It's a question many are asking as coronavirus vaccinations continue across the U.S.: are the COVID vaccines FDA approved?
The Food and Drug Administration on Monday granted Pfizer and BioNTech full U.S. approval of their COVID-19 vaccine – becoming the first in the U.S. to win the coveted designation.
So what does that mean? Here's a breakdown.
A look at the latest guidance from the FDA
Up until now, Pfizer's mRNA vaccine was on the U.S. market under an Emergency Use Authorization, which was granted by the FDA in December.
The companies submitted a Biologics License Application to the FDA on May 7 for patients age 16 and up. That application was approved Monday.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, 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,” Acting FDA Commissioner Dr. Janet Woodcock said in a statement.
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What about those under the age of 16?
The vaccine is also still available under emergency use authorization (EUA) for younger people ages 12 through 15 and for a third booster dose in those with compromised immune systems, the FDA said.
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While Pfizer is currently the only vaccine to be fully approved, it is also the only vaccine authorized for emergency use in adolescents between the ages of 12 and 17, though Moderna filed for such approval earlier this year.
Emergency use authorization allows a vaccine to become available prior to full approval in the case of public health emergencies. The FDA can revoke the EUA at any time.
"The vaccines met FDA’s rigorous scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization," the Centers for Disease Control and Prevention states on its website.
What about other vaccines?
Moderna's two-shot and Johnson & Johnson's single-shot vaccines continue to be available under an emergency use authorization as well.
Moderna also announced in June that it had begun a “rolling submission” to the FDA of data from its studies of the two-dose mRNA vaccine.
“We are pleased to announce this important step in the U.S. regulatory process for a Biologics License Application (BLA) of our COVID-19 vaccine,” Moderna CEO Stephane Bancel said in a press release at the time. “We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission.”
Large-scale studies of the shots continued after Moderna’s emergency authorization. The FDA will scrutinize the information to see if the vaccine meets stringent criteria for full licensure.
What is required to get full FDA approval?
Standard vaccine reviews generally take several months to a year or more to determine whether they are safe and effective for use in the general public.
FDA approval of a drug, which requires a rigorous and structured process, means that data on the drug’s effects have been reviewed by the Center for Drug Evaluation and Research, which rules on whether the drug's provided benefits "outweigh its known and potential risks for the intended population," according to the agency's website.
Chicago's top doctor said timing is one of the largest factors in getting full approval.
"The difference between authorization and approval, does not have anything to do with new studies or changes, it has to do with making sure that people have been followed for a long enough time," Chicago Department of Public Health Commissioner Dr. Allison Arwady said last month.
Before granting full approval, FDA scientists must painstakingly look through the companies' clinical trial data, including for any discrepancies or safety concerns, said Dr. Paul Offit, a voting member of the agency's Vaccines and Related Biological Products Advisory Committee.
Arwady echoed those comment.
"To be able to get the full approval, the companies had to be able to submit longer-term data on the safety of the vaccine," Arwady said. "And so after they were able to complete, for example, six months that everybody in these trials had completed six months of follow-up, there had not been any other safety concerns - that met that timeline for follow-up. Also, the FDA does extra looks at all of the vaccine manufacturing processes, and really all steps of the vaccine process - the same thing that we do for any other vaccine."
What can happen now that a vaccine is approved?
U.S. approval is likely to spur a new wave of vaccine mandates from corporate America. Major companies already told some or all of their employees that they must get fully vaccinated against COVID this fall. Still, some private businesses may have felt hesitant about requiring the shots, before full approval.
Full approval is also very beneficial to companies that submit an application, former FDA Commissioner Dr. Robert Califf said in a phone interview in May.
With it, Pfizer and BioNTech are now able to market the shots directly to U.S. consumers. Companies can't promote their products under an EUA.
"Once it has the full approval, you may start seeing more advertisements with direct marketing," Arwady said.
It also allows the shot to stay on the market once the pandemic is over and the U.S. is no longer considered in an "emergency."
Pfizer and BioNTech have said they expect to generate billions from the vaccine. Under full approval, the companies could also decide to charge more for the vaccines, health experts say.
What's next?
Pfizer and BioNTech also plan to ask the FDA to approve a third dose as a booster shot following full approval. Last week, the Biden administration said it was preparing to offer booster shots to all eligible Americans beginning the week of Sept. 20.
