FDA Panel rejects plans to administer Pfizer’s Covid booster dose to the general public

Friday’s influential Food and Drug Administration advisory board categorically rejected plans to administer booster shots of Pfizer and BioNTech’s Covid-19 vaccine to the general public, saying more data is needed. ..

However, the panel was still able to clear the shots of the elderly. Scientists continued to discuss the need for a third dose of the vaccine for the elderly after the first vote, leaving the possibility of other votes.

“In my opinion, it is likely to be beneficial to the elderly and may eventually be adapted to the general public. From a data perspective, I don’t think it’s there yet.” Vaccines and Infectious Diseases Ofer Levy, a illness expert at Boston Children’s Hospital, said after voting against the first proposal. The final aggregation failed at 16-2.

Pfizer’s share price fell more than 1% in intraday trading after the first vote. BioNTech’s share fell by more than 4%.

The non-binding decision by the FDA’s Vaccine and Related Biopharmaceutical Advisory Board is due to the Biden administration’s desire to begin offering booster shots as early as next week, awaiting approval from US health regulators. Agencies do not always follow the advice of the Commission, but they often do. The FDA’s final decision can take hours. The Centers for Disease Control and Prevention is planning a two-day meeting next week to discuss plans to distribute a third shot in the United States.

The Commission’s vote was expected to be controversial as some scientists, including: Two advanced FDA Officials attending the meeting on Friday said they were not completely convinced that all Americans vaccinated with Pfizer were in need of additional doses right now.

of Published paper A few days before the advisory board meeting, a major group of scientists showed that the available data show that vaccine protection against severe illness persists, even if efficacy for mild illness diminishes over time. Said that. The author, including two FDA officials and several World Health Organization scientists, argued in the medical journal The Lancet on Monday that it was not appropriate at this time to distribute booster shots to the general public.

Overview of plans to start last month Distribute boosters as early as next week, Government officials cited three CDC studies that showed that vaccine protection against Covid was reduced over the course of several months. Senior health officials said they were concerned that protection against severe illness, hospitalization and death could diminish in the coming months.

Prior to voting, some members of the committee are concerned that there is not enough data to make recommendations, while third shots are known to be at high risk over the age of 60. Some argued that it should be limited to a specific group, such as people. Severe illness. Some members expressed concern about the risk of myocarditis in young people, saying more research was needed.

Voting member Dr. Haley Guns was “impressed” by asking the Commission to examine the entire evidence presented on Friday, as some data, including safety, are still inadequate. “.

Another member, Dr. Paul Offit, said he would support boosters for people over the age of 60, but the high risk of myocarditis made it difficult to support the third shot of the younger group.

Prior to voting on Friday, the Commission listened to several presentations on data to support the widespread distribution of booster shots from Israeli health authorities. In late July.

Phil Krause, FDA’s vaccine regulator and co-author of The Lancet’s paper, said he was critical of the findings released Friday and said much of the data had not been reviewed or peer-reviewed by federal agencies. rice field. He said the model used was complex and scientists had to make sure it “gives you the right results.”

“This is part of the difficulty of seeing this kind of data without the FDA having the opportunity to review it,” he said.

In a document released by the FDA on Wednesday, Pfizer said an observational study in Israel showed that six months after the second dose, the third dose restored protection from infection to 95%. Stated. Data were collected from July 1st to August 30th, when the rapidly prevailing delta variants were booming across the country.

In a presentation on Friday, Dr. Sharon Elroy Price of the Israeli Ministry of Health claimed that the country would have exceeded the capacity of the hospital if it had not started distributing boosters at the end of July. Health officials have begun to see individuals in their 40s and 50s who are fully vaccinated tend to become seriously ill with Covid, she said.

“We didn’t want to wait to see those results, and we knew we needed to vaccinate more parts of the population to quickly reduce numbers,” she said. Told the committee. Israeli health officials expect an average of 2,000 serious cases by late August, she said. “We were able to mitigate that effect, and our severe cases are around 700 or less, and 10,000 confirmed cases still have days, but remain stable.”

She also cites data showing that of the approximately 2.9 million people who received additional doses, only one case was myocarditis, a rare cardiac inflammatory condition associated with the mRNA vaccine. , Said that booster shots were well tolerated by many.

The side effects of Pfizer’s boosters are comparable to those that appear after a second vaccination, Dr. Joohee Lee, a director of the FDA’s Vaccine Research Review Bureau, said during the meeting.

Of the 289 additional immune recipients aged 18-55 years monitored in Pfizer’s Phase 3 trial, 63.8% developed malaise, 48.4% suffered headache, and 39.1% experienced myalgia. .. The FDA investigated the side effects of 2,682 recipients aged 16-55 years who received Pfizer’s second Covid dose, with 61.5% of patients reporting fatigue, 54% headache, and 39.3% myalgia. bottom. One adverse event (swelling of the lymph nodes) occurred in 5.2% of booster immune recipients, but only 0.4% of recipients who received the first two doses.

“The majority were mild to moderate and they were resolved,” Lee said of a case of lymphadenopathy. “It is reported that it is in progress at this time.”

This is a developing story. Please check for updates.

FDA Panel rejects plans to administer Pfizer’s Covid booster dose to the general public

Source link FDA Panel rejects plans to administer Pfizer’s Covid booster dose to the general public

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