Moderna Files for Full US Approval of COVID-19 Vaccine

Moderna Inc on Tuesday filed for full U.S. approval of its COVID-19 vaccine for adults, the second drugmaker to do so after Pfizer Inc and its German partner BioNTech sought full clearance for their vaccine last month.

The U.S. Food and Drug Administration's emergency use authorization (EUA) allowed use of the vaccines during the pandemic, based on a minimum number of infections among the trial population and two months of safety data for vaccine recipients.

Full approval for the vaccines, based on six months of trial data, could be an important step in allaying vaccine hesitancy in the United States and other nations.

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 infection.

Moderna said on Tuesday it will continue to submit data to the FDA on a rolling basis over the coming weeks on its vaccine, authorized for 18-year-olds and above, 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.

The company has an agreement with the U.S. government to supply 300 million doses of its COVID-19 vaccine, authorized or approved for use in more than 40 countries.

Over 151 million doses of the vaccine have been distributed in 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.

Moderna in late May said its vaccine was found to be safe and effective in adolescents aged 12 to 17, and plans to request for emergency use authorization for the age group in early June.