Residents

Researchers have detected a highly contagious coronavirus variant in the United Kingdom, leading Prime Minister Boris Johnson to shut down parts of the country and triggering other nations to impose travel and shipping restrictions on England.

Mr. Johnson held a crisis meeting with ministers Monday after Saturday’s shutdown announcement. The prime minister said in a nationally televised address that this coronavirus variant may be “up to 70% more transmissible than the old variant” and was probably responsible for an increase in cases in southeastern England.

“There is still much we don’t know. While we are fairly certain the variant is transmitted more quickly, there is no evidence to suggest that it is more lethal or causes more severe illness. Equally there is no evidence to suggest the vaccine will be any less effective against the new variant,” he said.

Public Health England says it is working to learn as much about the variant as possible. “We know that mortality is a lagging indicator, and we will need to continually monitor this over the coming weeks,” the agency says.

That scientific uncertainty about the variant’s threat shook European nations that were rushing to ship goods to England in advance of a Dec. 31 Brexit deadline. Under Brexit, which is short for “British exit,” the United Kingdom will leave the European Union on Jan. 31, 2020. Until then, the two sides will come up with new trade and security relationships.

European Union members Austria, Belgium, Bulgaria, France, Germany, Ireland, Italy, and the Netherlands announced travel restrictions hours after Johnson’s speech.

Those restrictions created food uncertainty across the U.K., which imports about a quarter of its food from the EU, according to The New York Times. Long lines of trucks heading to ports in the U.K. came to a standstill on major roads such as the M20 near Kent and the Port of Dover.

Outside Europe, Canada, India, Iran, Israel, Hong Kong, Saudi Arabia, and Turkey banned all incoming flights from the U.K. And more bans could come.
 

The U.S. reaction

The United States has not imposed any new limits on travel with the United Kingdom, although New York Gov. Andrew Cuomo (D) has requested all passengers bound for John F. Kennedy International Airport from the U.K. be tested before boarding and a new travel ban be placed for Europe. He says the federal government must take action now to avoid a crisis situation like the one New York experienced in March and April.

“The United States has a number of flights coming in from the U.K. each day, and we have done absolutely nothing,” Mr. Cuomo said in a statement on the governor’s webpage. “To me, this is reprehensible because this is what happened in the spring. How many times in life do you have to make the same mistake before you learn?”

Leading U.S. health officials have downplayed the dangers of the virus.

“We don’t know that it’s more dangerous, and very importantly, we have not seen a single mutation yet that would make it evade the vaccine,” U.S. Assistant Secretary of Health and Human Services Adm. Brett Giroir, MD, said Sunday on ABC’s This Week with George Stephanopoulos. “I can’t say that won’t happen in the future, but right now it looks like the vaccine will cover everything that we see.”

Dr. Giroir said the HHS and other U.S. government agencies will monitor the variant.

“Viruses mutate,” he said. “We’ve seen almost 4,000 different mutations among this virus. There is no indication that the mutation right now that they’re talking about is overcoming England.”
 

Where did the variant come from?

Public Health England says the coronavirus variant had existed in the U.K. since September and circulated at very low levels until mid-November.

“The increase in cases linked to the new variant first came to light in late November when PHE was investigating why infection rates in Kent were not falling despite national restrictions. We then discovered a cluster linked to this variant spreading rapidly into London and Essex,” the agency said.

Public Health England says there’s no evidence the new variant is resistant to the Pfizer-BioNTech vaccine, which is now being given across the country to high-priority groups such as health care workers.

An article in The BMJ, a British medical journal, says the variant was first detected by Covid-19 Genomics UK, a consortium that tests the random genetic sequencing of positive COVID-19 samples around the U.K. The variant cases were mostly in the southeast of England.

A University of Birmingham professor said in a Dec. 15 briefing that the variant accounts for 20% of viruses sequenced in Norfolk, 10% in Essex, and 3% in Suffolk. “There are no data to suggest it had been imported from abroad, so it is likely to have evolved in the U.K.,” he said.

The variant is named VUI-202012/01, for the first “variant under investigation” in December 2020, BMJ says. It’s defined by a set of 17 mutations, with the most significant mutation in the spike protein the virus uses to bind to the human ACE2 receptor.

“Changes in this part of spike protein may, in theory, result in the virus becoming more infectious and spreading more easily between people,” the article says.

The European Centre for Disease Prevention and Control says the variant emerged during the time of year when people usually socialize more.

“There is no indication at this point of increased infection severity associated with the new variant,” the agency said. “A few cases with the new variant have to date been reported by Denmark and the Netherlands and, according to media reports, in Belgium.”

Mr. Johnson announced tighter restrictions on England’s hardest-hit areas, such as the southeast and east of England, where new coronavirus cases have continued to rise. And he said people must cut back on their Christmas socializing.

“In England, those living in tier 4 areas should not mix with anyone outside their own household at Christmas, though support bubbles will remain in place for those at particular risk of loneliness or isolation,” he said.

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

Researchers have detected a highly contagious coronavirus variant in the United Kingdom, leading Prime Minister Boris Johnson to shut down parts of the country and triggering other nations to impose travel and shipping restrictions on England.

Mr. Johnson held a crisis meeting with ministers Monday after Saturday’s shutdown announcement. The prime minister said in a nationally televised address that this coronavirus variant may be “up to 70% more transmissible than the old variant” and was probably responsible for an increase in cases in southeastern England.

“There is still much we don’t know. While we are fairly certain the variant is transmitted more quickly, there is no evidence to suggest that it is more lethal or causes more severe illness. Equally there is no evidence to suggest the vaccine will be any less effective against the new variant,” he said.

Public Health England says it is working to learn as much about the variant as possible. “We know that mortality is a lagging indicator, and we will need to continually monitor this over the coming weeks,” the agency says.

That scientific uncertainty about the variant’s threat shook European nations that were rushing to ship goods to England in advance of a Dec. 31 Brexit deadline. Under Brexit, which is short for “British exit,” the United Kingdom will leave the European Union on Jan. 31, 2020. Until then, the two sides will come up with new trade and security relationships.

European Union members Austria, Belgium, Bulgaria, France, Germany, Ireland, Italy, and the Netherlands announced travel restrictions hours after Johnson’s speech.

Those restrictions created food uncertainty across the U.K., which imports about a quarter of its food from the EU, according to The New York Times. Long lines of trucks heading to ports in the U.K. came to a standstill on major roads such as the M20 near Kent and the Port of Dover.

Outside Europe, Canada, India, Iran, Israel, Hong Kong, Saudi Arabia, and Turkey banned all incoming flights from the U.K. And more bans could come.
 

The U.S. reaction

The United States has not imposed any new limits on travel with the United Kingdom, although New York Gov. Andrew Cuomo (D) has requested all passengers bound for John F. Kennedy International Airport from the U.K. be tested before boarding and a new travel ban be placed for Europe. He says the federal government must take action now to avoid a crisis situation like the one New York experienced in March and April.

“The United States has a number of flights coming in from the U.K. each day, and we have done absolutely nothing,” Mr. Cuomo said in a statement on the governor’s webpage. “To me, this is reprehensible because this is what happened in the spring. How many times in life do you have to make the same mistake before you learn?”

Leading U.S. health officials have downplayed the dangers of the virus.

“We don’t know that it’s more dangerous, and very importantly, we have not seen a single mutation yet that would make it evade the vaccine,” U.S. Assistant Secretary of Health and Human Services Adm. Brett Giroir, MD, said Sunday on ABC’s This Week with George Stephanopoulos. “I can’t say that won’t happen in the future, but right now it looks like the vaccine will cover everything that we see.”

Dr. Giroir said the HHS and other U.S. government agencies will monitor the variant.

“Viruses mutate,” he said. “We’ve seen almost 4,000 different mutations among this virus. There is no indication that the mutation right now that they’re talking about is overcoming England.”
 

Where did the variant come from?

Public Health England says the coronavirus variant had existed in the U.K. since September and circulated at very low levels until mid-November.

“The increase in cases linked to the new variant first came to light in late November when PHE was investigating why infection rates in Kent were not falling despite national restrictions. We then discovered a cluster linked to this variant spreading rapidly into London and Essex,” the agency said.

Public Health England says there’s no evidence the new variant is resistant to the Pfizer-BioNTech vaccine, which is now being given across the country to high-priority groups such as health care workers.

An article in The BMJ, a British medical journal, says the variant was first detected by Covid-19 Genomics UK, a consortium that tests the random genetic sequencing of positive COVID-19 samples around the U.K. The variant cases were mostly in the southeast of England.

A University of Birmingham professor said in a Dec. 15 briefing that the variant accounts for 20% of viruses sequenced in Norfolk, 10% in Essex, and 3% in Suffolk. “There are no data to suggest it had been imported from abroad, so it is likely to have evolved in the U.K.,” he said.

The variant is named VUI-202012/01, for the first “variant under investigation” in December 2020, BMJ says. It’s defined by a set of 17 mutations, with the most significant mutation in the spike protein the virus uses to bind to the human ACE2 receptor.

“Changes in this part of spike protein may, in theory, result in the virus becoming more infectious and spreading more easily between people,” the article says.

The European Centre for Disease Prevention and Control says the variant emerged during the time of year when people usually socialize more.

“There is no indication at this point of increased infection severity associated with the new variant,” the agency said. “A few cases with the new variant have to date been reported by Denmark and the Netherlands and, according to media reports, in Belgium.”

Mr. Johnson announced tighter restrictions on England’s hardest-hit areas, such as the southeast and east of England, where new coronavirus cases have continued to rise. And he said people must cut back on their Christmas socializing.

“In England, those living in tier 4 areas should not mix with anyone outside their own household at Christmas, though support bubbles will remain in place for those at particular risk of loneliness or isolation,” he said.

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

Researchers have detected a highly contagious coronavirus variant in the United Kingdom, leading Prime Minister Boris Johnson to shut down parts of the country and triggering other nations to impose travel and shipping restrictions on England.

Mr. Johnson held a crisis meeting with ministers Monday after Saturday’s shutdown announcement. The prime minister said in a nationally televised address that this coronavirus variant may be “up to 70% more transmissible than the old variant” and was probably responsible for an increase in cases in southeastern England.

“There is still much we don’t know. While we are fairly certain the variant is transmitted more quickly, there is no evidence to suggest that it is more lethal or causes more severe illness. Equally there is no evidence to suggest the vaccine will be any less effective against the new variant,” he said.

Public Health England says it is working to learn as much about the variant as possible. “We know that mortality is a lagging indicator, and we will need to continually monitor this over the coming weeks,” the agency says.

That scientific uncertainty about the variant’s threat shook European nations that were rushing to ship goods to England in advance of a Dec. 31 Brexit deadline. Under Brexit, which is short for “British exit,” the United Kingdom will leave the European Union on Jan. 31, 2020. Until then, the two sides will come up with new trade and security relationships.

European Union members Austria, Belgium, Bulgaria, France, Germany, Ireland, Italy, and the Netherlands announced travel restrictions hours after Johnson’s speech.

Those restrictions created food uncertainty across the U.K., which imports about a quarter of its food from the EU, according to The New York Times. Long lines of trucks heading to ports in the U.K. came to a standstill on major roads such as the M20 near Kent and the Port of Dover.

Outside Europe, Canada, India, Iran, Israel, Hong Kong, Saudi Arabia, and Turkey banned all incoming flights from the U.K. And more bans could come.
 

The U.S. reaction

The United States has not imposed any new limits on travel with the United Kingdom, although New York Gov. Andrew Cuomo (D) has requested all passengers bound for John F. Kennedy International Airport from the U.K. be tested before boarding and a new travel ban be placed for Europe. He says the federal government must take action now to avoid a crisis situation like the one New York experienced in March and April.

“The United States has a number of flights coming in from the U.K. each day, and we have done absolutely nothing,” Mr. Cuomo said in a statement on the governor’s webpage. “To me, this is reprehensible because this is what happened in the spring. How many times in life do you have to make the same mistake before you learn?”

Leading U.S. health officials have downplayed the dangers of the virus.

“We don’t know that it’s more dangerous, and very importantly, we have not seen a single mutation yet that would make it evade the vaccine,” U.S. Assistant Secretary of Health and Human Services Adm. Brett Giroir, MD, said Sunday on ABC’s This Week with George Stephanopoulos. “I can’t say that won’t happen in the future, but right now it looks like the vaccine will cover everything that we see.”

Dr. Giroir said the HHS and other U.S. government agencies will monitor the variant.

“Viruses mutate,” he said. “We’ve seen almost 4,000 different mutations among this virus. There is no indication that the mutation right now that they’re talking about is overcoming England.”
 

Where did the variant come from?

Public Health England says the coronavirus variant had existed in the U.K. since September and circulated at very low levels until mid-November.

“The increase in cases linked to the new variant first came to light in late November when PHE was investigating why infection rates in Kent were not falling despite national restrictions. We then discovered a cluster linked to this variant spreading rapidly into London and Essex,” the agency said.

Public Health England says there’s no evidence the new variant is resistant to the Pfizer-BioNTech vaccine, which is now being given across the country to high-priority groups such as health care workers.

An article in The BMJ, a British medical journal, says the variant was first detected by Covid-19 Genomics UK, a consortium that tests the random genetic sequencing of positive COVID-19 samples around the U.K. The variant cases were mostly in the southeast of England.

A University of Birmingham professor said in a Dec. 15 briefing that the variant accounts for 20% of viruses sequenced in Norfolk, 10% in Essex, and 3% in Suffolk. “There are no data to suggest it had been imported from abroad, so it is likely to have evolved in the U.K.,” he said.

The variant is named VUI-202012/01, for the first “variant under investigation” in December 2020, BMJ says. It’s defined by a set of 17 mutations, with the most significant mutation in the spike protein the virus uses to bind to the human ACE2 receptor.

“Changes in this part of spike protein may, in theory, result in the virus becoming more infectious and spreading more easily between people,” the article says.

The European Centre for Disease Prevention and Control says the variant emerged during the time of year when people usually socialize more.

“There is no indication at this point of increased infection severity associated with the new variant,” the agency said. “A few cases with the new variant have to date been reported by Denmark and the Netherlands and, according to media reports, in Belgium.”

Mr. Johnson announced tighter restrictions on England’s hardest-hit areas, such as the southeast and east of England, where new coronavirus cases have continued to rise. And he said people must cut back on their Christmas socializing.

“In England, those living in tier 4 areas should not mix with anyone outside their own household at Christmas, though support bubbles will remain in place for those at particular risk of loneliness or isolation,” he said.

A version of this article first appeared on WebMD.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.

