(Adds background on Sanofi and AstraZeneca treatment for RSV)
By Patrick Wingrove and Leroy Leo
Jan 17 (Reuters) – Moderna Inc said on Tuesday its experimental messenger RNA vaccine for respiratory syncytial virus (RSV) was 83.7 percent effective in an late-stage trial at preventing at least two symptoms, such as cough and fever in older adults. 60 years and over.
RSV, which causes symptoms similar to a cold but can be fatal to young children and older adults, causes about 14,000 deaths annually in adults 65 and older. The disease surged in the United States and Europe this fall along with the flu and COVID-19.
There is currently no vaccine against the virus in adults. Moderna, Pfizer Inc and GSK Plc are racing to get their RSV vaccines to market first.
Pfizer and GSK filed for US regulatory approval late last year. Pfizer’s RSV vaccine was found to be 66.7% effective against two or more symptoms in late-stage trials. On the other hand, the antibody treatment nirsevimab from Sanofi and partner AstraZeneca Plc has obtained marketing authorization from the European Commission for the prevention of RSV in newborns and infants. It is currently under review by the US Food and Drug Administration.
Moderna said it intends to submit its vaccine, mRNA-1345, for consideration for regulatory approval globally in the first half of 2023.
The company’s president, Stephen Hoge, told Reuters that its vaccine appears to compare favorably with experimental injections from Pfizer and GSK.
“It’s very exciting to see the progress of RSV vaccines in older adults, and I think both vaccines have shown pretty remarkable results as well,” Hoge said. “We really think we’re in that upper class — 84% is a fantastic efficiency number.”
According to Cowen analyst Tyler Van Buren, the RSV vaccine market could be worth more than $10 billion globally, half of which would come from the United States.
Moderna’s study was conducted on about 37,000 participants aged 60 and older. Data analysis was performed after 64 participants contracted RSV. The company plans to release the full data at a medical meeting.
Hoge said Moderna had begun secondary analyzes of the vaccine’s effectiveness against more serious illnesses and hospitalization. He said it was too early to provide a potential price range for the vaccine, which he expects to be given annually.
Overall, the vaccine was found to be safe, with the most common side effects including pain at the injection site, fatigue and headache. Hoge said there was no concern about myocarditis, a type of heart inflammation linked to the COVID mRNA vaccines. (Reporting by Patrick Wingrove in New York and Leroy Leo and Mariam E Sunny in Bangalore; Additional reporting by Julie Steenhuysen in Chicago; Editing by Caroline Humer and Bill Berkrot)