Advisers to the FDA and former officials predict that full approval of Pfizer’s Covid-19 vaccine—currently authorized for emergency use—could come in September or October
The U.S. Food and Drug Administration is under pressure to swiftly grant full approval toshots, as vaccine mandates take on new urgency for schools, hospitals and employers amid surging cases from the rapidly spreading Delta variant.
Government agencies and companies are starting to mandate vaccines for at least some workers and in some circumstances. However, many employers and schools are holding off, saying that they can’t or won’t act, while the vaccines are still only authorized for emergency use. “We’d like to see it approved as fast as humanly possible, so we can really go back to just the more normal experience,” said Jim Malatras, chancellor of the State University of New York system, which serves 400,000 students. Under guidance from the state, he cannot impose a vaccine mandate for students until the shots are granted full approval. For now the school is requiring vaccines or weekly testing, similar toThree vaccines—from Pfizer Inc. and partner BioNTech SE , Moderna Inc.
Advisers to the FDA and former FDA officials familiar with the process predict that full approval of at least Pfizer’s vaccine could come in September or October. President Biden said Thursday he expects the approval of the vaccines to happen in the early fall. And FDA officials have said they intend to finish the process “far in advance” of the regulatory deadline following applications, which Pfizer says is in January.
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