Moderna said Tuesday it was requesting full approval in the United States of its COVID-19 vaccine for people over the age of 18, joining Pfizer, which made the same application last month.
He vaccine it is available from 18 December 2020 under an “emergency use authorization” aimed at making life-saving medicines available as quickly as possible.
More than 124 million doses of the vaccine have been administered in the United States.
“We are pleased to announce this important step in the US regulatory process for an organic product license (BLA) application for our COVID-19 vaccine, ”said Stephane Bancel, general manager of the company.
“We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the ongoing submission.”
Last week, Moderna announced that its vaccine was very effective in adolescents and that it would soon seek authorization from 12- to 17-year-olds.
The two-shot regimen is about 90 percent effective against symptomatic COVID-19 and 95 percent against severe disease.
© 2021 AFP
Citation: Moderna seeks full US approval for COVID-19 (2021, June 1) retrieved June 1, 2021 from https://medicalxpress.com/news/2021-06-moderna-full-covid -shot.html
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