful information that you can relay to the patient, saying that you have a significant decrease in the size of the tumor based on your initial EUS, and your chance of 3- to 5-year survival is going to be a lot higher, compared to somebody that didn’t have that tumor regression. Most of these patients will undergo an EUS anyway, and you’ll commonly if not always measure the tumor size while you’re in there. Now you can apply this information that you already have to give the patients some additional information if they do undergo surgery,” said Dr. Sealock, who was not involved in the research.

Previous efforts to prognosticate postsurgical survival focused on overall tumor burden using multidetector CT (MDCT), carbohydrate antigen 19-9 (CA19-9) levels, and histologic examination following surgery, but all suffer from various limitations. MDCT is not always accurate in its measurement of tumor size, other conditions can also raise CA19-9 levels, and pathologic findings are subjective because sometimes the amount of tumor before neoadjuvant therapy is uncertain.

The researchers mapped survival statistics to EUS and pathologic findings for 340 treatment-naive and 365 neoadjuvant-treated PDAC patients at the University of Pittsburgh Medical Center. They used a 200 patient cohort from the same center who had been treated with neoadjuvant therapy for validation.

Pathology examination revealed that, in the treatment-naive group, 71% of tumors were larger than the size determined during EUS. In 9% of cases there was no change in size (EUS versus pathology T-staging Pearson correlation coefficient, 0.586; P < .001). A similar analysis of MDCT showed a weaker correlation. There was no correlation between preoperative EUS/MDCT findings and postoperative pathology among patients who received neoadjuvant therapy.

In the neoadjuvant therapy group, tumor size was reduced in 31%, was unchanged in 53%, and actually grew in 16%. Three-year overall survival was highest in the reduced group (50%), and lower in the unchanged (37%) and tumor-growth (34%) groups. At 5 years, overall survival was 31%, 19%, and 16%, respectively (P = .003). Compared with those whose tumor size remained the same or grew, those with reduced tumor size had higher 3-year overall survival (50% vs. 33%) and 5-year overall survival (31% vs. 18%; P < .001).

The researchers used recursive positioning to identify the optimal threshold for tumor reduction, and found that a 47% or greater reduction was associated with 67% overall survival at 3 years and 47% at 5 years, compared with 32% and 16% for those with smaller reduction or tumors that maintained or increased in size (P < .001).

The researchers noted that, although their study is large, it remains retrospective in design. Another limitation they cited was that not all patients received the same neoadjuvant therapy. Furthermore, both EUS and pathologic evaluation can be subjective, and it can be difficult to correct for that.

“While additional studies are required, incorporating preoperative EUS and postoperative pathologic tumor size measurements into the standard evaluation of neoadjuvant-treated PDAC patients may guide subsequent management in the adjuvant setting,” the researchers concluded.

The study was funded in part by the National Pancreas Foundation, Sky Foundation, and the Pittsburgh Liver Research Center at the University of Pittsburgh. One author disclosed receiving an honorarium from Foundation Medicine, but the rest reported having nothing to disclose. Dr. Sealock has no relevant financial disclosures.

SOURCE: Das R et al. Clin Gastroenterol Hepatol. 2020 Dec 2. doi: 10.1016/j.cgh.2020.11.041.

In patients who undergo resection of pancreatic ductal adenocarcinoma (PDAC) after neoadjuvant therapy, reduction in tumor size between diagnosis and surgery is associated with improved survival, according to a new single-center, retrospective analysis. The researchers compared tumor size as measured by endoscopic ultrasound (EUS) and found that a threshold of 47% or greater reduction in tumor size at resection was associated with a doubling in the 3-year survival rate.

The study, led by Rohit Das, MD, of the University of Pittsburgh Medical Center, was published in Clinical Gastroenterology and Hepatology.

The research represents only a small percentage of patients since most diagnosed with PDAC have locally advanced or metastatic disease that rules out surgery. Still, the work puts more emphasis on measuring tumor size while performing EUS, according to Robert Jay Sealock, MD, who is an assistant professor of medicine at Baylor College of Medicine, Houston.

“This is some helpful information that you can relay to the patient, saying that you have a significant decrease in the size of the tumor based on your initial EUS, and your chance of 3- to 5-year survival is going to be a lot higher, compared to somebody that didn’t have that tumor regression. Most of these patients will undergo an EUS anyway, and you’ll commonly if not always measure the tumor size while you’re in there. Now you can apply this information that you already have to give the patients some additional information if they do undergo surgery,” said Dr. Sealock, who was not involved in the research.

Previous efforts to prognosticate postsurgical survival focused on overall tumor burden using multidetector CT (MDCT), carbohydrate antigen 19-9 (CA19-9) levels, and histologic examination following surgery, but all suffer from various limitations. MDCT is not always accurate in its measurement of tumor size, other conditions can also raise CA19-9 levels, and pathologic findings are subjective because sometimes the amount of tumor before neoadjuvant therapy is uncertain.

The researchers mapped survival statistics to EUS and pathologic findings for 340 treatment-naive and 365 neoadjuvant-treated PDAC patients at the University of Pittsburgh Medical Center. They used a 200 patient cohort from the same center who had been treated with neoadjuvant therapy for validation.

Pathology examination revealed that, in the treatment-naive group, 71% of tumors were larger than the size determined during EUS. In 9% of cases there was no change in size (EUS versus pathology T-staging Pearson correlation coefficient, 0.586; P < .001). A similar analysis of MDCT showed a weaker correlation. There was no correlation between preoperative EUS/MDCT findings and postoperative pathology among patients who received neoadjuvant therapy.

In the neoadjuvant therapy group, tumor size was reduced in 31%, was unchanged in 53%, and actually grew in 16%. Three-year overall survival was highest in the reduced group (50%), and lower in the unchanged (37%) and tumor-growth (34%) groups. At 5 years, overall survival was 31%, 19%, and 16%, respectively (P = .003). Compared with those whose tumor size remained the same or grew, those with reduced tumor size had higher 3-year overall survival (50% vs. 33%) and 5-year overall survival (31% vs. 18%; P < .001).

The researchers used recursive positioning to identify the optimal threshold for tumor reduction, and found that a 47% or greater reduction was associated with 67% overall survival at 3 years and 47% at 5 years, compared with 32% and 16% for those with smaller reduction or tumors that maintained or increased in size (P < .001).

The researchers noted that, although their study is large, it remains retrospective in design. Another limitation they cited was that not all patients received the same neoadjuvant therapy. Furthermore, both EUS and pathologic evaluation can be subjective, and it can be difficult to correct for that.

“While additional studies are required, incorporating preoperative EUS and postoperative pathologic tumor size measurements into the standard evaluation of neoadjuvant-treated PDAC patients may guide subsequent management in the adjuvant setting,” the researchers concluded.

The study was funded in part by the National Pancreas Foundation, Sky Foundation, and the Pittsburgh Liver Research Center at the University of Pittsburgh. One author disclosed receiving an honorarium from Foundation Medicine, but the rest reported having nothing to disclose. Dr. Sealock has no relevant financial disclosures.

SOURCE: Das R et al. Clin Gastroenterol Hepatol. 2020 Dec 2. doi: 10.1016/j.cgh.2020.11.041.

In patients who undergo resection of pancreatic ductal adenocarcinoma (PDAC) after neoadjuvant therapy, reduction in tumor size between diagnosis and surgery is associated with improved survival, according to a new single-center, retrospective analysis. The researchers compared tumor size as measured by endoscopic ultrasound (EUS) and found that a threshold of 47% or greater reduction in tumor size at resection was associated with a doubling in the 3-year survival rate.

The study, led by Rohit Das, MD, of the University of Pittsburgh Medical Center, was published in Clinical Gastroenterology and Hepatology.

The research represents only a small percentage of patients since most diagnosed with PDAC have locally advanced or metastatic disease that rules out surgery. Still, the work puts more emphasis on measuring tumor size while performing EUS, according to Robert Jay Sealock, MD, who is an assistant professor of medicine at Baylor College of Medicine, Houston.

“This is some helpful information that you can relay to the patient, saying that you have a significant decrease in the size of the tumor based on your initial EUS, and your chance of 3- to 5-year survival is going to be a lot higher, compared to somebody that didn’t have that tumor regression. Most of these patients will undergo an EUS anyway, and you’ll commonly if not always measure the tumor size while you’re in there. Now you can apply this information that you already have to give the patients some additional information if they do undergo surgery,” said Dr. Sealock, who was not involved in the research.

Previous efforts to prognosticate postsurgical survival focused on overall tumor burden using multidetector CT (MDCT), carbohydrate antigen 19-9 (CA19-9) levels, and histologic examination following surgery, but all suffer from various limitations. MDCT is not always accurate in its measurement of tumor size, other conditions can also raise CA19-9 levels, and pathologic findings are subjective because sometimes the amount of tumor before neoadjuvant therapy is uncertain.

The researchers mapped survival statistics to EUS and pathologic findings for 340 treatment-naive and 365 neoadjuvant-treated PDAC patients at the University of Pittsburgh Medical Center. They used a 200 patient cohort from the same center who had been treated with neoadjuvant therapy for validation.

Pathology examination revealed that, in the treatment-naive group, 71% of tumors were larger than the size determined during EUS. In 9% of cases there was no change in size (EUS versus pathology T-staging Pearson correlation coefficient, 0.586; P < .001). A similar analysis of MDCT showed a weaker correlation. There was no correlation between preoperative EUS/MDCT findings and postoperative pathology among patients who received neoadjuvant therapy.

In the neoadjuvant therapy group, tumor size was reduced in 31%, was unchanged in 53%, and actually grew in 16%. Three-year overall survival was highest in the reduced group (50%), and lower in the unchanged (37%) and tumor-growth (34%) groups. At 5 years, overall survival was 31%, 19%, and 16%, respectively (P = .003). Compared with those whose tumor size remained the same or grew, those with reduced tumor size had higher 3-year overall survival (50% vs. 33%) and 5-year overall survival (31% vs. 18%; P < .001).

The researchers used recursive positioning to identify the optimal threshold for tumor reduction, and found that a 47% or greater reduction was associated with 67% overall survival at 3 years and 47% at 5 years, compared with 32% and 16% for those with smaller reduction or tumors that maintained or increased in size (P < .001).

The researchers noted that, although their study is large, it remains retrospective in design. Another limitation they cited was that not all patients received the same neoadjuvant therapy. Furthermore, both EUS and pathologic evaluation can be subjective, and it can be difficult to correct for that.

“While additional studies are required, incorporating preoperative EUS and postoperative pathologic tumor size measurements into the standard evaluation of neoadjuvant-treated PDAC patients may guide subsequent management in the adjuvant setting,” the researchers concluded.

The study was funded in part by the National Pancreas Foundation, Sky Foundation, and the Pittsburgh Liver Research Center at the University of Pittsburgh. One author disclosed receiving an honorarium from Foundation Medicine, but the rest reported having nothing to disclose. Dr. Sealock has no relevant financial disclosures.

SOURCE: Das R et al. Clin Gastroenterol Hepatol. 2020 Dec 2. doi: 10.1016/j.cgh.2020.11.041.

The United States started 2021 they way it ended 2020: Setting new records amidst the coronavirus pandemic.

Courtesy NIAID-RML

The country passed the 20 million mark for coronavirus cases on Friday, setting the mark sometime around noon, according to Johns Hopkins University’s COVID-19 tracker. The total is nearly twice as many as the next worst country – India, which has 10.28 million cases.

Along with the case count, more than 346,000 Americans have now died of COVID-19, the disease caused by the coronavirus. That is 77% more fatalities than Brazil, which ranks second globally with 194,949 deaths.

More than 125,370 coronavirus patients were hospitalized on Thursday, the fourth record-setting day in a row, according to the COVID Tracking Project.

Going by official tallies, it took 292 days for the United States to reach its first 10 million cases, and just 54 more days to double it, CNN reported.

Meanwhile, 12.41 million doses of COVID-19 vaccines have been distributed in the United States as of Wednesday, according to the Centers for Disease Control and Prevention. Yet only 2.8 million people have received the first of a two-shot regimen.

The slower-than-hoped-for rollout of the Pfizer and Moderna vaccines comes as a new variant of the coronavirus has emerged in a third state. Florida officials announced a confirmed case of the new variant – believed to have originated in the United Kingdom – in Martin County in southeast Florida.

The state health department said on Twitter that the patient is a man in his 20s with no history of travel. The department said it is working with the CDC to investigate.

The variant has also been confirmed in cases in Colorado and California. It is believed to be more contagious. The BBC reported that the new variant increases the reproduction, or “R number,” by 0.4 and 0.7. The UK’s most recent R number has been estimated at 1.1-1.3, meaning anyone who has the coronavirus could be assumed to spread it to up to 1.3 people.

The R number needs to be below 1.0 for the spread of the virus to fall.

“There is a huge difference in how easily the variant virus spreads,” Professor Axel Gandy of London’s Imperial College told BBC News. “This is the most serious change in the virus since the epidemic began.”

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

The United States started 2021 they way it ended 2020: Setting new records amidst the coronavirus pandemic.

Courtesy NIAID-RML

The country passed the 20 million mark for coronavirus cases on Friday, setting the mark sometime around noon, according to Johns Hopkins University’s COVID-19 tracker. The total is nearly twice as many as the next worst country – India, which has 10.28 million cases.

Along with the case count, more than 346,000 Americans have now died of COVID-19, the disease caused by the coronavirus. That is 77% more fatalities than Brazil, which ranks second globally with 194,949 deaths.

More than 125,370 coronavirus patients were hospitalized on Thursday, the fourth record-setting day in a row, according to the COVID Tracking Project.

Going by official tallies, it took 292 days for the United States to reach its first 10 million cases, and just 54 more days to double it, CNN reported.

Meanwhile, 12.41 million doses of COVID-19 vaccines have been distributed in the United States as of Wednesday, according to the Centers for Disease Control and Prevention. Yet only 2.8 million people have received the first of a two-shot regimen.

The slower-than-hoped-for rollout of the Pfizer and Moderna vaccines comes as a new variant of the coronavirus has emerged in a third state. Florida officials announced a confirmed case of the new variant – believed to have originated in the United Kingdom – in Martin County in southeast Florida.

The state health department said on Twitter that the patient is a man in his 20s with no history of travel. The department said it is working with the CDC to investigate.

The variant has also been confirmed in cases in Colorado and California. It is believed to be more contagious. The BBC reported that the new variant increases the reproduction, or “R number,” by 0.4 and 0.7. The UK’s most recent R number has been estimated at 1.1-1.3, meaning anyone who has the coronavirus could be assumed to spread it to up to 1.3 people.

The R number needs to be below 1.0 for the spread of the virus to fall.

“There is a huge difference in how easily the variant virus spreads,” Professor Axel Gandy of London’s Imperial College told BBC News. “This is the most serious change in the virus since the epidemic began.”

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

The United States started 2021 they way it ended 2020: Setting new records amidst the coronavirus pandemic.

Courtesy NIAID-RML

The country passed the 20 million mark for coronavirus cases on Friday, setting the mark sometime around noon, according to Johns Hopkins University’s COVID-19 tracker. The total is nearly twice as many as the next worst country – India, which has 10.28 million cases.

Along with the case count, more than 346,000 Americans have now died of COVID-19, the disease caused by the coronavirus. That is 77% more fatalities than Brazil, which ranks second globally with 194,949 deaths.