Federal advisers on December 17 overwhelmingly recommended an emergency clearance to Moderna Inc’s COVID-19 vaccine, while noting concerns about potential allergic reactions and the challenges of continuing testing of this medicine.

The US Food and Drug Administration (FDA) put Moderna’s application before its Vaccines and Related Biological Products Advisory Committee. The panel voted 20-0 on this question: “Based on the totality of scientific evidence available, do the benefits of the Moderna COVID-19 Vaccine outweigh its risks for use in individuals 18 years of age and older?” There was one abstention.

The FDA is not bound to act on the recommendations of its advisers, but the agency usually takes the panel’s advice. The FDA cleared the similar Pfizer-BioNTech vaccine on December 11 through an emergency use authorization (EUA), following a positive vote for the product at a December 10 advisory committee meeting. In this case, the FDA staff appeared to be pushing for a broad endorsement of the Moderna vaccine, for which the agency appears likely to soon also grant an EUA.

Marion Gruber, PhD, director of the Office of Vaccines Research and Review at FDA’s Center for Biologics Evaluation and Research, earlier rebuffed attempts by some of the panelists to alter the voting question. Some panelists wanted to make tweaks, including a rephrasing to underscore the limited nature of an EUA, compared with a more complete approval through the biologics license application (BLA) process.

FDA panelist Michael Kurilla, MD, PhD, of the National Institutes of Health was the only panelist to abstain from voting. He said he was uncomfortable with the phrasing of the question.

“In the midst of a pandemic and with limited vaccine supply available, a blanket statement for individuals 18 years and older is just too broad,” he said. “I’m not convinced that for all of those age groups the benefits do actually outweigh the risks.”

In general, though, there was strong support for Moderna’s vaccine. FDA panelist James Hildreth Sr, MD, PhD, of Meharry Medical College in Nashville, Tennessee spoke of the “remarkable achievement” seen in having two vaccines ready for clearance by December for a virus that only emerged as a threat this year.

Study data indicate the primary efficacy endpoint demonstrated vaccine efficacy (VE) of 94.1% (95% CI, 89.3% - 96.8%) for the Moderna vaccine, with 11 COVID-19 cases in the vaccine group and 185 COVID-19 cases in the placebo group, the FDA staff noted during the meeting.

The advisers and FDA staff also honed in on several key issues with COVID-19 vaccines, including the challenge of having people in the placebo groups of studies seek to get cleared vaccines. Also of concern to the panel were early reports of allergic reactions seen with the Pfizer product.

Doran L. Fink, MD, PhD, an FDA official who has been closely involved with the COVID-19 vaccines, told the panel that two healthcare workers in Alaska had allergic reactions minutes after receiving the Pfizer vaccine, one of which was a case of anaphylactic reaction that resulted in hospitalization.

In the United Kingdom, there were two cases reported of notable allergic reactions, leading regulators there to issue a warning that people who have a history of significant allergic reactions should not currently receive the Pfizer-BioNTech vaccine.

The people involved in these incidents have recovered or are recovering, Fink said. But the FDA expects there will be additional reports of allergic reactions to COVID-19 vaccines.

“These cases underscores the need to remain vigilant during the early phase of the vaccination campaign,” Fink said. “To this end, FDA is working with Pfizer to further revise factsheets and prescribing information for their vaccine to draw attention to CDC guidelines for post- vaccination monitoring and management of immediate allergic reactions.”

mRNA vaccines in the lead

An FDA emergency clearance for Moderna’s product would be another vote of confidence in a new approach to making vaccines. Both the Pfizer-BioNTech and Moderna vaccines provide the immune system with a kind of blueprint in the form of genetic material, mRNA. The mRNA sets the stage for the synthesis of the signature spike protein that the SARS-CoV-2 virus uses to attach to and infect human cells.

In a December 15 commentary for this news organization Michael E. Pichichero, MD, wrote that the “revolutionary aspect of mRNA vaccines is the speed at which they can be designed and produced.”

“This is why they lead the pack among the SARS-CoV-2 vaccine candidates and why the National Institute of Allergy and Infectious Diseases provided financial, technical, and/or clinical support. Indeed, once the amino acid sequence of a protein can be determined (a relatively easy task these days) it’s straightforward to synthesize mRNA in the lab — and it can be done incredibly fast,” he wrote.

The FDA allowed one waiver for panelist James K. Hildreth in connection with his personal relationship to a trial participant and his university’s participation in vaccine testing.

This article first appeared on Medscape.com.

Federal advisers on December 17 overwhelmingly recommended an emergency clearance to Moderna Inc’s COVID-19 vaccine, while noting concerns about potential allergic reactions and the challenges of continuing testing of this medicine.

The US Food and Drug Administration (FDA) put Moderna’s application before its Vaccines and Related Biological Products Advisory Committee. The panel voted 20-0 on this question: “Based on the totality of scientific evidence available, do the benefits of the Moderna COVID-19 Vaccine outweigh its risks for use in individuals 18 years of age and older?” There was one abstention.

The FDA is not bound to act on the recommendations of its advisers, but the agency usually takes the panel’s advice. The FDA cleared the similar Pfizer-BioNTech vaccine on December 11 through an emergency use authorization (EUA), following a positive vote for the product at a December 10 advisory committee meeting. In this case, the FDA staff appeared to be pushing for a broad endorsement of the Moderna vaccine, for which the agency appears likely to soon also grant an EUA.

Marion Gruber, PhD, director of the Office of Vaccines Research and Review at FDA’s Center for Biologics Evaluation and Research, earlier rebuffed attempts by some of the panelists to alter the voting question. Some panelists wanted to make tweaks, including a rephrasing to underscore the limited nature of an EUA, compared with a more complete approval through the biologics license application (BLA) process.

FDA panelist Michael Kurilla, MD, PhD, of the National Institutes of Health was the only panelist to abstain from voting. He said he was uncomfortable with the phrasing of the question.

“In the midst of a pandemic and with limited vaccine supply available, a blanket statement for individuals 18 years and older is just too broad,” he said. “I’m not convinced that for all of those age groups the benefits do actually outweigh the risks.”

In general, though, there was strong support for Moderna’s vaccine. FDA panelist James Hildreth Sr, MD, PhD, of Meharry Medical College in Nashville, Tennessee spoke of the “remarkable achievement” seen in having two vaccines ready for clearance by December for a virus that only emerged as a threat this year.

Study data indicate the primary efficacy endpoint demonstrated vaccine efficacy (VE) of 94.1% (95% CI, 89.3% - 96.8%) for the Moderna vaccine, with 11 COVID-19 cases in the vaccine group and 185 COVID-19 cases in the placebo group, the FDA staff noted during the meeting.

The advisers and FDA staff also honed in on several key issues with COVID-19 vaccines, including the challenge of having people in the placebo groups of studies seek to get cleared vaccines. Also of concern to the panel were early reports of allergic reactions seen with the Pfizer product.

Doran L. Fink, MD, PhD, an FDA official who has been closely involved with the COVID-19 vaccines, told the panel that two healthcare workers in Alaska had allergic reactions minutes after receiving the Pfizer vaccine, one of which was a case of anaphylactic reaction that resulted in hospitalization.

In the United Kingdom, there were two cases reported of notable allergic reactions, leading regulators there to issue a warning that people who have a history of significant allergic reactions should not currently receive the Pfizer-BioNTech vaccine.

The people involved in these incidents have recovered or are recovering, Fink said. But the FDA expects there will be additional reports of allergic reactions to COVID-19 vaccines.

“These cases underscores the need to remain vigilant during the early phase of the vaccination campaign,” Fink said. “To this end, FDA is working with Pfizer to further revise factsheets and prescribing information for their vaccine to draw attention to CDC guidelines for post- vaccination monitoring and management of immediate allergic reactions.”

mRNA vaccines in the lead

An FDA emergency clearance for Moderna’s product would be another vote of confidence in a new approach to making vaccines. Both the Pfizer-BioNTech and Moderna vaccines provide the immune system with a kind of blueprint in the form of genetic material, mRNA. The mRNA sets the stage for the synthesis of the signature spike protein that the SARS-CoV-2 virus uses to attach to and infect human cells.

In a December 15 commentary for this news organization Michael E. Pichichero, MD, wrote that the “revolutionary aspect of mRNA vaccines is the speed at which they can be designed and produced.”

“This is why they lead the pack among the SARS-CoV-2 vaccine candidates and why the National Institute of Allergy and Infectious Diseases provided financial, technical, and/or clinical support. Indeed, once the amino acid sequence of a protein can be determined (a relatively easy task these days) it’s straightforward to synthesize mRNA in the lab — and it can be done incredibly fast,” he wrote.

The FDA allowed one waiver for panelist James K. Hildreth in connection with his personal relationship to a trial participant and his university’s participation in vaccine testing.

This article first appeared on Medscape.com.

Federal advisers on December 17 overwhelmingly recommended an emergency clearance to Moderna Inc’s COVID-19 vaccine, while noting concerns about potential allergic reactions and the challenges of continuing testing of this medicine.

The US Food and Drug Administration (FDA) put Moderna’s application before its Vaccines and Related Biological Products Advisory Committee. The panel voted 20-0 on this question: “Based on the totality of scientific evidence available, do the benefits of the Moderna COVID-19 Vaccine outweigh its risks for use in individuals 18 years of age and older?” There was one abstention.

The FDA is not bound to act on the recommendations of its advisers, but the agency usually takes the panel’s advice. The FDA cleared the similar Pfizer-BioNTech vaccine on December 11 through an emergency use authorization (EUA), following a positive vote for the product at a December 10 advisory committee meeting. In this case, the FDA staff appeared to be pushing for a broad endorsement of the Moderna vaccine, for which the agency appears likely to soon also grant an EUA.

Marion Gruber, PhD, director of the Office of Vaccines Research and Review at FDA’s Center for Biologics Evaluation and Research, earlier rebuffed attempts by some of the panelists to alter the voting question. Some panelists wanted to make tweaks, including a rephrasing to underscore the limited nature of an EUA, compared with a more complete approval through the biologics license application (BLA) process.

FDA panelist Michael Kurilla, MD, PhD, of the National Institutes of Health was the only panelist to abstain from voting. He said he was uncomfortable with the phrasing of the question.

“In the midst of a pandemic and with limited vaccine supply available, a blanket statement for individuals 18 years and older is just too broad,” he said. “I’m not convinced that for all of those age groups the benefits do actually outweigh the risks.”

In general, though, there was strong support for Moderna’s vaccine. FDA panelist James Hildreth Sr, MD, PhD, of Meharry Medical College in Nashville, Tennessee spoke of the “remarkable achievement” seen in having two vaccines ready for clearance by December for a virus that only emerged as a threat this year.

Study data indicate the primary efficacy endpoint demonstrated vaccine efficacy (VE) of 94.1% (95% CI, 89.3% - 96.8%) for the Moderna vaccine, with 11 COVID-19 cases in the vaccine group and 185 COVID-19 cases in the placebo group, the FDA staff noted during the meeting.

The advisers and FDA staff also honed in on several key issues with COVID-19 vaccines, including the challenge of having people in the placebo groups of studies seek to get cleared vaccines. Also of concern to the panel were early reports of allergic reactions seen with the Pfizer product.

Doran L. Fink, MD, PhD, an FDA official who has been closely involved with the COVID-19 vaccines, told the panel that two healthcare workers in Alaska had allergic reactions minutes after receiving the Pfizer vaccine, one of which was a case of anaphylactic reaction that resulted in hospitalization.

In the United Kingdom, there were two cases reported of notable allergic reactions, leading regulators there to issue a warning that people who have a history of significant allergic reactions should not currently receive the Pfizer-BioNTech vaccine.

The people involved in these incidents have recovered or are recovering, Fink said. But the FDA expects there will be additional reports of allergic reactions to COVID-19 vaccines.

“These cases underscores the need to remain vigilant during the early phase of the vaccination campaign,” Fink said. “To this end, FDA is working with Pfizer to further revise factsheets and prescribing information for their vaccine to draw attention to CDC guidelines for post- vaccination monitoring and management of immediate allergic reactions.”

mRNA vaccines in the lead

An FDA emergency clearance for Moderna’s product would be another vote of confidence in a new approach to making vaccines. Both the Pfizer-BioNTech and Moderna vaccines provide the immune system with a kind of blueprint in the form of genetic material, mRNA. The mRNA sets the stage for the synthesis of the signature spike protein that the SARS-CoV-2 virus uses to attach to and infect human cells.

In a December 15 commentary for this news organization Michael E. Pichichero, MD, wrote that the “revolutionary aspect of mRNA vaccines is the speed at which they can be designed and produced.”

“This is why they lead the pack among the SARS-CoV-2 vaccine candidates and why the National Institute of Allergy and Infectious Diseases provided financial, technical, and/or clinical support. Indeed, once the amino acid sequence of a protein can be determined (a relatively easy task these days) it’s straightforward to synthesize mRNA in the lab — and it can be done incredibly fast,” he wrote.

The FDA allowed one waiver for panelist James K. Hildreth in connection with his personal relationship to a trial participant and his university’s participation in vaccine testing.

This article first appeared on Medscape.com.

COVID-19 became a leading cause of death in the United States in 2020, particularly for people over age 35, according to a new report published in JAMA on Thursday.

Adults over age 45 were more likely to die from COVID-19 than car crashes, respiratory diseases, drug overdoses, and suicide. And those over age 55 faced even higher rates of dying because of the coronavirus.

“The current exponential increase in COVID-19 is reaching a calamitous scale in the U.S.,” the authors wrote. “Putting these numbers in perspective may be difficult.”

Population health researchers at Virginia Commonwealth University put COVID-19 deaths into context by comparing this year’s numbers to the leading causes of death for March through October 2018, sorting by age.

By October 2020, COVID-19 had become the third leading cause of death overall for those between the ages of 45 and 84 years, following after heart disease and cancer. For those over age 85, COVID-19 was the second leading cause of death, surpassing cancer and following behind heart disease.

For people aged 35-44 years, COVID-19 surpassed car crashes and respiratory diseases and was slightly lower than suicide, heart disease, and cancer. For those under age 35, drug overdoses, suicide, and car crashes remained the leading causes of death.

Importantly, the authors wrote, death rates for the two leading causes – heart disease and cancer – are about 1,700 and 1,600 per day, respectively. COVID-19 deaths have surpassed these numbers individually throughout December and, on Wednesday, beat them combined. More than 3,400 deaths were reported, according to the COVID Tracking Project, marking an all-time high that continues to increase. Hospitalizations were also at a new high, with more than 113,000 COVID-19 patients in hospitals across the country, and another 232,000 new cases were reported.

