The Food and Drug Administration on Monday approved a shot to protect vulnerable infants and young children from respiratory syncytial virus, offering one of the first means of protection against the disease that fills children’s hospitals year after year.
The monoclonal antibody shot is expected to be available at the beginning of the fall RSV season. The US Food and Drug Administration (FDA) is also considering approving Pfizer’s RSV vaccine for pregnant women that aims to protect children from the virus.
The treatment approved Monday, called Beyfortus by developers Sanofi and AstraZeneca, treats an illness that can be severe in the elderly and young infants. About 80,000 children ages 5 and under are hospitalized with the virus each year, according to the Centers for Disease Control and Prevention.
“RSV can cause serious illness in infants and some children and result in a large number of emergency department and doctor’s office visits each year,” said Dr. John Farley, an official in the FDA’s Center for Drug Evaluation and Research. “Today’s approval addresses an urgent need for products to help reduce the impact of RSV disease on children, families, and the health care system.”
The potential to reduce the effects of RSV will extend to the elderly: In recent months, the Food and Drug Administration 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, and the agency has estimated that more than 21,000 people in that age group would need to take the GSK vaccine to prevent One death from RSV in one. year; The figure was about 25,000 shots from Pfizer.
Agency advisors considering antibody injections to infants cast unanimous votes in June in favor of approving the treatment for infants. More than 3,200 infants were given the injection in studies that Sanofi and AstraZeneca submitted to the FDA. found one six-month study The efficacy against severe RSV requiring medical attention was 79 percent.
FDA advisors were more cautious about Pfizer’s respiratory syncytial vaccine for pregnant women. In May, a panel voted 10 to 4 that the vaccine was safe, a reflection of concerns about higher rates of premature birth among mothers who received the vaccine, compared to those who received a placebo.
Studies of a similar vaccine by GSK were halted after researchers discovered an increase in premature births. The agency has not made a decision on Pfizer’s parent vaccine, called Abrysvo, though a company spokeswoman said approval was expected in the coming weeks.