Moderna submits amendment to USFDA for its COVID-19 vaccine booster dose
The U.S. FDA approved the Biologics License Application (BLA) for SPIKEVAX (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 18 years of age and older on January 31, 2022.
Cambridge: Moderna, Inc. , a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has submitted a request to the U.S. Food and Drug Administration (FDA) for an amendment to the emergency use authorization (EUA) to allow for a fourth 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. 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 (CDC) and healthcare providers to determine the appropriate use of an additional booster dose of mRNA-1273, including for those at higher risk of COVID-19 due to age or comorbidities. This submission is based in part on recently published data generated in the United States and Israel following the emergence of Omicron.
The U.S. FDA approved the Biologics License Application (BLA) for SPIKEVAX (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 18 years of age and older on January 31, 2022. Moderna's COVID-19 vaccine was previously available under EUA in the U.S. from December 18, 2020. A booster dose of the Moderna COVID-19 vaccine at the 50 µg dose level is authorized for emergency use in the U.S. under EUA for adults 18 years and older. A third dose of the Moderna COVID-19 vaccine at the 100 µg dose level is authorized for emergency use in immunocompromised individuals 18 years of age or older in the United States who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
Moderna continues to collect and monitor real-world data on its COVID-19 vaccine. Real-world evidence continues to confirm the effectiveness and robust safety profile of the Moderna COVID-19 vaccine. Clinical trials are ongoing for Moderna's Omicron-specific booster (mRNA-1273.529) and a bivalent Omicron-specific booster.
SPIKEVAX (COVID-19 Vaccine, mRNA) is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.
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