KANSAS CITY, Kan. (WDAF) – Pfizer’s coronavirus vaccine may soon be the first to be fully approved by the Food and Drug Administration.
The New York Times reports that because of the delta variant and the number of surging COVID-19 cases, the FDA accelerated the timeline to fully approve Pfizer-BioNTech’s COVID-19 vaccine. According to the New York Times, the agency wants to grant full approval by Labor Day.
“I don’t think it’s too fast,” said Dr. Dana Hawkinson, infection prevention medical director at the University of Kansas Health System. “I think what we have seen through the course of this pandemic with anything, whether you’re looking at Remdesivir, the monoclonal antibodies, the vaccines, is all of these steps have been done diligently and with thoughtfulness. The data has been analyzed, it has been collected, all the trials have gone on, it’s just been expediting in the way that they’ve done it.”
Millions of people have received Pfizer’s version of the vaccine since the FDA granted the company emergency use authorization (EUA) late last year. Moderna’s and Johnson and Johnson’s vaccines also have emergency authorization.
Under the EUA, the FDA allowed the use of the coronavirus vaccines even though they weren’t fully approved because COVID-19 was considered a life-threatening emergency and there was no other alternative treatment available.
Since granting the EUAs, the FDA has spent months evaluating the vaccines and data from different studies and the vaccine companies. The administration takes all of those findings into account before granting full approval to a drug.
So, why is full approval important for something millions of people have already received?
Until full approval is granted, all three of the coronavirus vaccines currently offered in the U.S. are technically considered experimental treatments. Hospitals, universities, and other businesses have said they don’t feel comfortable requiring employees to get vaccinated until the FDA gives its approval. Once that happens, the vaccine will no longer be considered experimental. They also hope it will prevent legal ramifications that could surface with requiring workers to take an experimental vaccine.
Health experts have also said many unvaccinated people use the vaccines experimental status as a reason they don’t want to get the shot. Once it is fully approved, experts hope it will convince vaccine-hesitant people that the vaccines are safe to get.
“I think that is a game-changing moment. It’ll be fully authorized. I think you’ll see a lot of businesses and other places say we’re going to require vaccination. I think that’s going to start happening sooner and sooner. And I think that’s probably in many ways, if we’re going to protect ourselves as a society against COVID-19, it’s going to be the right thing to do,” Dr. Steve Stites, chief medical officer at the University of Kansas Health System, said Wednesday during an update with the hospital.
“There are very few other drugs, if any, that have (been given to people) … a billion times and studied across the world.. I think there has been a lot of focus on these medications, and lots of reports that this side effect or that side effect that people had to go evaluate. And because it’s so many people, we’ve been able to run down all those side effects. So I’m very confident that especially these messenger RNA drugs are going to be very safe,” Stites said.
Moderna filed for full FDA approval on June 1. The FDA said it needed the company to submit additional information before it would be considered for full approval.
Johnson and Johnson hasn’t applied for full approval yet.