Moderna’s COVID-19 vaccine receives emergency approval from FDA
pharmafile | December 21, 2020 | News story | Sales and Marketing | COVID-19, FDA, Moderna, US, Vaccine
Moderna has announced that the FDA yesterday authorised the emergency use of mRNA-1273, the biotechnology company’s vaccine against COVID-19 in individuals 18 years of age or older.
Under Operation Warp Speed, the Department of Defense, in partnership with the Department of Health and Human Services and the US Centers for Disease Control and Prevention (CDC), will manage allocation and distribution of the vaccine in the United States. Allocation and distribution will be prioritised according to populations identified by the CDC’s Advisory Committee on Immunization Practices.
Approximately 20 million doses will be delivered to the US government by the end of December, and Moderna expects to have between 100 million and 125 million doses available globally in the first quarter of next year – with 85-100 million of those available in the US.
The approval comes just a week after the US reached the grim milestone of 300,000 coronavirus-related deaths.
The FDA based its recommendation on the scientific evidence shared by the company, including a data analysis from the pivotal Phase III clinical study announced on November 30. The primary efficacy analysis conducted on 196 cases indicated a vaccine efficacy rate of 94.1%.
Stéphane Bancel, Chief Executive Officer of Moderna, said: “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 authorisation, while advancing clinical development with a Phase I, Phase II and pivotal Phase III study of 30,000 participants.
“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.”
Darcy Jimenez
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