Moderna latest to file for EUA of fourth dose of COVID-19 vaccine

18 March 2022

US mRNA specialist Moderna (Nasdaq: MRNA) is the latest to request to the US 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), also dubbed Spikevax, in adults 18 years of age and older who have received an initial booster of any of the authorized or approved COVID-19 vaccines. Spikevax sales of $17.7 billion were reported for full-year 2021.

The US filing comes just days after Comirnaty developers Pfizer (NYSE: PFE) and BioNTech (Nasdaq: BNTX) submitted an application to the US FDA for emergency use as an additional booster dose for their mega-billion dollar selling coronavirus vaccine.

The request to include adults over 18 years of age was made to provide exibility for the US 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.

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