FDA grants Emergency Use Authorisation to Pfizer-BioNTech COVID-19 Vaccine

Approval is based on an analysis of an ongoing RCT (n=36,523) which reported 95% efficacy in preventing COVID-19 disease with 8 COVID-19 cases in the vaccine group and 162 in the placebo group, of which 1 in the vaccine group and 3 in the placebo group were classified as severe.

SPS commentary:

At this time, data are not available to ascertain how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person.

FDA