Judicious use of stimulants may help patients with attention-deficit hyperactivity disorder (ADHD) and comorbid substance use disorder (SUD) stay in addiction treatment programs, research shows.

Results of a 5-year retrospective cohort study showed adult patients with ADHD attending an addiction recovery program were five times less likely to drop out of care if they were receiving stimulant medication within the first 90 days, compared with their peers who received no medication.

“When considering the risks and benefits of ADHD pharmacotherapy and particularly stimulant therapy in the addiction clinic, we should really be thinking about the risk of treatment dropout and poor retention if we do not treat the ADHD syndrome,” study investigator Kristopher A. Kast, MD, Vanderbilt University, Nashville, Tenn., told this news organization.

The findings were presented at the American Academy of Addiction Psychiatry annual meeting, which was held online this year.
 

Comorbidity common

“This study matters because this clinical situation comes up a lot, where you have patients who are presenting in the substance use disorder clinic who are experiencing symptoms of ADHD and who have been on stimulant therapy either as a child or young adult in the past,” said Dr. Kast, who conducted this study while he was at Massachusetts General Hospital in Boston.

About 25% of patients presenting to outpatient substance use care meet criteria for an ADHD diagnosis, and having both conditions worsens ADHD and SUD outcomes, he noted.

“ADHD treatment would be helpful to these people, but often clinicians are reluctant to prescribe stimulant medication because it’s a controlled substance. Especially early on in treatment, we’re often worried that such a medication could destabilize the patient,” said Dr. Kast.  

To examine the relationship between ADHD pharmacotherapy and retention in SUD treatment participants, the investigators assessed electronic medical record data from Mass General over a period of 5.5 years, from July 2014 to January 2020.

The data included information on 2,163 patients (63% men; mean age, 44 years) admitted to the addiction clinic. A total of 203 had a clinical diagnosis of ADHD (9.4%). Of these 203 participants, 171 were receiving ADHD pharmacotherapy and 32 were untreated.

Among all participants, the group with ADHD was significantly younger than the non-ADHD group (mean age, 38 vs. 45 years, respectively) and more likely to use cocaine (31% vs. 12%) and have private insurance (64% vs. 44%) (P < .001 for all comparisons).

Results showed ADHD stimulant therapy within the first 90 days of SUD treatment was a robust indication of retention. After adjusting for several variables, only ADHD pharmacotherapy was significantly associated with retention (hazard ratio, 0.59; 95% confidence interval, 0.4-0.9; P = .008).

“It was the only variable in a multivariate regression analysis that predicted longer-term retention. It was an even stronger predictor than Suboxone [buprenorphine and naloxone] therapy, with is traditionally strongly associated with retention,” Dr. Kast noted.

He added that, because this was a retrospective, nonrandomized study, it limited the ability to address confounding and unmeasured covariates.

“Our findings may not generalize to the undiagnosed group of patients who would be identified by standardized diagnostic instruments,” Kast said. “Future studies should address risk and number-needed-to-harm associated with ADHD pharmacotherapy.”
 

High dropout rate

Commenting on the findings for this news organization, Frances Levin, MD, professor of psychiatry at Columbia University Irving Medical Center, New York, noted that previous research has shown that patients with ADHD tend to do less well in addiction treatment and drop out of programs more frequently.

What has not been shown as effectively, at least in substance use treatment settings, is that treating ADHD makes a difference in terms of retention, she said.

Although Dr. Levin wasn’t involved in this study, she is currently part of a European study that is assessing SUD treatment-retention outcomes in patients with ADHD who have been randomly assigned to receive either stimulant or nonstimulant medication.

Clinicians are too often focused on risks for overtreatment, diversion, and misuse but what is underappreciated is the risk for undertreatment, Dr. Levin noted.

“This study reminds us of the dangers of undertreatment. Not using the right drugs may make people less likely to stay in treatment and continue their drug use,” she said.

“Misuse and diversion are much higher with immediate-release preparations, and for this reason it’s important to use the long-acting stimulants in this population. Often people do not make that distinction,” Dr. Levin added.

As an expert in the field for more than 2 decades, Dr. Levin said she has learned a lot about treating this type of patient. “You have to monitor them very closely, and never prescribe in a cavalier way,” she said.

“I have the same discussion with these patients that I have when I talk about buprenorphine for opioid use disorder. It is a tremendously powerful medication, saves many lives and prevents overdose, but there is a risk of misuse and diversion, albeit pretty low. It’s there, and you have to use it carefully, but I think being careful vs. never prescribing are two different things,” Dr. Levin said.  
 

‘Guidance and reassurance’

The traditional belief among the general medical community that controlled substances should always be avoided in patients with SUD has hindered treatment for many with comorbid ADHD, said Cornel Stanciu, MD, Dartmouth-Hitchcock Medical Center, Lebanon, N.H., when asked for comment.

“I have encountered many non–addiction-trained physicians who provide buprenorphine treatment for OUD, and they hesitate not only to assess for ADHD but also to implement standard of care treatment when such a diagnosis is made,” Dr. Stanciu told said in an interview.

He added that this practice often stems from fear of “being under the radar” of the U.S. Drug Enforcement Administration for what it might consider an aberrant prescribing pattern involving two controlled substances.

“Hopefully, studies such as Dr. Kast’s will continue to shine light on this issue and offer guidance and reassurance to those treating addictive disorders,” Dr. Stanciu said. 

Dr. Kast, Dr. Levin, and Dr. Stanciu have disclosed no relevant financial relationships.

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

Judicious use of stimulants may help patients with attention-deficit hyperactivity disorder (ADHD) and comorbid substance use disorder (SUD) stay in addiction treatment programs, research shows.

Results of a 5-year retrospective cohort study showed adult patients with ADHD attending an addiction recovery program were five times less likely to drop out of care if they were receiving stimulant medication within the first 90 days, compared with their peers who received no medication.

“When considering the risks and benefits of ADHD pharmacotherapy and particularly stimulant therapy in the addiction clinic, we should really be thinking about the risk of treatment dropout and poor retention if we do not treat the ADHD syndrome,” study investigator Kristopher A. Kast, MD, Vanderbilt University, Nashville, Tenn., told this news organization.

The findings were presented at the American Academy of Addiction Psychiatry annual meeting, which was held online this year.
 

Comorbidity common

“This study matters because this clinical situation comes up a lot, where you have patients who are presenting in the substance use disorder clinic who are experiencing symptoms of ADHD and who have been on stimulant therapy either as a child or young adult in the past,” said Dr. Kast, who conducted this study while he was at Massachusetts General Hospital in Boston.

About 25% of patients presenting to outpatient substance use care meet criteria for an ADHD diagnosis, and having both conditions worsens ADHD and SUD outcomes, he noted.

“ADHD treatment would be helpful to these people, but often clinicians are reluctant to prescribe stimulant medication because it’s a controlled substance. Especially early on in treatment, we’re often worried that such a medication could destabilize the patient,” said Dr. Kast.  

To examine the relationship between ADHD pharmacotherapy and retention in SUD treatment participants, the investigators assessed electronic medical record data from Mass General over a period of 5.5 years, from July 2014 to January 2020.

The data included information on 2,163 patients (63% men; mean age, 44 years) admitted to the addiction clinic. A total of 203 had a clinical diagnosis of ADHD (9.4%). Of these 203 participants, 171 were receiving ADHD pharmacotherapy and 32 were untreated.

Among all participants, the group with ADHD was significantly younger than the non-ADHD group (mean age, 38 vs. 45 years, respectively) and more likely to use cocaine (31% vs. 12%) and have private insurance (64% vs. 44%) (P < .001 for all comparisons).

Results showed ADHD stimulant therapy within the first 90 days of SUD treatment was a robust indication of retention. After adjusting for several variables, only ADHD pharmacotherapy was significantly associated with retention (hazard ratio, 0.59; 95% confidence interval, 0.4-0.9; P = .008).

“It was the only variable in a multivariate regression analysis that predicted longer-term retention. It was an even stronger predictor than Suboxone [buprenorphine and naloxone] therapy, with is traditionally strongly associated with retention,” Dr. Kast noted.

He added that, because this was a retrospective, nonrandomized study, it limited the ability to address confounding and unmeasured covariates.

“Our findings may not generalize to the undiagnosed group of patients who would be identified by standardized diagnostic instruments,” Kast said. “Future studies should address risk and number-needed-to-harm associated with ADHD pharmacotherapy.”
 

High dropout rate

Commenting on the findings for this news organization, Frances Levin, MD, professor of psychiatry at Columbia University Irving Medical Center, New York, noted that previous research has shown that patients with ADHD tend to do less well in addiction treatment and drop out of programs more frequently.

