Moderna officially seeking FDA approval for its COVID-19 vaccine
FILE – In this Dec. 29, 2020, file photo, Pat Moore, with the Chester County, Pa., Health Department, fills a syringe with Moderna COVID-19 vaccine before administering it to emergency medical workers and health care personnel at the Chester County Government Services Center in West Chester, Pa. Moderna says its COVID-19 vaccine strongly protects kids as young as 12. The company released the preliminary findings Tuesday, May 25, 2021, based on testing on more than 3,700 12- to 17-year-olds in the United States. (AP Photo/Matt Slocum, File)
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(NewsNation Now) — Moderna announced Tuesday it has officially filed for full approval from the U.S. Food and Drug Administration for its two-dose COVID-19 vaccine.
The vaccine is currently only authorized for emergency use in the United States. Full approval would signal the FDA’s full confidence in the vaccine and would be granted based on more data. Moderna said in a press release it will continue to submit data to the FDA on a rolling basis over the coming weeks with a request for a priority review.
The development comes just weeks after Pfizer and BioNTech sought full approval for their COVID-19 vaccine in the United States.
Moderna has an agreement with the government to supply 300 million doses of its COVID-19 vaccine.
More than 151 million doses of Moderna’s vaccine have been distributed around the United States, with roughly 124.5 million shots administered as of Monday, according to the Centers for Disease Control and Prevention.
Moderna said in April its vaccine showed strong protection against the coronavirus six months after people received their second shot, with the efficacy of more than 90% against all cases of COVID-19 and more than 95 percent against severe COVID-19.
Under an emergency use authorization, the FDA makes a product available to the public during an emergency based on the best available evidence, without waiting for all the evidence needed for full approval or clearance.
Full approval for the vaccines, which are at the forefront of global immunization efforts, could be an important step in allaying vaccine hesitancy, a growing concern in the United States and other wealthy nations.
The FDA previously authorized changes to Moderna’s vaccine to provide extra doses from each vial. The agency said it approved new vials from Moderna that can contain up to 15 doses each, compared with the original vials designed to hold 10 doses. Additionally, regulators said providers can safely extract up to 11 doses from the original 10-dose vials. Those changes will be added to instructions for health care workers.
