
Covid-19 roundup: Pfizer submits vaccine for full approval; Merkel opposes Biden proposal to suspend IP for vaccines
Pfizer and BioNTech said Friday that they’ve submitted a biologics license application to the FDA for full approval of their mRNA vaccine for those over the age of 16.
How long it will take the FDA to decide on the BLA will be set once it’s been formally accepted by the agency.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, previously told Endpoints News that the review of the BLA should take between three and four months, but it may be even faster than that.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.