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The Food and Drug Administration on Monday approved a vaccine to protect vulnerable infants and toddlers against respiratory syncytial virus, or RSV, offering one of the first protections against a disease that fills children’s hospitals year after year.
The monoclonal antibody vaccine should be available at the start of the fall RSV season. The FDA is also considering approval of an RSV vaccine by Pfizer for pregnant women that is intended to protect infants against the virus.
The treatment approved on Monday, called Beyfortus by its developers Sanofi and AstraZeneca, treats a disease that can be serious in the elderly and young infants. About 80,000 children ages 5 and younger are hospitalized each year with the virus, according to the Centers for Disease Control and Prevention.
“RSV can cause serious illness in infants and some children and results in a large number of emergency room and doctor’s office visits each year,” said Dr. John Farley, an official with the FDA Center for Drug Evaluation and Research. “Today’s approval responds to the great need for products to help reduce the impact of RSV disease on children, families and the healthcare system.”
The potential to mitigate 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. The virus is linked to 60,000 hospitalizations and up to 10,000 deaths each year among people 65 and older, according to the CDC. The agency estimated that more than 21,000 people in this 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 vaccine.
Agency advisers consider antibody vaccine for infants vote unanimously in June in favor of approving the treatment for infants. More than 3,200 infants received the vaccine in studies that Sanofi and AstraZeneca submitted to the FDA A six-month study found this efficacy against very severe RSV that required medical attention was 79%.
FDA advisers were more careful about an RSV injected by Pfizer for pregnant women. In May, a panel voted 10 to 4 that the vaccine was safe, reflecting concerns about slightly elevated 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 yet to make a decision on this Pfizer maternal vaccine, called Abrysvo, although a company spokeswoman said approval was expected in the coming weeks.
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