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.
What to know
- When do you think the FDA will give the Pfizer vaccine full approval?
- What are some of the differences between what’s required for an emergency use authorization compared to a full approval?
- But don’t we already have information on tens of millions of people who have gotten the vaccine?
- What are some of the manufacturing issues the FDA is looking at?
- Do you think a full approval will persuade unvaccinated people to get the shots?
- Does a full approval make it easier for employers and governments to require vaccines?