Pfizer Inc and BioNTech SE are seeking regulatory approval to expand the enrolment of their Phase 3 Covid-19 vaccine trial to include 44,000 participants, up from 30,000 at present. An application to amend the trial protocol has been submitted to the US Food and Drug Administration, the companies announced on 12 September.
The prospective vaccine, BNT162b2, is a single nucleoside-modified messenger RNA that encodes an optimised SARS-CoV-2 full length spike glycoprotein which is the target of virus neutralising antibodies.