Here's What the FDA's Full Approval of the Pfizer COVID-19 Vaccine Means for YouAug. 23, 2021 - Katie McCallum
(This article was updated on 11/8/2021)
The FDA's long-awaited decision is finally here. On August 23, 2021, the agency granted full approval to the first COVID-19 vaccine: Pfizer/BioNTech's COVID-19 vaccine.
"Nine months ago, the vaccine was granted emergency use authorization (EUA), which allowed it to be distributed in a timely manner during this devastating pandemic," explains Dr. H. Dirk Sostman, chief academic officer of Houston Methodist.
Since then, recent estimates suggest that COVID-19 vaccines, including Pfizer's vaccine, have saved a quarter of a million lives and prevented more than 1 million hospitalizations.
"Now, the FDA has taken a step beyond EUA and granted full approval to the Pfizer vaccine. Specifically, it's fully approved for the prevention of COVID-19 disease in people 16 years of age and older," says Dr. Sostman.
Pfizer's vaccine will continue to be available under its EUAs for:
- Teens who are between 12 to 15 years of age
- Younger children between 5 to 11 years of age
- Certain people as a third dose or booster shot
Additionally, the Moderna and Johnson & Johnson COVID-19 vaccines will still be offered under their respective EUAs.
"Full FDA approval of the Pfizer vaccine is significant because it firmly reinforces what we already knew: The COVID-19 vaccines are safe and effective," adds Dr. Sostman. "It comes at a time when cases are skyrocketing in the Houston area, so we are hopeful that this full approval will give people additional confidence to get vaccinated," adds Dr. Sostman.
Still, you might not be totally sure what "full approval" truly means — in general, as well as for you more specifically.
Full approval reinforces that the vaccine is safe and effective
"After hundreds of million vaccinations and reviewing nine months of data and information — not just from clinical trials, but large-scale vaccination efforts, too — the FDA has determined that the benefits of the vaccine continue to significantly outweigh the risk of getting COVID-19," says Dr. Sostman.
Before granting full approval, the FDA keeps its eye on a few things, including:
- Long-term effects and the potential for rare adverse events to arise
- How vaccine "efficacy" translates into real-world effectiveness
- Manufacturing quality control and consistency
One adverse event identified was the very small risk of experiencing an allergic reaction after receiving the vaccine. This didn't mean the vaccine was unsafe for most people, though. It simply changed how the vaccine is administered (people are monitored for 15 minutes after their shot) — and made this risk clearly known to those who are allergic to any of the vaccine's ingredients.
"For instance, vaccine distributors now knew they needed to ask about severe allergies before administering the vaccine," says Dr. Sostman.
Additionally, large-scale vaccination data helped inform how effective the vaccine is in the real world — bolstering the benefit of vaccination.
"Even with the more infectious Delta variant, Pfizer's vaccine continues to provide strong protection against severe disease and hospitalization," says Dr. Sostman.
Full approval may help ease vaccine hesitancy
More than 200 million Americans have received at least one dose of COVID-19 vaccine.
Still, others have remained hesitant.
"We're hopeful that full approval provides these people with the confidence needed to get vaccinated as soon as possible. COVID-19 has taken more than 600,000 lives in the U.S. alone and vaccination is the best tool we have to protect against more death," says Dr. Sostman.
The FDA's message is clear: Pfizer's COVID-19 vaccine meets the high standards for safety, effectiveness and manufacturing quality the agency requires of an approved product.
"If you're not yet vaccinated, now is the time. And if you have questions about the vaccines, I cannot stress enough how important it is to turn to a trusted health expert for guidance, rather than to social media that is full of myths and misinformation," adds Dr. Sostman.
For instance, your primary care doctor can help you understand how the vaccines work, the side effects that may occur and the benefits of vaccination. He or she can also provide tips on how to deal with vaccine anxiety and decision-making.
Full approval means a few more behind-the-scenes things
While it may not mean much to you right now, full approval means Pfizer is now free to market the vaccine and continue to offer it beyond the pandemic.
"The Pfizer-BioNTech COVID-19 vaccine will now also go by the name of Comirnaty and can be marketed for the prevention of COVID-19 disease in people16 years of age and older," says Dr. Sostman.
Full approval may also be the vote of confidence many employers have been waiting for before requiring employees to be vaccinated. Many hospitals, employers, universities and government agencies, including the U.S. military, have already indicated that vaccination will be mandated once FDA approval is granted. More are likely to mandate the vaccine now that it is fully approved. Final approval helps build confidence about the safety of vaccines and clarifies some legal questions about mandates.
Lastly, full approval now means that the Pfizer-BioNTech COVID-19 vaccine can be used "off label."
"What this means is that you and your health care provider can use the vaccine in a way that's not approved by the FDA. An example of that right now would be as a booster shot, which is different from the third shots already being administered to immunocompromised people," says Dr. Sostman.
This is very common with many FDA-approved medications that are used by physicians and patients outside of the FDA guidelines. But do keep in mind: If you and your health care provider make the decision to administer a booster shot of Pfizer, know that FDA has not determined that this specific use is safe and effective.