A panel of outside advisers to the United States Food and Drug Administration on Thursday overwhelmingly endorsed emergency use of Moderna Inc’s coronavirus vaccine, virtually assuring a second option for protecting against COVID-19 for a pandemic ravaged nation.
The committee voted 20-0 with one abstention that the benefits of the vaccine outweigh its risks in people aged 18 and older, one week after the same panel backed a similar vaccine from Pfizer Inc and German partner BioNTech SE, leading to an FDA emergency use authorization (EUA) a day later.
The FDA is expected to grant the EUA as early as late Thursday or Friday, providing another ray of hope to a nation that has lost more than 300,000 lives to COVID-19 - including a one-day high of 3,580 deaths on Wednesday - while record numbers of patients threaten to overwhelm U.S. hospitals and healthcare workers.
“To go from having a (genetic) sequence of a virus in January to having two vaccines available in December is a remarkable achievement,” said Dr. James Hildreth, chief executive of Meharry Medical College, who voted to recommend the vaccine for emergency use. The one abstention came from Dr. Michael Kurilla, who works at the National Institutes of Health and felt blanket authorization for those 18 and older was too broad.
“I’m not convinced that for all of those age groups the benefits do actually outweigh the risk. And I would prefer to see it more targeted towards people at high risk of serious and life threatening COVID disease,” he said.
The Moderna vaccine is set to begin distribution as soon as the FDA gives the green light. Health and Human Services Secretary Alex Azar told CNBC on Thursday that 5.9 million doses have been allotted for states and large cities and were ready to ship nationwide.