From FiercePharma.com….
Pfizer CEO Albert Bourla and his vaccine partner BioNTech have said the companies expect phase 3 data by the end of October—and that an FDA application could soon follow. But more than 60 researchers and bioethicists urged the partners to wait for more safety data before submitting their shot for a green light, Bloomberg reports.
The experts called on Pfizer to wait until late November at least to submit its vaccine to the FDA. That would give trial investigators enough time to compile at least 2 months of safety data after participants receive their second doses. Pfizer, for its part, has said it expects to know by the end of October whether its program works.
