Moderna requests FDA to authorize second Covid-19 booster shot for adults

Moderna submitted a request to the US Food and Drug Administration (FDA) for emergency use authorization on a fourth dose of its COVID-19 vaccine for adults 18 years of age and older

American biotechnology company Moderna submitted a request to the U.S. Food and Drug Administration (FDA) on Thursday for emergency use authorization (EUA) on a fourth dose of its COVID-19 vaccine for adults 18 years of age and older, who already received a booster dose of any approved or authorized shot.

The request to include adults over 18 years of age was made to provide flexibility for the U.S. Centers for Disease Control and Prevention and healthcare providers to "determine the appropriate use of an additional booster dose," including for those at higher risk of COVID-19 due to age or comorbidities, said the company in a statement.

 

Currently, a booster dose of the Moderna COVID-19 vaccine at the 50 microgram dose level is authorized by the FDA for emergency use in the United States for adults 18 years and older.

Moderna said it continues to collect and monitor real-world data on its COVID-19 vaccine. Clinical trials are ongoing for Moderna's Omicron-specific booster and a bivalent Omicron-specific booster.