COVID vaccine

COVID Vaccine FDA Approval: Here's How the Process Works

Currently, no coronavirus vaccine is fully approved by the FDA, but three were given emergency use authorization by the agency

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News that Moderna is seeking emergency use authorization of its COVID vaccine for teens and adolescents has led to some questions surrounding the approval process for coronavirus vaccines this week.

Currently, no coronavirus vaccine is fully approved by the U.S. Food and Drug Administration, but three were given emergency use authorization by the agency.

They include vaccines from Pfizer-BioNTech, Moderna and Johnson & Johnson.

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.

Pfizer is currently the only vaccine authorized for emergency use in adolescents between the ages of 12 and 17, though Moderna filed for such approval on Thursday.

So far, Moderna and Pfizer have both filed for full FDA approval, however.

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.

Moderna announced earlier this month 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. “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.

Once they gets full approval, Moderna and Pfizer can begin marketing the shots directly to consumers and selling them to individuals and private companies in the U.S.

NBC Chicago/Associated Press
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