The FDA approved Moderna's new mRNA RSV vaccine, bypassing its independent vaccine advisory committee, which typically offers recommendations for such drugs.
The mRNA respiratory syncytial virus (RSV) vaccine from Moderna was licensed by the U.S. Food and Drug Administration (FDA) last week for people 60 years of age and above.
As stated in its approval letter, the FDA approved the drug without consulting its independent vaccine advisory committee, which normally offers recommendations regarding such drugs. This was because the FDA did not view any "concerns or controversial issues" that would require consultation during the approval process.
For its new mRNA RSV medication, Moderna is conducting at least 11 clinical trials on a variety of various patient demographics, such as young children, adolescents, and healthy adults.
The vaccine is Moderna's second-ever FDA-approved medication, and it is sold under the brand name mResvia. Its COVID-19 Spikevax vaccination mak...