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FDA briefing document paves the way for Pfizer/BioNTech COVID-19 vaccine approval

Advisory Committee is set to meet today to discuss vaccine's safety and efficacy data

The US Food and Drug Administration (FDA) has published a briefing document ahead of an advisory committee meeting on 10 December, which is set to discuss the emergency use authorisation (EUA) request for Pfizer/BioNTech’s COVID-19 vaccine.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting will aim to evaluate the efficacy and safety data for the vaccine, BNT162b2.

The VRBPAC will ultimately aim to make recommendations to the FDA based on the data submitted as part of the EUA request, to inform the agency’s decision on whether to approve the vaccine or not.

That potential approval is looking increasingly likely, with the briefing document painting an overall favourable picture of Pfizer/BioNTech’s vaccine.

In the document the FDA reviewers confirmed that the ‘credible interval’ for BNT162b2’s vaccine efficacy (VE) was 90.3% to 97.6%, indicating a ‘true VE’ of at least 90.3%.

The FDA review of the EUA data also found that there was a high efficacy across all subgroups, including older participants and those with risk factors for developing severe COVID-19.

The agency, in concurrence with Pfizer/BioNTech’s own findings, also highlighted the ‘early onset’ of protection from COVID-19 after one just dose of BNT162b2, finding that 14 days after dose 1 COVID-19 cases ‘steadily’ accumulated in the placebo group, ‘while remaining virtually flat in the BNT162b2 group’.

‘The efficacy data suggest highly effective protection against COVID-19 in a broad population of individuals across demographic characteristics,’ the reviewers wrote in the document.

They continued: ‘The efficacy, safety and immunogenicity data in this EUA application support a positive assessment of risks and benefits for the Pfizer-BioNTech COVID-19 vaccine and fulfil the data requirements outlined in the FDA EUA guidance.’

The first doses of the Pfizer/BioNTech vaccine are currently being administered in the UK after it was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) last week.

Following the approval, the director of the US National Institute of Allergy and Infectious Diseases (NIAID) Dr Anthony Fauci initially commented that the UK’s approval process for the vaccine had been “rushed”.

In response to questions over the US Food and Drug Administration’s (FDA) handling of the regulatory process for the vaccine, Dr Fauci said that "they're doing it in a very careful way, appropriately”.

Fauci later apologised for the comments in an interview with the BBC, adding that he has “a great deal of confidence in what the UK does both scientifically and from a regulator standpoint”.

"Our process is one that takes more time than it takes in the UK. And that's just the reality. I did not mean to imply any sloppiness even though it came out that way,” he added.

Article by
Lucy Parsons

9th December 2020

From: Regulatory



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