More than 125,370 coronavirus patients were hospitalized on Thursday, the fourth record-setting day in a row, according to the COVID Tracking Project.

Going by official tallies, it took 292 days for the United States to reach its first 10 million cases, and just 54 more days to double it, CNN reported.

Meanwhile, 12.41 million doses of COVID-19 vaccines have been distributed in the United States as of Wednesday, according to the Centers for Disease Control and Prevention. Yet only 2.8 million people have received the first of a two-shot regimen.

The slower-than-hoped-for rollout of the Pfizer and Moderna vaccines comes as a new variant of the coronavirus has emerged in a third state. Florida officials announced a confirmed case of the new variant – believed to have originated in the United Kingdom – in Martin County in southeast Florida.

The state health department said on Twitter that the patient is a man in his 20s with no history of travel. The department said it is working with the CDC to investigate.

The variant has also been confirmed in cases in Colorado and California. It is believed to be more contagious. The BBC reported that the new variant increases the reproduction, or “R number,” by 0.4 and 0.7. The UK’s most recent R number has been estimated at 1.1-1.3, meaning anyone who has the coronavirus could be assumed to spread it to up to 1.3 people.

The R number needs to be below 1.0 for the spread of the virus to fall.

“There is a huge difference in how easily the variant virus spreads,” Professor Axel Gandy of London’s Imperial College told BBC News. “This is the most serious change in the virus since the epidemic began.”

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

The practice of medical students giving unconsented pelvic exams to women patients under anesthesia seems to be continuing, although recent new laws aim to change the situation.

“When I was doing ob.gyn. as a med student, the attending would have me do a pelvic right after the patient was under and before we started surgery,” said one participant in an online forum. “We didn’t exactly get permission but it was for teaching purposes.”

Yet others don’t see what the commotion is about. “There are a hundred things that are done during a surgery that don’t require your specific consent (some of them much more ‘humiliating’ than a pelvic exam). ... There’s not really much left to be shy about during a gyn/rectal/prostate surgery, let me put it that way,” one doctor wrote.

However, many physicians are adamantly opposed to the practice, and laws intended to stop or limit it are being enacted throughout the nation.
 

Renewed concerns have prompted new state laws

A few states have required consent for pelvic exams for many years, beginning with California in 2003. But up until 2019, providing pelvic exams without informed consent was illegal in only six states.

Continuing reports of unauthorized pelvic exams indicate that the practice has not disappeared. University of Michigan professor Maya M. Hammoud, MD, past president of the Association of Professors of Gynecology and Obstetrics, and many others attribute renewed interest in the issue to a 2018 article in the journal Bioethics by Phoebe Friesen, a medical ethicist at McGill University, Montreal, that laid out the ethical arguments against the practice.

Starting in 2019, an outpouring of new state bills have been introduced, and nine more states have passed laws. In addition, 14 other states considered similar bills but did not pass them, in some cases because teaching institutions argued that they were already dealing with the issue. This happened in Connecticut and Massachusetts, after representatives of Yale University, New Haven, Conn., met with legislators.

Laws against the practice have been passed by 15 states, including California, Florida, Illinois, and New York. Some teaching institutions have recently been clamping down on the practice, while many teaching physicians insist that at this point, it has all but ended.
 

A practice that may still continue

For many years, ethicists, women’s rights groups, state legislators, and organized medicine have been trying to eliminate the practice of unauthorized pelvic exams by medical students. Several key medical groups have come out against it, including the American Medical Association, the Association of American Medical Colleges, and the American College of Obstetricians and Gynecologists.

“Fifteen years ago, studies found a substantial number of cases, but my sense is that most of that has stopped,” said Dr. Hammoud. 

Yet despite these changes, there are some disturbing signs that the practice persists.

“I don’t have data, but anecdotally I see it still going on,” said Peter Ubel, MD, a professor at Duke University, Durham, N.C., who was involved in one of those early studies. “Every so often when I’m making a speech, a medical student tells me about performing a pelvic exam without getting permission.

“Perhaps in some cases the attending [physician] did get permission and didn’t tell the medical student, but that would also be a problem,” Dr. Ubel said. “The medical student should be informed that permission was given. This helps them be sensitive to the need to get consent.”

In a 2019 survey of medical students, 92% said they performed a pelvic exam on an anesthetized female patient, and of those, 61% did so without explicit patient consent.

The survey – involving 101 medical students at seven U.S. medical schools – also found that 11% of the medical students said they were extremely uncomfortable with the practice. But nearly one-third of the medical students said that opting out might jeopardize their grades and future careers.

“I tried to opt out once from doing a pelvic exam when I hadn’t met the patient beforehand,” one of them wrote. “The resident told me no.”
 

Some physicians defend the practice

Why do many medical students and doctors think that getting consent for pelvic exams is not necessary?

Some argue that patients implicitly give consent when they walk through the doors of a teaching hospital. “Sorry, but you inherently agree to that when you’re seen in an academic teaching hospital,” wrote one participant in a Student Doctor Network forum. “You agree to have residents and medical students participate in your care, not just an attending. If you just want an attending, then you are free to go to a nonteaching hospital. That’s the deal.”

Others argued that since the anesthetized patient couldn’t feel what was going on, it shouldn’t matter. “Things like pelvic exams, rectal exams, or even heroic trauma surgery occur for training purposes when there is no memory, no sensation and no harm to be done [and] society gains a better practitioner of the art of medicine,” a physician in Columbus, Ohio, wrote on Quora, an online forum.

Some doctors argue that they don’t ask for specific consent when they touch a variety of other body parts, and pelvic exams should be no different. Pelvic exams are needed before surgery of the pelvic area, but they have also been given to women undergoing surgery in a different part of the body.

In 2019 a woman told Deseret News in Utah that she had been recovering from stomach surgery when a resident physician mentioned something she had noticed “when we looked at your cervix.” When she asked why the physician had examined her cervix to prepare for stomach surgery, “no one could give her a good answer.”
 

A ‘positive goal’ doesn’t make it okay

What is missing in many defenses of the practice is any recognition that genitals are the most intimate part of the body, and that a patient’s desire for privacy ought to come first. In a survey of women undergoing gynecologic surgery, 72% expected to be asked for consent before medical students undertook pelvic examinations under anesthesia.

Overruling patients’ concerns about their own privacy is unethical, said Eli Y. Adashi, MD, professor of medical science and former dean of medicine and biological sciences at Brown University, Providence, R.I.

Dr. Adashi said the principle of patient autonomy in medical ethics directs that patients must be involved in decision-making about their care – even when caretakers are pursuing a positive goal, such as helping to educate future doctors.

“Conducting pelvic exams on unconscious women without their specific consent is simply untenable and never has been tenable, and it ought to be discontinued if it hasn’t been already,” says Dr. Adashi, who wrote an opinion piece on the issue for JAMA.

Furthermore, it has been shown that ignoring the need to get consent for pelvic exams makes physicians less concerned about getting patient consent in general. A study led by Dr. Ubel found that medical students who had completed an ob.gyn. clerkship thought getting patients’ consent was significantly less important than those who had not completed that clerkship.
 

Why give pelvic exams to anesthetized women?

Despite the controversy, a number of medical educators continue to direct medical students to perform pelvic exams on anesthetized women. Why is that?

“Pelvic exams are not easy to do,” Dr. Hammoud said. “Learners need to keep working on them; they have to do a lot of them in order to do them well.”

To teach pelvic exams, most medical schools provide standardized patients – paid volunteers who submit to exams and critique the medical student’s work afterwards – but these encounters are limited because of their cost, says Guy Benrubi, MD, professor and emeritus chair of the department of obstetrics and gynecology at the University of Florida, Jacksonville.

He said teaching programs therefore need to supplement exams on standardized patients with exams on unpaid volunteers who provide consent. Programs prefer anesthetized patients, Dr. Benrubi said, because they are easier for novices to work on. “With patients under anesthesia, the muscles are relaxed and it’s easier for learners to detect organs. All the same, you need to get consent.”
 

Teaching institutions stiffen consent requirements

Faced with growing opposition to pelvic exams without consent, teaching institutions as well as gynecologic educators have recently been tightening their policies.

Dr. Hammoud said she has always informed patients orally about the possibility of medical students performing pelvic exams on them, but now some institutions, including her own, want a more involved process. The university recently began consent in writing for pelvic exams.

In addition, the university also now requires that medical students meet patients before performing pelvic exams and that teaching physicians explain the students’ involvement.

Dr. Hammoud said some institutions now require a separate consent form for pelvic exams, but the University of Michigan simply directs that the possibility of the patient getting a pelvic exam be part of the consent form.

This requirement, called “explicit consent,” was endorsed by APGO. It differs from having a separate consent form for pelvic exams, which would highlight the possibility of a pelvic exam, as many women’s rights activists are calling for.

Why not have a separate form? Dr. Hammoud is concerned that it would unnecessarily alarm patients. “When you point out a certain issue, you’re in effect saying to the patient that this is not normal,” she said, noting that, when asked for consent to do the exams, most women agree to it.
 

New wave of state laws prompted by renewed concerns

Dr. Hammoud thinks the laws are unnecessary. “These laws are excessive for the vast majority of physicians who practice ethically. The profession should come up with its own standards rather than having a plethora of laws.”

Several of the more recent laws have a broader scope than the original laws. The original laws simply state that medical students or physicians must get informed consent, but they did not stipulate how informed consent should be obtained. (The laws also typically prohibit pelvic exams when surgery will be in a different area of the body.)

The new laws often follow this format, but some go well beyond it. Some also apply to rectal exams (Maine and Maryland), to men as well as women (Utah and Maryland) requires separate consent (Utah), and require consent for all pelvic exams (Florida). 
 

The struggle over Florida’s law

The original Florida bill was drafted in 2019 by state Sen. Lauren Book, a Democrat who is a victims’ rights advocate working with women who have undergone sexual trauma. In written comments for this article, she says not getting consent for pelvic exams is still going on.

“This disturbing practice is commonplace at medical schools and teaching hospitals across the country – including several Florida universities, based on accounts from current and former medical students and faculty,” Sen. Book stated. “At best, these exams have been wrongful learning experiences for medical students or at worst, the equivalent of a sexual assault.”

Dr. Ubel took exception to linking the teaching activities to sexual assault. “I understand why many women would be horrified by this practice, but it’s not as bad as it seems,” he said. “There is nothing sexual or prurient about these exams, and they are motivated purely by a desire to teach people to be better doctors. That said, patients have the right to say, ‘I don’t want it done to me.’ ” 

In early 2020, Dr. Benrubi was part of a coalition of medical groups that was trying to influence Sen. Book’s bill as it went through the legislature. Sen. Book’s original bill was relatively mild, “but then, late in the process, it was changed into a more sweeping bill with some unclear language,” he said.

The final version was passed and signed into law by Gov. Ron DeSantis, a conservative Republican, in June.

Dr. Benrubi said that a large number of state legislators, including Sen. Book, have been agreeable to fixing the bill. This was supposed to happen in a special session in the fall, but that never materialized, and so the fix will have to wait until the regular session in early 2021.

“The law should not apply to patients undergoing routine pelvic exams,” Dr. Benrubi said. “It should only apply to women patients under anesthesia.”

But while organized medicine wants to walk back the law, Dr. Book wants to expand it. “This upcoming session, I look forward to working with physicians to continue to hone this new law, and to work toward inclusion for males. Everyone has a right to consent.”

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

The practice of medical students giving unconsented pelvic exams to women patients under anesthesia seems to be continuing, although recent new laws aim to change the situation.

“When I was doing ob.gyn. as a med student, the attending would have me do a pelvic right after the patient was under and before we started surgery,” said one participant in an online forum. “We didn’t exactly get permission but it was for teaching purposes.”

Yet others don’t see what the commotion is about. “There are a hundred things that are done during a surgery that don’t require your specific consent (some of them much more ‘humiliating’ than a pelvic exam). ... There’s not really much left to be shy about during a gyn/rectal/prostate surgery, let me put it that way,” one doctor wrote.

However, many physicians are adamantly opposed to the practice, and laws intended to stop or limit it are being enacted throughout the nation.
 

Renewed concerns have prompted new state laws

A few states have required consent for pelvic exams for many years, beginning with California in 2003. But up until 2019, providing pelvic exams without informed consent was illegal in only six states.

Continuing reports of unauthorized pelvic exams indicate that the practice has not disappeared. University of Michigan professor Maya M. Hammoud, MD, past president of the Association of Professors of Gynecology and Obstetrics, and many others attribute renewed interest in the issue to a 2018 article in the journal Bioethics by Phoebe Friesen, a medical ethicist at McGill University, Montreal, that laid out the ethical arguments against the practice.

Starting in 2019, an outpouring of new state bills have been introduced, and nine more states have passed laws. In addition, 14 other states considered similar bills but did not pass them, in some cases because teaching institutions argued that they were already dealing with the issue. This happened in Connecticut and Massachusetts, after representatives of Yale University, New Haven, Conn., met with legislators.

Laws against the practice have been passed by 15 states, including California, Florida, Illinois, and New York. Some teaching institutions have recently been clamping down on the practice, while many teaching physicians insist that at this point, it has all but ended.
 

A practice that may still continue

For many years, ethicists, women’s rights groups, state legislators, and organized medicine have been trying to eliminate the practice of unauthorized pelvic exams by medical students. Several key medical groups have come out against it, including the American Medical Association, the Association of American Medical Colleges, and the American College of Obstetricians and Gynecologists.

“Fifteen years ago, studies found a substantial number of cases, but my sense is that most of that has stopped,” said Dr. Hammoud. 

Yet despite these changes, there are some disturbing signs that the practice persists.

“I don’t have data, but anecdotally I see it still going on,” said Peter Ubel, MD, a professor at Duke University, Durham, N.C., who was involved in one of those early studies. “Every so often when I’m making a speech, a medical student tells me about performing a pelvic exam without getting permission.

“Perhaps in some cases the attending [physician] did get permission and didn’t tell the medical student, but that would also be a problem,” Dr. Ubel said. “The medical student should be informed that permission was given. This helps them be sensitive to the need to get consent.”

In a 2019 survey of medical students, 92% said they performed a pelvic exam on an anesthetized female patient, and of those, 61% did so without explicit patient consent.

The survey – involving 101 medical students at seven U.S. medical schools – also found that 11% of the medical students said they were extremely uncomfortable with the practice. But nearly one-third of the medical students said that opting out might jeopardize their grades and future careers.

“I tried to opt out once from doing a pelvic exam when I hadn’t met the patient beforehand,” one of them wrote. “The resident told me no.”
 

Some physicians defend the practice

Why do many medical students and doctors think that getting consent for pelvic exams is not necessary?

Some argue that patients implicitly give consent when they walk through the doors of a teaching hospital. “Sorry, but you inherently agree to that when you’re seen in an academic teaching hospital,” wrote one participant in a Student Doctor Network forum. “You agree to have residents and medical students participate in your care, not just an attending. If you just want an attending, then you are free to go to a nonteaching hospital. That’s the deal.”

Others argued that since the anesthetized patient couldn’t feel what was going on, it shouldn’t matter. “Things like pelvic exams, rectal exams, or even heroic trauma surgery occur for training purposes when there is no memory, no sensation and no harm to be done [and] society gains a better practitioner of the art of medicine,” a physician in Columbus, Ohio, wrote on Quora, an online forum.

Some doctors argue that they don’t ask for specific consent when they touch a variety of other body parts, and pelvic exams should be no different. Pelvic exams are needed before surgery of the pelvic area, but they have also been given to women undergoing surgery in a different part of the body.

