BRIEF—FDA to convene AdCom for BNT162b2 COVID-19 vaccine candidate

The US Food and Drug Administration say it has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on December 10 to discuss the request for emergency use authorization (EUA) of a COVID-19 vaccine, dubbed BNT162b2, from Pfizer in partnership with BioNTech that was filed on Friday.

The submission is based on a vaccine efficacy rate of 95% (p<0.0001) demonstrated in the companies’ Phase III clinical study 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), in each case measured from seven days after the second dose.

If approved, the vaccine will be the fastest to market in history, and the first to use mRNA technology.

The FDA intends to make background materials available to the public, including the meeting agenda and committee roster, no later than two business days prior to the meeting.

EMA delay

A full submission to the European Medicines Agency, which was also expected this week, has been postponed because the EU regulator has asked for more trial data than its US counterpart, according to people familiar with the process, reported by the Financial Times.