“With COVID-19 mortality rates now exceeding these thresholds, this infectious disease has become deadlier than heart disease and cancer,” the authors wrote. “Its lethality may increase further as transmission increases with holiday travel and gatherings and with the intensified indoor exposure that winter brings.”

The reported number of COVID-19 deaths is likely a 20% underestimate, they wrote, attributable to delays in reporting and an increase in non–COVID-19 deaths that were undetected and untreated because of pandemic-related disruptions. Since the coronavirus is communicable and spreads easily, COVID-19 deaths are particularly unique and worrying, they said.

“Individuals who die from homicide or cancer do not transmit the risk of morbidity and mortality to those nearby,” they wrote. “Every COVID-19 death signals the possibility of more deaths among close contacts.”

The fall surge in cases and deaths is widespread nationally, as compared to the spring, with hot spots on both coasts and in rural areas, according to an accompanying editorial in JAMA from public health researchers at the Harvard T.H. Chan School of Public Health, Boston. People of color have faced twice the death rate as well, with one in 875 Black people and one in 925 Indigenous people dying from COVID-19, as compared with one in 1,625 White people.

“The year 2020 ends with COVID-19 massively surging, as it was in the spring, to be the leading cause of death,” they wrote. “The accelerating numbers of deaths fall far short of fully capturing each devastating human story: Every death represents untold loss for countless families.”

Vaccines offer hope, they said, but won’t prevent the upcoming increase in COVID-19 hospitalizations and deaths this winter. In 2021, containing the pandemic will require national coordination, resources to help overwhelmed health care workers, new support for state and local public health officials, a stimulus package for schools and businesses, and financial aid for people on the brink of eviction. The country needs federal coordination of testing, contact tracing, personal protective equipment, travel precautions, and a face mask mandate, they wrote.

“Ending this crisis will require not only further advances in treatment but also unprecedented commitment to all aspects of prevention, vaccination, and public health,” they wrote. “Only by doing so can future years see this illness revert back to the unfamiliar and unknown condition it once was.”

This article first appeared on WebMD.com.

COVID-19 became a leading cause of death in the United States in 2020, particularly for people over age 35, according to a new report published in JAMA on Thursday.

Adults over age 45 were more likely to die from COVID-19 than car crashes, respiratory diseases, drug overdoses, and suicide. And those over age 55 faced even higher rates of dying because of the coronavirus.

“The current exponential increase in COVID-19 is reaching a calamitous scale in the U.S.,” the authors wrote. “Putting these numbers in perspective may be difficult.”

Population health researchers at Virginia Commonwealth University put COVID-19 deaths into context by comparing this year’s numbers to the leading causes of death for March through October 2018, sorting by age.

By October 2020, COVID-19 had become the third leading cause of death overall for those between the ages of 45 and 84 years, following after heart disease and cancer. For those over age 85, COVID-19 was the second leading cause of death, surpassing cancer and following behind heart disease.

For people aged 35-44 years, COVID-19 surpassed car crashes and respiratory diseases and was slightly lower than suicide, heart disease, and cancer. For those under age 35, drug overdoses, suicide, and car crashes remained the leading causes of death.

Importantly, the authors wrote, death rates for the two leading causes – heart disease and cancer – are about 1,700 and 1,600 per day, respectively. COVID-19 deaths have surpassed these numbers individually throughout December and, on Wednesday, beat them combined. More than 3,400 deaths were reported, according to the COVID Tracking Project, marking an all-time high that continues to increase. Hospitalizations were also at a new high, with more than 113,000 COVID-19 patients in hospitals across the country, and another 232,000 new cases were reported.

“With COVID-19 mortality rates now exceeding these thresholds, this infectious disease has become deadlier than heart disease and cancer,” the authors wrote. “Its lethality may increase further as transmission increases with holiday travel and gatherings and with the intensified indoor exposure that winter brings.”

The reported number of COVID-19 deaths is likely a 20% underestimate, they wrote, attributable to delays in reporting and an increase in non–COVID-19 deaths that were undetected and untreated because of pandemic-related disruptions. Since the coronavirus is communicable and spreads easily, COVID-19 deaths are particularly unique and worrying, they said.

“Individuals who die from homicide or cancer do not transmit the risk of morbidity and mortality to those nearby,” they wrote. “Every COVID-19 death signals the possibility of more deaths among close contacts.”

The fall surge in cases and deaths is widespread nationally, as compared to the spring, with hot spots on both coasts and in rural areas, according to an accompanying editorial in JAMA from public health researchers at the Harvard T.H. Chan School of Public Health, Boston. People of color have faced twice the death rate as well, with one in 875 Black people and one in 925 Indigenous people dying from COVID-19, as compared with one in 1,625 White people.

“The year 2020 ends with COVID-19 massively surging, as it was in the spring, to be the leading cause of death,” they wrote. “The accelerating numbers of deaths fall far short of fully capturing each devastating human story: Every death represents untold loss for countless families.”

Vaccines offer hope, they said, but won’t prevent the upcoming increase in COVID-19 hospitalizations and deaths this winter. In 2021, containing the pandemic will require national coordination, resources to help overwhelmed health care workers, new support for state and local public health officials, a stimulus package for schools and businesses, and financial aid for people on the brink of eviction. The country needs federal coordination of testing, contact tracing, personal protective equipment, travel precautions, and a face mask mandate, they wrote.

“Ending this crisis will require not only further advances in treatment but also unprecedented commitment to all aspects of prevention, vaccination, and public health,” they wrote. “Only by doing so can future years see this illness revert back to the unfamiliar and unknown condition it once was.”

This article first appeared on WebMD.com.

COVID-19 became a leading cause of death in the United States in 2020, particularly for people over age 35, according to a new report published in JAMA on Thursday.

Adults over age 45 were more likely to die from COVID-19 than car crashes, respiratory diseases, drug overdoses, and suicide. And those over age 55 faced even higher rates of dying because of the coronavirus.

“The current exponential increase in COVID-19 is reaching a calamitous scale in the U.S.,” the authors wrote. “Putting these numbers in perspective may be difficult.”

Population health researchers at Virginia Commonwealth University put COVID-19 deaths into context by comparing this year’s numbers to the leading causes of death for March through October 2018, sorting by age.

By October 2020, COVID-19 had become the third leading cause of death overall for those between the ages of 45 and 84 years, following after heart disease and cancer. For those over age 85, COVID-19 was the second leading cause of death, surpassing cancer and following behind heart disease.

For people aged 35-44 years, COVID-19 surpassed car crashes and respiratory diseases and was slightly lower than suicide, heart disease, and cancer. For those under age 35, drug overdoses, suicide, and car crashes remained the leading causes of death.

Importantly, the authors wrote, death rates for the two leading causes – heart disease and cancer – are about 1,700 and 1,600 per day, respectively. COVID-19 deaths have surpassed these numbers individually throughout December and, on Wednesday, beat them combined. More than 3,400 deaths were reported, according to the COVID Tracking Project, marking an all-time high that continues to increase. Hospitalizations were also at a new high, with more than 113,000 COVID-19 patients in hospitals across the country, and another 232,000 new cases were reported.

“With COVID-19 mortality rates now exceeding these thresholds, this infectious disease has become deadlier than heart disease and cancer,” the authors wrote. “Its lethality may increase further as transmission increases with holiday travel and gatherings and with the intensified indoor exposure that winter brings.”

The reported number of COVID-19 deaths is likely a 20% underestimate, they wrote, attributable to delays in reporting and an increase in non–COVID-19 deaths that were undetected and untreated because of pandemic-related disruptions. Since the coronavirus is communicable and spreads easily, COVID-19 deaths are particularly unique and worrying, they said.

“Individuals who die from homicide or cancer do not transmit the risk of morbidity and mortality to those nearby,” they wrote. “Every COVID-19 death signals the possibility of more deaths among close contacts.”

The fall surge in cases and deaths is widespread nationally, as compared to the spring, with hot spots on both coasts and in rural areas, according to an accompanying editorial in JAMA from public health researchers at the Harvard T.H. Chan School of Public Health, Boston. People of color have faced twice the death rate as well, with one in 875 Black people and one in 925 Indigenous people dying from COVID-19, as compared with one in 1,625 White people.

“The year 2020 ends with COVID-19 massively surging, as it was in the spring, to be the leading cause of death,” they wrote. “The accelerating numbers of deaths fall far short of fully capturing each devastating human story: Every death represents untold loss for countless families.”

Vaccines offer hope, they said, but won’t prevent the upcoming increase in COVID-19 hospitalizations and deaths this winter. In 2021, containing the pandemic will require national coordination, resources to help overwhelmed health care workers, new support for state and local public health officials, a stimulus package for schools and businesses, and financial aid for people on the brink of eviction. The country needs federal coordination of testing, contact tracing, personal protective equipment, travel precautions, and a face mask mandate, they wrote.

“Ending this crisis will require not only further advances in treatment but also unprecedented commitment to all aspects of prevention, vaccination, and public health,” they wrote. “Only by doing so can future years see this illness revert back to the unfamiliar and unknown condition it once was.”

This article first appeared on WebMD.com.

Editor’s note: This article has been provided by The Doctors Company, the exclusively endorsed medical malpractice carrier for the Society of Hospital Medicine.

As the pandemic hits its third nationwide surge, families are gathering for the holidays, and medical practices are preparing for a potential increase in cases. Medical offices in states that were not strongly affected by the first and second waves of the virus may now be facing an influx of COVID-19 patients. Therefore, medical offices must remain very attentive to the widespread outbreak of COVID-19, continuing to proactively take steps to safely manage patients while protecting clinical staff.

Here are tips and resources for this season of the pandemic:

• Documentation: Maintain administrative records of how you have adapted to the evolving crisis, including the challenges you faced. For details, see Keep a COVID-19 Diary: Document Now in Case of Future Lawsuits.
• Legislation and Guidance: Reference the CDC; your state medical board; professional societies; and federal, state, and local authorities daily for public health guidance and new legislation, as this continues to be a fluid situation.
• Screening Criteria: Follow the CDC’s patient assessment protocol for early disease detection for patients presenting to your practice. Patients should be screened using these guidelines: Overview of Testing for SARS-CoV-2 (COVID-19). Essential visitors to your facility should also be assessed for symptoms of coronavirus and contact exposure and redirected to remain outside if suspect.
• Accepting Patients: Do not turn patients away simply because a patient calls with acute respiratory symptoms. Refusing assessment/care may lead to concerns of patient abandonment.
• Designated Triage Location: Check with your local public health authorities for locations designated to triage suspected patients, so exposure is limited in general medical offices.
• Telehealth Triage: Licensed staff should be trained in triage protocol to determine which patients can be managed safely at home. See Healthcare Facilities: Managing Operations During the COVID-19 Pandemic. The Doctors Company offers resources on telemedicine in our COVID-19 Telehealth Resource Center.
• Patient Testing: When there is a reasonable presumption that a patient may have been exposed to COVID-19, contact the local or state health department to coordinate testing using available community resources. See the CDC’s Testing for COVID-19 , the COVID-19 Testing Overview, and the Clinician Call Center.
• Elective Services: Check with regional governmental and health authorities on the provision of nonessential and elective health care visits and group-related activities. Many states continue or have reinstated restrictions on the provision of nonurgent, elective surgeries and procedures.
• Patient Precautions: Educational resources, including posters for use in the medical office, are available from the WHO and for health care workers from the CDC (Contact Precautions, Droplet Precautions, and Airborne Precautions). Reference the CDC’s and Interim Clinical Guidance for Management of Patients with Confirmed Coronavirus Disease (COVID-19) for patient management guidance.
• Provider/Staff Precautions: Follow Standard Precautions and Transmission-Based Precautions, including gloves, gowns, protective eyewear, and NIOSH-certified N95 respirators that have been properly fit-tested. If there is a shortage of N95 respirators in your facility, access current CDC respirator recommendations and review Optimizing Personal Protective Equipment (PPE) Supplies.
• Limit Exposure: Limit staff exposure to suspected patients, with the exam room door kept closed. Ideally, the designated exam room should be at the back of the office, far away from other staff and patients.
• Surface Disinfection: Once the patient exits the room, conduct surface disinfection while staff continues to wear PPE.
• Patient Education: Provide up-to-date, factual information on the virus to suspected COVID-19–positive patients and their close contacts.
• Provider/Staff Exposure: Screen health care personnel daily for symptoms/contacts relevant to COVID-19. Any unprotected occupational exposure by staff members should be assessed and monitored. See Interim U.S. Guidance for Risk Assessment and Work Restrictions for Healthcare Personnel with Potential Exposure to COVID-19. Should providers and/or staff test positive within your facility, conduct and document a risk assessment identifying contacts, type of interaction, and PPE in use, then contact local health authorities for additional instruction. The CDC provides guidance here under the section “Infection Control.” The health department may assist with patient notification if determined to be necessary. For return-to-work guidance, review the Criteria for Return to Work for Healthcare Personnel with SARS-CoV-2 Infection (Interim Guidance).
• Staff Training: Provide and document additional staff training as protocols change. Maintain training records in administrative files.

Ms. Hill is senior patient safety risk manager at The Doctors Company. The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each health care provider considering the circumstances of the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.

Editor’s note: This article has been provided by The Doctors Company, the exclusively endorsed medical malpractice carrier for the Society of Hospital Medicine.

As the pandemic hits its third nationwide surge, families are gathering for the holidays, and medical practices are preparing for a potential increase in cases. Medical offices in states that were not strongly affected by the first and second waves of the virus may now be facing an influx of COVID-19 patients. Therefore, medical offices must remain very attentive to the widespread outbreak of COVID-19, continuing to proactively take steps to safely manage patients while protecting clinical staff.

