Moderna requests FDA to authorise second COVID-19 booster shot for adults

Washington: American biotechnology company Moderna submitted a request to the US Food and Drug Administration (FDA) on Thursday for emergency use authorisation (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 authorised shot.

The request to include adults over 18 years of age was made to provide flexibility for the US 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.