What has not been shown as effectively, at least in substance use treatment settings, is that treating ADHD makes a difference in terms of retention, she said.

Although Dr. Levin wasn’t involved in this study, she is currently part of a European study that is assessing SUD treatment-retention outcomes in patients with ADHD who have been randomly assigned to receive either stimulant or nonstimulant medication.

Clinicians are too often focused on risks for overtreatment, diversion, and misuse but what is underappreciated is the risk for undertreatment, Dr. Levin noted.

“This study reminds us of the dangers of undertreatment. Not using the right drugs may make people less likely to stay in treatment and continue their drug use,” she said.

“Misuse and diversion are much higher with immediate-release preparations, and for this reason it’s important to use the long-acting stimulants in this population. Often people do not make that distinction,” Dr. Levin added.

As an expert in the field for more than 2 decades, Dr. Levin said she has learned a lot about treating this type of patient. “You have to monitor them very closely, and never prescribe in a cavalier way,” she said.

“I have the same discussion with these patients that I have when I talk about buprenorphine for opioid use disorder. It is a tremendously powerful medication, saves many lives and prevents overdose, but there is a risk of misuse and diversion, albeit pretty low. It’s there, and you have to use it carefully, but I think being careful vs. never prescribing are two different things,” Dr. Levin said.  
 

‘Guidance and reassurance’

The traditional belief among the general medical community that controlled substances should always be avoided in patients with SUD has hindered treatment for many with comorbid ADHD, said Cornel Stanciu, MD, Dartmouth-Hitchcock Medical Center, Lebanon, N.H., when asked for comment.

“I have encountered many non–addiction-trained physicians who provide buprenorphine treatment for OUD, and they hesitate not only to assess for ADHD but also to implement standard of care treatment when such a diagnosis is made,” Dr. Stanciu told said in an interview.

He added that this practice often stems from fear of “being under the radar” of the U.S. Drug Enforcement Administration for what it might consider an aberrant prescribing pattern involving two controlled substances.

“Hopefully, studies such as Dr. Kast’s will continue to shine light on this issue and offer guidance and reassurance to those treating addictive disorders,” Dr. Stanciu said. 

Dr. Kast, Dr. Levin, and Dr. Stanciu have disclosed no relevant financial relationships.

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

Judicious use of stimulants may help patients with attention-deficit hyperactivity disorder (ADHD) and comorbid substance use disorder (SUD) stay in addiction treatment programs, research shows.

Results of a 5-year retrospective cohort study showed adult patients with ADHD attending an addiction recovery program were five times less likely to drop out of care if they were receiving stimulant medication within the first 90 days, compared with their peers who received no medication.

“When considering the risks and benefits of ADHD pharmacotherapy and particularly stimulant therapy in the addiction clinic, we should really be thinking about the risk of treatment dropout and poor retention if we do not treat the ADHD syndrome,” study investigator Kristopher A. Kast, MD, Vanderbilt University, Nashville, Tenn., told this news organization.

The findings were presented at the American Academy of Addiction Psychiatry annual meeting, which was held online this year.
 

Comorbidity common

“This study matters because this clinical situation comes up a lot, where you have patients who are presenting in the substance use disorder clinic who are experiencing symptoms of ADHD and who have been on stimulant therapy either as a child or young adult in the past,” said Dr. Kast, who conducted this study while he was at Massachusetts General Hospital in Boston.

About 25% of patients presenting to outpatient substance use care meet criteria for an ADHD diagnosis, and having both conditions worsens ADHD and SUD outcomes, he noted.

“ADHD treatment would be helpful to these people, but often clinicians are reluctant to prescribe stimulant medication because it’s a controlled substance. Especially early on in treatment, we’re often worried that such a medication could destabilize the patient,” said Dr. Kast.  

To examine the relationship between ADHD pharmacotherapy and retention in SUD treatment participants, the investigators assessed electronic medical record data from Mass General over a period of 5.5 years, from July 2014 to January 2020.

The data included information on 2,163 patients (63% men; mean age, 44 years) admitted to the addiction clinic. A total of 203 had a clinical diagnosis of ADHD (9.4%). Of these 203 participants, 171 were receiving ADHD pharmacotherapy and 32 were untreated.

Among all participants, the group with ADHD was significantly younger than the non-ADHD group (mean age, 38 vs. 45 years, respectively) and more likely to use cocaine (31% vs. 12%) and have private insurance (64% vs. 44%) (P < .001 for all comparisons).

Results showed ADHD stimulant therapy within the first 90 days of SUD treatment was a robust indication of retention. After adjusting for several variables, only ADHD pharmacotherapy was significantly associated with retention (hazard ratio, 0.59; 95% confidence interval, 0.4-0.9; P = .008).

“It was the only variable in a multivariate regression analysis that predicted longer-term retention. It was an even stronger predictor than Suboxone [buprenorphine and naloxone] therapy, with is traditionally strongly associated with retention,” Dr. Kast noted.

He added that, because this was a retrospective, nonrandomized study, it limited the ability to address confounding and unmeasured covariates.

“Our findings may not generalize to the undiagnosed group of patients who would be identified by standardized diagnostic instruments,” Kast said. “Future studies should address risk and number-needed-to-harm associated with ADHD pharmacotherapy.”
 

High dropout rate

Commenting on the findings for this news organization, Frances Levin, MD, professor of psychiatry at Columbia University Irving Medical Center, New York, noted that previous research has shown that patients with ADHD tend to do less well in addiction treatment and drop out of programs more frequently.

What has not been shown as effectively, at least in substance use treatment settings, is that treating ADHD makes a difference in terms of retention, she said.

Although Dr. Levin wasn’t involved in this study, she is currently part of a European study that is assessing SUD treatment-retention outcomes in patients with ADHD who have been randomly assigned to receive either stimulant or nonstimulant medication.

Clinicians are too often focused on risks for overtreatment, diversion, and misuse but what is underappreciated is the risk for undertreatment, Dr. Levin noted.

“This study reminds us of the dangers of undertreatment. Not using the right drugs may make people less likely to stay in treatment and continue their drug use,” she said.

“Misuse and diversion are much higher with immediate-release preparations, and for this reason it’s important to use the long-acting stimulants in this population. Often people do not make that distinction,” Dr. Levin added.

As an expert in the field for more than 2 decades, Dr. Levin said she has learned a lot about treating this type of patient. “You have to monitor them very closely, and never prescribe in a cavalier way,” she said.

“I have the same discussion with these patients that I have when I talk about buprenorphine for opioid use disorder. It is a tremendously powerful medication, saves many lives and prevents overdose, but there is a risk of misuse and diversion, albeit pretty low. It’s there, and you have to use it carefully, but I think being careful vs. never prescribing are two different things,” Dr. Levin said.  
 

‘Guidance and reassurance’

The traditional belief among the general medical community that controlled substances should always be avoided in patients with SUD has hindered treatment for many with comorbid ADHD, said Cornel Stanciu, MD, Dartmouth-Hitchcock Medical Center, Lebanon, N.H., when asked for comment.

“I have encountered many non–addiction-trained physicians who provide buprenorphine treatment for OUD, and they hesitate not only to assess for ADHD but also to implement standard of care treatment when such a diagnosis is made,” Dr. Stanciu told said in an interview.

He added that this practice often stems from fear of “being under the radar” of the U.S. Drug Enforcement Administration for what it might consider an aberrant prescribing pattern involving two controlled substances.

“Hopefully, studies such as Dr. Kast’s will continue to shine light on this issue and offer guidance and reassurance to those treating addictive disorders,” Dr. Stanciu said. 

Dr. Kast, Dr. Levin, and Dr. Stanciu have 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.

The U.S. Food and Drug Administration today approved an oral form of androgen deprivation therapy (ADT) known as relugolix (Orgovyx) for the treatment of adult patients with advanced prostate cancer.

Relugolix is an oral gonadotropin-releasing hormone antagonist. The new pill form may mean fewer clinic visits for patients, an added benefit during the COVID-19 pandemic, said Richard Pazdur, MD, acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, in a press statement.

“Today’s approval marks the first oral drug in this class, and it may eliminate some patients’ need to visit the clinic for treatments that require administration by a health care provider,” he commented.

Relugolix works by preventing the pituitary gland from making luteinizing hormone and follicle-stimulating hormone, thus reducing the amount of testosterone the testicles can make.

In the open-label HERO trial, 930 patients with locally advanced or metastatic prostate cancer were randomly assigned to receive either once-daily oral relugolix or leuprolide injection every 3 months for 48 weeks.