Here are tips and resources for this season of the pandemic:

• Documentation: Maintain administrative records of how you have adapted to the evolving crisis, including the challenges you faced. For details, see Keep a COVID-19 Diary: Document Now in Case of Future Lawsuits.
• Legislation and Guidance: Reference the CDC; your state medical board; professional societies; and federal, state, and local authorities daily for public health guidance and new legislation, as this continues to be a fluid situation.
• Screening Criteria: Follow the CDC’s patient assessment protocol for early disease detection for patients presenting to your practice. Patients should be screened using these guidelines: Overview of Testing for SARS-CoV-2 (COVID-19). Essential visitors to your facility should also be assessed for symptoms of coronavirus and contact exposure and redirected to remain outside if suspect.
• Accepting Patients: Do not turn patients away simply because a patient calls with acute respiratory symptoms. Refusing assessment/care may lead to concerns of patient abandonment.
• Designated Triage Location: Check with your local public health authorities for locations designated to triage suspected patients, so exposure is limited in general medical offices.
• Telehealth Triage: Licensed staff should be trained in triage protocol to determine which patients can be managed safely at home. See Healthcare Facilities: Managing Operations During the COVID-19 Pandemic. The Doctors Company offers resources on telemedicine in our COVID-19 Telehealth Resource Center.
• Patient Testing: When there is a reasonable presumption that a patient may have been exposed to COVID-19, contact the local or state health department to coordinate testing using available community resources. See the CDC’s Testing for COVID-19 , the COVID-19 Testing Overview, and the Clinician Call Center.
• Elective Services: Check with regional governmental and health authorities on the provision of nonessential and elective health care visits and group-related activities. Many states continue or have reinstated restrictions on the provision of nonurgent, elective surgeries and procedures.
• Patient Precautions: Educational resources, including posters for use in the medical office, are available from the WHO and for health care workers from the CDC (Contact Precautions, Droplet Precautions, and Airborne Precautions). Reference the CDC’s and Interim Clinical Guidance for Management of Patients with Confirmed Coronavirus Disease (COVID-19) for patient management guidance.
• Provider/Staff Precautions: Follow Standard Precautions and Transmission-Based Precautions, including gloves, gowns, protective eyewear, and NIOSH-certified N95 respirators that have been properly fit-tested. If there is a shortage of N95 respirators in your facility, access current CDC respirator recommendations and review Optimizing Personal Protective Equipment (PPE) Supplies.
• Limit Exposure: Limit staff exposure to suspected patients, with the exam room door kept closed. Ideally, the designated exam room should be at the back of the office, far away from other staff and patients.
• Surface Disinfection: Once the patient exits the room, conduct surface disinfection while staff continues to wear PPE.
• Patient Education: Provide up-to-date, factual information on the virus to suspected COVID-19–positive patients and their close contacts.
• Provider/Staff Exposure: Screen health care personnel daily for symptoms/contacts relevant to COVID-19. Any unprotected occupational exposure by staff members should be assessed and monitored. See Interim U.S. Guidance for Risk Assessment and Work Restrictions for Healthcare Personnel with Potential Exposure to COVID-19. Should providers and/or staff test positive within your facility, conduct and document a risk assessment identifying contacts, type of interaction, and PPE in use, then contact local health authorities for additional instruction. The CDC provides guidance here under the section “Infection Control.” The health department may assist with patient notification if determined to be necessary. For return-to-work guidance, review the Criteria for Return to Work for Healthcare Personnel with SARS-CoV-2 Infection (Interim Guidance).
• Staff Training: Provide and document additional staff training as protocols change. Maintain training records in administrative files.

Ms. Hill is senior patient safety risk manager at The Doctors Company. The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each health care provider considering the circumstances of the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.

Editor’s note: This article has been provided by The Doctors Company, the exclusively endorsed medical malpractice carrier for the Society of Hospital Medicine.

As the pandemic hits its third nationwide surge, families are gathering for the holidays, and medical practices are preparing for a potential increase in cases. Medical offices in states that were not strongly affected by the first and second waves of the virus may now be facing an influx of COVID-19 patients. Therefore, medical offices must remain very attentive to the widespread outbreak of COVID-19, continuing to proactively take steps to safely manage patients while protecting clinical staff.

Here are tips and resources for this season of the pandemic:

• Documentation: Maintain administrative records of how you have adapted to the evolving crisis, including the challenges you faced. For details, see Keep a COVID-19 Diary: Document Now in Case of Future Lawsuits.
• Legislation and Guidance: Reference the CDC; your state medical board; professional societies; and federal, state, and local authorities daily for public health guidance and new legislation, as this continues to be a fluid situation.
• Screening Criteria: Follow the CDC’s patient assessment protocol for early disease detection for patients presenting to your practice. Patients should be screened using these guidelines: Overview of Testing for SARS-CoV-2 (COVID-19). Essential visitors to your facility should also be assessed for symptoms of coronavirus and contact exposure and redirected to remain outside if suspect.
• Accepting Patients: Do not turn patients away simply because a patient calls with acute respiratory symptoms. Refusing assessment/care may lead to concerns of patient abandonment.
• Designated Triage Location: Check with your local public health authorities for locations designated to triage suspected patients, so exposure is limited in general medical offices.
• Telehealth Triage: Licensed staff should be trained in triage protocol to determine which patients can be managed safely at home. See Healthcare Facilities: Managing Operations During the COVID-19 Pandemic. The Doctors Company offers resources on telemedicine in our COVID-19 Telehealth Resource Center.
• Patient Testing: When there is a reasonable presumption that a patient may have been exposed to COVID-19, contact the local or state health department to coordinate testing using available community resources. See the CDC’s Testing for COVID-19 , the COVID-19 Testing Overview, and the Clinician Call Center.
• Elective Services: Check with regional governmental and health authorities on the provision of nonessential and elective health care visits and group-related activities. Many states continue or have reinstated restrictions on the provision of nonurgent, elective surgeries and procedures.
• Patient Precautions: Educational resources, including posters for use in the medical office, are available from the WHO and for health care workers from the CDC (Contact Precautions, Droplet Precautions, and Airborne Precautions). Reference the CDC’s and Interim Clinical Guidance for Management of Patients with Confirmed Coronavirus Disease (COVID-19) for patient management guidance.
• Provider/Staff Precautions: Follow Standard Precautions and Transmission-Based Precautions, including gloves, gowns, protective eyewear, and NIOSH-certified N95 respirators that have been properly fit-tested. If there is a shortage of N95 respirators in your facility, access current CDC respirator recommendations and review Optimizing Personal Protective Equipment (PPE) Supplies.
• Limit Exposure: Limit staff exposure to suspected patients, with the exam room door kept closed. Ideally, the designated exam room should be at the back of the office, far away from other staff and patients.
• Surface Disinfection: Once the patient exits the room, conduct surface disinfection while staff continues to wear PPE.
• Patient Education: Provide up-to-date, factual information on the virus to suspected COVID-19–positive patients and their close contacts.
• Provider/Staff Exposure: Screen health care personnel daily for symptoms/contacts relevant to COVID-19. Any unprotected occupational exposure by staff members should be assessed and monitored. See Interim U.S. Guidance for Risk Assessment and Work Restrictions for Healthcare Personnel with Potential Exposure to COVID-19. Should providers and/or staff test positive within your facility, conduct and document a risk assessment identifying contacts, type of interaction, and PPE in use, then contact local health authorities for additional instruction. The CDC provides guidance here under the section “Infection Control.” The health department may assist with patient notification if determined to be necessary. For return-to-work guidance, review the Criteria for Return to Work for Healthcare Personnel with SARS-CoV-2 Infection (Interim Guidance).
• Staff Training: Provide and document additional staff training as protocols change. Maintain training records in administrative files.

Ms. Hill is senior patient safety risk manager at The Doctors Company. The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each health care provider considering the circumstances of the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.

The Centers for Disease Control and Prevention (CDC) advisory committee recommended on December 12 the recently authorized Pfizer-BioNTech COVID-19 vaccine for people age 16 and over in the United States, stating they found it was safe and effective.

The agency said it will quickly issue guidance to clinicians so they can determine when and when not to give the vaccine, and to help them communicate the risks and benefits to patients.

CDC staff gave a preview of those clinical considerations at the agency’s Advisory Committee on Immunization Practices (ACIP) meeting on December 12 and said it would be holding calls with clinicians on December 13 and 14.

The CDC will also issue guidance December 13 on how organizations can handle the workforce problems that might arise as health care workers experience side effects from vaccination.

ACIP voted 11-0, with three recusals, to recommend use of the Pfizer-BioNTech mRNA vaccine in individuals 16 years or older according to the guidelines of the Food and Drug Administration’s (FDA’s) emergency use authorization issued December 11.

The panel also voted unanimously to include the vaccine in 2021 immunization schedules. All panel members said the recommendation should go hand-in-hand with ACIP’s previous recommendation on December 1 that allocation of the vaccine be phased-in, with health care workers and residents and staff of long-term care facilities in phase 1a.

Allergies, pregnant women?

ACIP panelists said clinicians need more guidance on whether to use the vaccine in pregnant or breastfeeding women, the immunocompromised, or those who have a history of allergies.

The FDA health care provider information sheet said there is not enough data to recommend vaccinating those women or the immunocompromised, and also advises against giving the vaccine to individuals who have a history of serious allergic reaction to any component of the vaccine.

Peter Marks, MD, PhD, director of the FDA’s Center for Biologic Evaluation and Research (CBER) clarified this in a briefing on December 12, noting that women who are pregnant or lactating can make the decision in consultation with their physician. And, he said, patients with any other history of allergy should be able to safely get the vaccine.

The CDC — in its soon-to-be-released guidance — will make the same recommendations. For any woman considering vaccination, she should consider the level of COVID-19 in the community, her personal risk of contracting the virus, the risks to her or her fetus of developing the disease, and the vaccine’s known side effects, Sarah Mbaeyi, MD, MPH, a medical officer at the agency, said during the panel meeting December 12.

She added that the CDC will also urge physicians to advise women to take acetaminophen if they develop a fever after vaccination — to protect the developing fetus from fever.

Sandra Fryhofer, MD, representing the American Medical Association, commended the CDC for these recommendations. But she also called on Pfizer, the FDA, and the CDC to make data from the developmental and reproductive toxicity (DART) studies public as soon as possible.

“We really need to put those results on warp speed and get them out there to give our physicians and pregnant women more information,” said Fryhofer, an adjunct associate professor of medicine at Emory University School of Medicine in Atlanta, Georgia.

The American College of Obstetricians and Gynecologists (ACOG) will also soon release guidance for vaccinating pregnant and breastfeeding women, said Linda Eckert, MD, FACOG, an ACOG representative on the panel.

ACOG and the CDC met the morning of December 12 to discuss risks and benefits with experts in immunology, placental pathology, and vaccine kinetics, she said.

“The overall complete consensus was that we don’t see biological plausibility at this time for placental transfer of the mRNA and that we see that direct fetal exposure or the possibility of fetal inflammatory response is extremely unlikely,” said Eckert, professor of obstetrics and gynecology at the University of Washington, Seattle. “Clearly we are waiting on the data.”

A Pfizer official told the ACIP panel that preliminary data “show no indication of either developmental or reproductive toxicity,” and that the company plans to send the final DART data to the FDA at the end of December.

On the potential for allergic reactions, the CDC concurred with the FDA that the vaccine should not be given to people with a history of serious reactions. The agency added that the category should include anyone who has had a reaction to any vaccine or injectable drug product because injectables may contain the same ingredients as the Pfizer vaccine, said Mbaeyi.

The CDC will also urge clinicians to observe patients with a history of anaphylaxis for 30 minutes after vaccination and all patients for at least 15 minutes afterward.

Should teens be a special population?

At least one ACIP panel member — Henry Bernstein, DO, MHCM, FAAP — said he was concerned that backing use of the vaccine in 16- and 17-year-olds was a leap of faith, given that Pfizer had extremely limited data on this cohort.

Bernstein, professor of pediatrics at the Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York, also said that systemic reactions were more common in that age group.

He argued for making the 16- and 17-year-olds a “special population” that would get specific attention and guidance for vaccination from the federal agencies and professional societies.

Bernstein said he did not want to sow any more doubts in parents’ minds about vaccination, noting that hesitancy was a growing concern. “A successful pediatric vaccination program depends on creating and sustaining parental confidence in both the safety and effectiveness of this vaccine,” he said.

Many panelists, however, noted that there has been no evidence to suggest that the vaccine is not safe or less effective in that younger age group.

Yvonne Maldonado, MD, the American Academy of Pediatrics representative on the panel, said that this age group should not be denied the vaccine as they often have essential or front-line jobs that put them at higher risk for infection.

“I am very concerned about this message being sent out that this vaccine will not be safe in children,” said Maldonado, professor of pediatrics and health research and policy at Stanford University School of Medicine in California.

“We currently have no evidence that that is the case,” she said, adding there is also no indication younger children are biologically or physiologically different in their response or safety risk than 18-year-olds.

Vaccine = hope

Committee members breathed a sigh of relief at the end of the 2-day meeting, saying that although the Pfizer vaccine is not perfect, it represents a scientific milestone and a significant advance against the continuing march of the SARS-CoV-2 pandemic.

“This vaccine and future vaccines do provide a promise for a lot of progress in the future,” said panelist Beth P. Bell, MD, MPH, clinical professor of global health at the University of Washington School of Public Health in Seattle.

Peter Szilagyi, MD, MPH, executive vice-chair and vice-chair for research at the University of California, Los Angeles pediatrics department, said, “I’m really hopeful that this is the beginning of the end of the coronavirus pandemic.”

“The need for this vaccine is profound,” said Veronica McNally, president and CEO of the Franny Strong Foundation in West Bloomfield, Michigan.

The ACIP panel also made the argument that while the at least $10 billion spent on vaccine development by the federal government’s Operation Warp Speed alone has been a good investment, more spending is needed to actually get Americans vaccinated.

The imbalance between the two is “shocking and needs to be corrected,” said Bell. “We are not going to be able to protect the American public if we don’t have a way to deliver the vaccine to them.”

This article first appeared on Medscape.com.

The Centers for Disease Control and Prevention (CDC) advisory committee recommended on December 12 the recently authorized Pfizer-BioNTech COVID-19 vaccine for people age 16 and over in the United States, stating they found it was safe and effective.

The agency said it will quickly issue guidance to clinicians so they can determine when and when not to give the vaccine, and to help them communicate the risks and benefits to patients.

CDC staff gave a preview of those clinical considerations at the agency’s Advisory Committee on Immunization Practices (ACIP) meeting on December 12 and said it would be holding calls with clinicians on December 13 and 14.

The CDC will also issue guidance December 13 on how organizations can handle the workforce problems that might arise as health care workers experience side effects from vaccination.

ACIP voted 11-0, with three recusals, to recommend use of the Pfizer-BioNTech mRNA vaccine in individuals 16 years or older according to the guidelines of the Food and Drug Administration’s (FDA’s) emergency use authorization issued December 11.

The panel also voted unanimously to include the vaccine in 2021 immunization schedules. All panel members said the recommendation should go hand-in-hand with ACIP’s previous recommendation on December 1 that allocation of the vaccine be phased-in, with health care workers and residents and staff of long-term care facilities in phase 1a.

Allergies, pregnant women?

