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Food and Drug Administration Overwhelmingly Rejects Pfizer Booster for Healthy Adults

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Following an intense daylong public discussion, a panel of scientific advisors to the U.S. Food and Drug Administration (FDA) voted 16 to 2 against recommending the third shot of Pfizer’s COVID vaccine for people 16 and older.

The vote came after a sharp debate in which many of the panel’s independent experts, including infectious disease doctors and statisticians, challenged whether the data justified a broad rollout of extra shots when the vaccines appear to still offer robust protection against severe COVID-19 disease and hospitalization, at least in the U.S as reported in media.

‘It’s unclear that everyone needs to be boosted, other than a subset of the population that clearly would be at high risk for serious disease,’ said Dr Michael G. Kurilla, a committee member and official at the National Institutes of Health.

The issue of whether or not to approve boosters has become increasingly contentious, dividing scientists, both outside and inside the FDA, including two scientists who recently announced they are leaving the agency because of pressure from the Biden administration to approve boosters, despite the lack of data to support a third shot.

The Biden administration had hoped the FDA would approve a third shot of the Pfizer vaccine in time to begin rolling out boosters for Pfizer recipients next week.

‘It’s a welcome sight to see actual deliberations in meetings about vaccine booster shots at the FDA,’ said Mary Holland, president of Children’s Health Defense. ‘It’s encouraging that a panel of experts stood up to political and corporate pressure based on the lack of convincing data for safety and efficacy of boosters.’

Holland added:

The advisory panel’s vote is not binding, so the FDA doesn’t have to accept the results. But if the agency doesn’t, it will raise significant questions of political interference and pit agency scientists against political officials who signed off on the booster plan.

On Thursday, FDA scientists had expressed scepticism about the need for Pfizer COVID vaccine booster shots in a report released Wednesday. In the 23-page report, FDA officials said that based on their analysis of data submitted by Pfizer and BioNTech, they could not yet take a stance on whether to recommend COVID boosters for the general public.

The 23-page report analysed data submitted by Pfizer and BioNTech as part of the drugmakers’ request for authorisation for their vaccine to be given as a booster shot in people 16 years and older. Source

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