The Food and Drug Administration on Monday approved a shot to protect infants and vulnerable young children against respiratory syncytial virus, or RSV, offering one of the first defenses to an illness that fills children’s hospitals year after year.
The monoclonal antibody shot is expected to be available at the start of the fall RSV season. The FDA is also considering Pfizer’s approval of an RSV vaccine for pregnant women that is intended to protect infants from the virus.
The treatment approved Monday, called Beyfortus by its developers Sanofi and AstraZeneca, addresses a potentially serious illness in older adults and young infants. About 80,000 children age 5 and younger are hospitalized with the virus each year, according to the Centers for Disease Control and Prevention.
“RSV can cause serious disease in infants and some children and results in a large number of visits to emergency departments and physician offices each year,” said Dr. John Farley, an official in the FDA’s Center for Drug Evaluation and Research. “Today’s approval addresses the critical need for products to reduce the impact of RSV disease on children, families and the health care system.”
The potential to mitigate the effects of RSV extends to older adults: In recent months, the FDA has approved two vaccines against the virus for adults 60 and older. The virus is linked to 60,000 hospitalizations and up to 10,000 deaths each year in people 65 and older, according to the CDC The agency estimated that more than 21,000 people in that age group would need to take the GSK vaccine to prevent one RSV death in one. year; the number was nearly 25,000 for the Pfizer shot.
Agency advisers considering the antibody shot for infants voted unanimously in June in favor of allowing the treatment for infants. More than 3,200 infants were given the shot in studies submitted to the FDA by Sanofi and AstraZeneca One study took six months that efficacy against very severe RSV requiring medical attention was 79 percent.
FDA advisors were more cautious about Pfizer’s RSV shot intended for pregnant women. In May, a panel voted 10 to 4 that the vaccine was safe, citing concerns about slightly increased rates of premature births among mothers who received the vaccine, compared to those who received a placebo.
Studies of a similar vaccine by GSK were halted after researchers detected an increase in premature births. The agency has not yet made a decision on that Pfizer maternal vaccine, called Abrysvo, although a company spokesman said approval was expected in the coming weeks.