In 2019 a woman told Deseret News in Utah that she had been recovering from stomach surgery when a resident physician mentioned something she had noticed “when we looked at your cervix.” When she asked why the physician had examined her cervix to prepare for stomach surgery, “no one could give her a good answer.”
 

A ‘positive goal’ doesn’t make it okay

What is missing in many defenses of the practice is any recognition that genitals are the most intimate part of the body, and that a patient’s desire for privacy ought to come first. In a survey of women undergoing gynecologic surgery, 72% expected to be asked for consent before medical students undertook pelvic examinations under anesthesia.

Overruling patients’ concerns about their own privacy is unethical, said Eli Y. Adashi, MD, professor of medical science and former dean of medicine and biological sciences at Brown University, Providence, R.I.

Dr. Adashi said the principle of patient autonomy in medical ethics directs that patients must be involved in decision-making about their care – even when caretakers are pursuing a positive goal, such as helping to educate future doctors.

“Conducting pelvic exams on unconscious women without their specific consent is simply untenable and never has been tenable, and it ought to be discontinued if it hasn’t been already,” says Dr. Adashi, who wrote an opinion piece on the issue for JAMA.

Furthermore, it has been shown that ignoring the need to get consent for pelvic exams makes physicians less concerned about getting patient consent in general. A study led by Dr. Ubel found that medical students who had completed an ob.gyn. clerkship thought getting patients’ consent was significantly less important than those who had not completed that clerkship.
 

Why give pelvic exams to anesthetized women?

Despite the controversy, a number of medical educators continue to direct medical students to perform pelvic exams on anesthetized women. Why is that?

“Pelvic exams are not easy to do,” Dr. Hammoud said. “Learners need to keep working on them; they have to do a lot of them in order to do them well.”

To teach pelvic exams, most medical schools provide standardized patients – paid volunteers who submit to exams and critique the medical student’s work afterwards – but these encounters are limited because of their cost, says Guy Benrubi, MD, professor and emeritus chair of the department of obstetrics and gynecology at the University of Florida, Jacksonville.

He said teaching programs therefore need to supplement exams on standardized patients with exams on unpaid volunteers who provide consent. Programs prefer anesthetized patients, Dr. Benrubi said, because they are easier for novices to work on. “With patients under anesthesia, the muscles are relaxed and it’s easier for learners to detect organs. All the same, you need to get consent.”
 

Teaching institutions stiffen consent requirements

Faced with growing opposition to pelvic exams without consent, teaching institutions as well as gynecologic educators have recently been tightening their policies.

Dr. Hammoud said she has always informed patients orally about the possibility of medical students performing pelvic exams on them, but now some institutions, including her own, want a more involved process. The university recently began consent in writing for pelvic exams.

In addition, the university also now requires that medical students meet patients before performing pelvic exams and that teaching physicians explain the students’ involvement.

Dr. Hammoud said some institutions now require a separate consent form for pelvic exams, but the University of Michigan simply directs that the possibility of the patient getting a pelvic exam be part of the consent form.

This requirement, called “explicit consent,” was endorsed by APGO. It differs from having a separate consent form for pelvic exams, which would highlight the possibility of a pelvic exam, as many women’s rights activists are calling for.

Why not have a separate form? Dr. Hammoud is concerned that it would unnecessarily alarm patients. “When you point out a certain issue, you’re in effect saying to the patient that this is not normal,” she said, noting that, when asked for consent to do the exams, most women agree to it.
 

New wave of state laws prompted by renewed concerns

Dr. Hammoud thinks the laws are unnecessary. “These laws are excessive for the vast majority of physicians who practice ethically. The profession should come up with its own standards rather than having a plethora of laws.”

Several of the more recent laws have a broader scope than the original laws. The original laws simply state that medical students or physicians must get informed consent, but they did not stipulate how informed consent should be obtained. (The laws also typically prohibit pelvic exams when surgery will be in a different area of the body.)

The new laws often follow this format, but some go well beyond it. Some also apply to rectal exams (Maine and Maryland), to men as well as women (Utah and Maryland) requires separate consent (Utah), and require consent for all pelvic exams (Florida). 
 

The struggle over Florida’s law

The original Florida bill was drafted in 2019 by state Sen. Lauren Book, a Democrat who is a victims’ rights advocate working with women who have undergone sexual trauma. In written comments for this article, she says not getting consent for pelvic exams is still going on.

“This disturbing practice is commonplace at medical schools and teaching hospitals across the country – including several Florida universities, based on accounts from current and former medical students and faculty,” Sen. Book stated. “At best, these exams have been wrongful learning experiences for medical students or at worst, the equivalent of a sexual assault.”

Dr. Ubel took exception to linking the teaching activities to sexual assault. “I understand why many women would be horrified by this practice, but it’s not as bad as it seems,” he said. “There is nothing sexual or prurient about these exams, and they are motivated purely by a desire to teach people to be better doctors. That said, patients have the right to say, ‘I don’t want it done to me.’ ” 

In early 2020, Dr. Benrubi was part of a coalition of medical groups that was trying to influence Sen. Book’s bill as it went through the legislature. Sen. Book’s original bill was relatively mild, “but then, late in the process, it was changed into a more sweeping bill with some unclear language,” he said.

The final version was passed and signed into law by Gov. Ron DeSantis, a conservative Republican, in June.

Dr. Benrubi said that a large number of state legislators, including Sen. Book, have been agreeable to fixing the bill. This was supposed to happen in a special session in the fall, but that never materialized, and so the fix will have to wait until the regular session in early 2021.

“The law should not apply to patients undergoing routine pelvic exams,” Dr. Benrubi said. “It should only apply to women patients under anesthesia.”

But while organized medicine wants to walk back the law, Dr. Book wants to expand it. “This upcoming session, I look forward to working with physicians to continue to hone this new law, and to work toward inclusion for males. Everyone has a right to consent.”

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

The practice of medical students giving unconsented pelvic exams to women patients under anesthesia seems to be continuing, although recent new laws aim to change the situation.

“When I was doing ob.gyn. as a med student, the attending would have me do a pelvic right after the patient was under and before we started surgery,” said one participant in an online forum. “We didn’t exactly get permission but it was for teaching purposes.”

Yet others don’t see what the commotion is about. “There are a hundred things that are done during a surgery that don’t require your specific consent (some of them much more ‘humiliating’ than a pelvic exam). ... There’s not really much left to be shy about during a gyn/rectal/prostate surgery, let me put it that way,” one doctor wrote.

However, many physicians are adamantly opposed to the practice, and laws intended to stop or limit it are being enacted throughout the nation.
 

Renewed concerns have prompted new state laws

A few states have required consent for pelvic exams for many years, beginning with California in 2003. But up until 2019, providing pelvic exams without informed consent was illegal in only six states.

Continuing reports of unauthorized pelvic exams indicate that the practice has not disappeared. University of Michigan professor Maya M. Hammoud, MD, past president of the Association of Professors of Gynecology and Obstetrics, and many others attribute renewed interest in the issue to a 2018 article in the journal Bioethics by Phoebe Friesen, a medical ethicist at McGill University, Montreal, that laid out the ethical arguments against the practice.

Starting in 2019, an outpouring of new state bills have been introduced, and nine more states have passed laws. In addition, 14 other states considered similar bills but did not pass them, in some cases because teaching institutions argued that they were already dealing with the issue. This happened in Connecticut and Massachusetts, after representatives of Yale University, New Haven, Conn., met with legislators.

Laws against the practice have been passed by 15 states, including California, Florida, Illinois, and New York. Some teaching institutions have recently been clamping down on the practice, while many teaching physicians insist that at this point, it has all but ended.
 

A practice that may still continue

For many years, ethicists, women’s rights groups, state legislators, and organized medicine have been trying to eliminate the practice of unauthorized pelvic exams by medical students. Several key medical groups have come out against it, including the American Medical Association, the Association of American Medical Colleges, and the American College of Obstetricians and Gynecologists.

“Fifteen years ago, studies found a substantial number of cases, but my sense is that most of that has stopped,” said Dr. Hammoud. 

Yet despite these changes, there are some disturbing signs that the practice persists.

“I don’t have data, but anecdotally I see it still going on,” said Peter Ubel, MD, a professor at Duke University, Durham, N.C., who was involved in one of those early studies. “Every so often when I’m making a speech, a medical student tells me about performing a pelvic exam without getting permission.

“Perhaps in some cases the attending [physician] did get permission and didn’t tell the medical student, but that would also be a problem,” Dr. Ubel said. “The medical student should be informed that permission was given. This helps them be sensitive to the need to get consent.”

In a 2019 survey of medical students, 92% said they performed a pelvic exam on an anesthetized female patient, and of those, 61% did so without explicit patient consent.

The survey – involving 101 medical students at seven U.S. medical schools – also found that 11% of the medical students said they were extremely uncomfortable with the practice. But nearly one-third of the medical students said that opting out might jeopardize their grades and future careers.

“I tried to opt out once from doing a pelvic exam when I hadn’t met the patient beforehand,” one of them wrote. “The resident told me no.”
 

Some physicians defend the practice

Why do many medical students and doctors think that getting consent for pelvic exams is not necessary?

Some argue that patients implicitly give consent when they walk through the doors of a teaching hospital. “Sorry, but you inherently agree to that when you’re seen in an academic teaching hospital,” wrote one participant in a Student Doctor Network forum. “You agree to have residents and medical students participate in your care, not just an attending. If you just want an attending, then you are free to go to a nonteaching hospital. That’s the deal.”

Others argued that since the anesthetized patient couldn’t feel what was going on, it shouldn’t matter. “Things like pelvic exams, rectal exams, or even heroic trauma surgery occur for training purposes when there is no memory, no sensation and no harm to be done [and] society gains a better practitioner of the art of medicine,” a physician in Columbus, Ohio, wrote on Quora, an online forum.

Some doctors argue that they don’t ask for specific consent when they touch a variety of other body parts, and pelvic exams should be no different. Pelvic exams are needed before surgery of the pelvic area, but they have also been given to women undergoing surgery in a different part of the body.

In 2019 a woman told Deseret News in Utah that she had been recovering from stomach surgery when a resident physician mentioned something she had noticed “when we looked at your cervix.” When she asked why the physician had examined her cervix to prepare for stomach surgery, “no one could give her a good answer.”
 

A ‘positive goal’ doesn’t make it okay

What is missing in many defenses of the practice is any recognition that genitals are the most intimate part of the body, and that a patient’s desire for privacy ought to come first. In a survey of women undergoing gynecologic surgery, 72% expected to be asked for consent before medical students undertook pelvic examinations under anesthesia.

Overruling patients’ concerns about their own privacy is unethical, said Eli Y. Adashi, MD, professor of medical science and former dean of medicine and biological sciences at Brown University, Providence, R.I.

Dr. Adashi said the principle of patient autonomy in medical ethics directs that patients must be involved in decision-making about their care – even when caretakers are pursuing a positive goal, such as helping to educate future doctors.

“Conducting pelvic exams on unconscious women without their specific consent is simply untenable and never has been tenable, and it ought to be discontinued if it hasn’t been already,” says Dr. Adashi, who wrote an opinion piece on the issue for JAMA.

Furthermore, it has been shown that ignoring the need to get consent for pelvic exams makes physicians less concerned about getting patient consent in general. A study led by Dr. Ubel found that medical students who had completed an ob.gyn. clerkship thought getting patients’ consent was significantly less important than those who had not completed that clerkship.
 

Why give pelvic exams to anesthetized women?

Despite the controversy, a number of medical educators continue to direct medical students to perform pelvic exams on anesthetized women. Why is that?

“Pelvic exams are not easy to do,” Dr. Hammoud said. “Learners need to keep working on them; they have to do a lot of them in order to do them well.”

To teach pelvic exams, most medical schools provide standardized patients – paid volunteers who submit to exams and critique the medical student’s work afterwards – but these encounters are limited because of their cost, says Guy Benrubi, MD, professor and emeritus chair of the department of obstetrics and gynecology at the University of Florida, Jacksonville.

He said teaching programs therefore need to supplement exams on standardized patients with exams on unpaid volunteers who provide consent. Programs prefer anesthetized patients, Dr. Benrubi said, because they are easier for novices to work on. “With patients under anesthesia, the muscles are relaxed and it’s easier for learners to detect organs. All the same, you need to get consent.”
 

Teaching institutions stiffen consent requirements

Faced with growing opposition to pelvic exams without consent, teaching institutions as well as gynecologic educators have recently been tightening their policies.

Dr. Hammoud said she has always informed patients orally about the possibility of medical students performing pelvic exams on them, but now some institutions, including her own, want a more involved process. The university recently began consent in writing for pelvic exams.

In addition, the university also now requires that medical students meet patients before performing pelvic exams and that teaching physicians explain the students’ involvement.

Dr. Hammoud said some institutions now require a separate consent form for pelvic exams, but the University of Michigan simply directs that the possibility of the patient getting a pelvic exam be part of the consent form.

This requirement, called “explicit consent,” was endorsed by APGO. It differs from having a separate consent form for pelvic exams, which would highlight the possibility of a pelvic exam, as many women’s rights activists are calling for.

Why not have a separate form? Dr. Hammoud is concerned that it would unnecessarily alarm patients. “When you point out a certain issue, you’re in effect saying to the patient that this is not normal,” she said, noting that, when asked for consent to do the exams, most women agree to it.
 

New wave of state laws prompted by renewed concerns

Dr. Hammoud thinks the laws are unnecessary. “These laws are excessive for the vast majority of physicians who practice ethically. The profession should come up with its own standards rather than having a plethora of laws.”

Several of the more recent laws have a broader scope than the original laws. The original laws simply state that medical students or physicians must get informed consent, but they did not stipulate how informed consent should be obtained. (The laws also typically prohibit pelvic exams when surgery will be in a different area of the body.)

The new laws often follow this format, but some go well beyond it. Some also apply to rectal exams (Maine and Maryland), to men as well as women (Utah and Maryland) requires separate consent (Utah), and require consent for all pelvic exams (Florida). 
 

The struggle over Florida’s law

The original Florida bill was drafted in 2019 by state Sen. Lauren Book, a Democrat who is a victims’ rights advocate working with women who have undergone sexual trauma. In written comments for this article, she says not getting consent for pelvic exams is still going on.

“This disturbing practice is commonplace at medical schools and teaching hospitals across the country – including several Florida universities, based on accounts from current and former medical students and faculty,” Sen. Book stated. “At best, these exams have been wrongful learning experiences for medical students or at worst, the equivalent of a sexual assault.”

Dr. Ubel took exception to linking the teaching activities to sexual assault. “I understand why many women would be horrified by this practice, but it’s not as bad as it seems,” he said. “There is nothing sexual or prurient about these exams, and they are motivated purely by a desire to teach people to be better doctors. That said, patients have the right to say, ‘I don’t want it done to me.’ ” 

In early 2020, Dr. Benrubi was part of a coalition of medical groups that was trying to influence Sen. Book’s bill as it went through the legislature. Sen. Book’s original bill was relatively mild, “but then, late in the process, it was changed into a more sweeping bill with some unclear language,” he said.

The final version was passed and signed into law by Gov. Ron DeSantis, a conservative Republican, in June.

Dr. Benrubi said that a large number of state legislators, including Sen. Book, have been agreeable to fixing the bill. This was supposed to happen in a special session in the fall, but that never materialized, and so the fix will have to wait until the regular session in early 2021.

