Moderna completes filing process for full approval of COVID-19 vaccine
August 25, 2021; 10:24 AM EDT
(Reuters) – Moderna Inc (MRNA.O) has completed the real-time review process needed for a full approval for its COVID-19 vaccine in people aged 18 years and above, the company said on Wednesday.
The news comes within days of U.S. regulators granting full approval to Pfizer Inc (PFE.N)/BioNTech SE’s (22UAy.DE) COVID-19 vaccine, developed with the same mRNA technology as Moderna’s.
Messenger RNA (mRNA) vaccines prompt the human body to make a protein that is part of the pathogen, triggering an immune response.
U.S. health officials expect full approval for COVID-19 vaccines will help win over vaccine skeptics and prompt more state and local governments, as well as private employers, to impose vaccine mandates.
A healthcare worker prepares a syringe with the Moderna COVID-19 Vaccine at a pop-up vaccination site operated by SOMOS Community Care during the COVID-19 pandemic in Manhattan in New York City, New York, U.S., January 29, 2021. REUTERS/Mike Segar/File Photo
Moderna’s completed submission includes data from a late-stage study that showed 93% vaccine efficacy, even through six months after administration of the second dose, the company said in a statement.
As part of the submission, Moderna has requested a priority review designation for its vaccine, currently available in the United States for people aged 18 and older under an emergency use authorization (EUA) granted by the FDA in December.
So far, the company has released more than 300 million doses of the vaccine to the U.S. government.
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