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WHO set to review Pfizer/BioNTech COVID-19 vaccine for emergency use listing

Follows approval for emergency use in the UK yesterday

The World Health Organization (WHO) is set to review Pfizer/BioNTech’s COVID-19 vaccine after receiving data from the partner companies, Reuters reported.

Pfizer/BioNTech received their first emergency use authorisation for a COVID-19 vaccine from the UK’s MHRA yesterday, with doses reportedly set to be available by next week.

The UK regulatory approval and WHO emergency listing review are based on data from a final analysis of the vaccine, BNT162b2, which found that it has an efficacy rate of 95% in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective).

The vaccine efficacy rate was found to be consistent across age, gender, race and ethnicity, with the observed efficacy in adults over 65 coming in at over 94%.

The MHRA is also reviewing another mRNA-based COVID-19 vaccine, developed by Moderna, on a rolling basis. In phase 3 studies, Moderna’s vaccine demonstrated a final efficacy rate of 94%, comparable to Pfizer/BioNTech’s vaccine.

The WHO told Reuters that it is currently reviewing BNT162b2 for “possible listing for emergency use”, adding that it is “also in discussions with MHRA on the possibility of accessing some of the information from their assessment, which could expedite WHO’s emergency listing”.

BNT162b2 is also currently under regulatory review in a number of other regions, including with the European Medicines Agency and the US Food and Drug Administration (FDA). In November, the FDA announced that it had scheduled a meeting on 10 December to discuss the emergency use authorisation (EUA) request for BNT162b2.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) is set to meet and discuss the vaccine, as well as make recommendations to the FDA regarding the possible authorisation of the vaccine.

According to Axios, FDA commissioner Stephen Hahn has been called to the White House to discuss the agency’s timings for reviewing the vaccine, following the approval in the UK yesterday.

"We want to move quickly because this is a national emergency, but we will make sure that our scientists take the time they need to make an appropriate decision. It is our job to get this right and make the correct decision regarding vaccine safety and efficacy,” Hahn told Axios.

Article by
Lucy Parsons

3rd December 2020

From: Regulatory



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