“The law should not apply to patients undergoing routine pelvic exams,” Dr. Benrubi said. “It should only apply to women patients under anesthesia.”

But while organized medicine wants to walk back the law, Dr. Book wants to expand it. “This upcoming session, I look forward to working with physicians to continue to hone this new law, and to work toward inclusion for males. Everyone has a right to consent.”

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

People with obesity who lost weight as a result of bariatric surgery and who subsequently contracted COVID-19 were less likely to be admitted to the hospital for COVID, and the disease was less severe than among COVID patients with obesity who had not undergone the surgery, a new retrospective analysis shows.

The research was published in Surgery for Obesity and Related Diseases.

Because obesity is a well-known risk factor for poor COVID-19 outcomes, Ali Aminian, MD, Bariatric and Metabolic Institute, Cleveland Clinic, and colleagues decided to study whether weight-loss surgery had a bearing on outcomes of patients with COVID-19.

They matched 33 COVID-19 patients who had undergone metabolic surgery with 330 control patients with obesity who were infected with the virus during the first wave of the pandemic.

Surgery was associated with a 69% reduction in the risk of being hospitalized as a result of COVID-19. None of the surgery patients required intensive care, mechanical ventilation, or dialysis, and none died.

“Patients after bariatric surgery become significantly healthier and can fight the virus better,” said Dr. Aminian in a statement from his institution. “If confirmed by future studies, this can be added to the long list of health benefits of bariatric surgery.”
 

COVID-19 is a wake-up call for the consequences of obesity

Dr. Aminian said in an interview that COVID-19 is a “wake-up call to show the public and health care professionals that obesity is a major health problem and has multiple health consequences.”

More than 300 articles in the literature show that obesity is a major risk factor for poor outcomes following COVID-19 infection. Dr. Aminian said the pandemic has “improved public awareness about the consequences of obesity.”

Compared with last year at his institution, the intake of new patients “who would like to join a program to have surgery or have some tools to help them to lose weight is almost double,” he noted.

Furthermore, referrals to their unit from primary care physicians, as well as from endocrinologists and cardiologists, for bariatric surgery nearly doubled in recent months.

Although the unit had to stop all bariatric surgeries for around 6 weeks in April because of COVID-19, it has performed the same number of procedures this year as in 2019 and 2018.

Because of the recent surge in COVID cases in Ohio, bariatric procedures are once again on hold. “Elective operations that require hospital beds after surgery have been paused to provide beds for patients who have COVID-19,” he explained.
 

Small sample size, study should be repeated

For their study, Dr. Aminian and colleagues examined the records of 4,365 patients at the Cleveland Clinic Health System who tested positive for the virus between March 8 and July 22, 2020.

Of these, 1,003 had a body mass index of at least 35 mg/kg2; 482 had a BMI of at least 40. The team identified 33 patients who had previously undergone metabolic surgery, comprising 20 sleeve gastrectomies and 13 Roux-en-Y gastric bypasses.

The surgical patients were propensity matched in a 1:10 ratio with nonsurgical control patients with a BMI of at least 40. The patients were matched on the basis of age, sex, ethnicity, location, smoking status, and history of chronic obstructive pulmonary disease.

The mean BMI of surgical patients was 49.1 before their procedure. It fell to 37.2 by the time they tested positive for COVID-19. This compares with an average of 46.7 in the control group at the time they tested positive for the virus.

The team found that 18.2% of metabolic surgery patients were admitted to hospital versus 42.1% of control patients (P = .013).

Moreover, metabolic surgery patients did not require admission to the intensive care unit, nor did they require mechanical ventilation or dialysis, and none died. This compares with 13.0% (P = .021), 6.7% (P = .24), 1.5%, and 2.4%, respectively, of patients in the control group.

Multivariate analysis indicated that prior metabolic surgery was associated with lower hospital admission, at an odds ratio of 0.31 (P = .028), in comparison with control patients with obesity.

Acknowledging the limited sample size of their study, the team wrote: “As this study reflects findings early in the course of the pandemic, it will be of interest to repeat this study with larger data sets and later in the course of the pandemic.”
 

Continue as many aspects of obesity management as possible during pandemic

Dr. Aminian underlined that, for him, the take-home message from the study is that health care professionals should “ideally” continue all aspects of obesity management during the pandemic, including “medical management, behavioral therapy, lifestyle changes, and access to bariatric surgery.”

This is despite the fact that insurance coverage for bariatric surgery has “always been a challenge for many patients, since many insurance plans do not cover” bariatric procedures, he noted.

In July, the American Society for Metabolic and Bariatric Surgery issued a statement declaring that obesity surgery should not be considered an elective procedure and should be resumed as soon as it’s safe to do so during any resurgence of the COVID-19 pandemic.

The authors disclosed no relevant financial relationships.

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

People with obesity who lost weight as a result of bariatric surgery and who subsequently contracted COVID-19 were less likely to be admitted to the hospital for COVID, and the disease was less severe than among COVID patients with obesity who had not undergone the surgery, a new retrospective analysis shows.

The research was published in Surgery for Obesity and Related Diseases.

Because obesity is a well-known risk factor for poor COVID-19 outcomes, Ali Aminian, MD, Bariatric and Metabolic Institute, Cleveland Clinic, and colleagues decided to study whether weight-loss surgery had a bearing on outcomes of patients with COVID-19.

They matched 33 COVID-19 patients who had undergone metabolic surgery with 330 control patients with obesity who were infected with the virus during the first wave of the pandemic.

Surgery was associated with a 69% reduction in the risk of being hospitalized as a result of COVID-19. None of the surgery patients required intensive care, mechanical ventilation, or dialysis, and none died.

“Patients after bariatric surgery become significantly healthier and can fight the virus better,” said Dr. Aminian in a statement from his institution. “If confirmed by future studies, this can be added to the long list of health benefits of bariatric surgery.”
 

COVID-19 is a wake-up call for the consequences of obesity

Dr. Aminian said in an interview that COVID-19 is a “wake-up call to show the public and health care professionals that obesity is a major health problem and has multiple health consequences.”

More than 300 articles in the literature show that obesity is a major risk factor for poor outcomes following COVID-19 infection. Dr. Aminian said the pandemic has “improved public awareness about the consequences of obesity.”

Compared with last year at his institution, the intake of new patients “who would like to join a program to have surgery or have some tools to help them to lose weight is almost double,” he noted.

Furthermore, referrals to their unit from primary care physicians, as well as from endocrinologists and cardiologists, for bariatric surgery nearly doubled in recent months.

Although the unit had to stop all bariatric surgeries for around 6 weeks in April because of COVID-19, it has performed the same number of procedures this year as in 2019 and 2018.

Because of the recent surge in COVID cases in Ohio, bariatric procedures are once again on hold. “Elective operations that require hospital beds after surgery have been paused to provide beds for patients who have COVID-19,” he explained.
 

Small sample size, study should be repeated

For their study, Dr. Aminian and colleagues examined the records of 4,365 patients at the Cleveland Clinic Health System who tested positive for the virus between March 8 and July 22, 2020.

Of these, 1,003 had a body mass index of at least 35 mg/kg2; 482 had a BMI of at least 40. The team identified 33 patients who had previously undergone metabolic surgery, comprising 20 sleeve gastrectomies and 13 Roux-en-Y gastric bypasses.

The surgical patients were propensity matched in a 1:10 ratio with nonsurgical control patients with a BMI of at least 40. The patients were matched on the basis of age, sex, ethnicity, location, smoking status, and history of chronic obstructive pulmonary disease.

The mean BMI of surgical patients was 49.1 before their procedure. It fell to 37.2 by the time they tested positive for COVID-19. This compares with an average of 46.7 in the control group at the time they tested positive for the virus.

The team found that 18.2% of metabolic surgery patients were admitted to hospital versus 42.1% of control patients (P = .013).

Moreover, metabolic surgery patients did not require admission to the intensive care unit, nor did they require mechanical ventilation or dialysis, and none died. This compares with 13.0% (P = .021), 6.7% (P = .24), 1.5%, and 2.4%, respectively, of patients in the control group.

Multivariate analysis indicated that prior metabolic surgery was associated with lower hospital admission, at an odds ratio of 0.31 (P = .028), in comparison with control patients with obesity.

Acknowledging the limited sample size of their study, the team wrote: “As this study reflects findings early in the course of the pandemic, it will be of interest to repeat this study with larger data sets and later in the course of the pandemic.”
 

Continue as many aspects of obesity management as possible during pandemic

Dr. Aminian underlined that, for him, the take-home message from the study is that health care professionals should “ideally” continue all aspects of obesity management during the pandemic, including “medical management, behavioral therapy, lifestyle changes, and access to bariatric surgery.”

This is despite the fact that insurance coverage for bariatric surgery has “always been a challenge for many patients, since many insurance plans do not cover” bariatric procedures, he noted.

In July, the American Society for Metabolic and Bariatric Surgery issued a statement declaring that obesity surgery should not be considered an elective procedure and should be resumed as soon as it’s safe to do so during any resurgence of the COVID-19 pandemic.

The authors disclosed no relevant financial relationships.

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

People with obesity who lost weight as a result of bariatric surgery and who subsequently contracted COVID-19 were less likely to be admitted to the hospital for COVID, and the disease was less severe than among COVID patients with obesity who had not undergone the surgery, a new retrospective analysis shows.

The research was published in Surgery for Obesity and Related Diseases.

Because obesity is a well-known risk factor for poor COVID-19 outcomes, Ali Aminian, MD, Bariatric and Metabolic Institute, Cleveland Clinic, and colleagues decided to study whether weight-loss surgery had a bearing on outcomes of patients with COVID-19.

They matched 33 COVID-19 patients who had undergone metabolic surgery with 330 control patients with obesity who were infected with the virus during the first wave of the pandemic.

Surgery was associated with a 69% reduction in the risk of being hospitalized as a result of COVID-19. None of the surgery patients required intensive care, mechanical ventilation, or dialysis, and none died.

“Patients after bariatric surgery become significantly healthier and can fight the virus better,” said Dr. Aminian in a statement from his institution. “If confirmed by future studies, this can be added to the long list of health benefits of bariatric surgery.”
 

COVID-19 is a wake-up call for the consequences of obesity

Dr. Aminian said in an interview that COVID-19 is a “wake-up call to show the public and health care professionals that obesity is a major health problem and has multiple health consequences.”

More than 300 articles in the literature show that obesity is a major risk factor for poor outcomes following COVID-19 infection. Dr. Aminian said the pandemic has “improved public awareness about the consequences of obesity.”

Compared with last year at his institution, the intake of new patients “who would like to join a program to have surgery or have some tools to help them to lose weight is almost double,” he noted.

Furthermore, referrals to their unit from primary care physicians, as well as from endocrinologists and cardiologists, for bariatric surgery nearly doubled in recent months.

Although the unit had to stop all bariatric surgeries for around 6 weeks in April because of COVID-19, it has performed the same number of procedures this year as in 2019 and 2018.

Because of the recent surge in COVID cases in Ohio, bariatric procedures are once again on hold. “Elective operations that require hospital beds after surgery have been paused to provide beds for patients who have COVID-19,” he explained.
 

Small sample size, study should be repeated

For their study, Dr. Aminian and colleagues examined the records of 4,365 patients at the Cleveland Clinic Health System who tested positive for the virus between March 8 and July 22, 2020.

Of these, 1,003 had a body mass index of at least 35 mg/kg2; 482 had a BMI of at least 40. The team identified 33 patients who had previously undergone metabolic surgery, comprising 20 sleeve gastrectomies and 13 Roux-en-Y gastric bypasses.

The surgical patients were propensity matched in a 1:10 ratio with nonsurgical control patients with a BMI of at least 40. The patients were matched on the basis of age, sex, ethnicity, location, smoking status, and history of chronic obstructive pulmonary disease.

The mean BMI of surgical patients was 49.1 before their procedure. It fell to 37.2 by the time they tested positive for COVID-19. This compares with an average of 46.7 in the control group at the time they tested positive for the virus.

The team found that 18.2% of metabolic surgery patients were admitted to hospital versus 42.1% of control patients (P = .013).

Moreover, metabolic surgery patients did not require admission to the intensive care unit, nor did they require mechanical ventilation or dialysis, and none died. This compares with 13.0% (P = .021), 6.7% (P = .24), 1.5%, and 2.4%, respectively, of patients in the control group.

Multivariate analysis indicated that prior metabolic surgery was associated with lower hospital admission, at an odds ratio of 0.31 (P = .028), in comparison with control patients with obesity.

Acknowledging the limited sample size of their study, the team wrote: “As this study reflects findings early in the course of the pandemic, it will be of interest to repeat this study with larger data sets and later in the course of the pandemic.”
 

Continue as many aspects of obesity management as possible during pandemic

Dr. Aminian underlined that, for him, the take-home message from the study is that health care professionals should “ideally” continue all aspects of obesity management during the pandemic, including “medical management, behavioral therapy, lifestyle changes, and access to bariatric surgery.”

This is despite the fact that insurance coverage for bariatric surgery has “always been a challenge for many patients, since many insurance plans do not cover” bariatric procedures, he noted.

In July, the American Society for Metabolic and Bariatric Surgery issued a statement declaring that obesity surgery should not be considered an elective procedure and should be resumed as soon as it’s safe to do so during any resurgence of the COVID-19 pandemic.

The authors disclosed no relevant financial relationships.

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

Among women with type 2 endometrial cancer, diagnostic hysteroscopy may not be associated with increased odds of positive peritoneal cytology at the time of surgical staging or with decreased survival, according to a retrospective study of 127 patients.

Compared with another diagnostic method, dilation and curettage, hysteroscopy “might present equal safety” in this patient population, a researcher said at the meeting sponsored by AAGL, held virtually this year.
 

Possible associations between cytology and procedures

Prior research has found that positive peritoneal cytology may correlate with greater likelihood of death among patients with endometrial cancer, and researchers have wondered whether pressure on the uterine cavity during hysteroscopy increases the presence of positive peritoneal cytology. “According to some systematic reviews ... it seems that it does,” said study author Luiz Brito, MD, PhD, associate professor of obstetrics and gynecology at the University of Campinas in Brazil.

Nevertheless, research suggests that “most of the time hysteroscopy does not have a powerful impact on the prognosis of these patients,” he said.

Studies have tended to focus on patients with type 1 endometrial cancer, however. Type 2 endometrial cancer, which is more aggressive, “is scarcely studied,” Dr. Brito said. One retrospective study that focused on type 2 endometrial cancer included 140 patients. Among patients who underwent hysteroscopy, 30% had positive cytology. In comparison, 12% of patients in the curettage group had positive cytology. But the difference in disease-specific survival between groups was not statistically significant, and about 33% of the patients in each group developed a recurrence.

To examine associations between diagnostic methods and outcomes in another group of patients with type 2 endometrial cancer, Dr. Brito and colleagues analyzed data from a hospital registry in Brazil.

The database included 1,183 patients with endometrial cancer between 2002 and 2017, including 235 patients with type 2 endometrial cancer. After excluding patients with synchronous tumor and those who did not undergo surgery or did not have peritoneal cytology performed, 127 patients remained for the analysis. The study included follow-up to December 2019.

The researchers compared the prevalence of positive peritoneal cytology among 43 patients who underwent hysteroscopy with that among 84 patients who underwent curettage. The groups had similar baseline characteristics.

