Q&A: When might the coronavirus vaccines get full approval?

The FDA’s top vaccine official vowed to complete the process ‘as rapidly as possible,’ but would not speculate on the timetable. Other officials have suggested it could be a matter of weeks.

Peter Marks, director of the Center for Biologics Evaluation and Research at the Food and Drug Administration, testifies before a Senate hearing in May. The center oversees regulation of coronavirus vaccines. (Jim Lo Scalzo/EPA-EFE)

With many Americans still unvaccinated and the delta variant sparking a sharp rise in coronavirus cases, the Food and Drug Administration is under growing pressure to grant full approval to coronavirus vaccines being used under the agency’s emergency authority.

Some lawmakers and health care experts pushing for quick approvals note that the shots — particularly the highly effective mRNA vaccines by Pfizer-BioNTech and Moderna — have been administered to tens of millions of people in the United States and worldwide without significant problems. They argue that universities, governments and employers would feel more comfortable imposing vaccine mandates after full approvals, and predict some people would be more willing to get the shots.

Pfizer and BioNTech submitted their request for full approval, called a biologics license application, on May 7, and Moderna began a rolling submission in June. Johnson & Johnson has said it will submit its application later this year. Typically, it takes the agency at least several months to grant a full approval for a vaccine. But some officials have said that the Pfizer vaccine could be approved by late summer or early fall.

In an interview Friday, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, which regulates vaccines, said the agency is pursuing “an all hands-on-deck” strategy to accelerate an already expedited effort to grant full approval to the Pfizer-BioNTech vaccine. He said the agency was essentially “in a sprint” to complete the process.

He also discussed the differences between emergency use authorizations, which are temporary clearances for public health emergencies, and full approvals, which remain in effect indefinitely unless a problem with a vaccine emerges.

Coronavirus: What you need to know

Vaccines: The CDC recommends that everyone age 5 and older get an updated covid booster shot. New federal data shows adults who received the updated shots cut their risk of being hospitalized with covid-19 by 50 percent. Here’s guidance on when you should get the omicron booster and how vaccine efficacy could be affected by your prior infections.

New covid variant: The XBB.1.5 variant is a highly transmissible descendant of omicron that is now estimated to cause about half of new infections in the country. We answered some frequently asked questions about the bivalent booster shots.

Guidance: CDC guidelines have been confusing — if you get covid, here’s how to tell when you’re no longer contagious. We’ve also created a guide to help you decide when to keep wearing face coverings.

Where do things stand? See the latest coronavirus numbers in the U.S. and across the world. In the U.S., pandemic trends have shifted and now White people are more likely to die from covid than Black people. Nearly nine out of 10 covid deaths are people over the age 65.

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