FDA authorizes emergency use of Moderna booster in individuals 18 and older

FDA has extended the emergency use authorization (EUA) of a booster dose of the Moderna Covid-19 vaccine at the 50-µg dose level to all adults 18 and older. This booster can be used in everyone 18 years and older who has completed a primary vaccination with any other authorized or approved Covid vaccine.

“This emergency use authorization comes at a critical time as we enter the winter months and face increasing Covid-19 case counts and hospitalizations across the country,” says Stéphane Bancel, Moderna’s CEO. “We thank the FDA for their review, and are confident in the robust clinical evidence that a 50 µg booster dose of mRNA-1273 induces a strong immune response against Covid-19.”

The booster is to be administered at least six months after completion of any primary series Covid-19 vaccination. On Oct. 20, FDA authorized an EUA for a booster dose of the Moderna vaccine at the same dosage level for people aged 65 and older, adults 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.