FDA Approves Pfizer Vaccine

Alexandra Spath

The U.S. Food and Drug Administration (FDA) has issued full federal approval to the Pfizer-BioNTech COVID-19 Vaccine for those 16 years and older. 

The vaccine, which will now be marketed under the name Comirnaty, is still available under emergency use authorization for individuals ages 12 through 15 but is not recommended for children under age 12. Trials regarding vaccinating younger children are still underway. 

The approval comes at a time when vaccine hesitancy is proving itself to be an obstacle in the effort to curb the spread of COVID-19 in the United States. According to the CDC’s most recent report, roughly 52% of the U.S. population is fully vaccinated. FDA officials have expressed optimism that the new level of approval for the Pfizer vaccine will motivate unvaccinated Americans to get their shots. 

Acting FDA Commissioner Janet Woodcock, M.D. acknowledged that “while millions of peoplehave already safely received COVID-19 vaccines, we recognize that for some, the FDA approvalof a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts usone step closer to altering the course of this pandemic in the U.S.” 

The approval is also a victory for the administration of President Joe Biden in its efforts to increase the vaccination rate in the U.S. In a statement following the news from the FDA, Biden called on unvaccinated Americans to take action, saying, “if you’re one of the millions of Americans who said that they will not get the shot until it has full and final approval of the FDA, it has now happened. The moment you’ve been waiting for is here. It’s time for you to go get your vaccination and get it today.” 

FDA approval also makes it easier for institutions to mandate vaccinations for employees. School districts, corporations and most notably the Pentagon have announced mandates following the full approval of the Pfizer vaccine. 

The Department of Defense has implemented a vaccine requirement, a decision that will impact 1.4 million service members. Defense Secretary Lloyd J. Austin III issued a memorandum asserting that mandatory vaccination is “necessary to protect the Force and defend the American people.” 

A number of colleges and universities, including Villanova, have implemented vaccine requirements. Public school districts, including New York City, are beginning to do the same for employees.


The FDA and CDC will be conducting ongoing safety monitoring to identify safety concerns and evaluate risks associated with the vaccine.