ACIP panelists said clinicians need more guidance on whether to use the vaccine in pregnant or breastfeeding women, the immunocompromised, or those who have a history of allergies.

The FDA health care provider information sheet said there is not enough data to recommend vaccinating those women or the immunocompromised, and also advises against giving the vaccine to individuals who have a history of serious allergic reaction to any component of the vaccine.

Peter Marks, MD, PhD, director of the FDA’s Center for Biologic Evaluation and Research (CBER) clarified this in a briefing on December 12, noting that women who are pregnant or lactating can make the decision in consultation with their physician. And, he said, patients with any other history of allergy should be able to safely get the vaccine.

The CDC — in its soon-to-be-released guidance — will make the same recommendations. For any woman considering vaccination, she should consider the level of COVID-19 in the community, her personal risk of contracting the virus, the risks to her or her fetus of developing the disease, and the vaccine’s known side effects, Sarah Mbaeyi, MD, MPH, a medical officer at the agency, said during the panel meeting December 12.

She added that the CDC will also urge physicians to advise women to take acetaminophen if they develop a fever after vaccination — to protect the developing fetus from fever.

Sandra Fryhofer, MD, representing the American Medical Association, commended the CDC for these recommendations. But she also called on Pfizer, the FDA, and the CDC to make data from the developmental and reproductive toxicity (DART) studies public as soon as possible.

“We really need to put those results on warp speed and get them out there to give our physicians and pregnant women more information,” said Fryhofer, an adjunct associate professor of medicine at Emory University School of Medicine in Atlanta, Georgia.

The American College of Obstetricians and Gynecologists (ACOG) will also soon release guidance for vaccinating pregnant and breastfeeding women, said Linda Eckert, MD, FACOG, an ACOG representative on the panel.

ACOG and the CDC met the morning of December 12 to discuss risks and benefits with experts in immunology, placental pathology, and vaccine kinetics, she said.

“The overall complete consensus was that we don’t see biological plausibility at this time for placental transfer of the mRNA and that we see that direct fetal exposure or the possibility of fetal inflammatory response is extremely unlikely,” said Eckert, professor of obstetrics and gynecology at the University of Washington, Seattle. “Clearly we are waiting on the data.”

A Pfizer official told the ACIP panel that preliminary data “show no indication of either developmental or reproductive toxicity,” and that the company plans to send the final DART data to the FDA at the end of December.

On the potential for allergic reactions, the CDC concurred with the FDA that the vaccine should not be given to people with a history of serious reactions. The agency added that the category should include anyone who has had a reaction to any vaccine or injectable drug product because injectables may contain the same ingredients as the Pfizer vaccine, said Mbaeyi.

The CDC will also urge clinicians to observe patients with a history of anaphylaxis for 30 minutes after vaccination and all patients for at least 15 minutes afterward.

Should teens be a special population?

At least one ACIP panel member — Henry Bernstein, DO, MHCM, FAAP — said he was concerned that backing use of the vaccine in 16- and 17-year-olds was a leap of faith, given that Pfizer had extremely limited data on this cohort.

Bernstein, professor of pediatrics at the Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York, also said that systemic reactions were more common in that age group.

He argued for making the 16- and 17-year-olds a “special population” that would get specific attention and guidance for vaccination from the federal agencies and professional societies.

Bernstein said he did not want to sow any more doubts in parents’ minds about vaccination, noting that hesitancy was a growing concern. “A successful pediatric vaccination program depends on creating and sustaining parental confidence in both the safety and effectiveness of this vaccine,” he said.

Many panelists, however, noted that there has been no evidence to suggest that the vaccine is not safe or less effective in that younger age group.

Yvonne Maldonado, MD, the American Academy of Pediatrics representative on the panel, said that this age group should not be denied the vaccine as they often have essential or front-line jobs that put them at higher risk for infection.

“I am very concerned about this message being sent out that this vaccine will not be safe in children,” said Maldonado, professor of pediatrics and health research and policy at Stanford University School of Medicine in California.

“We currently have no evidence that that is the case,” she said, adding there is also no indication younger children are biologically or physiologically different in their response or safety risk than 18-year-olds.

Vaccine = hope

Committee members breathed a sigh of relief at the end of the 2-day meeting, saying that although the Pfizer vaccine is not perfect, it represents a scientific milestone and a significant advance against the continuing march of the SARS-CoV-2 pandemic.

“This vaccine and future vaccines do provide a promise for a lot of progress in the future,” said panelist Beth P. Bell, MD, MPH, clinical professor of global health at the University of Washington School of Public Health in Seattle.

Peter Szilagyi, MD, MPH, executive vice-chair and vice-chair for research at the University of California, Los Angeles pediatrics department, said, “I’m really hopeful that this is the beginning of the end of the coronavirus pandemic.”

“The need for this vaccine is profound,” said Veronica McNally, president and CEO of the Franny Strong Foundation in West Bloomfield, Michigan.

The ACIP panel also made the argument that while the at least $10 billion spent on vaccine development by the federal government’s Operation Warp Speed alone has been a good investment, more spending is needed to actually get Americans vaccinated.

The imbalance between the two is “shocking and needs to be corrected,” said Bell. “We are not going to be able to protect the American public if we don’t have a way to deliver the vaccine to them.”

This article first appeared on Medscape.com.

The Centers for Disease Control and Prevention (CDC) advisory committee recommended on December 12 the recently authorized Pfizer-BioNTech COVID-19 vaccine for people age 16 and over in the United States, stating they found it was safe and effective.

The agency said it will quickly issue guidance to clinicians so they can determine when and when not to give the vaccine, and to help them communicate the risks and benefits to patients.

CDC staff gave a preview of those clinical considerations at the agency’s Advisory Committee on Immunization Practices (ACIP) meeting on December 12 and said it would be holding calls with clinicians on December 13 and 14.

The CDC will also issue guidance December 13 on how organizations can handle the workforce problems that might arise as health care workers experience side effects from vaccination.

ACIP voted 11-0, with three recusals, to recommend use of the Pfizer-BioNTech mRNA vaccine in individuals 16 years or older according to the guidelines of the Food and Drug Administration’s (FDA’s) emergency use authorization issued December 11.

The panel also voted unanimously to include the vaccine in 2021 immunization schedules. All panel members said the recommendation should go hand-in-hand with ACIP’s previous recommendation on December 1 that allocation of the vaccine be phased-in, with health care workers and residents and staff of long-term care facilities in phase 1a.

Allergies, pregnant women?

ACIP panelists said clinicians need more guidance on whether to use the vaccine in pregnant or breastfeeding women, the immunocompromised, or those who have a history of allergies.

The FDA health care provider information sheet said there is not enough data to recommend vaccinating those women or the immunocompromised, and also advises against giving the vaccine to individuals who have a history of serious allergic reaction to any component of the vaccine.

Peter Marks, MD, PhD, director of the FDA’s Center for Biologic Evaluation and Research (CBER) clarified this in a briefing on December 12, noting that women who are pregnant or lactating can make the decision in consultation with their physician. And, he said, patients with any other history of allergy should be able to safely get the vaccine.

The CDC — in its soon-to-be-released guidance — will make the same recommendations. For any woman considering vaccination, she should consider the level of COVID-19 in the community, her personal risk of contracting the virus, the risks to her or her fetus of developing the disease, and the vaccine’s known side effects, Sarah Mbaeyi, MD, MPH, a medical officer at the agency, said during the panel meeting December 12.

She added that the CDC will also urge physicians to advise women to take acetaminophen if they develop a fever after vaccination — to protect the developing fetus from fever.

Sandra Fryhofer, MD, representing the American Medical Association, commended the CDC for these recommendations. But she also called on Pfizer, the FDA, and the CDC to make data from the developmental and reproductive toxicity (DART) studies public as soon as possible.

“We really need to put those results on warp speed and get them out there to give our physicians and pregnant women more information,” said Fryhofer, an adjunct associate professor of medicine at Emory University School of Medicine in Atlanta, Georgia.

The American College of Obstetricians and Gynecologists (ACOG) will also soon release guidance for vaccinating pregnant and breastfeeding women, said Linda Eckert, MD, FACOG, an ACOG representative on the panel.

ACOG and the CDC met the morning of December 12 to discuss risks and benefits with experts in immunology, placental pathology, and vaccine kinetics, she said.

“The overall complete consensus was that we don’t see biological plausibility at this time for placental transfer of the mRNA and that we see that direct fetal exposure or the possibility of fetal inflammatory response is extremely unlikely,” said Eckert, professor of obstetrics and gynecology at the University of Washington, Seattle. “Clearly we are waiting on the data.”

A Pfizer official told the ACIP panel that preliminary data “show no indication of either developmental or reproductive toxicity,” and that the company plans to send the final DART data to the FDA at the end of December.

On the potential for allergic reactions, the CDC concurred with the FDA that the vaccine should not be given to people with a history of serious reactions. The agency added that the category should include anyone who has had a reaction to any vaccine or injectable drug product because injectables may contain the same ingredients as the Pfizer vaccine, said Mbaeyi.

The CDC will also urge clinicians to observe patients with a history of anaphylaxis for 30 minutes after vaccination and all patients for at least 15 minutes afterward.

Should teens be a special population?

At least one ACIP panel member — Henry Bernstein, DO, MHCM, FAAP — said he was concerned that backing use of the vaccine in 16- and 17-year-olds was a leap of faith, given that Pfizer had extremely limited data on this cohort.

Bernstein, professor of pediatrics at the Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York, also said that systemic reactions were more common in that age group.

He argued for making the 16- and 17-year-olds a “special population” that would get specific attention and guidance for vaccination from the federal agencies and professional societies.

Bernstein said he did not want to sow any more doubts in parents’ minds about vaccination, noting that hesitancy was a growing concern. “A successful pediatric vaccination program depends on creating and sustaining parental confidence in both the safety and effectiveness of this vaccine,” he said.

Many panelists, however, noted that there has been no evidence to suggest that the vaccine is not safe or less effective in that younger age group.

Yvonne Maldonado, MD, the American Academy of Pediatrics representative on the panel, said that this age group should not be denied the vaccine as they often have essential or front-line jobs that put them at higher risk for infection.

“I am very concerned about this message being sent out that this vaccine will not be safe in children,” said Maldonado, professor of pediatrics and health research and policy at Stanford University School of Medicine in California.

“We currently have no evidence that that is the case,” she said, adding there is also no indication younger children are biologically or physiologically different in their response or safety risk than 18-year-olds.

Vaccine = hope

Committee members breathed a sigh of relief at the end of the 2-day meeting, saying that although the Pfizer vaccine is not perfect, it represents a scientific milestone and a significant advance against the continuing march of the SARS-CoV-2 pandemic.

“This vaccine and future vaccines do provide a promise for a lot of progress in the future,” said panelist Beth P. Bell, MD, MPH, clinical professor of global health at the University of Washington School of Public Health in Seattle.

Peter Szilagyi, MD, MPH, executive vice-chair and vice-chair for research at the University of California, Los Angeles pediatrics department, said, “I’m really hopeful that this is the beginning of the end of the coronavirus pandemic.”

“The need for this vaccine is profound,” said Veronica McNally, president and CEO of the Franny Strong Foundation in West Bloomfield, Michigan.

The ACIP panel also made the argument that while the at least $10 billion spent on vaccine development by the federal government’s Operation Warp Speed alone has been a good investment, more spending is needed to actually get Americans vaccinated.

The imbalance between the two is “shocking and needs to be corrected,” said Bell. “We are not going to be able to protect the American public if we don’t have a way to deliver the vaccine to them.”

This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has authorized Pfizer/BioNTech’s COVID-19 vaccine for emergency use in people 16 years of age and older. 

The much-anticipated emergency use authorization (EUA) of this vaccine — the first such approval in the United States — was greeted with optimism by infectious disease and pulmonary experts, although unanswered questions remain regarding use in people with allergic hypersensitivity, safety in pregnant women, and how smooth distribution will be.

“I am delighted. This is a first, firm step on a long path to getting this COVID pandemic under control,” William Schaffner, MD, professor of infectious diseases at the Vanderbilt University School of Medicine in Nashville, Tennessee, said in an interview.

The FDA gave the green light after the December 10 recommendation from the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting. The committee voted 17-4 in favor of the emergency authorization.

Allergic reactions reported in the UK

After vaccinations with the Pfizer vaccine began in the UK on December 8, reports surfaced of two healthcare workers who experienced allergic reactions. They have since recovered, but officials warned that people with a history of severe allergic reactions should not receive the Pfizer vaccine at this time.

“For the moment, they are asking people who have had notable allergic reactions to step aside while this is investigated. It shows you that the system is working,” Schaffner said.

Both vaccine recipients who experienced anaphylaxis carried EpiPens, as they were at high risk for allergic reactions, Hewlett said. Also, if other COVID-19 vaccines are approved for use in the future, people allergic to the Pfizer vaccine might have another option, he added.

Reassuring role models

Schaffner supports the CDC Advisory Committee on Immunization Practices (ACIP) decision to start vaccinations with healthcare workers and residents of long-term care facilities.

“Vaccinating healthcare workers, in particular, will be a model for the general public,” said Schaffner, who is also a former member of the IDSA board of directors. “If they see those of us in white coats and blue scrubs lining up for the vaccine, that will provide confidence.”

To further increase acceptance of the COVID-19 vaccine, public health officials need to provide information and reassure the general public, Schaffner said.

Hewlett agreed. “I know there are a lot of people in the population who are very hesitant about vaccines. As infection disease specialists and people in public health, we are trying to allay a lot of concerns people have.”

Reassurance will be especially important in minority communities. “They have been disproportionately affected by the virus, and they have a traditional history of not being optimally vaccinated,” Schaffner said. “We need to reach them in particular with good information and reassurance…so they can make good decisions for themselves and their families.”

No vaccine is 100% effective or completely free of side effects. “There is always a chance there can be adverse reactions, but we think for the most part this is going to be a safe and effective vaccine,” said Hewlett, medical director at the Division of Disease Control and deputy to commissioner of health at the Westchester County Department of Health in White Plains, New York.

Distribution: Smooth or full of strife?

In addition to the concern that some people will not take advantage of vaccination against COVID-19, there could be vaccine supply issues down the road, Schaffner said.

Culver agreed. “In the early phases, I expect that there will be some kinks to work out, but because the numbers are relatively small, this should be okay,” he said.

“I think when we start to get into larger-scale vaccination programs — the supply chain, transport, and storage will be a Herculean undertaking,” Culver added. “It will take careful coordination between healthcare providers, distributors, suppliers, and public health officials to pull this off.”

