Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced the US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Spikevax (Covid-19 Vaccine, mRNA) to prevent Covid-19 in individuals 18 years of age and older.
"Our Covid-19 vaccine has been administered to hundreds of millions of people around the world, protecting people from Covid-19 infection, hospitalization and death. The totality of real-world data and the full BLA for Spikevax in the United States reaffirms the importance of vaccination against this virus. This is a momentous milestone in Moderna's history as it is our first product to achieve licensure in the US," said St