Pfizer to Submit FDA Request ‘Within Days’ Over COVID-19 Vaccine

Pfizer, clearly not in the business of fucking around, said on Wednesday that the plan is now to submit a request to the FDA “within days” for an Emergency Use Authorization of its mRNA-based COVID-19 vaccine candidate BNT162b2.

The vaccine candidate, developed in collaboration with BioNTech, was reported earlier this month to have shown to have an efficacy rate of more than 90 percent based on early analysis. Now, with the conclusion of final efficacy analysis in the Phase 3 study, the vaccine candidate has shown an efficacy rate of 95 percent in participants without prior infection, the first primary objective. The second primary objective, i.e. the same efficacy rate in participants with and without prior infection, was also met by way of each case measured from seven days after the second dose.

“These achievements highlight the potential of mRNA as a new drug class,” Ugur Sahin, M.D.—CEO and co-founder of BioNTech—said Wednesday. “Our objective from the very beginning was to design and develop a vaccine that would generate rapid and potent protection against COVID-19 with a benign tolerability profile across all ages. We believe we have achieved this with our vaccine candidate BNT162b2 in all age groups studied so far and look forward to sharing further details with the regulatory authorities.”