Positive peritoneal cytology was more common in the curettage group than in the hysteroscopy group (10.7% vs. 4.6%), although the difference was not statistically significant. Lymphovascular invasion and advanced surgical staging were more common in the curettage group.

In a multivariate analysis, older age and advanced cancer staging were the only factors associated with decreased disease-free survival. Age, advanced cancer staging, and vascular invasion were associated with decreased disease-specific survival.

The researchers also had considered factors such as peritoneal cytology, diagnostic method, age of menarche, menopause time, parity, comorbidities, smoking status, body mass index, abnormal uterine bleeding, histological type, and adjuvant treatment.

A limitation of the study is that it relied on data from a public health system that often has long wait times for diagnosis and treatment, Dr. Brito noted.
 

Some doctors may forgo cytology

The available research raises questions about the role and relevance of peritoneal cytology in caring for patients with endometrial cancer, René Pareja, MD, a gynecologic oncologist at Instituto Nacional de Cancerología, Bogotá, Colombia, said in a discussion following the presentation.

Peritoneal cytology has not been part of endometrial cancer staging since 2009, Dr. Pareja said. Still, guidelines recommend that surgeons collect cytology during surgical staging, with the idea that the results could inform adjuvant treatment decisions.

“Peritoneal cytology is recommended in the guidelines, but there are no recommendations on how to proceed if it is positive,” Dr. Pareja said. “While some gynecologic oncologists continue to take cytology during endometrial cancer staging, some have stopped doing so. And in Colombia, most of us are not performing pelvic cytology.”

Although some studies indicate that hysteroscopy may increase the rate of positive cytology, positive cytology may not be associated with worse oncological outcomes independent of other risk factors for recurrence, said Dr. Pareja.

So far, studies have been retrospective. Furthermore, the sensitivity and specificity of pelvic cytology tests are not 100%. “Should we continue performing pelvic cytology given the results of this and other studies?” Dr. Pareja asked.

Despite limited knowledge about this variable, physicians may want to be aware if a patient has positive cytology, Dr. Brito suggested. “At least it will give us some red flags so we can be attentive to these patients.”

If researchers were to design a prospective study that incorporates hysteroscopic variables, it could provide more complete answers about the relationship between hysteroscopy and peritoneal cytology and clarify the importance of positive cytology, Dr. Brito said.

Dr. Brito had no relevant disclosures. Dr. Pareja disclosed consulting for Johnson & Johnson.

[email protected]

SOURCE: Oliveira Brito LG et al. J Minim Invasive Gynecol. 2020 Nov. doi: 10.1016/j.jmig.2020.08.356.

Among women with type 2 endometrial cancer, diagnostic hysteroscopy may not be associated with increased odds of positive peritoneal cytology at the time of surgical staging or with decreased survival, according to a retrospective study of 127 patients.

Compared with another diagnostic method, dilation and curettage, hysteroscopy “might present equal safety” in this patient population, a researcher said at the meeting sponsored by AAGL, held virtually this year.
 

Possible associations between cytology and procedures

Prior research has found that positive peritoneal cytology may correlate with greater likelihood of death among patients with endometrial cancer, and researchers have wondered whether pressure on the uterine cavity during hysteroscopy increases the presence of positive peritoneal cytology. “According to some systematic reviews ... it seems that it does,” said study author Luiz Brito, MD, PhD, associate professor of obstetrics and gynecology at the University of Campinas in Brazil.

Nevertheless, research suggests that “most of the time hysteroscopy does not have a powerful impact on the prognosis of these patients,” he said.

Studies have tended to focus on patients with type 1 endometrial cancer, however. Type 2 endometrial cancer, which is more aggressive, “is scarcely studied,” Dr. Brito said. One retrospective study that focused on type 2 endometrial cancer included 140 patients. Among patients who underwent hysteroscopy, 30% had positive cytology. In comparison, 12% of patients in the curettage group had positive cytology. But the difference in disease-specific survival between groups was not statistically significant, and about 33% of the patients in each group developed a recurrence.

To examine associations between diagnostic methods and outcomes in another group of patients with type 2 endometrial cancer, Dr. Brito and colleagues analyzed data from a hospital registry in Brazil.

The database included 1,183 patients with endometrial cancer between 2002 and 2017, including 235 patients with type 2 endometrial cancer. After excluding patients with synchronous tumor and those who did not undergo surgery or did not have peritoneal cytology performed, 127 patients remained for the analysis. The study included follow-up to December 2019.

The researchers compared the prevalence of positive peritoneal cytology among 43 patients who underwent hysteroscopy with that among 84 patients who underwent curettage. The groups had similar baseline characteristics.

Positive peritoneal cytology was more common in the curettage group than in the hysteroscopy group (10.7% vs. 4.6%), although the difference was not statistically significant. Lymphovascular invasion and advanced surgical staging were more common in the curettage group.

In a multivariate analysis, older age and advanced cancer staging were the only factors associated with decreased disease-free survival. Age, advanced cancer staging, and vascular invasion were associated with decreased disease-specific survival.

The researchers also had considered factors such as peritoneal cytology, diagnostic method, age of menarche, menopause time, parity, comorbidities, smoking status, body mass index, abnormal uterine bleeding, histological type, and adjuvant treatment.

A limitation of the study is that it relied on data from a public health system that often has long wait times for diagnosis and treatment, Dr. Brito noted.
 

Some doctors may forgo cytology

The available research raises questions about the role and relevance of peritoneal cytology in caring for patients with endometrial cancer, René Pareja, MD, a gynecologic oncologist at Instituto Nacional de Cancerología, Bogotá, Colombia, said in a discussion following the presentation.

Peritoneal cytology has not been part of endometrial cancer staging since 2009, Dr. Pareja said. Still, guidelines recommend that surgeons collect cytology during surgical staging, with the idea that the results could inform adjuvant treatment decisions.

“Peritoneal cytology is recommended in the guidelines, but there are no recommendations on how to proceed if it is positive,” Dr. Pareja said. “While some gynecologic oncologists continue to take cytology during endometrial cancer staging, some have stopped doing so. And in Colombia, most of us are not performing pelvic cytology.”

Although some studies indicate that hysteroscopy may increase the rate of positive cytology, positive cytology may not be associated with worse oncological outcomes independent of other risk factors for recurrence, said Dr. Pareja.

So far, studies have been retrospective. Furthermore, the sensitivity and specificity of pelvic cytology tests are not 100%. “Should we continue performing pelvic cytology given the results of this and other studies?” Dr. Pareja asked.

Despite limited knowledge about this variable, physicians may want to be aware if a patient has positive cytology, Dr. Brito suggested. “At least it will give us some red flags so we can be attentive to these patients.”

If researchers were to design a prospective study that incorporates hysteroscopic variables, it could provide more complete answers about the relationship between hysteroscopy and peritoneal cytology and clarify the importance of positive cytology, Dr. Brito said.

Dr. Brito had no relevant disclosures. Dr. Pareja disclosed consulting for Johnson & Johnson.

[email protected]

SOURCE: Oliveira Brito LG et al. J Minim Invasive Gynecol. 2020 Nov. doi: 10.1016/j.jmig.2020.08.356.

Among women with type 2 endometrial cancer, diagnostic hysteroscopy may not be associated with increased odds of positive peritoneal cytology at the time of surgical staging or with decreased survival, according to a retrospective study of 127 patients.

Compared with another diagnostic method, dilation and curettage, hysteroscopy “might present equal safety” in this patient population, a researcher said at the meeting sponsored by AAGL, held virtually this year.
 

Possible associations between cytology and procedures

Prior research has found that positive peritoneal cytology may correlate with greater likelihood of death among patients with endometrial cancer, and researchers have wondered whether pressure on the uterine cavity during hysteroscopy increases the presence of positive peritoneal cytology. “According to some systematic reviews ... it seems that it does,” said study author Luiz Brito, MD, PhD, associate professor of obstetrics and gynecology at the University of Campinas in Brazil.

Nevertheless, research suggests that “most of the time hysteroscopy does not have a powerful impact on the prognosis of these patients,” he said.

Studies have tended to focus on patients with type 1 endometrial cancer, however. Type 2 endometrial cancer, which is more aggressive, “is scarcely studied,” Dr. Brito said. One retrospective study that focused on type 2 endometrial cancer included 140 patients. Among patients who underwent hysteroscopy, 30% had positive cytology. In comparison, 12% of patients in the curettage group had positive cytology. But the difference in disease-specific survival between groups was not statistically significant, and about 33% of the patients in each group developed a recurrence.

To examine associations between diagnostic methods and outcomes in another group of patients with type 2 endometrial cancer, Dr. Brito and colleagues analyzed data from a hospital registry in Brazil.

The database included 1,183 patients with endometrial cancer between 2002 and 2017, including 235 patients with type 2 endometrial cancer. After excluding patients with synchronous tumor and those who did not undergo surgery or did not have peritoneal cytology performed, 127 patients remained for the analysis. The study included follow-up to December 2019.

The researchers compared the prevalence of positive peritoneal cytology among 43 patients who underwent hysteroscopy with that among 84 patients who underwent curettage. The groups had similar baseline characteristics.

Positive peritoneal cytology was more common in the curettage group than in the hysteroscopy group (10.7% vs. 4.6%), although the difference was not statistically significant. Lymphovascular invasion and advanced surgical staging were more common in the curettage group.

In a multivariate analysis, older age and advanced cancer staging were the only factors associated with decreased disease-free survival. Age, advanced cancer staging, and vascular invasion were associated with decreased disease-specific survival.

The researchers also had considered factors such as peritoneal cytology, diagnostic method, age of menarche, menopause time, parity, comorbidities, smoking status, body mass index, abnormal uterine bleeding, histological type, and adjuvant treatment.

A limitation of the study is that it relied on data from a public health system that often has long wait times for diagnosis and treatment, Dr. Brito noted.
 

Some doctors may forgo cytology

The available research raises questions about the role and relevance of peritoneal cytology in caring for patients with endometrial cancer, René Pareja, MD, a gynecologic oncologist at Instituto Nacional de Cancerología, Bogotá, Colombia, said in a discussion following the presentation.

Peritoneal cytology has not been part of endometrial cancer staging since 2009, Dr. Pareja said. Still, guidelines recommend that surgeons collect cytology during surgical staging, with the idea that the results could inform adjuvant treatment decisions.

“Peritoneal cytology is recommended in the guidelines, but there are no recommendations on how to proceed if it is positive,” Dr. Pareja said. “While some gynecologic oncologists continue to take cytology during endometrial cancer staging, some have stopped doing so. And in Colombia, most of us are not performing pelvic cytology.”

Although some studies indicate that hysteroscopy may increase the rate of positive cytology, positive cytology may not be associated with worse oncological outcomes independent of other risk factors for recurrence, said Dr. Pareja.

So far, studies have been retrospective. Furthermore, the sensitivity and specificity of pelvic cytology tests are not 100%. “Should we continue performing pelvic cytology given the results of this and other studies?” Dr. Pareja asked.

Despite limited knowledge about this variable, physicians may want to be aware if a patient has positive cytology, Dr. Brito suggested. “At least it will give us some red flags so we can be attentive to these patients.”

If researchers were to design a prospective study that incorporates hysteroscopic variables, it could provide more complete answers about the relationship between hysteroscopy and peritoneal cytology and clarify the importance of positive cytology, Dr. Brito said.

Dr. Brito had no relevant disclosures. Dr. Pareja disclosed consulting for Johnson & Johnson.

[email protected]

SOURCE: Oliveira Brito LG et al. J Minim Invasive Gynecol. 2020 Nov. doi: 10.1016/j.jmig.2020.08.356.

About twice as many patients were admitted to hospitals in France for COVID-19 during a 2-month period than were admitted for seasonal influenza during a 3-month period the previous year, according to a study published online in The Lancet Respiratory Medicine.

In-hospital mortality was nearly three times higher for COVID-19 than for seasonal influenza, researchers found. In addition, patients with COVID-19 were more likely to require invasive mechanical ventilation (9.7% vs. 4%) and had longer average ICU stays (15 days vs. 8 days).

“SARS-CoV-2 appears to have a higher potential for respiratory pathogenicity, leading to more respiratory complications in patients with fewer comorbidities, and it is associated with a higher risk of mortality, particularly in adolescents, although any conclusions for this age group must be treated with caution considering the small number of deaths,” wrote Lionel Piroth, MD, PhD, of the infectious diseases department, Dijon (France) University Hospital, and colleagues.

The study “is the largest to date to compare the two diseases and confirms that COVID-19 is far more serious than the flu,” study author Catherine Quantin, MD, PhD, said in a news release. “The finding that the COVID-19 death rate was three times higher than for seasonal influenza is particularly striking when reminded that the 2018/2019 flu season had been the worst in the past five years in France in terms of number of deaths,” continued Dr. Quantin, who jointly led the research. She is affiliated with the University Hospital of Dijon and Inserm.

The investigators analyzed data from a national database and compared 89,530 COVID-19 hospital admissions between March 1 and April 30, 2020, with 45,819 seasonal flu hospital admissions between Dec. 1, 2018, and Feb. 28, 2019.

The death rate was 16.9% among patients hospitalized with COVID-19, compared with 5.8% among patients hospitalized with influenza.

Fewer patients younger 18 years were hospitalized with COVID-19 than with seasonal influenza (1.4% vs. 19.5%; 1,227 vs. 8,942), but a larger proportion of those younger than 5 years required intensive care for COVID-19 (2.9% vs. 0.9%). The fatality rates in children younger than 5 years were similar for both groups (0.5% vs. 0.2%).

Among patients aged 11-17 years, 5 of 548 (1.1%) patients with COVID-19 died, compared with 1 of 804 (0.1%) patients with flu.

Testing practices for influenza likely varied across hospitals, whereas testing for COVID-19 may have been more standardized. This could be a limitation of the study, the researchers noted. In addition, flu seasons vary year to year, and influenza cases may depend on vaccination coverage and residual population immunity.

“The large sample size is an important strength of the study and it is assumed that the indication for hospital admission in the two periods was the same and thus does not bias the results,” Eskild Petersen, MD, DMsc, wrote in a comment accompanying the study. “The results ... clearly show that COVID-19 is more serious than seasonal influenza.”

Furthermore, this study and prior research show that “COVID-19 is not an innocent infection in children and adolescents,” said Dr. Petersen, who is affiliated with the University of Aarhus in Denmark and the European Society for Clinical Microbiology and Infectious Diseases Emerging Infections Task Force.

The study was funded by the French National Research Agency. Two authors have various financial ties to several pharmaceutical companies, details of which are available in the journal article. Dr. Petersen has disclosed no relevant financial relationships.

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

About twice as many patients were admitted to hospitals in France for COVID-19 during a 2-month period than were admitted for seasonal influenza during a 3-month period the previous year, according to a study published online in The Lancet Respiratory Medicine.

In-hospital mortality was nearly three times higher for COVID-19 than for seasonal influenza, researchers found. In addition, patients with COVID-19 were more likely to require invasive mechanical ventilation (9.7% vs. 4%) and had longer average ICU stays (15 days vs. 8 days).

“SARS-CoV-2 appears to have a higher potential for respiratory pathogenicity, leading to more respiratory complications in patients with fewer comorbidities, and it is associated with a higher risk of mortality, particularly in adolescents, although any conclusions for this age group must be treated with caution considering the small number of deaths,” wrote Lionel Piroth, MD, PhD, of the infectious diseases department, Dijon (France) University Hospital, and colleagues.

