Moderna seeks full US approval for COVID-19 shot
Moderna said Tuesday it was applying for full approval in the United States of its COVID-19 vaccine for people aged 18 and over, joining Pfizer which made the same request last month.
The vaccine has been available since December 18, 2020 under an "emergency use authorization" intended to make life-saving medications available as fast as possible.
More than 124 million doses of the vaccine have been administered in the US.
"We are pleased to announce this important step in the US regulatory process for a Biologics License Application (BLA) of our COVID-19 vaccine," said Stephane Bancel, the company's CEO.
"We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission."
Last week Moderna announced its vaccine was highly effective in adolescents and it would seek authorization among 12-to-17-year-olds soon.
The two-shot regime is around 90 percent effective against symptomatic COVID-19 and 95 percent effective against severe disease.
© 2021 AFP