The vaccine is currently available in the U.S. under an emergency use authorization (EUA) granted by the FDA on December 18, 2020. The BLA is supported by analyses from phase III clinical results, and Moderna will continue to submit data to the FDA to support the BLA on a rolling basis from the phase III trial over the coming weeks with a request for a priority review from the agency.

Thermo, Moderna ink COVID-19 vaccine manufacturing deal
Moderna has signed a deal with Thermo Fisher Scientific to provide manufacturing services and supply packaging for its COVID-19 vaccine.

Moderna vaccine 100% effective for teens
Moderna announced its phase II/III study of its COVID-19 vaccine in adolescents has met its primary immunogenicity endpoint with no cases of COVID-19...

Moderna inks South Korean mRNA vaccine collaborations
Moderna has inked two memoranda of understanding agreements with South Korea for messenger RNA (mRNA) vaccine research and manufacturing in that country.

Japan approves Moderna COVID-19 vaccine
Japan's Ministry of Health, Labour, and Welfare recently approved Moderna's COVID-19 vaccine, and distribution in the country by Takeda will begin immediately.

Moderna booster produces antibodies against SARS-CoV-2 variants
Moderna announced that initial results from a phase II study suggest a single booster dose of its messenger RNA (mRNA) vaccine candidates mRNA-1273 or...