FDA panel rejects Pfizer plan to give Covid booster doses to the general public

FDA panel rejects Pfizer plan to give Covid booster doses to the general public

On Friday, an influential Food and Drug Administration advisory committee rejected plans by Pfizer and BioNtech to give booster shots of the COVID-19 vaccine to the general public, saying they needed more data.

However, the panel can still clear shots for the older population. Scientists continued to debate the need for a third dose of vaccine for older populations after their initial vote, leaving the possibility of further votes open.

“It is, in my opinion, beneficial for the elderly, and may possibly be indicated for the general population. I don’t think we’re there yet in terms of the data, ”said Dr. Ofer Levy, vaccinator and infectious person at Boston Children’s Hospital. The American pathologist said after voting against the original proposal. The final count failed 16-2.

Pfizer shares fell more than 1% in intraday trading after early voting. BioNTech shares fell more than 4%.

The non-binding decision by the FDA’s Vaccines and Related Biologics Advisory Committee comes as the Biden administration has said it wants to start offering recalls to the general public as early as next week, pending clearance from the US health regulators. Although the agency did not always follow the advice of its committee, it often does. The FDA’s final decision could be made in a matter of hours. The Centers for Disease Control and Prevention has scheduled a two-day meeting next week to discuss plans for the third-round distribution in the United States.

The committee’s vote was to be controversial because some scientists, including two senior FDA officials involved in Friday’s meeting, said they were not entirely sure every American receiving the Pfizer vaccine would need the dose. additional at this time.

In an article published days before the advisory committee meeting, a leading group of scientists said available data shows vaccine protection against serious illnesses persists, even though efficacy against mild illnesses declines over time. . She goes. The authors, including two senior FDA officials and several scientists from the World Health Organization, argued in the medical journal The Lancet on Monday that widespread dissemination of booster injections to the general public was not appropriate in this moment.

Outlining plans last month to begin distributing boosters as early as next week, administration officials cited three CDC studies that showed the safety of the COVID vaccine weakened over several months. Senior health officials have said that while they are concerned about protection against serious illness, hospitalizations and deaths could “reduce” in the coming months, especially among those at high risk or those at high risk. early stages of a vaccination rollout. has been vaccinated for

Ahead of the vote, some committee members said they feared there was not enough data to make a recommendation, while others argued that the third shot should be limited to certain groups, like the over 60s. These are known to be high risk. serious illness. Some members expressed concern about the risk of myocarditis in young people, saying more research was needed.

Dr Hayley Gans, a voting member, said he was “stunned” that the FDA is asking the committee to review all of the evidence presented on Friday because some data, including safety, was still insufficient.

Another member, Dr Paul Offit, said he would support a booster for people over 60, but find it difficult to support a third injection for younger groups due to the high risk of myocarditis .

Ahead of Friday’s vote, the committee heard several presentations on data supporting the large-scale distribution of booster vaccines, including from health officials in Israel, where officials have started immunizing the vaccine. population of the country ahead of many other countries, and began to offer its citizens the third injection. . End of July.

Phil Krause, an FDA vaccine regulator and co-author of The Lancet article, criticized the results presented on Friday, saying most of the data had not been reviewed or peer reviewed by the agency federal. He said the models used were complex and scientists need to make sure they “give you the right results.”

“This is part of the difficulty of looking at data like this without giving the FDA a chance to review it,” he said.

In documents released by the FDA on Wednesday, Pfizer said an observational study in Israel showed a third dose of the COVID vaccine six months after a second injection restored protection against infection by 95%. Data was collected from July 1 to August 30, when the fast-spreading delta variant was increasing across the country.

In a presentation Friday, Dr Sharon Ellroy-Preis of the Israeli Ministry of Health argued that had officials not started handing out boosters in late July, the country’s hospital capacity would likely have been exceeded. Health officials have started to see a trend, they said, as people in their 40s and 50s who were fully vaccinated fall seriously ill with COVID.

“We didn’t want to wait to see these results and we knew we had to vaccinate a large part of the population to bring the numbers down quickly,” she told the committee. He said Israeli health officials expected severe cases to average 2,000 by the end of August. “We were able to mitigate that impact and our severe cases are around 700 or less and have remained stable, although we still have days out of 10,000 confirmed cases.”

She also said the booster shots were well tolerated by many, citing data showing there was only one case of myocarditis, a rare inflammatory heart disease that has been linked to mRNA vaccines. About 2.9 million people received additional doses.

The side effects of the Pfizer booster can also be compared to those experienced after taking a second dose of the vaccine, said Dr. An, head of the FDA’s Office of Vaccine Research and Review. Juhi Lee said at the meeting.

Of the 289 booster beneficiaries aged 18 to 55 in Pfizer’s Phase Three trial, 63.8% developed fatigue, 48.4% had headaches and 39.1% muscle pain. . The FDA studied side effects in 2,682 Pfizer second-dose COVID recipients aged 16 to 55, with 61.5% of patients reporting fatigue, 54% of headaches and muscle aches among 39, 3%. An 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. “Although one of them was apparently released by then. “

This is a developing story. Please check for updates.

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