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FDA sets 10 December date for Pfizer’s COVID-19 vaccine meeting

Independent experts will discuss EUA submission for mRNA-based vaccine

The US Food and Drug Administration (FDA) has scheduled a meeting on 10 December to discuss the emergency use authorisation (EUA) request for Pfizer and BioNTech’s COVID-19 vaccine 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.

The agency added in a statement that it will make background materials – including the meeting agenda and committee roster – available to the public two days prior to the meeting.

“The FDA has been preparing for the review of EUAs for COVID-19 vaccines for several months and stands ready to do so as soon as an EUA request is submitted,” said Stephen Hahn, FDA commissioner.

“While we cannot predict how long the FDA’s review will take, the FDA will review the request as expeditiously as possible, while still doing so in a thorough and science-based manner, so that we can help make available a vaccine that the American people deserve as soon as possible,” he added.

Pfizer and BioNTech announced that they had submitted an EUA for BNT162b2 on Friday.

The EUA submission followed the final analysis of a phase 3 study of BNT162b2, which showed that the vaccine has a 95% efficacy rate consistent across age, gender, race and ethnicity.

A number of other countries are also reviewing Pfizer/BioNTech’s vaccine candidate, including the UK.

On Sunday, The Telegraph reported that the UK government could approve BNT162b2 as early as this week after it was announced that the Medicines and Healthcare products Regulatory Agency (MHRA) had formally started its review of the vaccine.

The British newspaper also reported that the NHS has been told to prepare to start delivering the mRNA-based COVID-19 vaccine by 1 December.

“If approval is granted, the NHS will be ready to deliver. The NHS has vast experience in delivering widespread vaccination programmes and an enormous amount of work has taken place to ensure we have the logistical expertise, transport and workforce to roll out a vaccine according to clinical priority, at the speed at which it can be manufactured,” said Health Secretary Matt Hancock.

The UK government previously signed a deal with Pfizer/BioNTech for 40 million doses of BNT162b2, with the majority of the doses expected in the first half of 2021.

Article by
Lucy Parsons

24th November 2020

From: Regulatory



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