Monday, August 30, 2021

CDC panel backs full licensing of Pfizer-BioNTech COVID-19 vaccine

 

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The Pfizer-BioNTech COVID-19 vaccine remains extremely safe and worth using a federal advisory committee agreed Monday, recommending its use in people over 16.

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Biden urges Americans to get vaccinated after Pfizer COVID shot gets full FDA approval

The committee, known as the Advisory Committee on Immunization Practices (ACIP), reviewed data presented as part of the companies' request for a full license for the  vaccine.

The vaccine had been authorized for emergency use; on Aug. 23, the Food and Drug Administration issued it a biologics license application – the technical term for full approval – in people 16 and up. Its use in adolescents 12-15 will continue to have emergency authorization until more data accumulates. 

a woman looking at the camera: Priscilla Farag, 17, looks at registered nurse, Noleen Nobleza while getting the Pfizer COVID-19 vaccine at a vaccine clinic set up in the parking lot of CalOptima Saturday, Aug. 28, 2021, in Orange, Calif.© Jae C. Hong, AP Priscilla Farag, 17, looks at registered nurse, Noleen Nobleza while getting the Pfizer COVID-19 vaccine at a vaccine clinic set up in the parking lot of CalOptima Saturday, Aug. 28, 2021, in Orange, Calif.

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Emergency use was granted to speed the vaccine's availability during a time of crisis, based on two months' worth of data. Full approval is based on six months' worth.

On Monday, the ACIP publicly reviewed data for the first time that was part of the application process. 

Results, they said, were clear.

The Pfizer-BioNTech vaccine does carry a risk of two potentially dangerous side effects: swelling of the heart, called myocarditis, and allergic reactions. But those effects are mostly manageable, the data found, with allergic reactions largely caught during the 30-minute waiting period after vaccination and the vast majority of those with myocarditis leaving the hospital within a day or two. 

The vaccine also prevented most cases of severe disease and death, the data showed, and averted many more problems than it caused.

For example, out of every 1 million boys ages 16-17 who are vaccinated, 73 will likely come down with myocarditis, while preventing about 1,540 hospitalizations from COVID-19 infections.

And most cases of myocarditis after COVID-19 vaccinations have been mild, experts with the Centers for Disease Control and Prevention told the committee members, although it's too soon to know whether they will suffer any longer term consequences.

"I can't think of a vaccine for which we've had more efficacy and effectiveness and adverse event data than this vaccine," said committee member Dr. Sarah Long, a pediatric infectious disease expert at the Drexel University College of Medicine and

St. Christopher’s Hospital for Children, both in Philadelphia.

In voicing their support, several committee members said they hoped the vaccine's approval would make it more acceptable to people who have so far declined vaccinations. Nearly one-third of people who haven't been vaccinated said they'd be more likely to get vaccinated after full approval, the CDC's Dr. Kathleen Dooling told the group. 

The data also confirms that the emergency authorization was appropriate, said Dr. Oliver Brooks, chief medical officer with Watts HealthCare Corporation, a community health center in Los Angeles, who was attending his first ACIP meeting as a voting member.

Compared to December 2020, when the ACIP first signed off on the Pfizer vaccine, there is now six months of data post-vaccination instead of two, and a wide number of observational studies of how the vaccine performed in 680,000 people worldwide.

After taking its vote, the committee also discussed whether to support third vaccine doses for people who have already received two doses of the Pfizer-BioNTech or Moderna vaccines.

On Aug. 12, the committee approved third doses for people who are immunocompromised and who likely didn't get full protection from their first two doses.

The Biden Administration pledged earlier in August to make booster doses widely available beginning the week of Sept. 20 to anyone who was vaccinated at least eight  months earlier.

Committee members seemed concerned with that promise.

It isn't yet clear, CDC data shows, whether the recent increase in COVID-19 infections among those already vaccinated is due to waning immunity or the highly contagious delta variant.  

The CDC continues to "strongly advise against giving individuals an additional dose outside of the already recommended and authorized recommendations for immunocompromised persons," noted the CDC's Dr. Sara Oliver.

In light of the White House's pledge, many hospitals in the South, where the outbreak is currently at its worst, are already offering booster doses to staff and some patients, said Dr. Helen Talbot, of Vanderbilt University in Nashville.

But those who get vaccinated outside of formal authorization or approval cannot qualify for compensation by the federal government if they are injured by vaccination, one CDC official said.

Talbot said that limitation, which has not been well publicized and which she found "frightening," highlights the need for vaccine recommendations to go through normal avenues and not be circumvented by the White House.

Oliver and the committee members agreed that the most effective way to stop the spread of COVID-19 is to vaccinate the unvaccinated, both here and abroad.

The focus of future vaccination efforts should be to prevent severe disease, hospitalization and death rather than all infections, said committee chair Dr. Grace Lee, a pediatrician at the Lucile Packard Children’s Hospital and Stanford University School of Medicine, both in Stanford, California.

She said she supports "a strategy that highlights the importance of vaccinating the unvaccinated who are the ones predominantly getting vaccinated right now, as well as ensuring that those individuals who may continue to be vulnerable to hospitalization and death, particularly older adults, are included in conversations about boosters."

It's too early to think about getting rid of COVID-19, Lee said, when so many people around the world are still unvaccinated and getting infected.

Committee members also said they were concerned that although senior citizens remain at highest risk for severe COVID-19 infections, offering vaccines by age will discriminate against people of color, who often have shorter lifespans than whites, and their periods of high risk start at younger ages.

Contact Karen Weintraub at kweintraub@usatoday.com.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

This article originally appeared on USA TODAY: CDC panel backs full licensing of Pfizer-BioNTech COVID-19 vaccine

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