FDA Extends EUA Of Moderna's COVID-19 Vaccine Booster To The 50 Mcg Dose Level - Quick Facts

Biotechnology company Moderna, Inc. (MRNA) announced Friday that the U.S. Food and Drug Administration (FDA) has extended the emergency use authorization (EUA) of a booster dose of the Moderna COVID-19 vaccine at the 50 mcg dose level to all adults aged 18 and older.

This booster can be used in all individuals 18 years and older who have completed a primary vaccination with any other authorized or approved COVID-19 vaccine. It can be administered at least six months after completion of any primary series COVID-19 vaccination.

On October 20, the FDA granted EUA to the booster dose of the Moderna COVID-19 vaccine at the 50 mcg dose level for people aged 65 and older as well as adults aged 18 to 64 who are at high risk of severe COVID-19; and people aged 18 to 64 with frequent institutional or occupational exposure to SARS-CoV-2.

The Moderna COVID-19 booster vaccine is authorized for adults ages 18 and above regardless of occupational risk factors in many international markets. This follows the earlier approval of the 100 mcg mRNA 1273 third dose in immunocompromised individuals.

The FDA based this EUA on the totality of scientific evidence shared by the company including a data analysis from the Phase 2 clinical study of mRNA-1273, which was amended to offer a booster dose of mRNA-1273 at the 50 mcg dose level to interested participants 6-8 months following their second dose.

The safety profile following the booster dose was similar to that observed previously for dose 2 of mRNA-1273.

As a next step, the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) will meet to discuss a potential recommendation for rollout of COVID-19 boosters to Americans.

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