Moderna files for full U.S. approval of COVID-19 vaccine
June 1, 2021; 9:58 AM EDT
(Reuters) – Moderna Inc (MRNA.O) on Tuesday filed for full U.S. approval of its COVID-19 vaccine, becoming the second drugmaker to do so after Pfizer Inc (PFE.N) and its German partner BioNTech sought full clearance for their vaccine last month.
The U.S. Food and Drug Administration’s emergency use approval allowed the health regulator to authorize the vaccines during the pandemic, based on a minimum number of COVID-19 infections among the trial population and two months of safety data for vaccine recipients.
Full approval for the COVID-19 vaccines, which will be based on six months of trial data, could be an important step in allaying vaccine hesitancy in the United States and other wealthy nations.
Moderna said it will continue to submit data to the FDA on a rolling basis over the coming weeks, with a request for a priority review. On completion of the submission, the agency will notify the company when it is formally accepted for review, Moderna added.
Cambridge, Massachusetts-based Moderna has an agreement with the U.S. government to supply 300 million doses of its COVID-19 vaccine, which is authorized or approved for use in more than 40 countries.
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 May 30, according to the U.S. Centers for Disease Control and Prevention.
Over 135 million people or nearly 41% of the total U.S. population has been fully vaccinated as of May 30, according to the CDC data.
Moderna said in April its vaccine showed strong protection against the coronavirus six months after people received their second shot, with efficacy of more than 90% against all cases of COVID-19 and more than 95% against severe COVID-19.
Our Standards: The Thomson Reuters Trust Principles.