3 min
Updated: Aug 23, 2021
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.
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.
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.
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."
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