CEO Ugur Sahin: BioNTech and Pfizer will file for a Covid-19 vaccine EUA on Friday
The first application for a Covid-19 vaccine will reach the FDA’s desk tomorrow.
BioNTech CEO Ugur Sahin told CNN Wednesday that they and Pfizer plan to file for an emergency use authorization for their jointly developed vaccine on Friday. The two companies said that the submission could come “within days” after they announced their final efficacy results yesterday, but they had not given an exact date.
The EUA submission will come less than 11 months after scientists became aware of the existence of the virus now known as SARS-CoV-2, marking by several years the fastest a vaccine has ever gone from design to regulatory review. The efficacy results Pfizer showed this week suggested the vaccine was 95% effective at preventing symptomatic Covid-19.
Peter Marks, head of the agency’s vaccine and biologics division, told Business Insider this week that, once a submission is in, the EUA process will likely take “weeks.” The FDA’s internal reviewers will pour over data from the application and then send it to their advisory committee to publicly debate, question and provide a recommendation for or against authorization.
Moncef Slaoui, the scientific head of Operation Warp Speed, predicted that an authorization would come in mid-December. FDA reviewers have reportedly been told to set aside Dec. 8 through Dec. 10 on their calendars for hearings on the vaccine.
Moderna, which also showed around 95% efficacy in the first look at their Phase II readout, is also expected to file imminently for FDA authorization after they release their final results. Both Slaoui and Moderna CEO Stéphane Bancel said an FDA advisory hearing could cover both Moderna and Pfizer’s vaccine.
In addition to being the first Covid-19 vaccine to reach regulators, the Pfizer and Moderna candidates will also be the first mRNA vaccines or therapeutics to go before the agency.
For a look at all Endpoints News coronavirus stories, check out our special news channel.