The retail industry received another gift on Friday when the Food and Drug Administration granted emergency use authorization for a second COVID-19 vaccine.
Moderna became the second company after Pfizer-BioNTeh to be issued an emergency use authorization for its COVID-19 vaccine. FDA granted the authorization on Dec. 18, following Pfizer’s authorization on Dec. 11.
“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,” said Moderna CEO Stéphane Bancel. “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.”
Moderna said approximately 20 million doses will be delivered 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. Under Operation Warp Speed, the U.S. Department of Defense, in partnership with Health and Human Services and the Centers for Disease Control and Prevention, will manage allocation and distribution of the vaccine in the U.S.
Moderna’s manufacturing capacity for the COVID-19 vaccine is less than that previously shared by Pfizer-BioNTech. Those companies maintained at the time of their authorization that they had the ability to manufacture 50 million doses this year and 1.3 billion doses next year.
Other differences related to efficacy and administration. The Moderna vaccine was 94.1% effective in clinical trials and is administered in two injections one month apart. The Pfizer-BioNTech clinical data showed a 95% efficacy rate for dual injections administered three weeks apart.
A potential single dose vaccine from Johnson & Johnson’s Janssen subsidiary is currently in Phase 3 trial, the final phase before an emergency use authorization could be granted. The company recently said its trial was fully enrolled and it expects to receive interim data on efficacy in January 2021. If the data indicate the vaccine is safe and effective, the company said it would see emergency use authorization from FDA in February.