Moderna files for full U.S. approval of its Covid-19 vaccine on Tuesday, becoming the second manufacturer to do so. The vaccine is presently only approved for emergency use in the nation.
The news comes only weeks after competitor Pfizer and its German partner BioNTech sought full clearance in the United States for their Covid-19 vaccine.
Full clearance for the vaccines, which are at the vanguard of global vaccination efforts, might be a crucial step in reducing vaccination apprehension, which is becoming a rising worry in the United States and other rich countries.
It would also allow vaccine manufacturers to directly sell their injections, as well as assist businesses and government entities seeking vaccines for their staff.
The FDA would tell the firm when the submission is formally approved for review when it is completed, it said.
The United States government has agreed to buy 300 million doses of Moderna’s Covid-19 vaccine.
According to the US Centers for Disease Control and Prevention, more than 151 million doses of Moderna’s vaccine have been delivered across the country, with around 124.5 million injections delivered as of Monday.
During an emergency, the FDA makes a product available to the public based on the best available evidence, rather than waiting for all of the necessary evidence for complete approval or clearance.
Moderna said in April that six months after participants had their second injection, its vaccine demonstrated substantial protection against the coronavirus, with the effectiveness of more than 90% against all instances of Covid-19 and more than 95% against severe Covid-19.