Dr. Anthony Fauci, director of the National Institutes of Allergy and Infectious Diseases, said on CNN’s Newsroom Wednesday that he hopes full, formal US Food and Drug Administration approval of Covid-19 vaccines will come soon.
“I hope very soon,” he told CNN’s Jim Sciutto, when asked when he believed there would be full approval. “I don’t know exactly when, but when you’re getting a formal approval you have to have a certain amount of time just observing predominantly the safety, and obviously the safety looks really, really good in well over 140 million people having been vaccinated with at least a single dose.”
He said the FDA will work as expeditiously as possible, adding that the organization is the gold standard for safety globally.
“I hope they do it quickly, because as you say, people when they hear it’s still emergency use, they still have a little concern about how far you can go with it,” he said. “So, I’m with you on that. I’d like to see it really soon.”
Some background: Emergency use authorization means a medical product gets special authorization by the FDA to be used during an emergency, and that its known and potential benefits outweigh the known and potential risks – but it is short of full approval.
Vaccine makers will have to file a separate application for vaccines to be fully licensed. There are three Covid-19 vaccines in the United States with emergency use authorization – Pfizer/BioNTech, Moderna and Johnson & Johnson – and no Covid-19 vaccines have been approved by the FDA.
Some organizations, such as the University of California and California State University systems, have said they plan to require Covid-19 vaccination for faculty and staff only once the vaccine has received full FDA approval.