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The Food and Drug Administration gave its full approval for the Pfizer-BioNTech COVID-19 vaccine on Monday (August 23). It’s the first fully approved vaccine against the deadly virus since the pandemic began over a year ago.
While other COVID-19 vaccines still have emergency authorized use, of the two-dose Pfizer vaccine, the FDA says “the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” NPR reported.
So what does all of this mean for you?
Here, we’ll break down what the full approval process entails and what changes the full approval could bring about for us.
How the FDA Approves A Drug
In December 2020, the FDA permitted the emergency use of the Pfizer vaccine. In May 2021, the company applied for full approval, starting a lengthy process carried out by the FDA.
To fully approve a drug, the FDA reviews its benefits and risks while also looking at clinical trial data from the company.
Most of that work was already done because of the emergency use authorization. But the FDA didn’t have a key piece of data to give its final full approval: how people reacted six months after getting the vaccine.
With that data and facilities inspections, and other steps, the agency could give full approval for people 16 years old and over. For people between the ages of 12 and 15, the vaccine is still under emergency use authorization.
Pfizer also gets to officially brand its vaccine. They chose Comirnaty.
Kids, Schools, Employees
Kids under 12 years old should still not be vaccinated, health officials warn. Clinical trials in children are still underway and experts are cautioning not to get children under 12 vaccinated until the FDA clears them.
As far as vaccine requirements in schools and workplaces, officials say to prepare to see more mandates come down.
The Defense Department already announced all service members will be required to get vaccinated. Other government offices issued similar requirements even before the FDA gave full approval.
We could also see more universities requiring vaccines for students, staff and faculty, which isn’t new. Most colleges require meningitis vaccines for adults over 18 on campus.
NYC and New Jersey have implemented vaccine mandates for teachers and state employees as well.
Vaccine requirements at work may also be coming in the near future, if they haven’t been announced already.
What It Means For Daily Life
Carrying around recent negative COVID-19 test results or a vaccine card to prove your COVID-19 protection status might become a part of daily living depending on where you live.
In New Orleans, the city put a proof of vaccine requirement in place, meaning to visit restaurants and bars, you'd need your ID and vaccine card. Low vaccination rates and a surge in new cases around Louisiana prompted the requirement which is similar to NYC's vaccine pass program being rolled out to access gyms, eateries, movie theaters and more.
To learn more about the vaccine and COVID-19, please click here.
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