Full FDA approval for COVID 19 vaccine Spikevax

US mRNA vaccines specialist Moderna (Nasdaq: MRNA) saw its share close up more than 6% on Monday, and up a further 2.2% to $173.00 pre-market today, as it revealed that the US Food and Drug Administration has approved its Biologics License Application (BLA) for Spikevax (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 18 years of age and older.

Spikevax was approved by the FDA in December 2020 for emergency use and is the second COVI19 vaccine to gain full clearance, adding to the full approval of Pfizer (NYSE: PFE) and BioNTech’s (Nasdaq: BNTX) Comirnaty in August last year. Spikevax generated sales of $10.7 billion in the first nine months of 2021.

"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 rearms 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 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,"