Planning and distribution also should focus beyond US borders. Any issues in vaccine distribution or administration in the United States “will only be multiplied in several other parts of the world,” Culver said. Because COVID-19 is a pandemic, “we need to think about vaccinating globally.”

Investigating adverse events

Adverse events common to vaccinations in general — injection site pain, headaches, and fever — would not be unexpected with the COVID-19 vaccines. However, experts remain concerned that other, unrelated adverse events might be erroneously attributed to vaccination. For example, if a fall, heart attack, or death occurs within days of immunization, some might immediately blame the vaccine product.

“It’s important to remember that any new, highly touted medical therapy like this will receive a lot of scrutiny, so it would be unusual not to hear about something happening to somebody,” Culver said. Vaccine companies and health agencies will be carefully evaluating any reported adverse events to ensure no safety signal was missed in the trials.

“Fortunately, there are systems in place to investigate these events immediately,” Schaffner said.

Pregnancy recommendations pending

One question still looms: Is the COVID-19 vaccination safe for pregnant women? This isn’t just a question for the general public, either, Schaffner said. He estimated that about 70 percent of healthcare workers are women, and data suggests about 300,000 of these healthcare workers are pregnant.

“The CDC’s Advisory Committee on Immunization Practices will speak to that just as soon as the EUA is issued,” he added.

Patients are asking Culver about the priority order for vaccination. He said it’s difficult to provide firm guidance at this point.

People also have “lingering skepticism” about whether vaccine development was done in a prudent way, Culver said. Some people question whether the Pfizer vaccine and others were rushed to market. “So we try to spend time with the patients, reassuring them that all the usual safety evaluations were carefully done,” he said.

Another concern is whether mRNA vaccines can interact with human DNA. “The quick, short, and definitive answer is no,” Schaffner said. The m stands for messenger — the vaccines transmit information. "Once it gets into a cell, the mRNA does not go anywhere near the DNA, and once it transmits its information to the cell appropriately, it gets metabolized, and we excrete all the remnants."

Hewlett pointed out that investigations and surveillance will continue. Because this is an EUA and not full approval, “that essentially means they will still be obligated to collect a lot more data than they would ordinarily,” he said.

How long immunoprotection will last also remains an unknown. “The big question left on the table now is the durability,” Culver said. “Of course, we won’t know the answer to that for quite some time.”

Schaffner and Culver have disclosed no relevant financial relationships. Hewlett was an employee of Pfizer until mid-2019. His previous work as Pfizer’s senior medical director of global medical product evaluation was not associated with development of the COVID-19 vaccine.

This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has authorized Pfizer/BioNTech’s COVID-19 vaccine for emergency use in people 16 years of age and older. 

The much-anticipated emergency use authorization (EUA) of this vaccine — the first such approval in the United States — was greeted with optimism by infectious disease and pulmonary experts, although unanswered questions remain regarding use in people with allergic hypersensitivity, safety in pregnant women, and how smooth distribution will be.

“I am delighted. This is a first, firm step on a long path to getting this COVID pandemic under control,” William Schaffner, MD, professor of infectious diseases at the Vanderbilt University School of Medicine in Nashville, Tennessee, said in an interview.

The FDA gave the green light after the December 10 recommendation from the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting. The committee voted 17-4 in favor of the emergency authorization.

Allergic reactions reported in the UK

After vaccinations with the Pfizer vaccine began in the UK on December 8, reports surfaced of two healthcare workers who experienced allergic reactions. They have since recovered, but officials warned that people with a history of severe allergic reactions should not receive the Pfizer vaccine at this time.

“For the moment, they are asking people who have had notable allergic reactions to step aside while this is investigated. It shows you that the system is working,” Schaffner said.

Both vaccine recipients who experienced anaphylaxis carried EpiPens, as they were at high risk for allergic reactions, Hewlett said. Also, if other COVID-19 vaccines are approved for use in the future, people allergic to the Pfizer vaccine might have another option, he added.

Reassuring role models

Schaffner supports the CDC Advisory Committee on Immunization Practices (ACIP) decision to start vaccinations with healthcare workers and residents of long-term care facilities.

“Vaccinating healthcare workers, in particular, will be a model for the general public,” said Schaffner, who is also a former member of the IDSA board of directors. “If they see those of us in white coats and blue scrubs lining up for the vaccine, that will provide confidence.”

To further increase acceptance of the COVID-19 vaccine, public health officials need to provide information and reassure the general public, Schaffner said.

Hewlett agreed. “I know there are a lot of people in the population who are very hesitant about vaccines. As infection disease specialists and people in public health, we are trying to allay a lot of concerns people have.”

Reassurance will be especially important in minority communities. “They have been disproportionately affected by the virus, and they have a traditional history of not being optimally vaccinated,” Schaffner said. “We need to reach them in particular with good information and reassurance…so they can make good decisions for themselves and their families.”

No vaccine is 100% effective or completely free of side effects. “There is always a chance there can be adverse reactions, but we think for the most part this is going to be a safe and effective vaccine,” said Hewlett, medical director at the Division of Disease Control and deputy to commissioner of health at the Westchester County Department of Health in White Plains, New York.

Distribution: Smooth or full of strife?

In addition to the concern that some people will not take advantage of vaccination against COVID-19, there could be vaccine supply issues down the road, Schaffner said.

Culver agreed. “In the early phases, I expect that there will be some kinks to work out, but because the numbers are relatively small, this should be okay,” he said.

“I think when we start to get into larger-scale vaccination programs — the supply chain, transport, and storage will be a Herculean undertaking,” Culver added. “It will take careful coordination between healthcare providers, distributors, suppliers, and public health officials to pull this off.”

Planning and distribution also should focus beyond US borders. Any issues in vaccine distribution or administration in the United States “will only be multiplied in several other parts of the world,” Culver said. Because COVID-19 is a pandemic, “we need to think about vaccinating globally.”

Investigating adverse events

Adverse events common to vaccinations in general — injection site pain, headaches, and fever — would not be unexpected with the COVID-19 vaccines. However, experts remain concerned that other, unrelated adverse events might be erroneously attributed to vaccination. For example, if a fall, heart attack, or death occurs within days of immunization, some might immediately blame the vaccine product.

“It’s important to remember that any new, highly touted medical therapy like this will receive a lot of scrutiny, so it would be unusual not to hear about something happening to somebody,” Culver said. Vaccine companies and health agencies will be carefully evaluating any reported adverse events to ensure no safety signal was missed in the trials.

“Fortunately, there are systems in place to investigate these events immediately,” Schaffner said.

Pregnancy recommendations pending

One question still looms: Is the COVID-19 vaccination safe for pregnant women? This isn’t just a question for the general public, either, Schaffner said. He estimated that about 70 percent of healthcare workers are women, and data suggests about 300,000 of these healthcare workers are pregnant.

“The CDC’s Advisory Committee on Immunization Practices will speak to that just as soon as the EUA is issued,” he added.

Patients are asking Culver about the priority order for vaccination. He said it’s difficult to provide firm guidance at this point.

People also have “lingering skepticism” about whether vaccine development was done in a prudent way, Culver said. Some people question whether the Pfizer vaccine and others were rushed to market. “So we try to spend time with the patients, reassuring them that all the usual safety evaluations were carefully done,” he said.

Another concern is whether mRNA vaccines can interact with human DNA. “The quick, short, and definitive answer is no,” Schaffner said. The m stands for messenger — the vaccines transmit information. "Once it gets into a cell, the mRNA does not go anywhere near the DNA, and once it transmits its information to the cell appropriately, it gets metabolized, and we excrete all the remnants."

Hewlett pointed out that investigations and surveillance will continue. Because this is an EUA and not full approval, “that essentially means they will still be obligated to collect a lot more data than they would ordinarily,” he said.

How long immunoprotection will last also remains an unknown. “The big question left on the table now is the durability,” Culver said. “Of course, we won’t know the answer to that for quite some time.”

Schaffner and Culver have disclosed no relevant financial relationships. Hewlett was an employee of Pfizer until mid-2019. His previous work as Pfizer’s senior medical director of global medical product evaluation was not associated with development of the COVID-19 vaccine.

This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has authorized Pfizer/BioNTech’s COVID-19 vaccine for emergency use in people 16 years of age and older. 

The much-anticipated emergency use authorization (EUA) of this vaccine — the first such approval in the United States — was greeted with optimism by infectious disease and pulmonary experts, although unanswered questions remain regarding use in people with allergic hypersensitivity, safety in pregnant women, and how smooth distribution will be.

“I am delighted. This is a first, firm step on a long path to getting this COVID pandemic under control,” William Schaffner, MD, professor of infectious diseases at the Vanderbilt University School of Medicine in Nashville, Tennessee, said in an interview.

The FDA gave the green light after the December 10 recommendation from the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting. The committee voted 17-4 in favor of the emergency authorization.

Allergic reactions reported in the UK

After vaccinations with the Pfizer vaccine began in the UK on December 8, reports surfaced of two healthcare workers who experienced allergic reactions. They have since recovered, but officials warned that people with a history of severe allergic reactions should not receive the Pfizer vaccine at this time.

“For the moment, they are asking people who have had notable allergic reactions to step aside while this is investigated. It shows you that the system is working,” Schaffner said.

Both vaccine recipients who experienced anaphylaxis carried EpiPens, as they were at high risk for allergic reactions, Hewlett said. Also, if other COVID-19 vaccines are approved for use in the future, people allergic to the Pfizer vaccine might have another option, he added.

Reassuring role models

Schaffner supports the CDC Advisory Committee on Immunization Practices (ACIP) decision to start vaccinations with healthcare workers and residents of long-term care facilities.

“Vaccinating healthcare workers, in particular, will be a model for the general public,” said Schaffner, who is also a former member of the IDSA board of directors. “If they see those of us in white coats and blue scrubs lining up for the vaccine, that will provide confidence.”

To further increase acceptance of the COVID-19 vaccine, public health officials need to provide information and reassure the general public, Schaffner said.

Hewlett agreed. “I know there are a lot of people in the population who are very hesitant about vaccines. As infection disease specialists and people in public health, we are trying to allay a lot of concerns people have.”

Reassurance will be especially important in minority communities. “They have been disproportionately affected by the virus, and they have a traditional history of not being optimally vaccinated,” Schaffner said. “We need to reach them in particular with good information and reassurance…so they can make good decisions for themselves and their families.”

No vaccine is 100% effective or completely free of side effects. “There is always a chance there can be adverse reactions, but we think for the most part this is going to be a safe and effective vaccine,” said Hewlett, medical director at the Division of Disease Control and deputy to commissioner of health at the Westchester County Department of Health in White Plains, New York.

Distribution: Smooth or full of strife?

In addition to the concern that some people will not take advantage of vaccination against COVID-19, there could be vaccine supply issues down the road, Schaffner said.

Culver agreed. “In the early phases, I expect that there will be some kinks to work out, but because the numbers are relatively small, this should be okay,” he said.

“I think when we start to get into larger-scale vaccination programs — the supply chain, transport, and storage will be a Herculean undertaking,” Culver added. “It will take careful coordination between healthcare providers, distributors, suppliers, and public health officials to pull this off.”

Planning and distribution also should focus beyond US borders. Any issues in vaccine distribution or administration in the United States “will only be multiplied in several other parts of the world,” Culver said. Because COVID-19 is a pandemic, “we need to think about vaccinating globally.”

Investigating adverse events

Adverse events common to vaccinations in general — injection site pain, headaches, and fever — would not be unexpected with the COVID-19 vaccines. However, experts remain concerned that other, unrelated adverse events might be erroneously attributed to vaccination. For example, if a fall, heart attack, or death occurs within days of immunization, some might immediately blame the vaccine product.

“It’s important to remember that any new, highly touted medical therapy like this will receive a lot of scrutiny, so it would be unusual not to hear about something happening to somebody,” Culver said. Vaccine companies and health agencies will be carefully evaluating any reported adverse events to ensure no safety signal was missed in the trials.

“Fortunately, there are systems in place to investigate these events immediately,” Schaffner said.

Pregnancy recommendations pending

One question still looms: Is the COVID-19 vaccination safe for pregnant women? This isn’t just a question for the general public, either, Schaffner said. He estimated that about 70 percent of healthcare workers are women, and data suggests about 300,000 of these healthcare workers are pregnant.

“The CDC’s Advisory Committee on Immunization Practices will speak to that just as soon as the EUA is issued,” he added.

Patients are asking Culver about the priority order for vaccination. He said it’s difficult to provide firm guidance at this point.

People also have “lingering skepticism” about whether vaccine development was done in a prudent way, Culver said. Some people question whether the Pfizer vaccine and others were rushed to market. “So we try to spend time with the patients, reassuring them that all the usual safety evaluations were carefully done,” he said.

Another concern is whether mRNA vaccines can interact with human DNA. “The quick, short, and definitive answer is no,” Schaffner said. The m stands for messenger — the vaccines transmit information. "Once it gets into a cell, the mRNA does not go anywhere near the DNA, and once it transmits its information to the cell appropriately, it gets metabolized, and we excrete all the remnants."

Hewlett pointed out that investigations and surveillance will continue. Because this is an EUA and not full approval, “that essentially means they will still be obligated to collect a lot more data than they would ordinarily,” he said.

How long immunoprotection will last also remains an unknown. “The big question left on the table now is the durability,” Culver said. “Of course, we won’t know the answer to that for quite some time.”

Schaffner and Culver have disclosed no relevant financial relationships. Hewlett was an employee of Pfizer until mid-2019. His previous work as Pfizer’s senior medical director of global medical product evaluation was not associated with development of the COVID-19 vaccine.

This article first appeared on Medscape.com.

Patients with hematologic disease who develop COVID-19 may experience substantial morbidity and mortality related to SARS-CoV-2 infection, according to recent registry data reported at the all-virtual annual meeting of the American Society of Hematology.

Overall mortality was 28% for the first 250 patients entered into the ASH Research Collaborative COVID-19 Registry for Hematology, researchers reported in an abstract of their study findings.

However, the burden of death and moderate-to-severe COVID-19 outcomes was highest in patients with poorer prognosis and those with relapsed/refractory hematological disease, they added.

The most commonly represented malignancies were acute leukemia, non-Hodgkin lymphoma, and myeloma or amyloidosis, according to the report.

Taken together, the findings do support an “emerging consensus” that COVID-19 related morbidity and mortality is significant in these patients, authors said – however, the current findings may not be reason enough to support a change in treatment course for the underlying disease.

“We see no reason, based on our data, to withhold intensive therapies from patients with underlying hematologic malignancies and favorable prognoses, if aggressive supportive care is consistent with patient preferences,” wrote the researchers.

