Pfizer/BioNTech File for Covid Vaccine EUA

22.11.2020 - As planned, US drugmaker Pfizer and German biotech BioNTech filed an Emergency Use Authorization (EUA) request with the US Food and Drug Administration (FDA) for their mRNA-based Covid-19 vaccine candidate BNT162b2 on Nov. 20.

The developer duo is the first vaccine maker to apply for an EUA, but US biotech Moderna, which also has an mRNA candidate, said last week it hoped to submit a request by the end of December.

The FDA will decide whether to grant the application based on the efficacy and safety data the applicants provide. It is not clear when the agency will give the go-ahead, but due to the ongoing pandemic vaccines will be given priority in the approval chain.

Following the conditional green light, Pifzer-BioNTech plan to deliver the first doses. Depending on how fast the FDA completes its review, the companies could receive the nod during 2020, BioNTech CEO Ugur Şahin told US media. This, he said, would allow distribution of the first vaccine batches by December.

Data from a Phase 3 clinical trial showed the BNT162b2 candidate to be effective in preventing the virus in 95% of cases, with the success rate in the trial dipping minimally to 94% in adults over 65.  Moderna’s Phase 3 trial showed similar efficacy numbers.

Despite all the positive news, experts are warning the public to be patient. While the pandemic naturally creates urgency, Peter Marks, head of the FDA’s Center for Biologics Evaluation and Research, told the online journal Business Insider that the agency’s team will have to “take the amount of time that we need to take.” Reports say the health authority is discussing potential committee meetings for Dec. 8-10, 2020.

Along with the FDA, the advisory committee on immunization practices of the US Centers for Disease Control and Prevention (CDC) traditionally takes a deep look into vaccine data and makes recommendations about who should receive vaccines.  

Author: Dede Williams, Freelance Journalist