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11 Dec, 2020 01:47

FDA panel says ‘benefits outweigh risks’ for Pfizer vaccine & recommends emergency authorization in non-unanimous vote

FDA panel says ‘benefits outweigh risks’ for Pfizer vaccine & recommends emergency authorization in non-unanimous vote

An advisory panel of the US Food and Drug Administration has voted to recommend emergency approval for a coronavirus vaccine developed by Pfizer, saying its benefits overcome any risks despite dissent from some committee members.

The panel, part of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), voted 17-4 on Thursday to support emergency use for the inoculation, with one abstention. The principal question before the committee was whether the jab’s benefits outweighed its risks for “use in individuals 16 and older,” based on the available evidence.

While the five committee members who either opposed the measure or abstained did not offer an explicit rationale for their votes, a journalist who sat in on the panel’s nearly nine-hour virtual meeting, Dave Greber, noted there were objections “to the lack of available data” and the vaccine’s “shortened trial” period, as well as concerns that the jab’s lower age limit should be raised from 16 to 17 or 18. 

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However, the vote did not authorize a mass rollout of the inoculation, jointly developed by Pfizer and German pharma firm BioNTech, but merely recommended a course of action for US regulators.

“It is important to remember that the advisory committee is just that – it gives a recommendation to the FDA. It is nonbinding,” FDA Commissioner Stephen Hahn told CBS. “After we receive recommendations, we will incorporate that into our decision. We hope shortly thereafter, once we have the recommendations, we can make our own decision.”

With the panel meeting finished, approval for the vaccine is expected to come in a matter of days, with one FDA official saying on Wednesday that it could happen within “days to a week” after the committee’s recommendation.

Should the FDA give the green light, the US would become the fourth country to grant approval for the jab, following the UK, Bahrain, Canada and, most recently, Saudi Arabia. An authorization would also overcome heightened safety concerns after two British health workers suffered adverse reactions after receiving the vaccine, prompting UK officials to issue a warning that those with a history of “significant” allergic reactions should not take the immunization.

Pfizer CEO Albert Bourla hailed the committee’s decision after the meeting, saying the pharma giant is “pleased with the strong majority vote,” and will “stand at the ready to bring this vaccine to people in the US in an effort to help combat this devastating pandemic.”

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