Here's What Will Change If Pfizer's Vaccine Gets Full FDA Approval
The pharmaceutical company just became the first to seek full approval for its COVID vaccine.
There are currently three COVID vaccines available in the U.S., but all three—Pfizer's, Moderna's, and Johnson & Johnson's—are only being administered under emergency-use authorization by the U.S. Food and Drug Administration (FDA). Soon, however, one vaccine might change that. Pfizer and BioNTech just became the first vaccine makers to apply to the FDA for full approval of their COVID vaccine for use in adults 16 and older. The pharmaceutical companies announced on May 7 that they had submitted six-months worth of data to the FDA for the initiation of a Biologics License Application (BLA)—which would mean full approval.
"Following the successful delivery of more than 170 million doses to the U.S. population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future," Ugur Sahin, MD, CEO and co-founder of BioNTech, said in a statement.
According to The New York Times, the approval process is likely to take months, so it may be some time before we find out if Pfizer-BioNTech is FDA-approved. But if it's already being administered, what would change if Pfizer's vaccine gets full FDA approval? Read on to find out more about what's next for this shot, and for more on the future of vaccination, Pfizer's CEO Just Said How Often You'll Need a COVID Vaccine.
If approved, Pfizer could market its vaccine directly to consumers.
Once fully approved, Pfizer could market its vaccine directly to consumers, according to The New York Times. This, along with full approval from the FDA, is likely to help raise public confidence in the vaccine—which is important in a time when vaccinations have slowed in the U.S. The NYT reported on May 4 that the average number of people getting a first or single dose of a COVID vaccine each day had fallen by about 50 percent since April 13.
"We are essentially nearing the end of vaccinating those that were willingly waiting to get in line to get it. And so, the next push is going to be I think more critical than ever," Rupali Limaye, PhD, a public health researcher at Johns Hopkins, explained to the NYT. "I think people still have concerns about it even if they know that no corners were cut. It will nudge people to say, 'OK, it's been thoroughly vetted.'" And for more vaccine news, This One Vaccine May Protect You Against All Variants, New Study Says.
Companies, schools, and government agencies could require vaccination.
Many people have discussed the possibly of COVID vaccine mandates, but full approval could make this a reality. According to a local ABC affiliate, while legal debate has questioned whether companies and schools can require people to receive a vaccine that only has emergency-use authorization, it is certainly legal once a vaccine has full approval. In fact, the NYT reported that certain education institutions, like the University of California and California State University systems, said they would only require a vaccine once it has full approval. This may also push the U.S. military to mandate vaccinations for service members, which they can do once it become a standard, approved vaccine, per the NYT. And for more on the current state of the pandemic, Dr. Fauci Says "Herd Immunity" Is No Longer the Goal With COVID—This Is.
It will be harder for other companies to introduce new COVID vaccines.
There are a few drug companies with experimental COVID vaccines still under development, like San Diego-based Arcturus Therapeutics or Inovio Pharmaceuticals, ABC 10News reports. However, these shots may never see the light of day in terms of emergency-use authorization if Pfizer's vaccine gets full approval first. According to federal law, companies can only get an emergency-use authorization if "there is no adequate, approved, and available alternative." Consequently, other companies will have to forgo the faster emergency-use authorization route unless they can show their vaccine is better at tackling variants or better for certain populations—like people with drug allergies—than a fully approved COVID vaccine. And for more up-to-date information, sign up for our daily newsletter.
And Pfizer could become the only vaccine available for use after the pandemic.
While there are three vaccines currently being used in the U.S., they are all only authorized for emergency use. According to the NYT, emergency authorizations are meant to be temporary and can be revoked once a public health emergency is over. If Pfizer's vaccine receives full approval from the FDA, this will allow it to remain on the market even as the COVID pandemic comes to an end and is no longer considered an emergency. If the other COVID vaccines are still only being administered under emergency-use authorization, they won't be able to remain on the market. However, both Moderna and Johnson & Johnson have indicated that they plan to seek full approval from the FDA as well—though neither have applied yet. And for more on vaccines down the line, Moderna CEO Says a Booster Shot Will Be Available by This Date.