FDA panel recommends Pfizer Covid booster doses for individuals 65 years and older

An influential Advisory Committee to the Food and Drug Administration on Friday turned down a proposal to distribute booster shots of the Covid-19 vaccine from Pfizer and BioNTech to the general public, and scaled back plans to unanimously reduce the third vaccination to people 65 years of age and other at-risk Americans to recommend .

“In my opinion it is likely to be beneficial for the elderly and eventually could be indicated for the general population. I just think we’re not there yet in terms of the data, ”said Dr. Ofer Levy, a vaccine and infectious disease specialist at Boston Children’s Hospital.

The panel voted 16-2 against distributing the vaccines to Americans 16 and older before unanimously adopting an alternative plan to give boosters to older Americans and those at high risk of developing serious illness if they got the virus receive. This previously included people with diabetes, heart disease, obesity and other so-called comorbidities.

Pfizer stock closed 1.3% while BioNTech’s shares fell 3.6%.

The non-binding decision of the FDA’s Advisory Committee on Vaccines and Related Biological Products comes as the Biden government announced that it would begin offering booster vaccinations to the general public as early as next week pending approval from US health regulators . Although the agency has not always followed the advice of its committee, it often does. A final FDA decision could be made in a matter of hours. The Centers of Disease Control and Prevention has scheduled a two-day meeting next week to discuss plans to distribute the third syringes in the United States

“We’re not tied to your voice at the FDA just for you to understand. We can adjust this as needed,” recalled Dr. Peter Marks, the agency’s top vaccine regulator, joined the panel after the votes. He asked the group for suggestions on what other populations the FDA should consider for boosters, such as frontline health workers and other professions exposed to higher levels of exposure to Covid.

The committee’s vote was expected to be controversial as some scientists, including two senior FDA officials who attended Friday’s meeting, said they weren’t entirely convinced that any American who did the Pfizer vaccine now needed additional doses.

White House senior medical advisor Dr. Anthony Fauci said he wasn’t surprised they didn’t recommend the shots for anyone 16 and older. Fauci, who has publicly endorsed Booster, hesitated in an interview on Closing Bell on Friday to guess what the committee would ultimately decide.

“I don’t want to pre-empt the advisory committee at the time they are deliberating,” he said.

Liesl Eibschutz, a Dartmouth University medical student, loads a syringe of Pfizer COVID-19 vaccine before giving the vaccine on the first day people 16 and older get the vaccine at Kedren Health on Thursday, Angeles, California.

Allen J. Cockroaches | Los Angeles Times | Getty Images

In a paper released a few days prior to the advisory committee meeting, a leading group of scientists said the available data showed that vaccine protection against serious illnesses persists even as efficacy against mild illness wears off over time. The authors, including two senior FDA officials and several World Health Organization scientists, argued Monday in the medical journal The Lancet that widespread use of booster syringes to the general public is currently inappropriate.

While outlining plans last month to begin distributing boosters as early as next week, Biden government officials cited three CDC studies showing that vaccine protection against Covid had waned over several months. Senior health officials said at the time they feared protection from serious illnesses, hospitalizations and deaths could “wear off” in the coming months, especially for those at higher risk or vaccinated during the earlier stages of vaccination.

Before the vote, some committee members said they were concerned that there wasn’t enough data to make a recommendation, while others argued that the third shot should be limited to specific groups, e.g. illness. Some members raised concerns about the risk of myocarditis in younger people and said more research was needed.

Dr. Hayley Gans, a voting member, said she was “concerned” that the FDA asked the committee to review the entirety of the evidence presented Friday because some data, including on safety, were still inadequate.

Another member, Dr. Paul Offit said he would support boosters for people over 60 but struggled to support a third vaccination for younger groups due to a higher risk of myocarditis.

Ahead of Friday’s vote, the committee listened to several presentations on data supporting the widespread use of booster vaccinations, including by health officials in Israel, where officials began vaccinating the country’s population before many other countries and their citizens later July.

Phil Krause, an FDA vaccine regulator and co-author of The Lancet, criticized the results presented Friday, saying that much of the data had not been federally vetted or peer-reviewed. He said the models used are complex and scientists need to make sure they are “getting the right results.”

“That’s part of the difficulty of looking at this type of data without a way for the FDA to review it,” he said.

In documents released by the FDA on Wednesday, Pfizer said an observational study in Israel showed that a third dose of the Covid vaccine restored infection protection to 95% six months after a second vaccination. The data was collected from July 1 to August 30, when the rapidly expanding delta variant emerged across the country.

In a presentation on Friday, Dr. Sharon Elroy-Price of the Israeli Ministry of Health said that if officials there had not started distributing boosters in late July, the country would likely have exceeded its hospital capacity. Health officials began to see a trend that people in their 40s and 50s who were fully vaccinated became seriously ill with Covid.

“We didn’t want to wait for these results and we knew we had to vaccinate a larger section of the population to get the numbers down quickly,” she told the committee. Israeli health officials expected an average of 2,000 serious cases by the end of August, she said. “We have been able to dampen this effect and our severe cases are around 700 or less and have remained stable even though we still have days with 10,000 confirmed cases.”

She also said the booster was well tolerated by many people, citing data showing that out of approximately 2.9 million people who received the additional doses, there was only one case of myocarditis, a rare inflammation of the heart that occurred with mRNA vaccines.

Pfizer’s booster side effects are also similar to those seen after receiving the second dose of vaccine, said Dr. Joohee Lee, an officer with the FDA’s Office of Vaccines Research and Review, during the meeting.

Of the 289 booster recipients, ages 18 to 55 years old, observed in Pfizer’s Phase 3 study, 63.8% developed fatigue, 48.4% headache, and 39.1% muscle pain. The FDA examined side effects in 2,682 recipients of Pfizer’s second dose of Covid aged 16 to 55 years and reported fatigue in 61.5% of patients, headache in 54%, and muscle pain in 39.3%. One adverse event – swelling of the lymph nodes – occurred in 5.2% of booster recipients but only 0.4% of those who received their first two doses.

“The majority were mild to moderate and they resolved,” Lee said of the lymphadenopathy cases. “Though one is reported to be underway right now.”

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