Opinion: Pfizer vaccine's 3-month full approval, and less than 1-month sBLA OK — is the FDA's 'gold standard' evolving?
Pfizer’s recent full FDA approval for its Covid-19 vaccine was historic in many ways, not least of which was the lightning speed with which the agency pored over a gargantuan amount of data in a little more than three months.
By comparison, the FDA usually approves new drugs and vaccines somewhere between eight and 12 months, and for the two new vaccines in 2020, the approvals took about 12 months each.
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