April 1 Quick Takes: BioNTech, Pfizer to seek full approval of vaccine; plus CEPI’s call and FDA’s latest batch of expanded labels 

BioNTech SE (NASDAQ:BNTX) and  Pfizer Inc. (NYSE:PFE) are preparing to submit a BLA to FDA for the partners’ COVID-19 vaccine after reporting six-month efficacy data for BNT162b2. The partners, which did not specify a time frame for the submission, said the vaccine was 100% effective in preventing severe disease as defined by CDC and 95.3% effective against severe disease as defined by FDA. An analysis of 927 confirmed symptomatic COVID-19 cases showed BNT162b2 had 91.3% efficacy, measured from seven days through up to six months after the second dose. The product was 100% effective in preventing cases in South Africa, where the B.1.351 variant is prevalent.

CEPI call for proposals
The Coalition for Epidemic Preparedness Innovations has launched a call for proposals to develop broadly protective SARS-CoV-2 and Betacoronavirus vaccines. The coalition plans to invest up to $200 million in vaccine candidates up to clinical proof of concept as part of its $3.5 billion investment strategy...