What did the manufacturer of this vaccine ask the FDA for?

Moderna has applied to the US Food and Drug Administration (FDA) for a change in the marketing authorization (EUA) of its mRNA vaccine against COVID-19. If the Agency agrees, it will be possible to give a fourth dose of the vaccine to people from 18 years of age who have received a first booster dose of any authorized COVID-19 vaccine.

The application for inclusion in adults over 18 years of age was submitted to ensure that the US Centers for Disease Control (CDC) and healthcare providers can determine the appropriate use of an additional mRNA-1273 booster, including those at higher risk of severe COVID-19 due to age or comorbidities. The conclusion is based in part on recently published data in the US and Israel following the advent of the Omikron variant.

The FDA approved a biological drug approval (BLA) application for Moderna mRNA vaccine for subjects 18 years of age and older on January 31, 2022. Previously, the vaccine was available through an Emergency Use Procedure (EUA) from 18 December 2020.

A booster dose of Moderna is approved for use in the United States as an emergency under the EUA in adults 18 years of age and older. The third dose of the vaccine is approved in the US for emergency use in immunocompromised individuals over 18 years of age who have undergone solid organ transplant or who have been diagnosed with diseases considered equivalent to immunodeficiency.

The manufacturer continues to collect and monitor clinical practice data for the COVID-19 vaccine. Real-world evidence continues to support the efficacy and high safety profile of the vaccine. Omikron variant specific booster (mRNA-1273.529) and a bivalent Omikron variant specific booster (mRNA-1273.214) are currently being investigated.

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