The study met its primary endpoint, demonstrating that castration at 48 weeks was maintained in 96.7% of men receiving relugolix vs. 88.8% for patients receiving leuprolide; castration levels of testosterone had to be reached by day 29 and then sustained through the end of the treatment course.

Relugolix has the “potential to become a new standard for ADT and advanced prostate cancer,” commented study investigator Neal D. Shore, MD, of Carolina Urologic Research Center, Myrtle Beach, South Carolina, at the 2020 annual meeting of the American Society of Clinical Oncology, where the results were first presented.

They were published simultaneously in The New England Journal of Medicine.

At the ASCO meeting, David R. Wise, MD, PhD, Perlmutter Cancer Center at NYU Langone Health, New York, agreed that the drug could be practice-changing – but claimed that it would be for a subset of patients only, specifically, patients with a significant history of cardiovascular disease who are without gastrointestinal malabsorption.

Notably, in the study, relugolix cut the risk for major adverse cardiovascular events by 54% in comparison with leuprolide, as reported by Medscape Medical News.

According to the FDA, the most common side effects of relugolix include hot flush, increased glucose levels, increased triglyceride levels, musculoskeletal pain, decreased hemoglobin, fatigue, constipation, diarrhea, and increased levels of certain liver enzymes.

Concurrent use of relugolix with drugs that inhibit P-glycoprotein is contraindicated.

Also, health care providers should consider having patients undergo periodic electrocardiographic monitoring as well as periodic monitoring of electrolyte levels. Owing to the drug’s suppression of the pituitary gonadal system, any diagnostic test results of the pituitary gonadotropic and gonadal functions conducted during and after taking relugolix may be affected.

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

The U.S. Food and Drug Administration today approved an oral form of androgen deprivation therapy (ADT) known as relugolix (Orgovyx) for the treatment of adult patients with advanced prostate cancer.

Relugolix is an oral gonadotropin-releasing hormone antagonist. The new pill form may mean fewer clinic visits for patients, an added benefit during the COVID-19 pandemic, said Richard Pazdur, MD, acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, in a press statement.

“Today’s approval marks the first oral drug in this class, and it may eliminate some patients’ need to visit the clinic for treatments that require administration by a health care provider,” he commented.

Relugolix works by preventing the pituitary gland from making luteinizing hormone and follicle-stimulating hormone, thus reducing the amount of testosterone the testicles can make.

In the open-label HERO trial, 930 patients with locally advanced or metastatic prostate cancer were randomly assigned to receive either once-daily oral relugolix or leuprolide injection every 3 months for 48 weeks.

The study met its primary endpoint, demonstrating that castration at 48 weeks was maintained in 96.7% of men receiving relugolix vs. 88.8% for patients receiving leuprolide; castration levels of testosterone had to be reached by day 29 and then sustained through the end of the treatment course.

Relugolix has the “potential to become a new standard for ADT and advanced prostate cancer,” commented study investigator Neal D. Shore, MD, of Carolina Urologic Research Center, Myrtle Beach, South Carolina, at the 2020 annual meeting of the American Society of Clinical Oncology, where the results were first presented.

They were published simultaneously in The New England Journal of Medicine.

At the ASCO meeting, David R. Wise, MD, PhD, Perlmutter Cancer Center at NYU Langone Health, New York, agreed that the drug could be practice-changing – but claimed that it would be for a subset of patients only, specifically, patients with a significant history of cardiovascular disease who are without gastrointestinal malabsorption.

Notably, in the study, relugolix cut the risk for major adverse cardiovascular events by 54% in comparison with leuprolide, as reported by Medscape Medical News.

According to the FDA, the most common side effects of relugolix include hot flush, increased glucose levels, increased triglyceride levels, musculoskeletal pain, decreased hemoglobin, fatigue, constipation, diarrhea, and increased levels of certain liver enzymes.

Concurrent use of relugolix with drugs that inhibit P-glycoprotein is contraindicated.

Also, health care providers should consider having patients undergo periodic electrocardiographic monitoring as well as periodic monitoring of electrolyte levels. Owing to the drug’s suppression of the pituitary gonadal system, any diagnostic test results of the pituitary gonadotropic and gonadal functions conducted during and after taking relugolix may be affected.

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

The U.S. Food and Drug Administration today approved an oral form of androgen deprivation therapy (ADT) known as relugolix (Orgovyx) for the treatment of adult patients with advanced prostate cancer.

Relugolix is an oral gonadotropin-releasing hormone antagonist. The new pill form may mean fewer clinic visits for patients, an added benefit during the COVID-19 pandemic, said Richard Pazdur, MD, acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, in a press statement.

“Today’s approval marks the first oral drug in this class, and it may eliminate some patients’ need to visit the clinic for treatments that require administration by a health care provider,” he commented.

Relugolix works by preventing the pituitary gland from making luteinizing hormone and follicle-stimulating hormone, thus reducing the amount of testosterone the testicles can make.

In the open-label HERO trial, 930 patients with locally advanced or metastatic prostate cancer were randomly assigned to receive either once-daily oral relugolix or leuprolide injection every 3 months for 48 weeks.

The study met its primary endpoint, demonstrating that castration at 48 weeks was maintained in 96.7% of men receiving relugolix vs. 88.8% for patients receiving leuprolide; castration levels of testosterone had to be reached by day 29 and then sustained through the end of the treatment course.

Relugolix has the “potential to become a new standard for ADT and advanced prostate cancer,” commented study investigator Neal D. Shore, MD, of Carolina Urologic Research Center, Myrtle Beach, South Carolina, at the 2020 annual meeting of the American Society of Clinical Oncology, where the results were first presented.

They were published simultaneously in The New England Journal of Medicine.

At the ASCO meeting, David R. Wise, MD, PhD, Perlmutter Cancer Center at NYU Langone Health, New York, agreed that the drug could be practice-changing – but claimed that it would be for a subset of patients only, specifically, patients with a significant history of cardiovascular disease who are without gastrointestinal malabsorption.

Notably, in the study, relugolix cut the risk for major adverse cardiovascular events by 54% in comparison with leuprolide, as reported by Medscape Medical News.

According to the FDA, the most common side effects of relugolix include hot flush, increased glucose levels, increased triglyceride levels, musculoskeletal pain, decreased hemoglobin, fatigue, constipation, diarrhea, and increased levels of certain liver enzymes.

Concurrent use of relugolix with drugs that inhibit P-glycoprotein is contraindicated.

Also, health care providers should consider having patients undergo periodic electrocardiographic monitoring as well as periodic monitoring of electrolyte levels. Owing to the drug’s suppression of the pituitary gonadal system, any diagnostic test results of the pituitary gonadotropic and gonadal functions conducted during and after taking relugolix may be affected.

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

Key clinical point: The unified protocol (UP), a transdiagnostic skill-based therapy, is effective for the treatment of emotional disorders in multiple sclerosis (MS).

Major finding: Compared with treatment as usual (TAU), the UP intervention group significantly improved depression, anxiety, emotional dysregulation, positive and negative affects, and worry symptoms (P less than .001 for all).

Study details: Seventy adults with MS were randomly assigned to either UP or TAU group.

Disclosures: The authors received no financial support for the research, authorship, and/or publication of the study. The authors declared no conflicts of interest.

Source: Nazari N et al. BMC Psychol. 2020 Oct 31. doi: 10.1186/s40359-020-00480-8.

Key clinical point: The unified protocol (UP), a transdiagnostic skill-based therapy, is effective for the treatment of emotional disorders in multiple sclerosis (MS).

Major finding: Compared with treatment as usual (TAU), the UP intervention group significantly improved depression, anxiety, emotional dysregulation, positive and negative affects, and worry symptoms (P less than .001 for all).

Study details: Seventy adults with MS were randomly assigned to either UP or TAU group.

Disclosures: The authors received no financial support for the research, authorship, and/or publication of the study. The authors declared no conflicts of interest.

Source: Nazari N et al. BMC Psychol. 2020 Oct 31. doi: 10.1186/s40359-020-00480-8.

Key clinical point: The unified protocol (UP), a transdiagnostic skill-based therapy, is effective for the treatment of emotional disorders in multiple sclerosis (MS).

Major finding: Compared with treatment as usual (TAU), the UP intervention group significantly improved depression, anxiety, emotional dysregulation, positive and negative affects, and worry symptoms (P less than .001 for all).

Study details: Seventy adults with MS were randomly assigned to either UP or TAU group.

Disclosures: The authors received no financial support for the research, authorship, and/or publication of the study. The authors declared no conflicts of interest.

Source: Nazari N et al. BMC Psychol. 2020 Oct 31. doi: 10.1186/s40359-020-00480-8.

Key clinical point: One year of natalizumab treatment in relapsing-remitting multiple sclerosis (RRMS) improved absenteeism and work productivity loss.

