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Moderna asks FDA’s approval for the 4th Dose Covid-19 Vaccine

Moderna 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 exibility 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 company said.

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 said.
Moderna noted that it continues to collect and monitor real-world data on its COVID-19 vaccine. Real-world evidence continues to confirm the effectiveness and robust safety prole 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 (mRNA1273.214).

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