ASH President Stephanie Lee, MD, MPH, said these registry findings are important to better understand how SARS-CoV-2 is affecting not only patients with hematologic diseases, but also individuals who experience COVID-19-related hematologic complications.

However, the findings are limited due to the heterogeneity of diseases, symptoms, and treatments represented in the registry, said Dr. Lee, associate director of the clinical research division at Fred Hutchinson Cancer Center in Seattle.

“More data will be coming in, but I think this is an example of trying to harness real-world information to try to learn things until we get more controlled studies,” Dr. Lee said in a media briefing held in advance of the ASH meeting.
 

Comorbidities and more

Patients with blood cancers are often older and may have comorbidities such as diabetes or hypertension that have been linked to poor COVID-19 outcomes, according to the authors of the report, led by William A. Wood, MD, MPH, associate professor of medicine with the UNC Lineberger Comprehensive Cancer Center in Chapel Hill, N.C.

Moreover, these patients may have underlying immune dysfunction and may receive chemotherapy or immunotherapy that is “profoundly immunosuppressive,” Dr. Wood and coauthors said in their report.

To date, however, risks of morbidity and mortality related to SARS-CoV-2 infection have not been well defined in this patient population, authors said.

More data is emerging now from the ASH Research Collaborative COVID-19 Registry for Hematology, which includes data on patients positive for COVID-19 who have a past or present hematologic condition or have experienced a hematologic complication related to COVID-19.

All data from the registry is being made available through a dashboard on the ASH Research Collaborative website, which as of Dec. 1, 2020, included 693 complete cases.

The data cut in the ASH abstract includes the first 250 patients enrolled at 74 sites around the world, the authors said. The most common malignancies included acute leukemia in 33%, non-Hodgkin lymphoma in 27%, and myeloma or amyloidosis in 16%.

The most frequently reported symptoms included fever in 73%, cough in 67%, dyspnea in 50%, and fatigue in 40%, according to that report.

At the time of this data snapshot, treatment with COVID-19-directed therapies including hydroxychloroquine or azithromycin were common, reported in 76 and 59 patients, respectively, in the cohort.

Batch submissions from sites with high incidence of COVID-19 infection are ongoing. The registry has been expanded to include nonmalignant hematologic diseases, and the registry will continue to accumulate data as a resource for the hematology community.

Overall mortality was 28% at the time, according to the abstract, with nearly all of the deaths occurring in patients classified as having COVID-19 that was moderate (i.e., requiring hospitalization) or severe (i.e., requiring ICU admission).

“In some instances, death occurred after a decision was made to forgo ICU admission in favor of a palliative approach,” said Dr. Wood and coauthors in their report.

Dr. Wood reported research funding from Pfizer, consultancy with Teladoc/Best Doctors, and honoraria from the ASH Research Collaborative. Coauthors provided disclosures related to Celgene, Madrigal Pharmaceuticals, Pharmacyclics, and Amgen, among others.

SOURCE: Wood WA et al. ASH 2020, Abstract 215.

Patients with hematologic disease who develop COVID-19 may experience substantial morbidity and mortality related to SARS-CoV-2 infection, according to recent registry data reported at the all-virtual annual meeting of the American Society of Hematology.

Overall mortality was 28% for the first 250 patients entered into the ASH Research Collaborative COVID-19 Registry for Hematology, researchers reported in an abstract of their study findings.

However, the burden of death and moderate-to-severe COVID-19 outcomes was highest in patients with poorer prognosis and those with relapsed/refractory hematological disease, they added.

The most commonly represented malignancies were acute leukemia, non-Hodgkin lymphoma, and myeloma or amyloidosis, according to the report.

Taken together, the findings do support an “emerging consensus” that COVID-19 related morbidity and mortality is significant in these patients, authors said – however, the current findings may not be reason enough to support a change in treatment course for the underlying disease.

“We see no reason, based on our data, to withhold intensive therapies from patients with underlying hematologic malignancies and favorable prognoses, if aggressive supportive care is consistent with patient preferences,” wrote the researchers.

ASH President Stephanie Lee, MD, MPH, said these registry findings are important to better understand how SARS-CoV-2 is affecting not only patients with hematologic diseases, but also individuals who experience COVID-19-related hematologic complications.

However, the findings are limited due to the heterogeneity of diseases, symptoms, and treatments represented in the registry, said Dr. Lee, associate director of the clinical research division at Fred Hutchinson Cancer Center in Seattle.

“More data will be coming in, but I think this is an example of trying to harness real-world information to try to learn things until we get more controlled studies,” Dr. Lee said in a media briefing held in advance of the ASH meeting.
 

Comorbidities and more

Patients with blood cancers are often older and may have comorbidities such as diabetes or hypertension that have been linked to poor COVID-19 outcomes, according to the authors of the report, led by William A. Wood, MD, MPH, associate professor of medicine with the UNC Lineberger Comprehensive Cancer Center in Chapel Hill, N.C.

Moreover, these patients may have underlying immune dysfunction and may receive chemotherapy or immunotherapy that is “profoundly immunosuppressive,” Dr. Wood and coauthors said in their report.

To date, however, risks of morbidity and mortality related to SARS-CoV-2 infection have not been well defined in this patient population, authors said.

More data is emerging now from the ASH Research Collaborative COVID-19 Registry for Hematology, which includes data on patients positive for COVID-19 who have a past or present hematologic condition or have experienced a hematologic complication related to COVID-19.

All data from the registry is being made available through a dashboard on the ASH Research Collaborative website, which as of Dec. 1, 2020, included 693 complete cases.

The data cut in the ASH abstract includes the first 250 patients enrolled at 74 sites around the world, the authors said. The most common malignancies included acute leukemia in 33%, non-Hodgkin lymphoma in 27%, and myeloma or amyloidosis in 16%.

The most frequently reported symptoms included fever in 73%, cough in 67%, dyspnea in 50%, and fatigue in 40%, according to that report.

At the time of this data snapshot, treatment with COVID-19-directed therapies including hydroxychloroquine or azithromycin were common, reported in 76 and 59 patients, respectively, in the cohort.

Batch submissions from sites with high incidence of COVID-19 infection are ongoing. The registry has been expanded to include nonmalignant hematologic diseases, and the registry will continue to accumulate data as a resource for the hematology community.

Overall mortality was 28% at the time, according to the abstract, with nearly all of the deaths occurring in patients classified as having COVID-19 that was moderate (i.e., requiring hospitalization) or severe (i.e., requiring ICU admission).

“In some instances, death occurred after a decision was made to forgo ICU admission in favor of a palliative approach,” said Dr. Wood and coauthors in their report.

Dr. Wood reported research funding from Pfizer, consultancy with Teladoc/Best Doctors, and honoraria from the ASH Research Collaborative. Coauthors provided disclosures related to Celgene, Madrigal Pharmaceuticals, Pharmacyclics, and Amgen, among others.

SOURCE: Wood WA et al. ASH 2020, Abstract 215.

Patients with hematologic disease who develop COVID-19 may experience substantial morbidity and mortality related to SARS-CoV-2 infection, according to recent registry data reported at the all-virtual annual meeting of the American Society of Hematology.

Overall mortality was 28% for the first 250 patients entered into the ASH Research Collaborative COVID-19 Registry for Hematology, researchers reported in an abstract of their study findings.

However, the burden of death and moderate-to-severe COVID-19 outcomes was highest in patients with poorer prognosis and those with relapsed/refractory hematological disease, they added.

The most commonly represented malignancies were acute leukemia, non-Hodgkin lymphoma, and myeloma or amyloidosis, according to the report.

Taken together, the findings do support an “emerging consensus” that COVID-19 related morbidity and mortality is significant in these patients, authors said – however, the current findings may not be reason enough to support a change in treatment course for the underlying disease.

“We see no reason, based on our data, to withhold intensive therapies from patients with underlying hematologic malignancies and favorable prognoses, if aggressive supportive care is consistent with patient preferences,” wrote the researchers.

ASH President Stephanie Lee, MD, MPH, said these registry findings are important to better understand how SARS-CoV-2 is affecting not only patients with hematologic diseases, but also individuals who experience COVID-19-related hematologic complications.

However, the findings are limited due to the heterogeneity of diseases, symptoms, and treatments represented in the registry, said Dr. Lee, associate director of the clinical research division at Fred Hutchinson Cancer Center in Seattle.

“More data will be coming in, but I think this is an example of trying to harness real-world information to try to learn things until we get more controlled studies,” Dr. Lee said in a media briefing held in advance of the ASH meeting.
 

Comorbidities and more

Patients with blood cancers are often older and may have comorbidities such as diabetes or hypertension that have been linked to poor COVID-19 outcomes, according to the authors of the report, led by William A. Wood, MD, MPH, associate professor of medicine with the UNC Lineberger Comprehensive Cancer Center in Chapel Hill, N.C.

Moreover, these patients may have underlying immune dysfunction and may receive chemotherapy or immunotherapy that is “profoundly immunosuppressive,” Dr. Wood and coauthors said in their report.

To date, however, risks of morbidity and mortality related to SARS-CoV-2 infection have not been well defined in this patient population, authors said.

More data is emerging now from the ASH Research Collaborative COVID-19 Registry for Hematology, which includes data on patients positive for COVID-19 who have a past or present hematologic condition or have experienced a hematologic complication related to COVID-19.

All data from the registry is being made available through a dashboard on the ASH Research Collaborative website, which as of Dec. 1, 2020, included 693 complete cases.

The data cut in the ASH abstract includes the first 250 patients enrolled at 74 sites around the world, the authors said. The most common malignancies included acute leukemia in 33%, non-Hodgkin lymphoma in 27%, and myeloma or amyloidosis in 16%.

The most frequently reported symptoms included fever in 73%, cough in 67%, dyspnea in 50%, and fatigue in 40%, according to that report.

At the time of this data snapshot, treatment with COVID-19-directed therapies including hydroxychloroquine or azithromycin were common, reported in 76 and 59 patients, respectively, in the cohort.

Batch submissions from sites with high incidence of COVID-19 infection are ongoing. The registry has been expanded to include nonmalignant hematologic diseases, and the registry will continue to accumulate data as a resource for the hematology community.

Overall mortality was 28% at the time, according to the abstract, with nearly all of the deaths occurring in patients classified as having COVID-19 that was moderate (i.e., requiring hospitalization) or severe (i.e., requiring ICU admission).

“In some instances, death occurred after a decision was made to forgo ICU admission in favor of a palliative approach,” said Dr. Wood and coauthors in their report.

Dr. Wood reported research funding from Pfizer, consultancy with Teladoc/Best Doctors, and honoraria from the ASH Research Collaborative. Coauthors provided disclosures related to Celgene, Madrigal Pharmaceuticals, Pharmacyclics, and Amgen, among others.

SOURCE: Wood WA et al. ASH 2020, Abstract 215.

Among people with COVID-19, those with systemic autoimmune rheumatic diseases had an elevated 30-day risk of hospitalization, ICU admission, need for mechanical ventilation, and acute kidney injury, compared to a group without rheumatic diseases at 4 months in a match-controlled study.

When investigators expanded the study to 6 months, the difference in need for mechanical ventilation disappeared. However, relative risk for venous thromboembolism (VTE) emerged as 74% higher among people with COVID-19 and with rheumatic disease, said Kristin D’Silva, MD, who presented the findings during a plenary session at the virtual annual meeting of the American College of Rheumatology. She noted that rheumatic disease itself could contribute to VTE risk.

Comorbidities including hypertension, diabetes, and asthma were more common among people with systemic autoimmune rheumatic diseases (SARDs). After adjustment for comorbidities, “the risks of hospitalization and ICU admission were attenuated, suggesting comorbidities are likely key mediators of the increased risk of severe COVID-19 outcomes observed in SARDs patients versus comparators,” Dr. D’Silva, a rheumatology fellow at Massachusetts General Hospital in Boston, said in an interview.

“The risk of venous thromboembolism persisted even after adjusting for comorbidities,” Dr. D’Silva said. Patients with SARDs should be closely monitored for VTE during COVID-19 infection, she added. “Patients with significant cardiovascular, pulmonary, and metabolic comorbidities should be closely monitored for severe COVID-19.”

At the same time, a systematic review of 15 published studies revealed a low incidence of COVID-19 infection among people with rheumatic disease. Furthermore, most experienced a mild clinical course and low mortality, Akhil Sood, MD, said when presenting results of his poster at the meeting.

Underlying immunosuppression, chronic inflammation, comorbidities, and disparities based on racial, ethnic, and socioeconomic status could predispose people with rheumatic disease to poorer COVID-19 outcomes. However, the risks and outcomes of COVID-19 infection among this population “are not well understood,” said Dr. Sood, a second-year resident in internal medicine at the University of Texas Medical Branch in Galveston.

Elevated risks in match-controlled study

Dr. D’Silva and colleagues examined a COVID-19 population and compared 716 people with SARDs and another 716 people from the general public at 4 months, as well as 2,379 people each in similar groups at 6 months. They used real-time electronic medical record data from the TriNetX research network to identify ICD-10 codes for inflammatory arthritis, connective tissue diseases, and systemic vasculitis. They also used ICD-10 codes and positive PCR tests to identify people with COVID-19.

Mean age was 57 years and women accounted for 79% of both groups evaluated at 4 months. Those with SARDs were 23% more likely to be hospitalized (relative risk, 1.23; 95% confidence interval, 1.01-1.50). This group was 75% more likely to be admitted to the ICU (RR, 1.75; 95% CI, 1.11-2.75), 77% more likely to require mechanical ventilation (RR, 1.77; 95% CI, 1.06-2.96), and 83% more likely to experience acute kidney injury (RR, 1.83; 95% CI, 1.11-3.00).

Risk of death was not significantly higher in the SARDs group (RR, 1.16; 95% CI, 0.73-1.86).

When Dr. D’Silva expanded the study to more people at 6 months, they added additional 30-day outcomes of interest: renal replacement therapy, VTE, and ischemic stroke. Risk of need for renal replacement therapy, for example, was 81% higher in the SARDs group (RR, 1.81; 95% CI, 1.07-3.07). Risk of stroke was not significantly different between groups.The improvement in mechanical ventilation risk between 4 and 6 months was not completely unexpected, Dr. D’Silva said. The relative risk dropped from 1.77 to 1.05. “This is not particularly surprising given national trends in the general population reporting decreased severe outcomes of COVID-19 including mortality as the pandemic progresses. This is likely multifactorial including changes in COVID-19 management (such as increasing use of nonintubated prone positioning rather than early intubation and treatments such as dexamethasone and remdesivir), decreased strain on hospitals and staffing compared to the early crisis phase of the pandemic, and higher testing capacity leading to detection of milder cases.”