Major finding: One year of natalizumab exposure showed an early improvement in absenteeism scores (mean change, −4.2; P = .0190) and the work productivity loss scores (mean change, −7.2; P = .0456).

Study details: The data come from the WANT observational study of 91 Italian patients with RRMS.

Disclosures: The WANT study was funded by Biogen. The authors reported relationships with various pharmaceutical companies.

Source: Capra R et al. Neurol Sci. 2020 Nov 17. doi: 10.1007/s10072-020-04838-z.

Key clinical point: One year of natalizumab treatment in relapsing-remitting multiple sclerosis (RRMS) improved absenteeism and work productivity loss.

Major finding: One year of natalizumab exposure showed an early improvement in absenteeism scores (mean change, −4.2; P = .0190) and the work productivity loss scores (mean change, −7.2; P = .0456).

Study details: The data come from the WANT observational study of 91 Italian patients with RRMS.

Disclosures: The WANT study was funded by Biogen. The authors reported relationships with various pharmaceutical companies.

Source: Capra R et al. Neurol Sci. 2020 Nov 17. doi: 10.1007/s10072-020-04838-z.

Key clinical point: One year of natalizumab treatment in relapsing-remitting multiple sclerosis (RRMS) improved absenteeism and work productivity loss.

Major finding: One year of natalizumab exposure showed an early improvement in absenteeism scores (mean change, −4.2; P = .0190) and the work productivity loss scores (mean change, −7.2; P = .0456).

Study details: The data come from the WANT observational study of 91 Italian patients with RRMS.

Disclosures: The WANT study was funded by Biogen. The authors reported relationships with various pharmaceutical companies.

Source: Capra R et al. Neurol Sci. 2020 Nov 17. doi: 10.1007/s10072-020-04838-z.

Key clinical point: In patients with early multiple sclerosis (MS), depressive symptoms are linked to cognitive multitasking.

Major finding: Depressive symptoms in early MS cohort had a stronger association with cognitive multitasking (R² = 0.125) than with traditional monotasking procedures, including a SPEED composite variable (R² = 0.079; P less than .001).

Study details: RADIEMS was a cohort study on 185 patients with MS diagnosed in less than or equal to 5 years.

Disclosures: The study was funded by the U.S. Department of Health and Human Services, National Institutes of Health, and Eunice Kennedy Shriver National Institute of Child Health and Human Development. The authors declared no conflicts of interest.

Source: Glukhovsky L et al. Mult Scler. 2020 Nov 16. doi: 10.1177/1352458520958359.

Key clinical point: In patients with early multiple sclerosis (MS), depressive symptoms are linked to cognitive multitasking.

Major finding: Depressive symptoms in early MS cohort had a stronger association with cognitive multitasking (R² = 0.125) than with traditional monotasking procedures, including a SPEED composite variable (R² = 0.079; P less than .001).

Study details: RADIEMS was a cohort study on 185 patients with MS diagnosed in less than or equal to 5 years.

Disclosures: The study was funded by the U.S. Department of Health and Human Services, National Institutes of Health, and Eunice Kennedy Shriver National Institute of Child Health and Human Development. The authors declared no conflicts of interest.

Source: Glukhovsky L et al. Mult Scler. 2020 Nov 16. doi: 10.1177/1352458520958359.

Key clinical point: In patients with early multiple sclerosis (MS), depressive symptoms are linked to cognitive multitasking.

Major finding: Depressive symptoms in early MS cohort had a stronger association with cognitive multitasking (R² = 0.125) than with traditional monotasking procedures, including a SPEED composite variable (R² = 0.079; P less than .001).

Study details: RADIEMS was a cohort study on 185 patients with MS diagnosed in less than or equal to 5 years.

Disclosures: The study was funded by the U.S. Department of Health and Human Services, National Institutes of Health, and Eunice Kennedy Shriver National Institute of Child Health and Human Development. The authors declared no conflicts of interest.

Source: Glukhovsky L et al. Mult Scler. 2020 Nov 16. doi: 10.1177/1352458520958359.

Key clinical point: This meta-analysis found no significant association between multiple sclerosis and vitiligo.

Major finding: No significant association of multiple sclerosis with prevalent vitiligo was found (pooled odds ratio, 1.33; 95% confidence interval, 0.80-2.22).

Study details: A meta-analysis of 6 case-control studies including 12,930 participants.

Disclosures: No study sponsor was identified. The authors declared no conflicts of interest.

Source: Shen MH et al. Sci Rep. 2020 Oct 20. doi: 10.1038/s41598-020-74298-0.

Key clinical point: This meta-analysis found no significant association between multiple sclerosis and vitiligo.

Major finding: No significant association of multiple sclerosis with prevalent vitiligo was found (pooled odds ratio, 1.33; 95% confidence interval, 0.80-2.22).

Study details: A meta-analysis of 6 case-control studies including 12,930 participants.

Disclosures: No study sponsor was identified. The authors declared no conflicts of interest.

Source: Shen MH et al. Sci Rep. 2020 Oct 20. doi: 10.1038/s41598-020-74298-0.

Key clinical point: This meta-analysis found no significant association between multiple sclerosis and vitiligo.

Major finding: No significant association of multiple sclerosis with prevalent vitiligo was found (pooled odds ratio, 1.33; 95% confidence interval, 0.80-2.22).

Study details: A meta-analysis of 6 case-control studies including 12,930 participants.

Disclosures: No study sponsor was identified. The authors declared no conflicts of interest.

Source: Shen MH et al. Sci Rep. 2020 Oct 20. doi: 10.1038/s41598-020-74298-0.

The Pfizer COVID-19 vaccine was shown to be highly effective in a large trial, but clinicians will be waiting and watching for reactions and adverse events in their vaccinated patients.

A two-dose regimen of the BNT162b2 mRNA COVID-19 vaccine was found to be safe and 95% effective in preventing SARS-CoV-2 infection in persons aged 16 years and older, according to an ongoing phase 2/3 trial. Pfizer and BioNTech published safety and efficacy results from the landmark global phase 1/2/3 trial of their COVID-19 vaccine candidate in the New England Journal of Medicine .

“We previously reported phase 1 safety and immunogenicity results from clinical trials of the vaccine candidate BNT162b2,” lead author Fernando P. Polack, MD, of Vanderbilt University, Nashville, Tenn., and colleagues wrote. “This data set and [present] trial results are the basis for an application for emergency-use authorization,” they explained.
 

The BNT162b2 vaccine trial

Among 43,448 individuals aged 16 years and older, the efficacy, safety, and immunogenicity of the BNT162b2 vaccine candidate was evaluated in a continuous phase 1/2/3 study. Participants were randomly assigned (1:1) to receive two injections of either 30 mcg of BNT162b2 (n = 21,720) or saline placebo (n = 21,728) administered intramuscularly 21 days apart. The safety evaluation, where subjects were monitored 30 minutes post vaccination for acute reactions, was observer blinded.

Eligibility criteria included healthy individuals or those with stable chronic medical conditions, including viral hepatitis B and C, as well as human immunodeficiency virus. Persons with a diagnosis of an immunocompromising condition, those receiving immunosuppressive therapy, and individuals with a medical history of COVID-19 were excluded.

The first primary endpoint was efficacy of BNT162b2 against laboratory-confirmed COVID-19 with onset at least 7 days following the second dose. The primary safety endpoint was local and systemic reactions occurring within 7 days post injection of BNT162b2 or placebo.
 

Safety

“At the data cutoff date of Oct. 9, a total of 37,706 participants had a median of at least 2 months of safety data available after the second dose and contributed to the main safety data set,” the authors wrote.

Among these participants, 83% were White, 28% were Hispanic or Latinx, and 9% were Black or African American; 49% of subjects were female and the median age was 52 years, with 42% over aged 55 years.

Overall, BNT162b2 had a favorable safety profile. Mild to moderate pain at the injection site within 7 days after the injection was the most frequently reported local reaction (<1% across all age groups reported severe pain). Most local reactions resolved within 1-2 days and no grade 4 reactions were reported.

The investigators reported: “Fever (temperature, ≥38° C) was reported after the second dose by 16% of younger vaccine recipients and by 11% of older recipients. Only 0.2% of vaccine recipients and 0.1% of placebo recipients reported fever (temperature, 38.9-40° C) after the first dose, as compared with 0.8% and 0.1%, respectively, after the second dose.”

BNT162b2 recipients had more injection-site pain than those receiving the placebo. After the first and second doses, younger recipients (under 55 years) had more pain at the injection site (83 vs. 14 and 78 vs. 12 events, respectively), redness (5 vs. 1 and 6 vs. 1), and swelling (6 vs. 0 and 6 vs. 0), compared with placebo recipients.

