Moderna Files for Full U.S. Approval of COVID-19 Vaccine

Moderna Inc. on Tuesday filed for full U.S. approval of its COVID-19 vaccine, which is currently only authorized for emergency use in the country, becoming the second drugmaker to seek a broader regulatory nod.

The development comes weeks after rival Pfizer Inc. and its German partner BioNTech SE sought full approval for their COVID-19 vaccine in the United States.

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.

It would also allow the vaccine makers to market their shots directly, as well as help companies and government agencies looking for vaccinations for their employees.

Moderna said it will continue to submit data to the U.S. Food and Drug Administration on a rolling basis over the coming weeks with a request for a priority review.

On completion of the submission, the FDA will notify the company when it is formally accepted for review, it added.

Moderna has an agreement with the U.S. 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 U.S. Centers for Disease Control and Prevention.

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.

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.