Advisers to the Food and Drug Administration have thrown their support behind an experimental flu shot from Moderna, heightening the chance that the vaccine could soon complete a dramatic regulatory turnaround.
By a unanimous, 9-0 vote, panelists concluded that the benefits of vaccination with Moderna’s mRNA-1010 outweigh the risks in adults between 50 and 64 years of age. Panelists separately all voted that the shot appeared similarly beneficial for adults aged 65 and older. Moderna is seeking standard approval for mRNA-1010 in the former group and an accelerated approval in the latter. A decision is expected by Aug. 5.
"The studies that were presented today were very well conducted. They have very clear results that are very robust," said Flor Munoz-Rivas, a panelist and associate professor of pediatrics and infectious disease at Baylor College of Medicine. Should the FDA approve Moderna's shot, the U.S. will be "better prepared for emerging strains or pandemic strains in the future."
“The data were very convincing," added Stanley Perlman, a pediatric disease expert at the University of Iowa. "Putting it all together, the benefits outweigh the problems, the risks, in my opinion"
The FDA does not always follow its panelists' advice, but it typically does.
