Waiting for the COVID-19 Vaccines to Receive FDA Approval?

Update: As of Monday, August 23rd, the FDA has officially granted Pfizer BioNTech's COVID-19 vaccine full approval. To read more about it, click here.

Last week, COVID-19 daily cases spiked nearly 70% to 26,000 per day. Hospitalization rates jumped up by 33%. This is due to the new, Delta COVID-19 variant- more transmissible than any variant before it. Yet, even as cases begin to rise again, vaccination rates have stalled.

For millions of Americans, the lack of FDA approval for all three COVID-19 vaccines has caused hesitancy and a reluctance to receive a vaccination. But when will that seal of approval be allotted to these vaccines?

How are the vaccines being distributed without FDA approval?

The Pfizer, Moderna, and Johnson & Johnson COVID-19 vaccines were all allotted Emergency Use Authorization (EUA) around 7 months ago. Since then, over 336,000,000 vaccines have been administered. According to the CDC, over 160,000,000 Americans are fully vaccinated. While this number may seem astronomical, it’s still only 55% of the total U.S. population. To reach herd immunity, over 70% immunity is required.

To receive a EUA, manufacturers must follow a very strict set of guidelines. Such guidelines include information on the vaccines’ quality and consistency, as well as efficacy and safety details from clinical trials with tens of thousands of participants. The COVID-19 vaccines marked the first time ever that EAUs have been administered for a new vaccine.

From EUA to FDA approved:

For a vaccine to move from an emergency use authorization to being classified as FDA approved, further clinical trial data and real-world effectiveness and safety must be scrutinized. The FDA will inspect manufacturing facilities to ensure quality control is held to its strict standards.

But luckily, the FDA has already been studying the data from the millions of Americans who have already received the vaccine. This will likely speed up the approval process. On July 16th, Pfizer’s application was accepted by the FDA “under priority review.” While this process typically takes at least 10 months, an FDA official told CNN last week that the decision will likely be published in only 2 months. Unfortunately, Moderna’s application has not yet been accepted, likely because the company’s application is still lacking some of the required materials.

What happens after approval?

The stamp of FDA approval on the vaccines would offer some great benefits. Namely, it would mean more Americans would get vaccinated. Around 30% of unvaccinated people say they are waiting until the vaccines are FDA approved.

Once a vaccine is officially FDA approved, organizations can begin to officially require mandatory vaccinations. Around 6% of unvaccinated adults reported they would only get vaccinated if it was required by an employer, school, or to travel. Already, over 500 universities and high-profile hospitals require vaccinations. But, once the COVID-19 vaccine is officially approved, it may be a required immunization for public and private schools, though that is decided by the state government.

Waiting until FDA approval?

There is really no reason to wait until the vaccines are officially FDA approved. The COVID-19 vaccines have had their safety and efficacy scrutinized and studied more than any other biologics (vaccines, antibodies, molecules) in history. The mRNA vaccines have proved their safety time and time again through clinical trials, independent research, and the experiences of the hundreds of millions of people around the world who have been vaccinated.

Moreover, the Delta COVID-19 variant is not something to take lightly. It's responsible for 83% of new U.S. coronavirus cases, an increase of 52% in only two weeks.

Just this week, a physician in Alabama shared in a post on Facebook that patients dying of COVID-19 are begging for the vaccine, only to be told it's too late. She continues to describe how when telling family members of a COVID-19 death that would have been prevented with a vaccination, "They cry. And they tell me they didn't know. They thought it was a hoax. They thought it was political... They thought it was 'just the flu."

Regardless of vaccination status, 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 / Norfolk locations. We also offer telemedicine for residents of Virginia and North Carolina!