News that Moderna is seeking full approval of its COVID vaccine by the U.S. Food and Drug Administration has led to some questions surrounding the approval process for the coronavirus vaccines this week.
Currently, no coronavirus vaccine is fully approved by the FDA, 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.
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"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.
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 Tuesday it has begun a “rolling submission” to the FDA of data from its studies of the two-dose mRNA vaccine.
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“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 it gets full approval, Moderna can begin marketing the shots directly to consumers and selling them to individuals and private companies in the U.S.
Moderna is the second COVID-19 vaccine maker to seek full approval, following Pfizer and German partner BioNTech.
Last week, Moderna also announced that its vaccine appears safe and effective in kids as young as 12. The company plans to seek emergency authorization for teen use this month.
