The U.S. Food and Drug Administration's Antimicrobial Drugs Advisory Committee voted on Thursday in favor of approving a new respiratory syncytial virus treatment for infants. File Photo by Cheryl Holt
June 8 (UPI) -- The U.S. Food and Drug Administration's Antimicrobial Drugs Advisory Committee voted on Thursday in favor of approving a new respiratory syncytial virus treatment for infants.
The committee voted unanimously in favor of the recommendation by a count of 21 to 0.
The AADAC is independent, but the FAA normally follows its recommendations.
Also called human respiratory syncytial virus, RSV is a common and contagious virus that affects the respiratory tract.
The RSV treatment comes after cases of the virus spiked last winter.
The panel also voted 19-2 to recommend a second dose of the treatment to children up to age two that are prone to severe infections.
The monoclonal antibody drug was developed by AstraZeneca, partnered with Sanofi. It already is approved for use in Canada, Britain and the rest of Europe.
While not common, the virus can cause severe complications in adults, as well.
In the fall, health experts said they were seeing an increase in RSV cases as the COVID-19 pandemic subsided.
"There is good immune-based data, there's good safety data and there's good efficacy data that shows that the product will prevent a significant number of cases of RSV lower respiratory tract disease," panel member Mary Anne Jackson, dean of the University of Missouri-Kansas City School of Medicine, told the committee before voting yes on Thursday.
Clinical data from a study of almost 1,500 infants shows the single-treatment lowers the risk of developing the disease to the point where a doctor's visit is required, by 75%.
At the end of May, the FDA approved a second dose of Pfizer's RSV vaccine for people over the age of 60.