The Food and Drug Administration on Monday approved a shot to protect infants and vulnerable children from respiratory syncytial virus, or RSV, offering one of the first protections for the disease that hits 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 approving an RSV vaccine by Pfizer for pregnant women to protect infants from the virus.
The treatment approved Monday, called Beaufort by its developers Sanofi and AstraZeneca, addresses a disease that can be serious in older adults and young infants. According to the Centers for Disease Control and Prevention, about 80,000 children age 5 and younger are hospitalized each year because of this virus.
“RSV can cause serious illness in infants and some children and results in a large number of emergency department and physician office visits each year,” said Dr. John Farley, an officer in the FDA’s Center for Drug Evaluation and Research. ” “Today’s approval addresses the great need for products that can help reduce the impact of RSV disease on children, families, and the health care system.”
The ability to blunt the effects of RSV will extend to older adults: In recent months, the FDA has approved two vaccines against the virus for adults 60 and older. According to the CDC, the virus is linked to 60,000 hospitalizations and up to 10,000 deaths each year in people 65 and older. The agency estimates that more than 21,000 people in that age group would need to get the GSK vaccine to prevent one RSV death. Year; For the Pfizer shot, the number was around 25,000.
Advisers to the agency considering the antibody shot for infants voted unanimously in favor of approving the treatment for infants in June. In the studies that Sanofi and AstraZeneca submitted to the FDA, more than 3,200 infants were given the vaccine. A six-month study found Efficacy against very severe RSV that required medical attention was 79 percent.
FDA advisors were more cautious about Pfizer’s RSV shot for pregnant women. In May, a panel voted 10 to 4 that the vaccine was safe, a reflection of concerns about a slightly increased rate of premature birth among mothers who received the vaccine compared to mothers who received a placebo. .
A similar vaccine study by GSK was halted after researchers found an increase in premature births. The agency has not yet made a decision on that maternal Pfizer vaccine, called Abrisvo, though a company spokeswoman said approval is expected in the coming weeks.