The US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Moderna’s Spikevax, an mRNA vaccine for prevention of 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, hospitalisation 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 Stéphane Bancel, Chief Executive Officer of Moderna. “The full licensure of Spikevax in the US now joins that in Canada, Japan, the European Union, the UK, Israel, and other countries, where the adolescent indication is also approved. We are grateful to the US FDA for their thorough review of our application. We are humbled by the role that Spikevax is playing to help end this pandemic.”