Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said he “would be astounded” if Pfizer/BioNTech’s Covid-19 vaccine does not receive full approval from the US Food and Drug Administration by the end of August.
“I don’t want to get ahead of the FDA, but likely, from what we’re hearing, it’s going to be in a matter of a month or so,” Fauci told CNN on Saturday. “I would hope, by the time we get to the end of August, that we have full approval. “But even between now and then, people should realize that the data of the efficacy and real-world effectiveness of these vaccines is really extraordinary – not only in the United States, but in multiple countries throughout the world. So I would be astounded if we did not get full approval within that timeframe."
On Friday: Pfizer and BioNTech announced that the FDA had granted priority review designation to the companies’ application for approval of their Covid-19 vaccine. The goal date for a decision from the FDA is January 2022, the companies said.
Pfizer and BioNTech began submitting their Biologics License Application for their Covid-19 vaccine for people ages 16 and older in May.