Prognosis
FDA Sets Goals That May Put Vaccine Out of Reach Before Vote
- Two-month safety data, expert panel review to be required
- FDA vaccine guidance had been under review at White House
This article is for subscribers only.
The U.S. Food and Drug Administration plans to have an expert panel review any Covid-19 vaccine application for emergency use, and wants to see at least two months of safety data, the agency said Tuesday.
The requirements will almost certainly add to the time it will take to review any vaccine, potentially past President Donald Trump’s goal of having one by Election Day next month. While the FDA has said it plans to work as quickly as possible, it has also said it won’t cut scientific corners or bend to political pressure to rush a vaccine.