The study “is the largest to date to compare the two diseases and confirms that COVID-19 is far more serious than the flu,” study author Catherine Quantin, MD, PhD, said in a news release. “The finding that the COVID-19 death rate was three times higher than for seasonal influenza is particularly striking when reminded that the 2018/2019 flu season had been the worst in the past five years in France in terms of number of deaths,” continued Dr. Quantin, who jointly led the research. She is affiliated with the University Hospital of Dijon and Inserm.

The investigators analyzed data from a national database and compared 89,530 COVID-19 hospital admissions between March 1 and April 30, 2020, with 45,819 seasonal flu hospital admissions between Dec. 1, 2018, and Feb. 28, 2019.

The death rate was 16.9% among patients hospitalized with COVID-19, compared with 5.8% among patients hospitalized with influenza.

Fewer patients younger 18 years were hospitalized with COVID-19 than with seasonal influenza (1.4% vs. 19.5%; 1,227 vs. 8,942), but a larger proportion of those younger than 5 years required intensive care for COVID-19 (2.9% vs. 0.9%). The fatality rates in children younger than 5 years were similar for both groups (0.5% vs. 0.2%).

Among patients aged 11-17 years, 5 of 548 (1.1%) patients with COVID-19 died, compared with 1 of 804 (0.1%) patients with flu.

Testing practices for influenza likely varied across hospitals, whereas testing for COVID-19 may have been more standardized. This could be a limitation of the study, the researchers noted. In addition, flu seasons vary year to year, and influenza cases may depend on vaccination coverage and residual population immunity.

“The large sample size is an important strength of the study and it is assumed that the indication for hospital admission in the two periods was the same and thus does not bias the results,” Eskild Petersen, MD, DMsc, wrote in a comment accompanying the study. “The results ... clearly show that COVID-19 is more serious than seasonal influenza.”

Furthermore, this study and prior research show that “COVID-19 is not an innocent infection in children and adolescents,” said Dr. Petersen, who is affiliated with the University of Aarhus in Denmark and the European Society for Clinical Microbiology and Infectious Diseases Emerging Infections Task Force.

The study was funded by the French National Research Agency. Two authors have various financial ties to several pharmaceutical companies, details of which are available in the journal article. Dr. Petersen has disclosed no relevant financial relationships.

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

About twice as many patients were admitted to hospitals in France for COVID-19 during a 2-month period than were admitted for seasonal influenza during a 3-month period the previous year, according to a study published online in The Lancet Respiratory Medicine.

In-hospital mortality was nearly three times higher for COVID-19 than for seasonal influenza, researchers found. In addition, patients with COVID-19 were more likely to require invasive mechanical ventilation (9.7% vs. 4%) and had longer average ICU stays (15 days vs. 8 days).

“SARS-CoV-2 appears to have a higher potential for respiratory pathogenicity, leading to more respiratory complications in patients with fewer comorbidities, and it is associated with a higher risk of mortality, particularly in adolescents, although any conclusions for this age group must be treated with caution considering the small number of deaths,” wrote Lionel Piroth, MD, PhD, of the infectious diseases department, Dijon (France) University Hospital, and colleagues.

The study “is the largest to date to compare the two diseases and confirms that COVID-19 is far more serious than the flu,” study author Catherine Quantin, MD, PhD, said in a news release. “The finding that the COVID-19 death rate was three times higher than for seasonal influenza is particularly striking when reminded that the 2018/2019 flu season had been the worst in the past five years in France in terms of number of deaths,” continued Dr. Quantin, who jointly led the research. She is affiliated with the University Hospital of Dijon and Inserm.

The investigators analyzed data from a national database and compared 89,530 COVID-19 hospital admissions between March 1 and April 30, 2020, with 45,819 seasonal flu hospital admissions between Dec. 1, 2018, and Feb. 28, 2019.

The death rate was 16.9% among patients hospitalized with COVID-19, compared with 5.8% among patients hospitalized with influenza.

Fewer patients younger 18 years were hospitalized with COVID-19 than with seasonal influenza (1.4% vs. 19.5%; 1,227 vs. 8,942), but a larger proportion of those younger than 5 years required intensive care for COVID-19 (2.9% vs. 0.9%). The fatality rates in children younger than 5 years were similar for both groups (0.5% vs. 0.2%).

Among patients aged 11-17 years, 5 of 548 (1.1%) patients with COVID-19 died, compared with 1 of 804 (0.1%) patients with flu.

Testing practices for influenza likely varied across hospitals, whereas testing for COVID-19 may have been more standardized. This could be a limitation of the study, the researchers noted. In addition, flu seasons vary year to year, and influenza cases may depend on vaccination coverage and residual population immunity.

“The large sample size is an important strength of the study and it is assumed that the indication for hospital admission in the two periods was the same and thus does not bias the results,” Eskild Petersen, MD, DMsc, wrote in a comment accompanying the study. “The results ... clearly show that COVID-19 is more serious than seasonal influenza.”

Furthermore, this study and prior research show that “COVID-19 is not an innocent infection in children and adolescents,” said Dr. Petersen, who is affiliated with the University of Aarhus in Denmark and the European Society for Clinical Microbiology and Infectious Diseases Emerging Infections Task Force.

The study was funded by the French National Research Agency. Two authors have various financial ties to several pharmaceutical companies, details of which are available in the journal article. Dr. Petersen has disclosed no relevant financial relationships.

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

Moderna’s COVID-19 vaccine — the second now cleared for emergency use in the United States — was endorsed by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) on December 19.

The panel voted 11-0, with three recusals, to recommend use of Moderna’s vaccine for people aged 18 years and older, while seeking more information on risk for anaphylaxis. This vote followed the December 18th decision by the US Food and Drug Administration (FDA) to grant emergency use authorization (EUA) for the vaccine, known as mRNA-1273.

On December 11, the FDA granted the first US emergency clearance for a COVID-19 vaccine to the Pfizer-BioNTech product. ACIP met the following day and voted to endorse the use of that vaccine, with a vote of 11-0 and three recusals. The Pfizer-BioNTech COVID-19 vaccine is recommended for use in people aged 16 years and older.

Moderna’s vaccine is expected to help curb the pandemic, with clinical trial data showing a 94.1% efficacy rate. But there’s also concerns about side effects noted in testing of both vaccines and in the early rollout of the Pfizer vaccine, particularly anaphylaxis.

“There are likely going to be lots of bumps in the road” with the introduction of the COVID-19 vaccines, but these are being disclosed to the public in a way that is “fair and transparent,” said ACIP member Beth P. Bell, MD, MPH.

“Our systems so far appear to be doing what they are supposed to do” in terms of determining risks from the COVID-19 vaccine, added Bell, who is a clinical professor in the department of global health at the University of Washington’s School of Public Health in Seattle. The Moderna EUA  “represents progress towards ending this horrific pandemic,” she said.

In a new forecast released this week, the CDC projects that the number of newly reported COVID-19 deaths will likely increase over the next 4 weeks, with 15,800 to 27,700 new deaths likely to be reported in the week ending January 9, 2021. That could bring the total number of COVID-19 deaths in the United States to between 357,000 and 391,000 by this date, according to the agency.

ACIP panelist Lynn Bahta, RN, MPH, CPH, said she had been “eager” to have the panel proceed with its endorsement of the Moderna vaccine, “especially in light of the fact that we are seeing an average 2600 deaths a day.”

Having two COVID-19 vaccines available might help slow down the pandemic, “despite the fact that we still have a lot to learn both about the disease and the vaccine,” said Bahta, who is an immunization consultant with the Minnesota Department of Health in Saint Paul.

ACIP members encouraged Moderna officials who presented at the meeting to continue studies for potential complications associated with the vaccine when given to women who are pregnant or breastfeeding.

Panelists also pressed for more data on the risk for Bell’s palsy, which the FDA staff also had noted in the agency’s review of Moderna’s vaccine. Moderna has reported four cases from a pivotal study, one in the placebo group and three among study participants who received the company’s vaccine. These cases occurred between 15 and 33 days after vaccination, and are all resolved or resolving, according to Moderna.

There was also a question raised about how many doses of vaccine might be squeezed out of a vial. CDC will explore this topic further at its meeting on COVID-19 vaccines December 20, said Nancy Messonnier, MD, director of the agency’s National Center for Immunization and Respiratory Diseases, at the Saturday meeting.

“In this time of public health crisis, none of us would want to squander a single dose of a vaccine that’s potentially lifesaving,” CDC’s Messonnier said. “We’re going to plan to have a short discussion of that issue tomorrow.”

Messonnier also responded to a comment made during the meeting about cases where people who received COVID-19 vaccine were unaware of the CDC’s V-safe tool.

V-safe is a smartphone-based tool that uses text messaging and web surveys to help people keep in touch with the medical community after getting the COVID-19 vaccine and is seen as a way to help spot side effects. Messonnier asked that people listening to the webcast of the ACIP meeting help spread the word about the CDC’s V-safe tool.

“Our perception, based on the number of people who have enrolled in V-safe, is that the message is getting out to many places, but even one site that doesn’t have this information is something that we want to try to correct,” she said.

Anaphylaxis concerns

The chief concern for ACIP members and CDC staff about COVID-19 vaccines appeared to be reports of allergic reactions. Thomas Clark, MD, MPH, a CDC staff member, told the ACIP panel that, as of December 18, the agency had identified six cases of anaphylaxis following administration of the Pfizer-BioNTech vaccine that met a certain standard, known as the Brighton Collaboration criteria.

Additional case reports have been reviewed and determined not to be anaphylaxis, Clark said. All suspect cases were identified through processes such as the federal Vaccine Adverse Event Reporting System (VAERS), he said.

People who experience anaphylaxis following COVID-19 vaccination should not receive additional doses of the shot, Clark said in his presentation to ACIP. Members of the panel asked Clark whether there have been any discernible patterns to these cases, such as geographic clusters.

Clark replied that it was “early” in the process to make reports, with investigations still ongoing. He did note that the people who had anaphylaxis following vaccination had received their doses from more than one production lot, with multiple lots having been distributed.

“You folks may have seen in the news a couple of cases from Alaska, but we’ve had reports from other jurisdictions so there’s no obvious clustering geographically,” Clark said.

Another CDC staff member, Sarah Mbaeyi, MD, MPH, noted in her presentation that there should be an observation period of 30 minutes following COVID-19 vaccination for anyone with a history of anaphylaxis for any reason, and of at least 15 minutes for other recipients.

Disclosure of ingredients used in the COVID-19 vaccines might help people with an allergy assess these products, the representative for the American Medical Association, Sandra Fryhofer, MD, told ACIP. As such, she thanked CDC’s Mbaeyi for including a breakout of ingredients in her presentation to the panel. Fryhofer encouraged Moderna officials to be as transparent as possible in disclosing the ingredients of the company’s COVID-19 vaccine.

“That might be important because I think it’s very essential that we figure out what might be triggering these anaphylactic reactions, because that is definitely going to affect the vaccine implementation,” Fryhofer said.

The three ACIP members who had conflicts that prevented their voting were Robert L. Atmar, MD, who said at the Saturday meeting he had participated in COVID-19 trials, including research on the Moderna vaccine; Sharon E. Frey, MD, who said at the Saturday meeting that she had been involved with research on COVID-19 vaccines, including Moderna’s; and Paul Hunter, MD, who said he has received a grant from Pfizer for pneumococcal vaccines.

The other panel members have reported no relevant financial relationships.

This article first appeared on Medscape.com.

Moderna’s COVID-19 vaccine — the second now cleared for emergency use in the United States — was endorsed by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) on December 19.

The panel voted 11-0, with three recusals, to recommend use of Moderna’s vaccine for people aged 18 years and older, while seeking more information on risk for anaphylaxis. This vote followed the December 18th decision by the US Food and Drug Administration (FDA) to grant emergency use authorization (EUA) for the vaccine, known as mRNA-1273.

On December 11, the FDA granted the first US emergency clearance for a COVID-19 vaccine to the Pfizer-BioNTech product. ACIP met the following day and voted to endorse the use of that vaccine, with a vote of 11-0 and three recusals. The Pfizer-BioNTech COVID-19 vaccine is recommended for use in people aged 16 years and older.

Moderna’s vaccine is expected to help curb the pandemic, with clinical trial data showing a 94.1% efficacy rate. But there’s also concerns about side effects noted in testing of both vaccines and in the early rollout of the Pfizer vaccine, particularly anaphylaxis.

“There are likely going to be lots of bumps in the road” with the introduction of the COVID-19 vaccines, but these are being disclosed to the public in a way that is “fair and transparent,” said ACIP member Beth P. Bell, MD, MPH.

“Our systems so far appear to be doing what they are supposed to do” in terms of determining risks from the COVID-19 vaccine, added Bell, who is a clinical professor in the department of global health at the University of Washington’s School of Public Health in Seattle. The Moderna EUA  “represents progress towards ending this horrific pandemic,” she said.

In a new forecast released this week, the CDC projects that the number of newly reported COVID-19 deaths will likely increase over the next 4 weeks, with 15,800 to 27,700 new deaths likely to be reported in the week ending January 9, 2021. That could bring the total number of COVID-19 deaths in the United States to between 357,000 and 391,000 by this date, according to the agency.

ACIP panelist Lynn Bahta, RN, MPH, CPH, said she had been “eager” to have the panel proceed with its endorsement of the Moderna vaccine, “especially in light of the fact that we are seeing an average 2600 deaths a day.”

Having two COVID-19 vaccines available might help slow down the pandemic, “despite the fact that we still have a lot to learn both about the disease and the vaccine,” said Bahta, who is an immunization consultant with the Minnesota Department of Health in Saint Paul.

ACIP members encouraged Moderna officials who presented at the meeting to continue studies for potential complications associated with the vaccine when given to women who are pregnant or breastfeeding.

Panelists also pressed for more data on the risk for Bell’s palsy, which the FDA staff also had noted in the agency’s review of Moderna’s vaccine. Moderna has reported four cases from a pivotal study, one in the placebo group and three among study participants who received the company’s vaccine. These cases occurred between 15 and 33 days after vaccination, and are all resolved or resolving, according to Moderna.

There was also a question raised about how many doses of vaccine might be squeezed out of a vial. CDC will explore this topic further at its meeting on COVID-19 vaccines December 20, said Nancy Messonnier, MD, director of the agency’s National Center for Immunization and Respiratory Diseases, at the Saturday meeting.

“In this time of public health crisis, none of us would want to squander a single dose of a vaccine that’s potentially lifesaving,” CDC’s Messonnier said. “We’re going to plan to have a short discussion of that issue tomorrow.”

Messonnier also responded to a comment made during the meeting about cases where people who received COVID-19 vaccine were unaware of the CDC’s V-safe tool.

V-safe is a smartphone-based tool that uses text messaging and web surveys to help people keep in touch with the medical community after getting the COVID-19 vaccine and is seen as a way to help spot side effects. Messonnier asked that people listening to the webcast of the ACIP meeting help spread the word about the CDC’s V-safe tool.

“Our perception, based on the number of people who have enrolled in V-safe, is that the message is getting out to many places, but even one site that doesn’t have this information is something that we want to try to correct,” she said.

Anaphylaxis concerns

The chief concern for ACIP members and CDC staff about COVID-19 vaccines appeared to be reports of allergic reactions. Thomas Clark, MD, MPH, a CDC staff member, told the ACIP panel that, as of December 18, the agency had identified six cases of anaphylaxis following administration of the Pfizer-BioNTech vaccine that met a certain standard, known as the Brighton Collaboration criteria.

