FDA approval for Emergency Use Authorization of second booster dose of COVID-19 Vaccine, mRNA-1273.
Moderna, Inc. announced hat it has received approval from the FDA for its amendment to the emergency use authorization (EUA) to allow for a second booster dose of its COVID-19 vaccine (mRNA-1273) at the 50 µg dose level in adults 50 years of age and older who have received an initial booster of any of the authorized or approved COVID-19 vaccines and adults 18 years of age and older with certain kinds of immunocompromise.
Data continue to show that mRNA boosters remain the best defense against severe infection and death, and vaccines are a foundational part of our public health protection. Now, healthcare providers have the opportunity to advise higher-risk people about when and how to get boosted and build immunity in advance of future outbreaks.
The application to amend the EUA has been based on published data from Israel indicating the safety and effectiveness of administering a fourth dose of mRNA vaccine during the Omicron variant surge.
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