The same trend was observed for patients aged over 55 years, with vaccine recipients reporting more pain at the injection site (71 vs. 9 and 66 vs. 8 events, respectively), redness (5 vs. 1 and 7 vs. 1), and swelling (7 vs. 1 and 7 vs. 1) than placebo recipients.

Pain was less common overall among vaccine recipients aged over 55 years (71% reported pain after the first dose; 66% post second dose) than among younger vaccine recipients (83% post first dose; 78% post second dose).

The most common systemic events following the second dose were fatigue and headache, which occurred in 59% and 52% of younger vaccine recipients and 51% and 39% of older vaccine recipients, respectively. But fatigue and headache were also reported by participants in the placebo group (23% and 24%, respectively, post second dose, among younger vaccine recipients; 17% and 14% among older recipients).

The incidence of serious adverse events was low and similar in the vaccine (0.6%) and placebo (0.5%) arms. Severe systemic events occurred in 2% or less of vaccine recipients following either dose, except for fatigue (3.8%) and headache (2.0%) post second dose. No deaths were considered to be vaccine or placebo related.

“The safety appears comparable to other vaccines, but the relatively short period of observation, 2 months, and the relatively small number of subjects who have received the vaccine (less than 30,000), compared to the hundreds of millions likely to ultimately receive the vaccine, precludes conclusions regarding the potential for rare long term adverse effects,” David L. Bowton, MD, FCCP, a pulmonologist and professor emeritus of critical care anesthesiology at Wake Forest University, Winston-Salem, N.C., said in an interview. “Clinicians should be aware of the risk of anaphylactic reactions and discuss it with their patients [who have] a history of these reactions.”
 

Efficacy

Among 36,523 subjects without evidence of existing or prior COVID-19 infection, 8 cases of COVID-19 with onset at least 7 days after the second dose were seen among vaccine recipients and 162 among placebo recipients, corresponding to 95.0% vaccine efficacy (95% credible interval, 90.3%-97.6%).

“Supplemental analyses indicated that vaccine efficacy among subgroups defined by age, sex, race, ethnicity, obesity, and presence of a coexisting condition was generally consistent with that observed in the overall population,” the authors wrote.

Between the first and second doses, 39 cases of COVID-19 were observed among BNT162b2 recipients and 82 cases among placebo recipients, corresponding to 52% vaccine efficacy during the 21-day interval (95% CI, 29.5%-68.4%) suggesting early protection may begin as soon as 12 days after the first injection.

“This is an incredible achievement given that an effective vaccine has never been developed and approved for use in such a short timeframe,” Dr. Bowton explained. “That the vaccine is highly effective in reducing the incidence of symptomatic COVID-19 seems incontrovertible.”

“This vaccine has shockingly amazing efficacy and is well tolerated, and the results are beyond even optimistic projections,” Douglas S. Paauw, MD, of the University of Washington, Seattle, said in an interview.
 

Questions remain

“It is not yet known if the vaccine prevents asymptomatic infections, with their attendant risk of contagion, as rates of seroconversion of trial participants against betacoronavirus nucleoproteins not included in the vaccine has not been reported,” Dr. Bowton commented.

“Common questions our patients will ask us remain unanswered for now, [including] how long will the protection last, is it safe in pregnant women, and does it prevent asymptomatic infection,” Dr. Paauw explained. “We do not know everything about longer term side effects, but the benefits of this vaccine appear to outweigh the risks of the vaccine.”

The researchers noted these and other limitations in their report, acknowledging that longer follow-up is needed to evaluate long-term safety of the vaccine.

This study was supported by BioNTech and Pfizer. Several authors disclosed financial relationships with Pfizer and other pharmaceutical companies outside the submitted work. Dr. Bowton and Dr. Paauw had no conflicts to disclose.

SOURCE: Polack FP et al. N Engl J Med. 2020 Dec 10. doi: 10.1056/NEJMoa2034577
 

The Pfizer COVID-19 vaccine was shown to be highly effective in a large trial, but clinicians will be waiting and watching for reactions and adverse events in their vaccinated patients.

A two-dose regimen of the BNT162b2 mRNA COVID-19 vaccine was found to be safe and 95% effective in preventing SARS-CoV-2 infection in persons aged 16 years and older, according to an ongoing phase 2/3 trial. Pfizer and BioNTech published safety and efficacy results from the landmark global phase 1/2/3 trial of their COVID-19 vaccine candidate in the New England Journal of Medicine .

“We previously reported phase 1 safety and immunogenicity results from clinical trials of the vaccine candidate BNT162b2,” lead author Fernando P. Polack, MD, of Vanderbilt University, Nashville, Tenn., and colleagues wrote. “This data set and [present] trial results are the basis for an application for emergency-use authorization,” they explained.
 

The BNT162b2 vaccine trial

Among 43,448 individuals aged 16 years and older, the efficacy, safety, and immunogenicity of the BNT162b2 vaccine candidate was evaluated in a continuous phase 1/2/3 study. Participants were randomly assigned (1:1) to receive two injections of either 30 mcg of BNT162b2 (n = 21,720) or saline placebo (n = 21,728) administered intramuscularly 21 days apart. The safety evaluation, where subjects were monitored 30 minutes post vaccination for acute reactions, was observer blinded.

Eligibility criteria included healthy individuals or those with stable chronic medical conditions, including viral hepatitis B and C, as well as human immunodeficiency virus. Persons with a diagnosis of an immunocompromising condition, those receiving immunosuppressive therapy, and individuals with a medical history of COVID-19 were excluded.

The first primary endpoint was efficacy of BNT162b2 against laboratory-confirmed COVID-19 with onset at least 7 days following the second dose. The primary safety endpoint was local and systemic reactions occurring within 7 days post injection of BNT162b2 or placebo.
 

Safety

“At the data cutoff date of Oct. 9, a total of 37,706 participants had a median of at least 2 months of safety data available after the second dose and contributed to the main safety data set,” the authors wrote.

Among these participants, 83% were White, 28% were Hispanic or Latinx, and 9% were Black or African American; 49% of subjects were female and the median age was 52 years, with 42% over aged 55 years.

Overall, BNT162b2 had a favorable safety profile. Mild to moderate pain at the injection site within 7 days after the injection was the most frequently reported local reaction (<1% across all age groups reported severe pain). Most local reactions resolved within 1-2 days and no grade 4 reactions were reported.

The investigators reported: “Fever (temperature, ≥38° C) was reported after the second dose by 16% of younger vaccine recipients and by 11% of older recipients. Only 0.2% of vaccine recipients and 0.1% of placebo recipients reported fever (temperature, 38.9-40° C) after the first dose, as compared with 0.8% and 0.1%, respectively, after the second dose.”

BNT162b2 recipients had more injection-site pain than those receiving the placebo. After the first and second doses, younger recipients (under 55 years) had more pain at the injection site (83 vs. 14 and 78 vs. 12 events, respectively), redness (5 vs. 1 and 6 vs. 1), and swelling (6 vs. 0 and 6 vs. 0), compared with placebo recipients.

The same trend was observed for patients aged over 55 years, with vaccine recipients reporting more pain at the injection site (71 vs. 9 and 66 vs. 8 events, respectively), redness (5 vs. 1 and 7 vs. 1), and swelling (7 vs. 1 and 7 vs. 1) than placebo recipients.

Pain was less common overall among vaccine recipients aged over 55 years (71% reported pain after the first dose; 66% post second dose) than among younger vaccine recipients (83% post first dose; 78% post second dose).

The most common systemic events following the second dose were fatigue and headache, which occurred in 59% and 52% of younger vaccine recipients and 51% and 39% of older vaccine recipients, respectively. But fatigue and headache were also reported by participants in the placebo group (23% and 24%, respectively, post second dose, among younger vaccine recipients; 17% and 14% among older recipients).

The incidence of serious adverse events was low and similar in the vaccine (0.6%) and placebo (0.5%) arms. Severe systemic events occurred in 2% or less of vaccine recipients following either dose, except for fatigue (3.8%) and headache (2.0%) post second dose. No deaths were considered to be vaccine or placebo related.

“The safety appears comparable to other vaccines, but the relatively short period of observation, 2 months, and the relatively small number of subjects who have received the vaccine (less than 30,000), compared to the hundreds of millions likely to ultimately receive the vaccine, precludes conclusions regarding the potential for rare long term adverse effects,” David L. Bowton, MD, FCCP, a pulmonologist and professor emeritus of critical care anesthesiology at Wake Forest University, Winston-Salem, N.C., said in an interview. “Clinicians should be aware of the risk of anaphylactic reactions and discuss it with their patients [who have] a history of these reactions.”
 

