That would give trial investigators enough time to compile at least 2 months of safety data after participants receive their second doses.
A Pfizer spokeswoman said the company is “very appreciativeâ€Â of the experts’ input, and that the company is “committed to providing sufficient efficacy and safety data to help FDA determine the best regulatory mechanism for making the vaccine available to the public.â€Â .
“We anticipate providing FDA with safety data, including the median of two months safety data after the second dose, on a rolling basis,†she added.
The drugmaker will track safety and outcomes data for two years during the trial. .