That marks the first full approval for a COVID-19 vaccine in the U.S., and might pave the way for more vaccine mandates and ease concerns of those who are unvaccinated.
More than 170 million people in the U.S. have already been vaccinated with COVID-19 vaccines in the U.S. under what’s known as an emergency use authorizations, a fast-tracked approval for medical products to be used under emergency scenarios, such as a pandemic.
To be granted emergency approvals, the vaccines had to meet a high bar. Moderna, Johnson & Johnson and Pfizer-BioNTech had to submit thorough data and prove that they were highly safe and effective at protecting against COVID-19 before they were granted emergency approval. Trial participants were followed for 2 months after vaccination, to ensure there were no side effects.
Pfizer-BioNTech was the first COVID-19 vaccine to be granted an emergency use authorization in December 2020. Under the emergency approval, more than 92 million people in the U.S. have been fully vaccinated with the Pfizer-BioNTech vaccine, according to the Centers for Disease Control and Prevention (CDC).
To meet full approval, the companies have to submit a “biologics license application” that includes at least 6 months of post-vaccination followup on clinical trial participants, more details of the manufacturing process, vaccine manufacturing site inspections and quality tests of samples of the vaccine.
“We evaluated scientific data and information included in hundreds of thousands of pages,” conducted their own safety and effectiveness analysis and performed a detailed assessment of manufacturing facilities, Dr. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, said in a statement on Monday.
Experts think a full approval might help ease the concerns of some people who were vaccine hesitant.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” Dr. Janet Woodcock, acting commissioner of the FDA, said in the statement.”While millions of people have already safely received Covid-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated.”
What’s more, full approval could lead to more vaccination mandates, as many businesses were waiting for full approval before requiring their employees to be vaccinated, according to NBC News.
The full approval for Pfizer-BioNTech includes people 16 years of age or older, but children ages 12 to 15 can still receive the vaccine under emergency authorization. Moderna has also applied for full approval, but Johnson & Johnson has not yet applied (both have emergency use authorizations), according to NBC News.
The Pfizer-BioNTech vaccine will now be marketed as Comirnaty.