Additional case reports have been reviewed and determined not to be anaphylaxis, Clark said. All suspect cases were identified through processes such as the federal Vaccine Adverse Event Reporting System (VAERS), he said.

People who experience anaphylaxis following COVID-19 vaccination should not receive additional doses of the shot, Clark said in his presentation to ACIP. Members of the panel asked Clark whether there have been any discernible patterns to these cases, such as geographic clusters.

Clark replied that it was “early” in the process to make reports, with investigations still ongoing. He did note that the people who had anaphylaxis following vaccination had received their doses from more than one production lot, with multiple lots having been distributed.

“You folks may have seen in the news a couple of cases from Alaska, but we’ve had reports from other jurisdictions so there’s no obvious clustering geographically,” Clark said.

Another CDC staff member, Sarah Mbaeyi, MD, MPH, noted in her presentation that there should be an observation period of 30 minutes following COVID-19 vaccination for anyone with a history of anaphylaxis for any reason, and of at least 15 minutes for other recipients.

Disclosure of ingredients used in the COVID-19 vaccines might help people with an allergy assess these products, the representative for the American Medical Association, Sandra Fryhofer, MD, told ACIP. As such, she thanked CDC’s Mbaeyi for including a breakout of ingredients in her presentation to the panel. Fryhofer encouraged Moderna officials to be as transparent as possible in disclosing the ingredients of the company’s COVID-19 vaccine.

“That might be important because I think it’s very essential that we figure out what might be triggering these anaphylactic reactions, because that is definitely going to affect the vaccine implementation,” Fryhofer said.

The three ACIP members who had conflicts that prevented their voting were Robert L. Atmar, MD, who said at the Saturday meeting he had participated in COVID-19 trials, including research on the Moderna vaccine; Sharon E. Frey, MD, who said at the Saturday meeting that she had been involved with research on COVID-19 vaccines, including Moderna’s; and Paul Hunter, MD, who said he has received a grant from Pfizer for pneumococcal vaccines.

The other panel members have reported no relevant financial relationships.

This article first appeared on Medscape.com.

Moderna’s COVID-19 vaccine — the second now cleared for emergency use in the United States — was endorsed by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) on December 19.

The panel voted 11-0, with three recusals, to recommend use of Moderna’s vaccine for people aged 18 years and older, while seeking more information on risk for anaphylaxis. This vote followed the December 18th decision by the US Food and Drug Administration (FDA) to grant emergency use authorization (EUA) for the vaccine, known as mRNA-1273.

On December 11, the FDA granted the first US emergency clearance for a COVID-19 vaccine to the Pfizer-BioNTech product. ACIP met the following day and voted to endorse the use of that vaccine, with a vote of 11-0 and three recusals. The Pfizer-BioNTech COVID-19 vaccine is recommended for use in people aged 16 years and older.

Moderna’s vaccine is expected to help curb the pandemic, with clinical trial data showing a 94.1% efficacy rate. But there’s also concerns about side effects noted in testing of both vaccines and in the early rollout of the Pfizer vaccine, particularly anaphylaxis.

“There are likely going to be lots of bumps in the road” with the introduction of the COVID-19 vaccines, but these are being disclosed to the public in a way that is “fair and transparent,” said ACIP member Beth P. Bell, MD, MPH.

“Our systems so far appear to be doing what they are supposed to do” in terms of determining risks from the COVID-19 vaccine, added Bell, who is a clinical professor in the department of global health at the University of Washington’s School of Public Health in Seattle. The Moderna EUA  “represents progress towards ending this horrific pandemic,” she said.

In a new forecast released this week, the CDC projects that the number of newly reported COVID-19 deaths will likely increase over the next 4 weeks, with 15,800 to 27,700 new deaths likely to be reported in the week ending January 9, 2021. That could bring the total number of COVID-19 deaths in the United States to between 357,000 and 391,000 by this date, according to the agency.

ACIP panelist Lynn Bahta, RN, MPH, CPH, said she had been “eager” to have the panel proceed with its endorsement of the Moderna vaccine, “especially in light of the fact that we are seeing an average 2600 deaths a day.”

Having two COVID-19 vaccines available might help slow down the pandemic, “despite the fact that we still have a lot to learn both about the disease and the vaccine,” said Bahta, who is an immunization consultant with the Minnesota Department of Health in Saint Paul.

ACIP members encouraged Moderna officials who presented at the meeting to continue studies for potential complications associated with the vaccine when given to women who are pregnant or breastfeeding.

Panelists also pressed for more data on the risk for Bell’s palsy, which the FDA staff also had noted in the agency’s review of Moderna’s vaccine. Moderna has reported four cases from a pivotal study, one in the placebo group and three among study participants who received the company’s vaccine. These cases occurred between 15 and 33 days after vaccination, and are all resolved or resolving, according to Moderna.

There was also a question raised about how many doses of vaccine might be squeezed out of a vial. CDC will explore this topic further at its meeting on COVID-19 vaccines December 20, said Nancy Messonnier, MD, director of the agency’s National Center for Immunization and Respiratory Diseases, at the Saturday meeting.

“In this time of public health crisis, none of us would want to squander a single dose of a vaccine that’s potentially lifesaving,” CDC’s Messonnier said. “We’re going to plan to have a short discussion of that issue tomorrow.”

Messonnier also responded to a comment made during the meeting about cases where people who received COVID-19 vaccine were unaware of the CDC’s V-safe tool.

V-safe is a smartphone-based tool that uses text messaging and web surveys to help people keep in touch with the medical community after getting the COVID-19 vaccine and is seen as a way to help spot side effects. Messonnier asked that people listening to the webcast of the ACIP meeting help spread the word about the CDC’s V-safe tool.

“Our perception, based on the number of people who have enrolled in V-safe, is that the message is getting out to many places, but even one site that doesn’t have this information is something that we want to try to correct,” she said.

Anaphylaxis concerns

The chief concern for ACIP members and CDC staff about COVID-19 vaccines appeared to be reports of allergic reactions. Thomas Clark, MD, MPH, a CDC staff member, told the ACIP panel that, as of December 18, the agency had identified six cases of anaphylaxis following administration of the Pfizer-BioNTech vaccine that met a certain standard, known as the Brighton Collaboration criteria.

Additional case reports have been reviewed and determined not to be anaphylaxis, Clark said. All suspect cases were identified through processes such as the federal Vaccine Adverse Event Reporting System (VAERS), he said.

People who experience anaphylaxis following COVID-19 vaccination should not receive additional doses of the shot, Clark said in his presentation to ACIP. Members of the panel asked Clark whether there have been any discernible patterns to these cases, such as geographic clusters.

Clark replied that it was “early” in the process to make reports, with investigations still ongoing. He did note that the people who had anaphylaxis following vaccination had received their doses from more than one production lot, with multiple lots having been distributed.

“You folks may have seen in the news a couple of cases from Alaska, but we’ve had reports from other jurisdictions so there’s no obvious clustering geographically,” Clark said.

Another CDC staff member, Sarah Mbaeyi, MD, MPH, noted in her presentation that there should be an observation period of 30 minutes following COVID-19 vaccination for anyone with a history of anaphylaxis for any reason, and of at least 15 minutes for other recipients.

Disclosure of ingredients used in the COVID-19 vaccines might help people with an allergy assess these products, the representative for the American Medical Association, Sandra Fryhofer, MD, told ACIP. As such, she thanked CDC’s Mbaeyi for including a breakout of ingredients in her presentation to the panel. Fryhofer encouraged Moderna officials to be as transparent as possible in disclosing the ingredients of the company’s COVID-19 vaccine.

“That might be important because I think it’s very essential that we figure out what might be triggering these anaphylactic reactions, because that is definitely going to affect the vaccine implementation,” Fryhofer said.

The three ACIP members who had conflicts that prevented their voting were Robert L. Atmar, MD, who said at the Saturday meeting he had participated in COVID-19 trials, including research on the Moderna vaccine; Sharon E. Frey, MD, who said at the Saturday meeting that she had been involved with research on COVID-19 vaccines, including Moderna’s; and Paul Hunter, MD, who said he has received a grant from Pfizer for pneumococcal vaccines.

The other panel members have reported no relevant financial relationships.

This article first appeared on Medscape.com.

As expected, the US Food and Drug Administration granted Moderna an emergency use authorization (EUA) for its messenger RNA COVID-19 vaccine December 18. The vaccine becomes the second authorized for emergency use in the United States, and will likely increase the number of vaccine doses available in the coming days.

There is one final step — the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices will need to recommend its use, as it did 2 days after the Pfizer/BioNTech mRNA vaccine received its EUA on December 10.

The EUA for the Moderna vaccine is “a major milestone in trying to contain this pandemic,” Hana Mohammed El Sahly, MD, told Medscape Medical News.

Scaling up distribution of the two vaccine products will come next. She notes that even under less emergent conditions, making sure people who need a vaccine receive it can be hard. “I hope the media attention around this will make more people aware that there are vaccines that might help them,” said El Sahly, chair of the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC).

The EUA for the Moderna vaccine follows a review by the independent VRBPAC members on December 17, which voted 20-0 with one abstention to recommend the EUA. The vaccine is authorized for use in people 18 and older.


Emergency approval of a second COVID-19 vaccine “is great — we need all the tools we can to fight this pandemic,” Stephen Schrantz, MD, infectious disease specialist and assistant professor of medicine at the University of Chicago, told Medscape Medical News. “The early data coming from Moderna looks good, and I agree with the FDA that an EUA is indicated.

“It’s incumbent upon all us healthcare professionals to put ourselves out there as supporting this vaccine and supporting people getting it,” Schrantz continued. “We want to make sure people who are on the fence understand this is a safe vaccine that has been vetted appropriately through the FDA and through phase 3 clinical trials.”

“I know the critical role physicians play as vaccine influencers,” AMA President Susan Bailey, MD, said during a December 14 webinar for journalists reporting on COVID-19 vaccines. “We have to continue to do what physicians have always done: review the evidence and trust the science. Lives are at stake.” The webinar was cosponsored by the AMA and the Poynter Institute.

Ramping up healthcare provider immunizations

“I am very excited to see the FDA’s positive review of the Moderna vaccine. We have been waiting to have another vaccine we can use for healthcare workers and staff, and now we have it,” Aneesh Mehta, MD, of Emory University School of Medicine in Atlanta, Georgia, told Medscape Medical News.

“We had been hoping for a vaccine with a 70% or 80% efficacy, and to see two vaccines now with greater than 90% efficacy is remarkable,” he added.

The efficacy levels associated with both mRNA vaccines “did exceed expectations for sure — this is not what we built the studies around. It was surprising in the good sense of the word,” said El Sahly, who is also associate professor of molecular virology and microbiology at Baylor College of Medicine in Houston, Texas.

Unanswered questions remain

Schrantz likewise said the high efficacy rate was important but not all that is needed. “[W]hat we know about this vaccine is it is very effective at preventing disease. We don’t have any understanding at this time whether or not these vaccines prevent infection and transmissibility.”

Bailey said, “The jury is still out on whether or not you can still transmit the virus after you’ve had the vaccine. Hopefully not, but we don’t really know that for sure.”

“It’s risky to think that once you get the shot in your arm everything goes back to normal. It doesn’t,” Bailey added.

Another unknown is the duration of protection following immunization. The Pfizer and Moderna products “have similar constructs, seem to have a reasonable safety profile, and excellent short-term efficacy,” El Sahly said. She cautioned, however, that long-term efficacy still needs to be determined.

Whether any rare adverse events will emerge in the long run is another question. Answers could come over time from the ongoing phase 3 trials, as well as from post-EUA surveillance among vaccine recipients.  

“Our work is not done after issuing an EUA,” FDA Commissioner Stephen Hahn, MD, said in a JAMA webinar on December 14. The FDA is closely monitoring for any adverse event rates above the normal background incidence. “We are going to be transparent about it if we are seeing anything that is not at base level.”

“The key is to be humble, keep your eyes open and know that once the vaccine is out there, there may be things we learn that we don’t know now. That is true for virtually any medical innovation,” Paul Offit, MD, director of The Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the FDA VRBPAC, said during the AMA/Poynter Institute webinar.

During the same webinar, an attendee asked about prioritizing immunization for spouses and family members of healthcare workers. “My husband wants to know that too,” replied Patricia A. Stinchfield, APRN, CNP, pediatric nurse practitioner in infectious diseases at Children’s Minnesota, St. Paul.

“It is true we should be thinking about our healthcare workers’ family members. But at this point in time we just don’t have the supplies to address it that way,” said Stinchfield, who is also the president-elect of the National Foundation for Infectious Diseases.

Advantages beyond the numbers?

“The major advantage of having two vaccines is sheer volume,” Mehta said. An additional advantage of more than one product is the potential to offer an option when a specific vaccine is contraindicated. “We could offer someone a different vaccine…similar to what we do with the influenza vaccine.”

“The more the merrier in terms of having more vaccine products,” Schrantz said. Despite differences in shipping, storage, minimum age requirements, and dosing intervals, the Pfizer and Moderna vaccines are very similar, he said. “Really the only difference between these two vaccines is the proprietary lipid nanoparticle — the delivery vehicle if you will.”

Both vaccines “appear very similar in their capacity to protect against disease, to protect [people in] various racial and ethnic backgrounds, and in their capacity to protect against severe disease,” Offit said.

In terms of vaccines in the development pipeline, “We don’t know but we might start to see a difference with the Johnson & Johnson vaccine or the Janssen vaccine, which are single dose. They might confer some advantages, but we are waiting on the safety and efficacy data,” Schrantz said.

As a two-dose vaccine, the AstraZeneca product does not offer an advantage on the dosing strategy, “but it is easier to transport than the mRNA vaccines,” he said. Some concerns with the initial data on the AstraZeneca vaccine will likely need to be addressed before the company applies for an EUA, Schrantz added.

“That is an important question,” El Sahly said. The ongoing studies should provide more data from participants of all ages and ethnic backgrounds that “will allow us to make a determination as to whether there is any difference between these two vaccines.

She added that the Pfizer and Moderna vaccines seem comparable from the early data. “We’ll see if this stands in the long run.”

Future outlook

Now that the FDA approved emergency use of two COVID-19 vaccines, “we need each state to quickly implement their plans to get the vaccines into the hands of providers who need to give the vaccines,” Mehta said. “We are seeing very effective rollout in multiple regions of the country. And we hope to see that continue as we get more vaccines from manufacturers over the coming months.”

“Within a year of identifying the sequence of this virus we have two large clinical vaccine trials that show efficacy,” Offit said. “That was an amazing technologic accomplishment, but now comes the hard part. Mass producing this vaccine, getting it out there, making sure everybody who most benefits gets it, is going to be really, really hard.”

“But I’m optimistic,” Offit said. “If we can do this by next Thanksgiving, we’re going to see a dramatic drop in the number of cases, hospitalizations and deaths, and we can get our lives back together again.”

“My greatest hope is that a year from now we look back and realize we did something really amazing together,” Bailey said, “and we have a feeling of accomplishment and appreciation for all the hard work that has been done.”

Mehta shared the important message he shares when walking around the hospital: “While these vaccines are coming and they are very promising, we need to continue to remember the 3 Ws: wearing a mask, washing your hands, and watching your distance,” he said.

