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FDA expert panel recommends EUA for Pfizer/BioNTech COVID-19 vaccine

Formal approval in the US could follow 'within days'

A US Food and Drug Administration (FDA) advisory committee panel recommended Pfizer/BioNTech’s COVID-19 vaccine for emergency use following an hours long meeting held yesterday. 

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on 10 December to evaluate the efficacy and safety data for the vaccine, BNT162b2, and make recommendations to the FDA regarding a potential emergency use authorisation (EUA) for the shot in the US.

Over the course of the meeting, which consisted of a number of independent experts, the panellists discussed certain points of contention regarding the efficacy and safety of the vaccine.

This included some concerns around whether there was enough data to support using the vaccine in 16-17 year olds, but ultimately the group decided that the data was sufficient enough to warrant a recommendation in this age group.

The experts also discussed the recent allergic reactions to BNT162b2 observed in the UK, as well as the follow-up data and longevity of protection against COVID-19 offered by the shot.

“There is very little information about what happens to people who get the vaccine and then get exposed to COVID-19,” said Dr Oveta Fuller, an associate professor of microbiology and immunology at the University of Michigan, who voted no to recommending the vaccine for emergency use.

“We don’t even know what’s going to happen to people in the long term who get these lipid particles and mRNA vaccine. With this limited risk assessment, I think uptake in the community is going to be fairly poor,” she added.

However, after discussing all the available safety and efficacy data, the committee voted 17-4 that the benefits of the vaccine outweigh the risks for immunisation in people aged 16 years and older.

Pfizer expects to have 6.4 million doses of BNT162b2 ready to roll out in the US in late December, according to the BBC.

This would mean that there would be enough doses to vaccinate around three million people, as the full vaccination regimen for BN162b2 includes two doses.

On Wednesday, US Department of Health and Human Services (HHS) secretary Alex Azar said that following the expert meeting, the US “could then have a vaccine within days, and be administering it to the most vulnerable by next week".

The Pfizer/BioNTech has been approved for emergency use in a number of regions now, including the UK, Canada, Bahrain and Saudi Arabia.

Article by
Lucy Parsons

11th December 2020

From: Regulatory



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