What You Need to Know About the FDA's Approval of Pfizer's COVID-19 Vaccine

On Monday, August 23rd, the U.S. Food and Drug Administration finally gave official approval to the first COVID-19 vaccine. The vaccine is known as the Pfizer-BioNTech COVID-19 Vaccine.

This blog will summarise the FDA’s official statement and what this means in the global fight against COVID-19.

We’ve compiled the top points from the FDA’s News Release:

- The Pfizer-BioNTech COVID-19 Vaccine is the first COVID-19 vaccine to receive FDA approval.

- The vaccine will still be available under Emergency Use Authorization (EUA) for individuals 12-15 years old.

- The FDA analyzed data from Pfizer’s clinical trials that included over 40,000 participants.

- The Pfizer BioNTech vaccine was found to be 91% effective in preventing COVID-19 disease.

- The Pfizer-BioNTech vaccine will now be marketed as Comirnaty.

- The Pfizer vaccine contains messenger RNA, a kind of genetic material, that is used by the body to mimic one of the proteins in the coronavirus. This will cause a person’s immune system to build immunity against COVID-19.

- The mRNA in the Pfizer vaccine is only present in the body for a short time and will not alter or assimilate to your genetic material.

The Bottom Line:

FDA approval is another great step towards the end of the coronavirus pandemic. With the new approval status, there is hope that the 31% of unvaccinated people who said they were more likely to get vaccinated after FDA approval will now be motivated to get the shot.

The FDA scoured through hundreds of thousands of pages of data and included inspections of the factories where the vaccine is produced. This data comes from Pfizer’s clinical trials that were comprised of over 40,000 people from the United States, the European Union, Turkey, South Africa, and South America. This is around the average size of vaccine clinical trials. The data from Pfizer’s clinical trials demonstrated that the vaccine is 91% effective in preventing a coronavirus infection. While this is a slight drop from the previous 95% efficacy rate that was presented to the FDA in December, the number is still much higher than the 50% threshold set by the World Health Organization for an effective vaccine.

With the FDA's stamp of approval, more companies will likely begin to mandate vaccinations for their employees. Pfizer will also now be able to market its shots directly to consumers in the United States, meaning advertisements for the vaccine will likely be seen in the near future. The Moderna and Johnson & Johnson vaccines are still under FDA review but are still available under the EUA. There is little information on when exactly we can expect the FDA to grant such approval. Moderna’s application has not yet been accepted, likely because the company’s application is still lacking some of the required materials.

The Johnson Center for Health will continue to advocate for the vaccine to eligible patients. We also advocate for a third, booster shot when they become available in September. COVID-19 is unlike any virus we have encountered before. We have to trust the scientists and doctors working diligently to prevent the spread while saving the lives of millions throughout the world.

In the meantime, as you wait for a booster shot, you should still be working to optimize your health in order to protect yourself from the future, potentially more dangerous strains of COVID-19.

The Johnson Center recommends a multi-faceted plan to obtain optimal health- encompassing biological and genomic testing, nutritional supplementation, and dietary and wellness plans. To learn more, click here. If you have any more questions about your path to optimal health, email our office at thejohnsoncenter@gmail.com or call 276-235-3205.

The Johnson Center for Health services patients in-person in our Blacksburg and Virginia Beach locations. We also offer telemedicine for residents of Virginia and North Carolina!