Moderna, an American biotechnology company, submitted an emergency use authorization (EUA) request to the US Food and Drug Administration (FDA) on Thursday for a fourth dose of its COVID-19 vaccine for adults 18 years and older who have already received a booster dose of any approved or authorised shot.
According to the company, the request to include adults over the age of 18 was made to give the US Centers for Disease Control and Prevention and healthcare providers more flexibility in “determining the appropriate use of an additional booster dose,” including for those at higher risk of COVID-19 due to age or comorbidities.
The FDA has approved a booster dose of the Moderna COVID-19 vaccine at a 50 microgram dosage level for emergency use in people 18 and older in the United States.
Moderna stated that real-world data on their COVID-19 vaccine is still being collected and monitored. Moderna’s Omicron-specific booster and a bivalent Omicron-specific booster are now undergoing clinical studies.