Efficacy

Among 36,523 subjects without evidence of existing or prior COVID-19 infection, 8 cases of COVID-19 with onset at least 7 days after the second dose were seen among vaccine recipients and 162 among placebo recipients, corresponding to 95.0% vaccine efficacy (95% credible interval, 90.3%-97.6%).

“Supplemental analyses indicated that vaccine efficacy among subgroups defined by age, sex, race, ethnicity, obesity, and presence of a coexisting condition was generally consistent with that observed in the overall population,” the authors wrote.

Between the first and second doses, 39 cases of COVID-19 were observed among BNT162b2 recipients and 82 cases among placebo recipients, corresponding to 52% vaccine efficacy during the 21-day interval (95% CI, 29.5%-68.4%) suggesting early protection may begin as soon as 12 days after the first injection.

“This is an incredible achievement given that an effective vaccine has never been developed and approved for use in such a short timeframe,” Dr. Bowton explained. “That the vaccine is highly effective in reducing the incidence of symptomatic COVID-19 seems incontrovertible.”

“This vaccine has shockingly amazing efficacy and is well tolerated, and the results are beyond even optimistic projections,” Douglas S. Paauw, MD, of the University of Washington, Seattle, said in an interview.
 

Questions remain

“It is not yet known if the vaccine prevents asymptomatic infections, with their attendant risk of contagion, as rates of seroconversion of trial participants against betacoronavirus nucleoproteins not included in the vaccine has not been reported,” Dr. Bowton commented.

“Common questions our patients will ask us remain unanswered for now, [including] how long will the protection last, is it safe in pregnant women, and does it prevent asymptomatic infection,” Dr. Paauw explained. “We do not know everything about longer term side effects, but the benefits of this vaccine appear to outweigh the risks of the vaccine.”

The researchers noted these and other limitations in their report, acknowledging that longer follow-up is needed to evaluate long-term safety of the vaccine.

This study was supported by BioNTech and Pfizer. Several authors disclosed financial relationships with Pfizer and other pharmaceutical companies outside the submitted work. Dr. Bowton and Dr. Paauw had no conflicts to disclose.

SOURCE: Polack FP et al. N Engl J Med. 2020 Dec 10. doi: 10.1056/NEJMoa2034577
 

The Pfizer COVID-19 vaccine was shown to be highly effective in a large trial, but clinicians will be waiting and watching for reactions and adverse events in their vaccinated patients.

A two-dose regimen of the BNT162b2 mRNA COVID-19 vaccine was found to be safe and 95% effective in preventing SARS-CoV-2 infection in persons aged 16 years and older, according to an ongoing phase 2/3 trial. Pfizer and BioNTech published safety and efficacy results from the landmark global phase 1/2/3 trial of their COVID-19 vaccine candidate in the New England Journal of Medicine .

“We previously reported phase 1 safety and immunogenicity results from clinical trials of the vaccine candidate BNT162b2,” lead author Fernando P. Polack, MD, of Vanderbilt University, Nashville, Tenn., and colleagues wrote. “This data set and [present] trial results are the basis for an application for emergency-use authorization,” they explained.
 

The BNT162b2 vaccine trial

Among 43,448 individuals aged 16 years and older, the efficacy, safety, and immunogenicity of the BNT162b2 vaccine candidate was evaluated in a continuous phase 1/2/3 study. Participants were randomly assigned (1:1) to receive two injections of either 30 mcg of BNT162b2 (n = 21,720) or saline placebo (n = 21,728) administered intramuscularly 21 days apart. The safety evaluation, where subjects were monitored 30 minutes post vaccination for acute reactions, was observer blinded.

Eligibility criteria included healthy individuals or those with stable chronic medical conditions, including viral hepatitis B and C, as well as human immunodeficiency virus. Persons with a diagnosis of an immunocompromising condition, those receiving immunosuppressive therapy, and individuals with a medical history of COVID-19 were excluded.

The first primary endpoint was efficacy of BNT162b2 against laboratory-confirmed COVID-19 with onset at least 7 days following the second dose. The primary safety endpoint was local and systemic reactions occurring within 7 days post injection of BNT162b2 or placebo.
 

Safety

“At the data cutoff date of Oct. 9, a total of 37,706 participants had a median of at least 2 months of safety data available after the second dose and contributed to the main safety data set,” the authors wrote.

Among these participants, 83% were White, 28% were Hispanic or Latinx, and 9% were Black or African American; 49% of subjects were female and the median age was 52 years, with 42% over aged 55 years.

Overall, BNT162b2 had a favorable safety profile. Mild to moderate pain at the injection site within 7 days after the injection was the most frequently reported local reaction (<1% across all age groups reported severe pain). Most local reactions resolved within 1-2 days and no grade 4 reactions were reported.

The investigators reported: “Fever (temperature, ≥38° C) was reported after the second dose by 16% of younger vaccine recipients and by 11% of older recipients. Only 0.2% of vaccine recipients and 0.1% of placebo recipients reported fever (temperature, 38.9-40° C) after the first dose, as compared with 0.8% and 0.1%, respectively, after the second dose.”

BNT162b2 recipients had more injection-site pain than those receiving the placebo. After the first and second doses, younger recipients (under 55 years) had more pain at the injection site (83 vs. 14 and 78 vs. 12 events, respectively), redness (5 vs. 1 and 6 vs. 1), and swelling (6 vs. 0 and 6 vs. 0), compared with placebo recipients.

The same trend was observed for patients aged over 55 years, with vaccine recipients reporting more pain at the injection site (71 vs. 9 and 66 vs. 8 events, respectively), redness (5 vs. 1 and 7 vs. 1), and swelling (7 vs. 1 and 7 vs. 1) than placebo recipients.

Pain was less common overall among vaccine recipients aged over 55 years (71% reported pain after the first dose; 66% post second dose) than among younger vaccine recipients (83% post first dose; 78% post second dose).

The most common systemic events following the second dose were fatigue and headache, which occurred in 59% and 52% of younger vaccine recipients and 51% and 39% of older vaccine recipients, respectively. But fatigue and headache were also reported by participants in the placebo group (23% and 24%, respectively, post second dose, among younger vaccine recipients; 17% and 14% among older recipients).

The incidence of serious adverse events was low and similar in the vaccine (0.6%) and placebo (0.5%) arms. Severe systemic events occurred in 2% or less of vaccine recipients following either dose, except for fatigue (3.8%) and headache (2.0%) post second dose. No deaths were considered to be vaccine or placebo related.

“The safety appears comparable to other vaccines, but the relatively short period of observation, 2 months, and the relatively small number of subjects who have received the vaccine (less than 30,000), compared to the hundreds of millions likely to ultimately receive the vaccine, precludes conclusions regarding the potential for rare long term adverse effects,” David L. Bowton, MD, FCCP, a pulmonologist and professor emeritus of critical care anesthesiology at Wake Forest University, Winston-Salem, N.C., said in an interview. “Clinicians should be aware of the risk of anaphylactic reactions and discuss it with their patients [who have] a history of these reactions.”
 

Efficacy

Among 36,523 subjects without evidence of existing or prior COVID-19 infection, 8 cases of COVID-19 with onset at least 7 days after the second dose were seen among vaccine recipients and 162 among placebo recipients, corresponding to 95.0% vaccine efficacy (95% credible interval, 90.3%-97.6%).

“Supplemental analyses indicated that vaccine efficacy among subgroups defined by age, sex, race, ethnicity, obesity, and presence of a coexisting condition was generally consistent with that observed in the overall population,” the authors wrote.

Between the first and second doses, 39 cases of COVID-19 were observed among BNT162b2 recipients and 82 cases among placebo recipients, corresponding to 52% vaccine efficacy during the 21-day interval (95% CI, 29.5%-68.4%) suggesting early protection may begin as soon as 12 days after the first injection.

“This is an incredible achievement given that an effective vaccine has never been developed and approved for use in such a short timeframe,” Dr. Bowton explained. “That the vaccine is highly effective in reducing the incidence of symptomatic COVID-19 seems incontrovertible.”

“This vaccine has shockingly amazing efficacy and is well tolerated, and the results are beyond even optimistic projections,” Douglas S. Paauw, MD, of the University of Washington, Seattle, said in an interview.
 

Questions remain

“It is not yet known if the vaccine prevents asymptomatic infections, with their attendant risk of contagion, as rates of seroconversion of trial participants against betacoronavirus nucleoproteins not included in the vaccine has not been reported,” Dr. Bowton commented.