When the 6-month analysis was further adjusted for comorbidities and a history of prior hospitalization within 1 year, only risk for acute kidney injury and VTE remained significant with relative risks of 1.33 and 1.60, respectively, likely because comorbidities are causal intermediates of COVID-19 30-day outcomes rather than confounders.

When asked to comment on the results, session comoderator Victoria K. Shanmugam, MD, said in an interview that the study “is of great interest both to rheumatologists and to patients with rheumatic disease.”

The higher risk of hospitalization, ICU admission, mechanical ventilation, acute kidney injury, and heart failure “is an important finding with implications for how our patients navigate risk during this pandemic,” said Dr. Shanmugam, director of the division of rheumatology at George Washington University in Washington.
 

Lower risks emerge in systematic review

The 15 observational studies in the systematic review included 11,815 participants. A total of 179, or 1.5%, tested positive for COVID-19.

“The incidence of COVID-19 infection among patients with rheumatic disease was low,” Dr. Sood said.

Within the COVID-19-positive group, almost 50% required hospitalization, 10% required ICU admission, and 8% died. The pooled event rate for hospitalization was 0.440 (95% CI, 0.296-0.596), while for ICU admission it was 0.132 (95% CI, 0.087-0.194) and for death it was 0.125 (95% CI, 0.082-0.182).
 

Different calculations of risk

The two studies seem to offer contradictory findings, but the disparities could be explained by study design differences. For example, Dr. D’Silva’s study evaluated a population with COVID-19 and compared those with SARDs versus a matched group from the general public. Dr. Sood and colleagues assessed study populations with rheumatic disease and assessed incidence of SARS-CoV-2 infection and difference in outcomes.

“We are asking very different questions,” Dr. D’Silva said.

“The study by D’Silva et al. was able to account for different factors to reduce confounding,” Dr. Sood said, adding that Dr. D’Silva and colleagues included a high proportion of minorities, compared with a less diverse population in the systematic review, which featured a large number of studies from Italy.

The authors of the two studies had no relevant financial disclosures to report.

SOURCES: D’Silva K et al. Arthritis Rheumatol. 2020;72(suppl 10): Abstract 0430, and Sood A et al. Arthritis Rheumatol. 2020;72(suppl 10): Abstract 0008.

Among people with COVID-19, those with systemic autoimmune rheumatic diseases had an elevated 30-day risk of hospitalization, ICU admission, need for mechanical ventilation, and acute kidney injury, compared to a group without rheumatic diseases at 4 months in a match-controlled study.

When investigators expanded the study to 6 months, the difference in need for mechanical ventilation disappeared. However, relative risk for venous thromboembolism (VTE) emerged as 74% higher among people with COVID-19 and with rheumatic disease, said Kristin D’Silva, MD, who presented the findings during a plenary session at the virtual annual meeting of the American College of Rheumatology. She noted that rheumatic disease itself could contribute to VTE risk.

Comorbidities including hypertension, diabetes, and asthma were more common among people with systemic autoimmune rheumatic diseases (SARDs). After adjustment for comorbidities, “the risks of hospitalization and ICU admission were attenuated, suggesting comorbidities are likely key mediators of the increased risk of severe COVID-19 outcomes observed in SARDs patients versus comparators,” Dr. D’Silva, a rheumatology fellow at Massachusetts General Hospital in Boston, said in an interview.

“The risk of venous thromboembolism persisted even after adjusting for comorbidities,” Dr. D’Silva said. Patients with SARDs should be closely monitored for VTE during COVID-19 infection, she added. “Patients with significant cardiovascular, pulmonary, and metabolic comorbidities should be closely monitored for severe COVID-19.”

At the same time, a systematic review of 15 published studies revealed a low incidence of COVID-19 infection among people with rheumatic disease. Furthermore, most experienced a mild clinical course and low mortality, Akhil Sood, MD, said when presenting results of his poster at the meeting.

Underlying immunosuppression, chronic inflammation, comorbidities, and disparities based on racial, ethnic, and socioeconomic status could predispose people with rheumatic disease to poorer COVID-19 outcomes. However, the risks and outcomes of COVID-19 infection among this population “are not well understood,” said Dr. Sood, a second-year resident in internal medicine at the University of Texas Medical Branch in Galveston.

Elevated risks in match-controlled study

Dr. D’Silva and colleagues examined a COVID-19 population and compared 716 people with SARDs and another 716 people from the general public at 4 months, as well as 2,379 people each in similar groups at 6 months. They used real-time electronic medical record data from the TriNetX research network to identify ICD-10 codes for inflammatory arthritis, connective tissue diseases, and systemic vasculitis. They also used ICD-10 codes and positive PCR tests to identify people with COVID-19.

Mean age was 57 years and women accounted for 79% of both groups evaluated at 4 months. Those with SARDs were 23% more likely to be hospitalized (relative risk, 1.23; 95% confidence interval, 1.01-1.50). This group was 75% more likely to be admitted to the ICU (RR, 1.75; 95% CI, 1.11-2.75), 77% more likely to require mechanical ventilation (RR, 1.77; 95% CI, 1.06-2.96), and 83% more likely to experience acute kidney injury (RR, 1.83; 95% CI, 1.11-3.00).

Risk of death was not significantly higher in the SARDs group (RR, 1.16; 95% CI, 0.73-1.86).

When Dr. D’Silva expanded the study to more people at 6 months, they added additional 30-day outcomes of interest: renal replacement therapy, VTE, and ischemic stroke. Risk of need for renal replacement therapy, for example, was 81% higher in the SARDs group (RR, 1.81; 95% CI, 1.07-3.07). Risk of stroke was not significantly different between groups.The improvement in mechanical ventilation risk between 4 and 6 months was not completely unexpected, Dr. D’Silva said. The relative risk dropped from 1.77 to 1.05. “This is not particularly surprising given national trends in the general population reporting decreased severe outcomes of COVID-19 including mortality as the pandemic progresses. This is likely multifactorial including changes in COVID-19 management (such as increasing use of nonintubated prone positioning rather than early intubation and treatments such as dexamethasone and remdesivir), decreased strain on hospitals and staffing compared to the early crisis phase of the pandemic, and higher testing capacity leading to detection of milder cases.”

When the 6-month analysis was further adjusted for comorbidities and a history of prior hospitalization within 1 year, only risk for acute kidney injury and VTE remained significant with relative risks of 1.33 and 1.60, respectively, likely because comorbidities are causal intermediates of COVID-19 30-day outcomes rather than confounders.

When asked to comment on the results, session comoderator Victoria K. Shanmugam, MD, said in an interview that the study “is of great interest both to rheumatologists and to patients with rheumatic disease.”

The higher risk of hospitalization, ICU admission, mechanical ventilation, acute kidney injury, and heart failure “is an important finding with implications for how our patients navigate risk during this pandemic,” said Dr. Shanmugam, director of the division of rheumatology at George Washington University in Washington.
 

Lower risks emerge in systematic review

The 15 observational studies in the systematic review included 11,815 participants. A total of 179, or 1.5%, tested positive for COVID-19.

“The incidence of COVID-19 infection among patients with rheumatic disease was low,” Dr. Sood said.

Within the COVID-19-positive group, almost 50% required hospitalization, 10% required ICU admission, and 8% died. The pooled event rate for hospitalization was 0.440 (95% CI, 0.296-0.596), while for ICU admission it was 0.132 (95% CI, 0.087-0.194) and for death it was 0.125 (95% CI, 0.082-0.182).
 

Different calculations of risk

The two studies seem to offer contradictory findings, but the disparities could be explained by study design differences. For example, Dr. D’Silva’s study evaluated a population with COVID-19 and compared those with SARDs versus a matched group from the general public. Dr. Sood and colleagues assessed study populations with rheumatic disease and assessed incidence of SARS-CoV-2 infection and difference in outcomes.

“We are asking very different questions,” Dr. D’Silva said.

“The study by D’Silva et al. was able to account for different factors to reduce confounding,” Dr. Sood said, adding that Dr. D’Silva and colleagues included a high proportion of minorities, compared with a less diverse population in the systematic review, which featured a large number of studies from Italy.

The authors of the two studies had no relevant financial disclosures to report.

SOURCES: D’Silva K et al. Arthritis Rheumatol. 2020;72(suppl 10): Abstract 0430, and Sood A et al. Arthritis Rheumatol. 2020;72(suppl 10): Abstract 0008.

Among people with COVID-19, those with systemic autoimmune rheumatic diseases had an elevated 30-day risk of hospitalization, ICU admission, need for mechanical ventilation, and acute kidney injury, compared to a group without rheumatic diseases at 4 months in a match-controlled study.

When investigators expanded the study to 6 months, the difference in need for mechanical ventilation disappeared. However, relative risk for venous thromboembolism (VTE) emerged as 74% higher among people with COVID-19 and with rheumatic disease, said Kristin D’Silva, MD, who presented the findings during a plenary session at the virtual annual meeting of the American College of Rheumatology. She noted that rheumatic disease itself could contribute to VTE risk.

Comorbidities including hypertension, diabetes, and asthma were more common among people with systemic autoimmune rheumatic diseases (SARDs). After adjustment for comorbidities, “the risks of hospitalization and ICU admission were attenuated, suggesting comorbidities are likely key mediators of the increased risk of severe COVID-19 outcomes observed in SARDs patients versus comparators,” Dr. D’Silva, a rheumatology fellow at Massachusetts General Hospital in Boston, said in an interview.

“The risk of venous thromboembolism persisted even after adjusting for comorbidities,” Dr. D’Silva said. Patients with SARDs should be closely monitored for VTE during COVID-19 infection, she added. “Patients with significant cardiovascular, pulmonary, and metabolic comorbidities should be closely monitored for severe COVID-19.”

At the same time, a systematic review of 15 published studies revealed a low incidence of COVID-19 infection among people with rheumatic disease. Furthermore, most experienced a mild clinical course and low mortality, Akhil Sood, MD, said when presenting results of his poster at the meeting.

Underlying immunosuppression, chronic inflammation, comorbidities, and disparities based on racial, ethnic, and socioeconomic status could predispose people with rheumatic disease to poorer COVID-19 outcomes. However, the risks and outcomes of COVID-19 infection among this population “are not well understood,” said Dr. Sood, a second-year resident in internal medicine at the University of Texas Medical Branch in Galveston.

Elevated risks in match-controlled study

Dr. D’Silva and colleagues examined a COVID-19 population and compared 716 people with SARDs and another 716 people from the general public at 4 months, as well as 2,379 people each in similar groups at 6 months. They used real-time electronic medical record data from the TriNetX research network to identify ICD-10 codes for inflammatory arthritis, connective tissue diseases, and systemic vasculitis. They also used ICD-10 codes and positive PCR tests to identify people with COVID-19.

Mean age was 57 years and women accounted for 79% of both groups evaluated at 4 months. Those with SARDs were 23% more likely to be hospitalized (relative risk, 1.23; 95% confidence interval, 1.01-1.50). This group was 75% more likely to be admitted to the ICU (RR, 1.75; 95% CI, 1.11-2.75), 77% more likely to require mechanical ventilation (RR, 1.77; 95% CI, 1.06-2.96), and 83% more likely to experience acute kidney injury (RR, 1.83; 95% CI, 1.11-3.00).

Risk of death was not significantly higher in the SARDs group (RR, 1.16; 95% CI, 0.73-1.86).

When Dr. D’Silva expanded the study to more people at 6 months, they added additional 30-day outcomes of interest: renal replacement therapy, VTE, and ischemic stroke. Risk of need for renal replacement therapy, for example, was 81% higher in the SARDs group (RR, 1.81; 95% CI, 1.07-3.07). Risk of stroke was not significantly different between groups.The improvement in mechanical ventilation risk between 4 and 6 months was not completely unexpected, Dr. D’Silva said. The relative risk dropped from 1.77 to 1.05. “This is not particularly surprising given national trends in the general population reporting decreased severe outcomes of COVID-19 including mortality as the pandemic progresses. This is likely multifactorial including changes in COVID-19 management (such as increasing use of nonintubated prone positioning rather than early intubation and treatments such as dexamethasone and remdesivir), decreased strain on hospitals and staffing compared to the early crisis phase of the pandemic, and higher testing capacity leading to detection of milder cases.”

When the 6-month analysis was further adjusted for comorbidities and a history of prior hospitalization within 1 year, only risk for acute kidney injury and VTE remained significant with relative risks of 1.33 and 1.60, respectively, likely because comorbidities are causal intermediates of COVID-19 30-day outcomes rather than confounders.

When asked to comment on the results, session comoderator Victoria K. Shanmugam, MD, said in an interview that the study “is of great interest both to rheumatologists and to patients with rheumatic disease.”

The higher risk of hospitalization, ICU admission, mechanical ventilation, acute kidney injury, and heart failure “is an important finding with implications for how our patients navigate risk during this pandemic,” said Dr. Shanmugam, director of the division of rheumatology at George Washington University in Washington.
 

Lower risks emerge in systematic review

The 15 observational studies in the systematic review included 11,815 participants. A total of 179, or 1.5%, tested positive for COVID-19.

“The incidence of COVID-19 infection among patients with rheumatic disease was low,” Dr. Sood said.

Within the COVID-19-positive group, almost 50% required hospitalization, 10% required ICU admission, and 8% died. The pooled event rate for hospitalization was 0.440 (95% CI, 0.296-0.596), while for ICU admission it was 0.132 (95% CI, 0.087-0.194) and for death it was 0.125 (95% CI, 0.082-0.182).
 

Different calculations of risk

The two studies seem to offer contradictory findings, but the disparities could be explained by study design differences. For example, Dr. D’Silva’s study evaluated a population with COVID-19 and compared those with SARDs versus a matched group from the general public. Dr. Sood and colleagues assessed study populations with rheumatic disease and assessed incidence of SARS-CoV-2 infection and difference in outcomes.

“We are asking very different questions,” Dr. D’Silva said.

“The study by D’Silva et al. was able to account for different factors to reduce confounding,” Dr. Sood said, adding that Dr. D’Silva and colleagues included a high proportion of minorities, compared with a less diverse population in the systematic review, which featured a large number of studies from Italy.

The authors of the two studies had no relevant financial disclosures to report.

SOURCES: D’Silva K et al. Arthritis Rheumatol. 2020;72(suppl 10): Abstract 0430, and Sood A et al. Arthritis Rheumatol. 2020;72(suppl 10): Abstract 0008.