Pfizer Vaccine Receives Full FDA Approval. What are the Implications?

​On August 23, 2021, the Food and Drug Administration (FDA) granted full approval to the Pfizer/BioNTech COVID-19 vaccine for people age 16 and older. This vaccine had been authorized for emergency use since December 11th for people age 16 and older. In May the emergency use authorization was expanded to include children age 12-15, which still remains in effect. Of the approximately 170 million Americans who are fully vaccinated, about 54% received the Pfizer vaccine. The approval comes 97 days after Pfizer provided the FDA with over 340,000 pages of documents to support their application. The FDA had reportedly been working on the application around the clock, and the approval took about half the time that it normally does.
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Now that the Pfizer vaccine has received the FDA’s gold standard for safety, effectiveness, and manufacturing quality, will it provide the impetus for vaccine holdouts to get vaccinated? What are the other implications of the Pfizer vaccine approval, and what about the other COVID-19 vaccines?

​Vaccine Holdouts: Public health officials are hopeful that the FDA approval of Pfizer’s vaccine will motivate more people to get the vaccine. As of August 23rd, there were approximately 82 million eligible Americans who had not yet received a COVID vaccine, for a variety of different reasons. According to the Kaiser Family Foundation, 3 in 10 unvaccinated adults said that they would be more likely to get vaccinated if one of the vaccines were to receive full FDA approval, https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-june-2021/. This is certainly encouraging, but only time will tell. It has been known for some time that a major reason for vaccine hesitancy is due to the notion that COVID vaccines are “experimental”. The FDA approval of the Pfizer vaccine takes this excuse off the table.

​Vaccine Mandates: Mandating a vaccine that had not received full FDA approval was problematic from a legal and ethical standpoint. But that has all changed. On the same day that the Pfizer vaccine received full FDA approval the Pentagon announced that it would require all active-duty service members to be vaccinated. Many large employers, school districts, universities, and other public and private entities have also announced vaccine mandates in recent days. Many organizations and municipalities have tried to increase vaccination rates by offering prizes and giveaways, with limited success. Mandates might help to push some people who are still on the fence about getting vaccinated.

​Other Implications of Full FDA Approval:

• Marketing: Pfizer is now able to market and advertise it’s COVID -19 vaccine by name. It will do so under the brand name “Comirnaty”.
• Off-Label Use: This refers to the use of an approved drug for a medical condition that it was not originally approved for, or in a different dose or form. Once the FDA approves a drug, a physician generally may prescribe it for an unapproved use when they judge that it is medically appropriate for their patient. In the case of the Pfizer vaccine, off-label uses could include vaccinating children under the age of 12, or using it for booster shots.

​Booster Shots are Coming: The Biden Administration prematurely announced that starting September 20, 2021 booster shots would become available for adults eight months after their second shot of either the Moderna or Pfizer COVID vaccine.  But before this can happen each vaccine manufacturer needs to receive FDA approval to provide boosters for their particular vaccine. To date only Pfizer has provided the FDA with initial data to justify a booster shot. Pfizer plans to submit its full application within days to provide boosters to people age 16 and older. Moderna and Johnson & Johnson will submit their data later this fall. 

Approval for boosters is not a matter of if, but when. The data coming in is overwhelmingly positive. This week Pfizer released data showing a third dose given 5-8 months after the second dose resulted in a 3- fold increase in coronavirus fighting antibodies,   https://www.reuters.com/world/us/pfizer-starts-process-seek-us-approval-covid-19-vaccine-booster-2021-08-25/. Data coming out of South Africa shows a 9-fold increase in antibodies from a booster dose of the Johnson & Johnson vaccine given 6 months after the first,  https://www.cnn.com/2021/08/25/health/johnson-vaccine-booster-data/index.html.
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If you can’t wait for the FDA to officially sanction booster shots, simply ask your personal physician. If you have been fully vaccinated with the Pfizer vaccine, your physician may legally provide a third dose now that it has received full FDA approval. 

Vaccine Inequity: ​Not everyone is happy about the U.S. and other developed countries rolling out booster shots. The head of the World Health Organization called the strategy “a mockery of vaccine equity”. With only about 2% of the African population fully vaccinated, I tend to agree. We have seen how contagious the delta variant is. Unvaccinated people are the incubators of new coronavirus variants, which could one day overcome the protection offered by current vaccines.
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The full FDA approval of the Pfizer vaccine is a good thing. It legitimizes this important weapon against COVID-19, which is still rampaging through the world. It eliminates the stigma of being “experimental” used by many as an excuse for not getting vaccinated. FDA approval provides legal cover for businesses, organizations and schools to mandate COVID vaccines when they deem it necessary. In the weeks and months ahead, Moderna and Johnson & Johnson will be submitting applications for full FDA approval for their vaccines. COVID vaccines have saved countless lives and have been used safely in hundreds of millions of people around the world. Full FDA approval of these vital vaccines can’t come soon enough. 

​Here is a link to the FDA press release on the full authorization of the Pfizer COVID vaccine, https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine.

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Thanks,
Armchair American