“With the combination of those 3Ws and those vaccines, we will hopefully come through this COVID pandemic.”

El Sahly receives funding through the NIH for her research, including her role as co-chair of the Moderna vaccine phase 3 clinical trial. Schrantz is a site investigator for the Moderna and Janssen vaccine trials. Mehta also receives funding through the NIH. None of these experts had any relevant financial disclosures.

This article first appeared on Medscape.com.

As expected, the US Food and Drug Administration granted Moderna an emergency use authorization (EUA) for its messenger RNA COVID-19 vaccine December 18. The vaccine becomes the second authorized for emergency use in the United States, and will likely increase the number of vaccine doses available in the coming days.

There is one final step — the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices will need to recommend its use, as it did 2 days after the Pfizer/BioNTech mRNA vaccine received its EUA on December 10.

The EUA for the Moderna vaccine is “a major milestone in trying to contain this pandemic,” Hana Mohammed El Sahly, MD, told Medscape Medical News.

Scaling up distribution of the two vaccine products will come next. She notes that even under less emergent conditions, making sure people who need a vaccine receive it can be hard. “I hope the media attention around this will make more people aware that there are vaccines that might help them,” said El Sahly, chair of the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC).

The EUA for the Moderna vaccine follows a review by the independent VRBPAC members on December 17, which voted 20-0 with one abstention to recommend the EUA. The vaccine is authorized for use in people 18 and older.


Emergency approval of a second COVID-19 vaccine “is great — we need all the tools we can to fight this pandemic,” Stephen Schrantz, MD, infectious disease specialist and assistant professor of medicine at the University of Chicago, told Medscape Medical News. “The early data coming from Moderna looks good, and I agree with the FDA that an EUA is indicated.

“It’s incumbent upon all us healthcare professionals to put ourselves out there as supporting this vaccine and supporting people getting it,” Schrantz continued. “We want to make sure people who are on the fence understand this is a safe vaccine that has been vetted appropriately through the FDA and through phase 3 clinical trials.”

“I know the critical role physicians play as vaccine influencers,” AMA President Susan Bailey, MD, said during a December 14 webinar for journalists reporting on COVID-19 vaccines. “We have to continue to do what physicians have always done: review the evidence and trust the science. Lives are at stake.” The webinar was cosponsored by the AMA and the Poynter Institute.

Ramping up healthcare provider immunizations

“I am very excited to see the FDA’s positive review of the Moderna vaccine. We have been waiting to have another vaccine we can use for healthcare workers and staff, and now we have it,” Aneesh Mehta, MD, of Emory University School of Medicine in Atlanta, Georgia, told Medscape Medical News.

“We had been hoping for a vaccine with a 70% or 80% efficacy, and to see two vaccines now with greater than 90% efficacy is remarkable,” he added.

The efficacy levels associated with both mRNA vaccines “did exceed expectations for sure — this is not what we built the studies around. It was surprising in the good sense of the word,” said El Sahly, who is also associate professor of molecular virology and microbiology at Baylor College of Medicine in Houston, Texas.

Unanswered questions remain

Schrantz likewise said the high efficacy rate was important but not all that is needed. “[W]hat we know about this vaccine is it is very effective at preventing disease. We don’t have any understanding at this time whether or not these vaccines prevent infection and transmissibility.”

Bailey said, “The jury is still out on whether or not you can still transmit the virus after you’ve had the vaccine. Hopefully not, but we don’t really know that for sure.”

“It’s risky to think that once you get the shot in your arm everything goes back to normal. It doesn’t,” Bailey added.

Another unknown is the duration of protection following immunization. The Pfizer and Moderna products “have similar constructs, seem to have a reasonable safety profile, and excellent short-term efficacy,” El Sahly said. She cautioned, however, that long-term efficacy still needs to be determined.

Whether any rare adverse events will emerge in the long run is another question. Answers could come over time from the ongoing phase 3 trials, as well as from post-EUA surveillance among vaccine recipients.  

“Our work is not done after issuing an EUA,” FDA Commissioner Stephen Hahn, MD, said in a JAMA webinar on December 14. The FDA is closely monitoring for any adverse event rates above the normal background incidence. “We are going to be transparent about it if we are seeing anything that is not at base level.”

“The key is to be humble, keep your eyes open and know that once the vaccine is out there, there may be things we learn that we don’t know now. That is true for virtually any medical innovation,” Paul Offit, MD, director of The Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the FDA VRBPAC, said during the AMA/Poynter Institute webinar.

During the same webinar, an attendee asked about prioritizing immunization for spouses and family members of healthcare workers. “My husband wants to know that too,” replied Patricia A. Stinchfield, APRN, CNP, pediatric nurse practitioner in infectious diseases at Children’s Minnesota, St. Paul.

“It is true we should be thinking about our healthcare workers’ family members. But at this point in time we just don’t have the supplies to address it that way,” said Stinchfield, who is also the president-elect of the National Foundation for Infectious Diseases.

Advantages beyond the numbers?

“The major advantage of having two vaccines is sheer volume,” Mehta said. An additional advantage of more than one product is the potential to offer an option when a specific vaccine is contraindicated. “We could offer someone a different vaccine…similar to what we do with the influenza vaccine.”

“The more the merrier in terms of having more vaccine products,” Schrantz said. Despite differences in shipping, storage, minimum age requirements, and dosing intervals, the Pfizer and Moderna vaccines are very similar, he said. “Really the only difference between these two vaccines is the proprietary lipid nanoparticle — the delivery vehicle if you will.”

Both vaccines “appear very similar in their capacity to protect against disease, to protect [people in] various racial and ethnic backgrounds, and in their capacity to protect against severe disease,” Offit said.

In terms of vaccines in the development pipeline, “We don’t know but we might start to see a difference with the Johnson & Johnson vaccine or the Janssen vaccine, which are single dose. They might confer some advantages, but we are waiting on the safety and efficacy data,” Schrantz said.

As a two-dose vaccine, the AstraZeneca product does not offer an advantage on the dosing strategy, “but it is easier to transport than the mRNA vaccines,” he said. Some concerns with the initial data on the AstraZeneca vaccine will likely need to be addressed before the company applies for an EUA, Schrantz added.

“That is an important question,” El Sahly said. The ongoing studies should provide more data from participants of all ages and ethnic backgrounds that “will allow us to make a determination as to whether there is any difference between these two vaccines.

She added that the Pfizer and Moderna vaccines seem comparable from the early data. “We’ll see if this stands in the long run.”

Future outlook

Now that the FDA approved emergency use of two COVID-19 vaccines, “we need each state to quickly implement their plans to get the vaccines into the hands of providers who need to give the vaccines,” Mehta said. “We are seeing very effective rollout in multiple regions of the country. And we hope to see that continue as we get more vaccines from manufacturers over the coming months.”

“Within a year of identifying the sequence of this virus we have two large clinical vaccine trials that show efficacy,” Offit said. “That was an amazing technologic accomplishment, but now comes the hard part. Mass producing this vaccine, getting it out there, making sure everybody who most benefits gets it, is going to be really, really hard.”

“But I’m optimistic,” Offit said. “If we can do this by next Thanksgiving, we’re going to see a dramatic drop in the number of cases, hospitalizations and deaths, and we can get our lives back together again.”

“My greatest hope is that a year from now we look back and realize we did something really amazing together,” Bailey said, “and we have a feeling of accomplishment and appreciation for all the hard work that has been done.”

Mehta shared the important message he shares when walking around the hospital: “While these vaccines are coming and they are very promising, we need to continue to remember the 3 Ws: wearing a mask, washing your hands, and watching your distance,” he said.

“With the combination of those 3Ws and those vaccines, we will hopefully come through this COVID pandemic.”

El Sahly receives funding through the NIH for her research, including her role as co-chair of the Moderna vaccine phase 3 clinical trial. Schrantz is a site investigator for the Moderna and Janssen vaccine trials. Mehta also receives funding through the NIH. None of these experts had any relevant financial disclosures.

This article first appeared on Medscape.com.

As expected, the US Food and Drug Administration granted Moderna an emergency use authorization (EUA) for its messenger RNA COVID-19 vaccine December 18. The vaccine becomes the second authorized for emergency use in the United States, and will likely increase the number of vaccine doses available in the coming days.

There is one final step — the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices will need to recommend its use, as it did 2 days after the Pfizer/BioNTech mRNA vaccine received its EUA on December 10.

The EUA for the Moderna vaccine is “a major milestone in trying to contain this pandemic,” Hana Mohammed El Sahly, MD, told Medscape Medical News.

Scaling up distribution of the two vaccine products will come next. She notes that even under less emergent conditions, making sure people who need a vaccine receive it can be hard. “I hope the media attention around this will make more people aware that there are vaccines that might help them,” said El Sahly, chair of the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC).

The EUA for the Moderna vaccine follows a review by the independent VRBPAC members on December 17, which voted 20-0 with one abstention to recommend the EUA. The vaccine is authorized for use in people 18 and older.


Emergency approval of a second COVID-19 vaccine “is great — we need all the tools we can to fight this pandemic,” Stephen Schrantz, MD, infectious disease specialist and assistant professor of medicine at the University of Chicago, told Medscape Medical News. “The early data coming from Moderna looks good, and I agree with the FDA that an EUA is indicated.

“It’s incumbent upon all us healthcare professionals to put ourselves out there as supporting this vaccine and supporting people getting it,” Schrantz continued. “We want to make sure people who are on the fence understand this is a safe vaccine that has been vetted appropriately through the FDA and through phase 3 clinical trials.”

“I know the critical role physicians play as vaccine influencers,” AMA President Susan Bailey, MD, said during a December 14 webinar for journalists reporting on COVID-19 vaccines. “We have to continue to do what physicians have always done: review the evidence and trust the science. Lives are at stake.” The webinar was cosponsored by the AMA and the Poynter Institute.

Ramping up healthcare provider immunizations

“I am very excited to see the FDA’s positive review of the Moderna vaccine. We have been waiting to have another vaccine we can use for healthcare workers and staff, and now we have it,” Aneesh Mehta, MD, of Emory University School of Medicine in Atlanta, Georgia, told Medscape Medical News.

“We had been hoping for a vaccine with a 70% or 80% efficacy, and to see two vaccines now with greater than 90% efficacy is remarkable,” he added.

The efficacy levels associated with both mRNA vaccines “did exceed expectations for sure — this is not what we built the studies around. It was surprising in the good sense of the word,” said El Sahly, who is also associate professor of molecular virology and microbiology at Baylor College of Medicine in Houston, Texas.

Unanswered questions remain

Schrantz likewise said the high efficacy rate was important but not all that is needed. “[W]hat we know about this vaccine is it is very effective at preventing disease. We don’t have any understanding at this time whether or not these vaccines prevent infection and transmissibility.”

Bailey said, “The jury is still out on whether or not you can still transmit the virus after you’ve had the vaccine. Hopefully not, but we don’t really know that for sure.”

“It’s risky to think that once you get the shot in your arm everything goes back to normal. It doesn’t,” Bailey added.

Another unknown is the duration of protection following immunization. The Pfizer and Moderna products “have similar constructs, seem to have a reasonable safety profile, and excellent short-term efficacy,” El Sahly said. She cautioned, however, that long-term efficacy still needs to be determined.

Whether any rare adverse events will emerge in the long run is another question. Answers could come over time from the ongoing phase 3 trials, as well as from post-EUA surveillance among vaccine recipients.  

“Our work is not done after issuing an EUA,” FDA Commissioner Stephen Hahn, MD, said in a JAMA webinar on December 14. The FDA is closely monitoring for any adverse event rates above the normal background incidence. “We are going to be transparent about it if we are seeing anything that is not at base level.”

“The key is to be humble, keep your eyes open and know that once the vaccine is out there, there may be things we learn that we don’t know now. That is true for virtually any medical innovation,” Paul Offit, MD, director of The Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the FDA VRBPAC, said during the AMA/Poynter Institute webinar.

During the same webinar, an attendee asked about prioritizing immunization for spouses and family members of healthcare workers. “My husband wants to know that too,” replied Patricia A. Stinchfield, APRN, CNP, pediatric nurse practitioner in infectious diseases at Children’s Minnesota, St. Paul.

“It is true we should be thinking about our healthcare workers’ family members. But at this point in time we just don’t have the supplies to address it that way,” said Stinchfield, who is also the president-elect of the National Foundation for Infectious Diseases.

Advantages beyond the numbers?

“The major advantage of having two vaccines is sheer volume,” Mehta said. An additional advantage of more than one product is the potential to offer an option when a specific vaccine is contraindicated. “We could offer someone a different vaccine…similar to what we do with the influenza vaccine.”

“The more the merrier in terms of having more vaccine products,” Schrantz said. Despite differences in shipping, storage, minimum age requirements, and dosing intervals, the Pfizer and Moderna vaccines are very similar, he said. “Really the only difference between these two vaccines is the proprietary lipid nanoparticle — the delivery vehicle if you will.”

Both vaccines “appear very similar in their capacity to protect against disease, to protect [people in] various racial and ethnic backgrounds, and in their capacity to protect against severe disease,” Offit said.

In terms of vaccines in the development pipeline, “We don’t know but we might start to see a difference with the Johnson & Johnson vaccine or the Janssen vaccine, which are single dose. They might confer some advantages, but we are waiting on the safety and efficacy data,” Schrantz said.

As a two-dose vaccine, the AstraZeneca product does not offer an advantage on the dosing strategy, “but it is easier to transport than the mRNA vaccines,” he said. Some concerns with the initial data on the AstraZeneca vaccine will likely need to be addressed before the company applies for an EUA, Schrantz added.

“That is an important question,” El Sahly said. The ongoing studies should provide more data from participants of all ages and ethnic backgrounds that “will allow us to make a determination as to whether there is any difference between these two vaccines.

She added that the Pfizer and Moderna vaccines seem comparable from the early data. “We’ll see if this stands in the long run.”

Future outlook

Now that the FDA approved emergency use of two COVID-19 vaccines, “we need each state to quickly implement their plans to get the vaccines into the hands of providers who need to give the vaccines,” Mehta said. “We are seeing very effective rollout in multiple regions of the country. And we hope to see that continue as we get more vaccines from manufacturers over the coming months.”

“Within a year of identifying the sequence of this virus we have two large clinical vaccine trials that show efficacy,” Offit said. “That was an amazing technologic accomplishment, but now comes the hard part. Mass producing this vaccine, getting it out there, making sure everybody who most benefits gets it, is going to be really, really hard.”

“But I’m optimistic,” Offit said. “If we can do this by next Thanksgiving, we’re going to see a dramatic drop in the number of cases, hospitalizations and deaths, and we can get our lives back together again.”

“My greatest hope is that a year from now we look back and realize we did something really amazing together,” Bailey said, “and we have a feeling of accomplishment and appreciation for all the hard work that has been done.”

Mehta shared the important message he shares when walking around the hospital: “While these vaccines are coming and they are very promising, we need to continue to remember the 3 Ws: wearing a mask, washing your hands, and watching your distance,” he said.

“With the combination of those 3Ws and those vaccines, we will hopefully come through this COVID pandemic.”

El Sahly receives funding through the NIH for her research, including her role as co-chair of the Moderna vaccine phase 3 clinical trial. Schrantz is a site investigator for the Moderna and Janssen vaccine trials. Mehta also receives funding through the NIH. None of these experts had any relevant financial disclosures.

This article first appeared on Medscape.com.