Did the FDA Approve the COVID-19 Vaccines?

Some people wonder if “emergency use authorization” (EUA) means the FDA did not approve the COVID-19 vaccines. Dr. Paul Offit explains why EUA is not that different from the usual process of vaccine approval, known as a biologics license application (BLA).


Did the FDA approve the COVID-19 vaccines?

Paul Offit, MD: Hi, my name is Paul Offit. I'm talking to you today from the Vaccine Education Center at the Children's Hospital of Philadelphia. It is Tuesday, May 4th, 2021. I think some people have been a little frightened, I think, by the language that surrounded this vaccine, these COVID-19 vaccines — words like, or phrases like: Operation Warp Speed, or the race to develop a vaccine, or who's going to be the first to cross the finish line — I think have been a little scary.
Also, the process by which vaccines have been approved essentially by the Food and Drug Administration is also a little different than what normally happens. What normally happens is that companies submit a biologics license application. Usually that application takes about 10 months or so to process. And then the vaccine is licensed, and the company has the right then to distribute that product. That's not the way it's happened here. It's now through something called emergency use authorization, and I think that has scared people or made them wonder whether or not critical parts of the timeline have been reduced or cut or ignored, or worse that safety guidelines have also been ignored.

So, let me tell you the way this has worked. And I think the other thing probably that people are a little concerned about is that hydroxychloroquine, which was also approved through emergency use authorization, was shown ultimately not to work to either prevent or treat COVID-19, and then ultimately that emergency use authorization was withdrawn. So, I can see where people are concerned about the phrase “emergency use authorization” when it comes to FDA approval.

Now, what isn't different about biological license applications or approval through emergency use authorization is the size of the trials. The size of these trials, the 30,000-person trial by Moderna or 44,000-person trial by Johnson & Johnson or 44,000-person trial by Pfizer, are the same size of any typical adult or pediatric vaccine trial. The other thing that's not different between an EUA and a biologics license application, or licensure, is the safety follow-up. Typically, it is recommended that all children or adults be followed for at least two months after the last dose. Because when you've looked at the serious side effects that have been associated, occasionally, very rarely with vaccines, they all occur within six weeks of a dose. So that's not different. The real difference really is just length of follow-up for efficacy. So, when the FDA approved these vaccines — back in December the two mRNA vaccines, or the end of February for the Johnson & Johnson vaccine — when they approved those vaccines, they could say that those vaccines were highly effective for a few months, but they didn't know whether they were highly effective for longer than that. So, that's really the only difference. On the other hand, when you've had, you know, more than 570,000 people die from this virus, you're not going to do a two- or three- or four-year study to see how long efficacy lasts. You're going to put the vaccine out there and then see whether it lasts for a year or two or three, and worst-case scenario if it doesn't, you can always give a booster dose.

Now, it’s my understanding that by late summer, these vaccines, specifically the two mRNA vaccines, will be submitted for licensure. So, I think we probably will have licensed products by the end of the summer. But I just want to reassure people that the difference really is only in length of follow-up for efficacy as a distinction between a licensed application and approval through emergency use authorization.

Thank you.

Related Centers and Programs: Vaccine Education Center

Last Reviewed on Jun 01, 2021