“Common questions our patients will ask us remain unanswered for now, [including] how long will the protection last, is it safe in pregnant women, and does it prevent asymptomatic infection,” Dr. Paauw explained. “We do not know everything about longer term side effects, but the benefits of this vaccine appear to outweigh the risks of the vaccine.”

The researchers noted these and other limitations in their report, acknowledging that longer follow-up is needed to evaluate long-term safety of the vaccine.

This study was supported by BioNTech and Pfizer. Several authors disclosed financial relationships with Pfizer and other pharmaceutical companies outside the submitted work. Dr. Bowton and Dr. Paauw had no conflicts to disclose.

SOURCE: Polack FP et al. N Engl J Med. 2020 Dec 10. doi: 10.1056/NEJMoa2034577
 

Like most health care workers at his hospital in Lafayette, Ind., Ramesh Adhikari, MD, FHM, occasionally gets an email noting that a patient he saw later tested positive for COVID-19. He’s reminded to self-monitor for symptoms. But 10 months into the pandemic, it has become increasingly unlikely for contact tracing investigations to result in clinicians quarantining.

The very act of working in the hospital, Dr. Adhikari said, means being likely to see COVID-19 every day, whether in a known patient or an asymptomatic person who tests positive later. If hospitalists had to quarantine after every interaction with a COVID-positive person, there wouldn’t be anyone left to do their jobs.

“It’s really hard to do [contact tracing] in health care workers thoroughly because of the way we work,” Dr. Adhikari said. “It’s impossible to do it absolutely.”

In a recently updated guidance, the Centers for Disease Control and Prevention extended more leeway in contact tracing when community rates of COVID-19 surge, even allowing that contact tracing “may not be possible” in certain situations. And by defining an exposure more narrowly – health care workers are only considered “exposed” if their contact was more than 15 minutes or lacking in some form of PPE – the guidelines suggest that hospitals can rely more on universal PPE and screening protocols, as Dr. Adhikari’s hospital does, and less on extensive contact tracing to curtail viral spread.

Accordingly, while contact tracing has gotten more lax, doctors say, universal precautions – including full PPE and screening of symptoms for patients and health care workers – have become more stringent.

It’s a shift from the beginning of the pandemic. At first, CDC recommended wearing masks only during aerosol-producing procedures. Exposures were frequently reported and health care workers sent home. With more evidence in favor of stricter PPE requirements, hospitals including the one where Shyam Odeti, MD, FHM, works in Johnson City, Tenn., have adopted a universal precaution strategy – requiring masks everywhere and a gown, face shield, gloves, and N95 to enter a COVID-positive patient’s room. Thus, most exposures fall into that low-risk category.

“If I get it and am asymptomatic, I don’t think my colleagues would be exposed by any means because of these stringent policies being enforced,” said Dr. Odeti, a hospitalist who often wears a surgical mask on top of his N95 all day. “And U.S. health care is not in a state that can afford to quarantine health care workers for 14 days.”
 

Can universal PPE precautions supplant contact tracing?

The extent of contact tracing varies by hospital. Larger university and community hospitals often have infection control and occupational health teams that can do their own contact tracing, while smaller institutions can’t always spare staff. And some state health departments get involved with contact tracing of health care workers while others do not.

“I would venture to say that most hospitals are doing something in terms of contact tracing,” said Pam Falk, MPH, CIC, a member of the Association for Professionals in Infection Control and Epidemiology’s COVID-19 task force and an infection control consultant. “It kind of depends on their bandwidth.”

But there’s no longer a norm. Outside of a pandemic, with ample staffing and far fewer instances that need to be investigated, standards for contact tracing are higher, Dr. Falk said: When a patient is found to have an airborne disease such as tuberculosis, measles, mumps, or chickenpox, a hospital’s infection prevention team should investigate, confirm the diagnosis and identify everyone who was exposed. The hospital’s occupational health team assists in deciding who will likely need prophylactic treatment and if employees should be furloughed. The thoroughness of such measures has always depended on a hospital’s bandwidth.

Because PPE seems to be able to contain COVID-19 better than some of the older diseases targeted by contact tracing, universal protections may be a reasonable alternative in current circumstances, doctors said – if PPE is available.

“At the end of the day, universal source control with surgical masks – and ideally eye protection for clinicians as well – should prevent most transmissions,” said Aaron Richterman, MD, from the division of infectious diseases at the Hospital of the University of Pennsylvania, Philadelphia, who coauthored a JAMA commentary on decreased transmission rates in hospitals.

Contact tracing is still useful, though, to identify weaknesses in universal protection measures, he said.

“I don’t think it’s worth abandoning. It’s like a tool in the toolbox. All are imperfect, and none work 100% of the time,” Dr. Richterman said, but using all of them can achieve a fairly high measure of safety. Of the tools, universal masking likely works the best, he contends, so it should be the top pick for hospitals without resources to use all of the tools.

A recent incident at Brigham and Women’s Hospital in Boston is a case study in how contact tracing can work together with universal protections to identify cracks in the system, said Dr. Richterman, who worked at the hospital earlier in the pandemic.

Mass General Brigham adopted a universal masking policy for staff and patients in March 2020. Then, when the system experienced an outbreak in September, the hospital did “a very detailed public evaluation that included contact tracing and universal testing,” Dr. Richterman said. Testing even included genetic analysis of the virus to confirm which cases were hospital acquired. In the end, the hospital identified weaknesses in infection control that could be rectified, such as clinicians eating too close together.

“The approach is not to point fingers, but to say: ‘What’s wrong with the system and how do we improve?’ ” Dr. Richterman said. “To ask, why did that maskless transmission happen? Is there not enough space to eat? Are people working too many hours? It’s useful for systems to understand where transmissions are happening.”

Amith Skandhan, MD, SFHM, a hospitalist in Dothan, Ala., is comfortable without much contact tracing as long as there is universal PPE use. His hospital informs clinicians of exposures, but “basically we’re trained to treat every patient as if they had COVID,” he said, so “I feel more secure in the hospital than in the community.” Masks have become so habitual they’re like part of your regular clothing, he said – you feel incomplete if you don’t have one.

While ad hoc approaches to contact tracing may be useful in the current stage of the pandemic, they are likely to be short-lived: Once a community’s positivity rate falls, the CDC’s guidance suggests how hospitals can return to full contact tracing.

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

Like most health care workers at his hospital in Lafayette, Ind., Ramesh Adhikari, MD, FHM, occasionally gets an email noting that a patient he saw later tested positive for COVID-19. He’s reminded to self-monitor for symptoms. But 10 months into the pandemic, it has become increasingly unlikely for contact tracing investigations to result in clinicians quarantining.

The very act of working in the hospital, Dr. Adhikari said, means being likely to see COVID-19 every day, whether in a known patient or an asymptomatic person who tests positive later. If hospitalists had to quarantine after every interaction with a COVID-positive person, there wouldn’t be anyone left to do their jobs.

“It’s really hard to do [contact tracing] in health care workers thoroughly because of the way we work,” Dr. Adhikari said. “It’s impossible to do it absolutely.”

In a recently updated guidance, the Centers for Disease Control and Prevention extended more leeway in contact tracing when community rates of COVID-19 surge, even allowing that contact tracing “may not be possible” in certain situations. And by defining an exposure more narrowly – health care workers are only considered “exposed” if their contact was more than 15 minutes or lacking in some form of PPE – the guidelines suggest that hospitals can rely more on universal PPE and screening protocols, as Dr. Adhikari’s hospital does, and less on extensive contact tracing to curtail viral spread.

Accordingly, while contact tracing has gotten more lax, doctors say, universal precautions – including full PPE and screening of symptoms for patients and health care workers – have become more stringent.

It’s a shift from the beginning of the pandemic. At first, CDC recommended wearing masks only during aerosol-producing procedures. Exposures were frequently reported and health care workers sent home. With more evidence in favor of stricter PPE requirements, hospitals including the one where Shyam Odeti, MD, FHM, works in Johnson City, Tenn., have adopted a universal precaution strategy – requiring masks everywhere and a gown, face shield, gloves, and N95 to enter a COVID-positive patient’s room. Thus, most exposures fall into that low-risk category.

“If I get it and am asymptomatic, I don’t think my colleagues would be exposed by any means because of these stringent policies being enforced,” said Dr. Odeti, a hospitalist who often wears a surgical mask on top of his N95 all day. “And U.S. health care is not in a state that can afford to quarantine health care workers for 14 days.”
 

Can universal PPE precautions supplant contact tracing?

The extent of contact tracing varies by hospital. Larger university and community hospitals often have infection control and occupational health teams that can do their own contact tracing, while smaller institutions can’t always spare staff. And some state health departments get involved with contact tracing of health care workers while others do not.

