On Thursday, the U.S. Food and Drug Administration’s Antimicrobial Drugs Advisory Committee unanimously voted in favor of approving a new respiratory syncytial virus (RSV) treatment for infants. The committee voted 21 to 0 in favor of the recommendation. RSV, also known as human respiratory syncytial virus, is a common and contagious virus that affects the respiratory tract. Last winter, cases of the virus significantly spiked, leading to the development of the monoclonal antibody drug, developed by AstraZeneca in partnership with Sanofi, which is already approved for use in Canada, Britain, and the rest of Europe.
The panel also recommended a second dose of the treatment to children up to age two that are prone to severe infections, voting in favor of the recommendation 19-2. The drug has good safety data and efficacy data which shows that it will prevent a significant number of RSV lower respiratory tract disease cases. Mary Anne Jackson, dean of the University of Missouri-Kansas City School of Medicine and a panel member, said, “There is good immune-based data… the product will prevent a significant number of cases of RSV lower respiratory tract disease.”
Clinical data shows that the single treatment decreases the risk of developing the disease to the point where a doctor’s visit is required by 75%, based on a study of almost 1,500 infants. The FDA approved a second dose of Pfizer’s RSV vaccine for people over the age of 60 at the end of May. Although rare in adults, the virus can cause severe complications. Health experts noted an increase in RSV cases in the fall as the COVID-19 pandemic subsided.
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