RSV produces symptoms similar to a cold and can lead to death for young children and older adults
Moderna Inc. announced on Tuesday that a late-stage trial found that its experimental messenger RNA vaccine for respiratory syncytial virus was 83.7% effective in preventing at least two symptoms in adults ages 60 and older.
RSV produces symptoms similar to a cold and can lead to death for young children and older adults. It results in about 14,000 deaths per year in adults who are at least 65 years old. RSV, the flu, and coronavirus all soared in the U.S. and Europe this fall.
There is no vaccine for adults currently on the market, but Moderna, Pfizer Inc., and GSK Plc. are each looking to be the first to release their RSV vaccines.
Pfizer and GSK filed applications for U.S. regulatory approval at the end of last year. Pfizer’s RSV vaccine was reported to be 66.7% effective against two or more symptoms in late-stage trials.
Meanwhile, Sanofi and partner AstraZeneca Plc’s antibody treatment Nirsevimab has received marketing approval from the European Commission for the prevention of RSV in newborns and infants. It is currently under review by the U.S. Food and Drug Administration.
Moderna said it plans to submit its vaccine, mRNA-1345, for regulatory approval consideration globally in the first half of this year. Company president Stephen Hoge said its vaccine compares favorably to the experimental Pfizer and GSK shots.
“It’s very exciting to see progress in RSV vaccines in older adults, and I think both of those vaccines have shown pretty remarkable results as well,” he said. “We really think we’re in that top class – 84% is a terrific efficacy number.”
According to Cowen analyst Tyler Van Buren, The RSV vaccine market could be worth more than $10 billion globally, and half of that would come from the U.S.
Moderna’s study included about 37,000 participants ages 60 years and older. The data analysis was performed after 64 participants became infected with RSV. Moderna said it intends to release the complete data at a medical meeting.
Hoge said the company began a secondary analysis of the vaccine’s efficacy against more severe disease and hospitalization and that it was too early to give a potential price range for the vaccine. The vaccine is expected to be administered on an annual basis.
The vaccine was generally found safe, with the most common side effects being injection-site pain, fatigue and headache. Hoge said the company had no concerns about myocarditis, a type of heart inflammation linked to mRNA COVID vaccines.
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