Moderna Seeks Authorization for Second COVID-19 Booster Shot for Adults

Moderna has submitted a request to the Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of an additional booster dose of its COVID-19 vaccine, mRNA-1273, in adults 18 years of age and older who have received an initial booster of any of the authorized or approved COVID-19 vaccines.

According to Moderna, the EUA submission is “based in part on recently published data generated in the United States (US) and Israel following the emergence of Omicron.” This submission comes shortly after Pfizer and BioNTech submitted an EUA request for an additional booster dose of their COVID-19 vaccine for adults 65 years of age and older who have received an initial booster of any of the authorized or approved COVID-19 vaccines.

The Moderna COVID-19 vaccine is approved under the trade name Spikevax for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. A 50mcg booster dose of the Moderna COVID-19 vaccine is authorized for emergency use for adults 18 years of age and older, and a third dose of 100mcg is under EUA for immunocompromised adults.

The Company is currently investigating its Omicron-specific booster (mRNA-1273.529) and a bivalent Omicron-specific booster (mRNA-1273.214) in ongoing clinical trials.

Reference

Moderna submits amendment to the Emergency Use Authorization for an additional booster dose of its COVID-19 vaccine in the US. News release. Moderna, Inc. Accessed March 18, 2022. https://investors.modernatx.com/news/news-details/2022/Moderna-Submits-Amendment-to-the-Emergency-Use-Authorization-for-an-Additional-Booster-Dose-of-its-COVID-19-Vaccine-in-the-U.S/default.aspx