On Monday, August 23, 2021, the FDA granted full approval to the Pfizer/BioNTech COVID-19 vaccine for people ages 16 and older.
This marks the very first Coronavirus vaccine to be approved by the FDA in the United States.
A lot of people are hoping that now that the vaccine is officially approved by the FDA, that more people will get it, and fewer people will hesitate to get it out of safety concerns.
The Pfizer/BioNTech vaccine, which is still available under emergency use authorization for individuals ages 12 through 15, has been given to more than 92 million people in the United States.
This is out of 170 million people in the U.S. who are currently fully vaccinated.
According to a statement issued by FDA Acting Commissioner, Dr Janet Woodcock, the fact that this vaccine has received FDA approval can give the public confidence that the vaccine meets the FDA’s gold standards for safety, effectiveness, and manufacturing quality.
The commissioner also called the FDA approval for the COVID vaccine “a pivotal moment” for the United States in their fight against the Covid pandemic.
What About The Emergency Use Vaccine Stock That’s Already On The Shelves?
According to the FDA, health care providers who currently have vaccine stock on the shelves can continue to use it, as the FDA approved vaccine and the emergency use authorized vaccine have the same formulation and can be used interchangeably.
What About Children 12 To 15? Can They Still Get The Vaccine, Even Though It’s Only Approved For Individuals 16 And Older?
Yes, children ages 12 to 15 can still get the vaccine under the emergency use authorization.
Will Vaccine Authorization Pave The Way To More Vaccine Mandates?
According to reports, businesses and universities have been talking a lot about creating vaccine requirements in an effort to create safer spaces for people to work and learn.
And by all accounts, COVID-19 vaccine approval by the FDA paves the way for making it easier for schools, businesses, and other entities to set their own custom vaccination requirements and mandates.
How Does The FDA Know That The Vaccine Is Safe?
According to news reports, the FDA granted the Pfizer/BioNTech vaccine priority review, and even pulled in extra help to speed up final approval.
According to reports, they worked ‘around the clock,’ conducted their own analysis of the vaccine, and did a benefit-risk assessment based on real world data that’s been gathered since the vaccine was granted emergency use authorization.
According to news sources, Moderna has also begun the process of applying for full approval for its COVID-19 vaccine for individuals ages 18 and up.
Johnson & Johnson has not yet filed for full FDA approval for its vaccine.
It’s believed that fast FDA approval will help to combat vaccine hesitancy, which according to experts, has been a stumbling block in helping to reach herd immunity status against the Coronavirus in the United States population.