FDA committee confirms Pfizer, BioNtech’s Covid-19 vaccine safety data

9 December 2020 (Last Updated December 9th, 2020 12:20)

The US Food and Drug Administration (FDA) advisory committee has released a briefing document confirming safety and efficacy data of Pfizer and its German partner BioNTech's Covid-19 vaccine candidate, BNT162b2.

FDA committee confirms Pfizer, BioNtech’s Covid-19 vaccine safety data
As per the committee’s advice, the FDA will decide on giving nod for the vaccine. Credit: FDA

The US Food and Drug Administration (FDA) advisory committee has released a briefing document confirming safety and efficacy data of Pfizer and its German partner BioNTech’s Covid-19 vaccine candidate, BNT162b2.

As per the analysis by FDA scientists, the vaccine appears to provide some protection against the disease following a single dose.

BNT162b2 could give greater protection that lasts at least two months after the second dose, the FDA noted.

Also, according to the document, the vaccine’s efficacy against Covid-19 was 95%, occurring at least seven days after the second dose with no serious safety concerns noted.

Efficacy data is similar to that previously reported by Pfizer.

The data, considered for emergency use authorisation (EUA) in the US, proposes two 30µg doses of BNT162b2 taken 21 days apart.

In November, the companies applied for an EUA from the FDA for the vaccine.

In a meeting on 10 December, the FDA’s Vaccines and Related Biological Products Advisory Committee will give recommendations to the FDA on the effectiveness and potential benefits of the vaccine based on the document.

Recommendations will include whether BNT162b2 can prevent Covid-19 in people aged 16 years or above and its potential benefits outweigh risks.

Under the committee’s advice, the FDA will decide on giving approval for the vaccine.

If approved, the first recipients of BNT162b2 would be healthcare workers and nursing home residents.

AP quoted FDA Commissioner Stephen Hahn as saying in an interview: “We want people to see this discussion, to see the issues that are brought up, and have a vigorous discussion of the data elements by the outside experts.

“That will be an important part of showing what goes into our decision making.”

Meanwhile, the UK started administering the Covid-19 vaccine, developed by Pfizer and BioNTech, outside a clinical trial, becoming the first country in the world to administer the new vaccine.