FDA panel recommends boosters only for the elderly and those at high risk

  • The Food and Drug Administration’s vaccine advisory committee voted unanimously to recommend boosters for people 65 years of age and older.
  • The recommendation also includes people aged 16 and over at high risk of severe COVID-19.
  • The Pfizer-BioNTech COVID-19 vaccine is currently fully approved in the United States as a two-dose regimen for persons 16 years of age and older under the brand name Comirnaty.

People aged 65 and over and those at high risk of severe COVID-19 or infection may soon receive a third dose of the Pfizer-BioNTech COVID-19 vaccine.

The Food and Drug Administration (FDA) Vaccine Advisory Committee voted unanimously today to recommend booster shots for people 65 years of age and older who received two doses of the Pfizer-BioNTech vaccine ago. at least 6 months.

Also included in the recommendation are people aged 16 and over at high risk of severe COVID-19.

If the FDA follows the committee’s recommendations, the approval would be granted as an Emergency Use Authorization (EUA), rather than full approval.

The Pfizer-BioNTech vaccine is currently fully approved in the United States as a two-dose regimen for persons 16 years of age and older under the brand name Comirnaty.

Initial doses of the vaccine are also available as part of an EUA for 12 to 15 year olds. This group would not be eligible for boosters at this time.

Emergency approval, which was initially used for all COVID-19 vaccines, is a faster regulatory route intended for a public health emergency, such as a pandemic.

As part of the EUA, the FDA will continue to monitor data on the safety and effectiveness of booster doses for these groups.

After the vote, the group of independent experts also informally recommended that the EUA be amended to include “healthcare workers or others at high risk of occupational exposure”.

All members agreed with this addition.

“This is a truly amazing vote for people who are at serious risk of COVID: the elderly, as well as those at risk [of infection] in health facilities and other high risk settings. A third dose will protect them, ”said a member of the committee. Dr Amanda Cohn, chief medical officer at the Centers for Disease Control and Prevention (CDC).

She pointed out that many people in these high-risk groups were vaccinated in December 2020 or January of this year, so they are more likely to be at risk of infection due to decreased immunity after vaccination. .

People with weakened immune systems can already receive a third dose of an mRNA vaccine in the United States. These are not considered a booster dose, but as a way to help boost people’s initial immune response.

The FDA is not required to follow the advice of the panel, but it generally does.

The CDC’s Advisory Committee on Immunization Practices (ACIP) will meet to discuss whether the CDC should recommend the deployment of Pfizer-BioNTech boosters for these groups.

During the one-day meeting, the FDA advisory group reviewed Pfizer’s evidence for the safety and effectiveness of a third dose of its vaccine.

The panel also heard from two Israeli researchers, who presented data from that country suggesting a decline in the protection offered by the vaccine several months after the second dose.

The data showed that all age groups saw their protection against infection diminished 6 months after vaccination.

There has also been a decline in protection against critical illness among those 60 years of age or older. This trend was less clear for the younger age groups.

To justify their approval, scientists at Pfizer cited actual data from Israel, as well as data from laboratory studies and clinical trials.

Laboratory data has shown an increase in antibody levels after a third dose given at least 6 months after the second dose.

Data from clinical trials showed that the side effects of the third dose were similar to those of the first two. In some cases, the side effects were less severe after the third dose.

“These data, and all the scientific evidence presented at the meeting, underscore our belief that boosters will be an essential tool in the ongoing effort to control the spread of this virus”, Kathrin U. Jansen, PhD, senior vice president and head of vaccine research and development at Pfizer, said in a press release.

The FDA advisory committee initially voted on whether to recommend recalls for anyone 16 years of age or older.

This vote failed, with 2 members voting for and 16 members voting against.

Some members felt that while there was strong evidence for the benefits of a booster for the elderly, more safety data was needed for younger age groups.

In particular, they focused on the risk of heart inflammation: myocarditis and pericarditis. These conditions can occur after vaccination with an mRNA vaccine.

They are more common after the second dose and in adolescent males and young adults. Most people recover quickly with treatment.

Israel recently began rolling out boosters of the Pfizer-BioNTech vaccine to younger age groups.

Dr Sharon Alroy-Preis, director of public health services at Israel’s health ministry, told the meeting that more than 6,000 young people between the ages of 16 and 18 have received a third dose.

The Israeli Ministry of Health is actively monitoring all cases of heart inflammation in this group.

So far, the rate of myocarditis or pericarditis appears to be lower after the third dose than after the second dose, she said. However, Alroy-Preis added that these young adults were followed for less than 30 days.

Some members of the FDA committee felt that longer follow-up would be necessary to find out the real risk of heart inflammation after a booster dose.

Not all fully vaccinated healthcare workers are at risk for severe COVID-19, although many are at risk of contracting the coronavirus from exposure to COVID-19 patients.

However, several members felt that this group should be included in the EUA because of the impact that infections among healthcare workers would have on the ability of hospitals to cope with the influx of critically ill patients.

“The [healthcare] systems are so overloaded now that we can’t even get healthcare workers to get mild infections or to test positive because staying home it [creates] even more a risk of failure of the whole system ”, said a member of the committee Dr Stanley Perlman, professor of microbiology and immunology and pediatrics at the University of Iowa.

Committee members also decided to expand their informal recommendation to include others at high risk of infection due to their work.

This could include other frontline workers, infrastructure workers and teachers.

When ACIP meets, it will “refine some of our recommendations,” said Dr Arnold Monto, Acting Chairman of the FDA Advisory Board and Professor of Epidemiology at the University of Michigan.

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