Pfizer CEO Albert Bourla suggested Tuesday that an FDA emergency-use authorization (EUA) request for the coronavirus vaccine it is co-developing with BioNTech is imminent. “We are very close to submitting for an [EUA],” Bourla reportedly said at a STAT News summit, but he would not specify how soon the filing could come, saying “let us not create expectations, we will announce it as soon as we are doing it.”
Last week, Pfizer and BioNTech reported results from the first interim analysis of a phase 3 study showing that their mRNA-based COVID-19 vaccine BNT162b2 was more than 90% effective at preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection.
Safety milestone met
Pfizer has said it would not request an EUA for the vaccine before it met a key safety milestone, which was projected to be in the third week of November. Under recent FDA guidance, companies must provide 2 months of safety data on half of trial participants following the final dose of a potential COVID-19 vaccine. On Tuesday, Bourla said the trial has already hit the required safety milestone, although he noted that important questions about the BNT162b2 vaccine still remain. “When it comes to how durable the protection could be, this is something we don’t know yet,” he said, adding that Pfizer would soon release more detailed efficacy results.
The news coincides with the launch by Pfizer of a pilot program in the US to help the company plan for the anticipated eventual distribution of BNT162b2.