The U.S. Food and Drug Administration has given its full approval of Pfizer’s COVID-19 vaccine for those 16 and older. Health experts believe this will lead to more people getting vaccinated and more schools and businesses mandating the shots.
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The vaccine from Pfizer and partner BioNTech is the first to go from emergency use authorization to full approval in the United States. Pfizer's vaccine is still under emergency use authorization for those between the ages of 12 and 15.
Some businesses, school districts, and state and local governments have already required employees to be fully vaccinated, and doors may open even wider now that Pfizer got the green light.
“I do believe that once the vaccine is fully approved, that’s gonna give more impetus to some businesses, schools to mandate vaccination,” Dr. Scott Gottlieb, former FDA commissioner and Pfizer board member, said on CBS’ “Face the Nation” on Sunday.
“They’ve been waiting for full approval. They feel they’ll be on stronger legal ground to mandate vaccination in that setting.”
Gottlieb and other health experts are also hopeful the portion of people considered to be vaccine-hesitant, who were waiting for full FDA approval, will now become comfortable and get the vaccine.
There is a significant difference in the amount of information needed to get emergency use authorization versus full FDA approval. A decision for emergency use is based on the best evidence available at the time, and the FDA makes a product available “when there are no adequate, approved and available options.”
When a company applies for a Biologics License Application (BLA) for full approval — which Pfizer and BioNTech initiated on May 7 — FDA officials go over a massive amount of data. The submittal includes information about clinical trial participants up to six months after they received their second dose. There are thorough details about the manufacturing process and the facilities where the vaccine is produced.
“You have a lot more data to review than for an emergency use authorization,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, told The Washington Post earlier this month. “In terms of pages to review the change is an order of magnitude. It’s going from tens of thousands of pages to hundreds of thousands of pages.”
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Full approval means Pfizer is allowed to market its vaccine to the public, and it can remain in the marketplace for an indefinite amount of time. The company can also now give it a name: Comirnaty.
Vaccines and drugs that are granted emergency use authorization can only remain available as long as an emergency is in effect.
Moderna began the process of seeking a BLA about a month after Pfizer did, and so far, a timeline on FDA approval is not clear. Johnson & Johnson is expected to follow suit sometime in the coming months.
The Biden administration is looking to begin the distribution of booster shots the week of Sept. 20, with the expectation that people would get boosters eight months after receiving their second dose of either the Pfizer or Moderna vaccines. Currently, only those who are immunocompromised can get a booster.
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