The FDA published its analysis of the safety and efficacy of BNT162b2 today ahead of a meeting on Thursday this week of a group of independent medical experts - the Vaccines and Related Biological Products Advisory Committee - that will evaluate the Pfizer/BioNTech vaccine for emergency use in the US.
On November 20, the two companies submitted an Emergency Use Authorization (EUA) request to the FDA for their COVID-19 vaccine candidate, intended to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years or older.
The US regulator’s analysis shows the most common solicited adverse reactions to the Pfizer/BioNTech vaccine were injection site reactions (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%). Severe adverse reactions occurred in 0.0% to 4.6% of participants, were more frequent after dose 2 than after dose 1 and were generally less frequent in participants over the age of 55 as compared to younger participants.
The analysis confirms vaccine effectiveness of 95%, assessed a week following the administration of the two dose regime.
The FDA report also said clinical data submitted would suggest the vaccine was 82% effective after the first dose, but more information was needed to draw a conclusive response as regards that.
Pfizer recommends two doses of the vaccine about three weeks apart.
The UK today began a vaccination campaign against COVID-19 with the Pfizer/BioNTech vaccine based on its emergency use approval in that market. Bahrain approved emergency use for the vaccine on Friday [December 4], making it only the second country in the world, after the UK, to grant such regulatory status.
In the hand of the regulators
Dr Albert Bourla, CEO of Pfizer, asked during a media briefing today as to whether the EUA in the US was likely to be granted this week given today's developments, said:
“That is not [up] to me to either decide or to predict. I expect a very intense meeting with the advisory committee [on Thursday]. These are experts. They will ask a lot of questions. We have answers, we believe, to all the questions they will ask. I think they will vote yes given the strength of the data. Then it is up to the FDA to conclude the process and give us the license.”
He added that the US watchdog should take as much time as it needs in terms of making the decision on EUA in order to ensure a high level of trust in the vaccine in the general population.
