F.D.A. Approve R.S.V. Shot for infants

Respiratory virus is a global killer of babies and young children.

Foods and The administration on Monday approved a vaccine to protect vulnerable infants and toddlers against respiratory syncytial virus, or R.S.V., offering one of the first protections against a disease that fills children's hospitals year after year. /p>

The monoclonal antibody vaccine should be available in early fall R.S.V. season. The F.D.A. is also considering approving an R.S.V. Pfizer's vaccine for pregnant women intended to protect infants from the virus.

The treatment approved on Monday, called Beyfortus by its developers Sanofi and AstraZeneca, treats a disease that can be severe in the elderly and young infants. About 80,000 children ages 5 and under are hospitalized each year with the virus, according to the Centers for Disease Control and Prevention.

“R.S.V. 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 F.D.A. Center for Drug Evaluation and Research, said. "Today's approval responds to the great need for products to help reduce the impact of R.S.V. disease on children, families and the healthcare system. will extend to older adults: In recent months, the F.D.A. 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 this age group would need to take the GSK vaccine to prevent one R.S.V. death in one year; the number was nearly 25,000 for the Pfizer vaccine.

Agency advisers considering the antibody vaccine for infants voted unanimously in June to approve the treatment for infants. More than 3,200 infants have received the vaccine in studies that Sanofi and AstraZeneca submitted to the F.D.A. A six-month study found that the effectiveness against R.S.V. requiring medical attention was 79%.

F.D.A. advisors were more cautious about an R.S.V. shot by Pfizer aimed at pregnant women. In May, a panel voted 10 to 4 that the vaccine was safe, reflecting concerns about slightly elevated rates of preterm birth among mothers who received the vaccine, compared to those who received a placebo. /p>

Studies of a similar vaccine by GSK were halted after researchers detected an increase in preterm births. The agency has yet to make a decision on this Pfizer maternal vaccine, called Abrysvo, although a company spokeswoman said approval is expected in the coming weeks.