“I would venture to say that most hospitals are doing something in terms of contact tracing,” said Pam Falk, MPH, CIC, a member of the Association for Professionals in Infection Control and Epidemiology’s COVID-19 task force and an infection control consultant. “It kind of depends on their bandwidth.”

But there’s no longer a norm. Outside of a pandemic, with ample staffing and far fewer instances that need to be investigated, standards for contact tracing are higher, Dr. Falk said: When a patient is found to have an airborne disease such as tuberculosis, measles, mumps, or chickenpox, a hospital’s infection prevention team should investigate, confirm the diagnosis and identify everyone who was exposed. The hospital’s occupational health team assists in deciding who will likely need prophylactic treatment and if employees should be furloughed. The thoroughness of such measures has always depended on a hospital’s bandwidth.

Because PPE seems to be able to contain COVID-19 better than some of the older diseases targeted by contact tracing, universal protections may be a reasonable alternative in current circumstances, doctors said – if PPE is available.

“At the end of the day, universal source control with surgical masks – and ideally eye protection for clinicians as well – should prevent most transmissions,” said Aaron Richterman, MD, from the division of infectious diseases at the Hospital of the University of Pennsylvania, Philadelphia, who coauthored a JAMA commentary on decreased transmission rates in hospitals.

Contact tracing is still useful, though, to identify weaknesses in universal protection measures, he said.

“I don’t think it’s worth abandoning. It’s like a tool in the toolbox. All are imperfect, and none work 100% of the time,” Dr. Richterman said, but using all of them can achieve a fairly high measure of safety. Of the tools, universal masking likely works the best, he contends, so it should be the top pick for hospitals without resources to use all of the tools.

A recent incident at Brigham and Women’s Hospital in Boston is a case study in how contact tracing can work together with universal protections to identify cracks in the system, said Dr. Richterman, who worked at the hospital earlier in the pandemic.

Mass General Brigham adopted a universal masking policy for staff and patients in March 2020. Then, when the system experienced an outbreak in September, the hospital did “a very detailed public evaluation that included contact tracing and universal testing,” Dr. Richterman said. Testing even included genetic analysis of the virus to confirm which cases were hospital acquired. In the end, the hospital identified weaknesses in infection control that could be rectified, such as clinicians eating too close together.

“The approach is not to point fingers, but to say: ‘What’s wrong with the system and how do we improve?’ ” Dr. Richterman said. “To ask, why did that maskless transmission happen? Is there not enough space to eat? Are people working too many hours? It’s useful for systems to understand where transmissions are happening.”

Amith Skandhan, MD, SFHM, a hospitalist in Dothan, Ala., is comfortable without much contact tracing as long as there is universal PPE use. His hospital informs clinicians of exposures, but “basically we’re trained to treat every patient as if they had COVID,” he said, so “I feel more secure in the hospital than in the community.” Masks have become so habitual they’re like part of your regular clothing, he said – you feel incomplete if you don’t have one.

While ad hoc approaches to contact tracing may be useful in the current stage of the pandemic, they are likely to be short-lived: Once a community’s positivity rate falls, the CDC’s guidance suggests how hospitals can return to full contact tracing.

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

Like most health care workers at his hospital in Lafayette, Ind., Ramesh Adhikari, MD, FHM, occasionally gets an email noting that a patient he saw later tested positive for COVID-19. He’s reminded to self-monitor for symptoms. But 10 months into the pandemic, it has become increasingly unlikely for contact tracing investigations to result in clinicians quarantining.

The very act of working in the hospital, Dr. Adhikari said, means being likely to see COVID-19 every day, whether in a known patient or an asymptomatic person who tests positive later. If hospitalists had to quarantine after every interaction with a COVID-positive person, there wouldn’t be anyone left to do their jobs.

“It’s really hard to do [contact tracing] in health care workers thoroughly because of the way we work,” Dr. Adhikari said. “It’s impossible to do it absolutely.”

In a recently updated guidance, the Centers for Disease Control and Prevention extended more leeway in contact tracing when community rates of COVID-19 surge, even allowing that contact tracing “may not be possible” in certain situations. And by defining an exposure more narrowly – health care workers are only considered “exposed” if their contact was more than 15 minutes or lacking in some form of PPE – the guidelines suggest that hospitals can rely more on universal PPE and screening protocols, as Dr. Adhikari’s hospital does, and less on extensive contact tracing to curtail viral spread.

Accordingly, while contact tracing has gotten more lax, doctors say, universal precautions – including full PPE and screening of symptoms for patients and health care workers – have become more stringent.

It’s a shift from the beginning of the pandemic. At first, CDC recommended wearing masks only during aerosol-producing procedures. Exposures were frequently reported and health care workers sent home. With more evidence in favor of stricter PPE requirements, hospitals including the one where Shyam Odeti, MD, FHM, works in Johnson City, Tenn., have adopted a universal precaution strategy – requiring masks everywhere and a gown, face shield, gloves, and N95 to enter a COVID-positive patient’s room. Thus, most exposures fall into that low-risk category.

“If I get it and am asymptomatic, I don’t think my colleagues would be exposed by any means because of these stringent policies being enforced,” said Dr. Odeti, a hospitalist who often wears a surgical mask on top of his N95 all day. “And U.S. health care is not in a state that can afford to quarantine health care workers for 14 days.”
 

Can universal PPE precautions supplant contact tracing?

The extent of contact tracing varies by hospital. Larger university and community hospitals often have infection control and occupational health teams that can do their own contact tracing, while smaller institutions can’t always spare staff. And some state health departments get involved with contact tracing of health care workers while others do not.

“I would venture to say that most hospitals are doing something in terms of contact tracing,” said Pam Falk, MPH, CIC, a member of the Association for Professionals in Infection Control and Epidemiology’s COVID-19 task force and an infection control consultant. “It kind of depends on their bandwidth.”

But there’s no longer a norm. Outside of a pandemic, with ample staffing and far fewer instances that need to be investigated, standards for contact tracing are higher, Dr. Falk said: When a patient is found to have an airborne disease such as tuberculosis, measles, mumps, or chickenpox, a hospital’s infection prevention team should investigate, confirm the diagnosis and identify everyone who was exposed. The hospital’s occupational health team assists in deciding who will likely need prophylactic treatment and if employees should be furloughed. The thoroughness of such measures has always depended on a hospital’s bandwidth.

Because PPE seems to be able to contain COVID-19 better than some of the older diseases targeted by contact tracing, universal protections may be a reasonable alternative in current circumstances, doctors said – if PPE is available.

“At the end of the day, universal source control with surgical masks – and ideally eye protection for clinicians as well – should prevent most transmissions,” said Aaron Richterman, MD, from the division of infectious diseases at the Hospital of the University of Pennsylvania, Philadelphia, who coauthored a JAMA commentary on decreased transmission rates in hospitals.

Contact tracing is still useful, though, to identify weaknesses in universal protection measures, he said.

“I don’t think it’s worth abandoning. It’s like a tool in the toolbox. All are imperfect, and none work 100% of the time,” Dr. Richterman said, but using all of them can achieve a fairly high measure of safety. Of the tools, universal masking likely works the best, he contends, so it should be the top pick for hospitals without resources to use all of the tools.

A recent incident at Brigham and Women’s Hospital in Boston is a case study in how contact tracing can work together with universal protections to identify cracks in the system, said Dr. Richterman, who worked at the hospital earlier in the pandemic.

Mass General Brigham adopted a universal masking policy for staff and patients in March 2020. Then, when the system experienced an outbreak in September, the hospital did “a very detailed public evaluation that included contact tracing and universal testing,” Dr. Richterman said. Testing even included genetic analysis of the virus to confirm which cases were hospital acquired. In the end, the hospital identified weaknesses in infection control that could be rectified, such as clinicians eating too close together.

“The approach is not to point fingers, but to say: ‘What’s wrong with the system and how do we improve?’ ” Dr. Richterman said. “To ask, why did that maskless transmission happen? Is there not enough space to eat? Are people working too many hours? It’s useful for systems to understand where transmissions are happening.”

Amith Skandhan, MD, SFHM, a hospitalist in Dothan, Ala., is comfortable without much contact tracing as long as there is universal PPE use. His hospital informs clinicians of exposures, but “basically we’re trained to treat every patient as if they had COVID,” he said, so “I feel more secure in the hospital than in the community.” Masks have become so habitual they’re like part of your regular clothing, he said – you feel incomplete if you don’t have one.

While ad hoc approaches to contact tracing may be useful in the current stage of the pandemic, they are likely to be short-lived: Once a community’s positivity rate falls, the CDC’s guidance suggests how hospitals can return to full contact tracing.

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