Moderna's COVID-19 Vaccine Becomes Second To Score Complete FDA Approval

The FDA has given complete approval to Moderna Inc's MRNA COVID-19 vaccine, dubbed Spikevax, to prevent COVID-19 in individuals 18 years of age and older.

• "The full licensure of Spikevax in the U.S. now joins that in Canada, Japan, the European Union, the UK, Israel, and other countries, where the adolescent indication is also approved," said Stéphane Bancel, Chief Executive Officer.
• The FDA based its decision on the totality of scientific evidence shared by the Company in its submission package, which included follow-up data from the Phase 3 COVE study showing high efficacy and favorable safety approximately six months after the second dose. 
• Related: After Pfizer, Moderna Kickstarts Omicron-Targeted COVID-19 Vaccine Trial.
• Moderna also submitted manufacturing and facilities data required by the FDA for licensure.
• Moderna's COVID-19 vaccine was available under Emergency Use Authorization (EUA) in the U.S. from December 18, 2020. 
• A booster dose of the Moderna COVID-19 vaccine at the 50 µg dose level is authorized for emergency use in the U.S. under EUA for adults 18 years and older. 
• A third dose of the Moderna COVID-19 vaccine at the 100 µg dose level is authorized for emergency use in immunocompromised individuals 18 years of age or older in the U.S. who have undergone solid organ transplantation.
• Price Action: MRNA shares are up 2.50% at $163.46 during the market session on the last check Monday.