Why has the FDA not approved it? What does it typically take for the FDA to approve a vaccine?
Read this and it explains everything about emergency use authorizations and approvals.
Just process. Has to work through 4 phases. The manufacturer must submit 6 months of data after phase 3 testing, which the FDA then takes about 6 months to review. Probably November 2021 in this case.
So it’s entirely possible the FDA could decline approval a year from now?
Given the demonstrated efficacy, that’s highly unlikely.
So at this point it’s proven efficacy. Is it just red tape?
Yes. New drug applications are submitted to the FDA and are the equivalent of 10,000 to 100,000 pages of data. They typically take nearly a year to review and approve.