Moderna vaccine gets nod for emergency use in United States
First Published Dec 19, 2020, 8:20 AM IST
Moderna Inc's coronavirus vaccine has received emergency use authorization from the US Food and Drug Administration. Moderna's mRNA-1273 is the second vaccine to be allowed for emergency use against COVID-19 in individuals 18 years of age or older.
Moderna will deliver approximately 20 million doses to the U.S. government by the end of December 2020. The company expects to have between 100 million and 125 million doses available globally in the first quarter of 2021, with 85-100 million of those available in the U.S.
Stéphane Bancel, Chief Executive Officer of Moderna, said: "I want to thank the thousands of participants in our clinical trials and the staff at our clinical trial sites who have been on the front lines of the fight against the virus. I want to thank the NIH and NIAID for their scientific leadership and our partners at BARDA and Operation Warp Speed who have been instrumental to accelerating our progress to this point."
"I am proud of what the Moderna team has achieved in collaboration with our partners. We were able to create and manufacture the Moderna COVID-19 Vaccine in 11 months from sequence to authorization, while advancing clinical development with a Phase 1, Phase 2 and pivotal Phase 3 study of 30,000 participants," Stéphane said.
"It has been a 10-year scientific, entrepreneurial and medical journey and I am thankful to all those who have helped us get here today. We remain focused on scaling up manufacturing to help us protect as many people as we can from this terrible disease," she added.
The primary efficacy analysis conducted on 196 cases indicated a vaccine efficacy rate of 94.1%.