The Food and Drug Administration on Monday approved an injection to protect babies and vulnerable toddlers from respiratory syncytial virus, or RSV, providing one of the first protections for a disease that fills children’s hospitals year after year.
The monoclonal antibody injection 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 babies against the virus.
The treatment approved Monday, dubbed Beyfortus by developers Sanofi and AstraZeneca, targets a disease that can be serious in older adults and young babies. About 80,000 children ages 5 and younger 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 results in a high number of visits to the emergency department and physician’s offices each year,” said Dr. John Farley, an official of the FDA Center for Drug Evaluation and Research. “Today’s approval addresses the great need for products to help reduce the impact of RSV disease on children, families and the healthcare system.”
The potential to mitigate RSV’s effects will extend to older adults: In recent months, the FDA has approved two vaccines against the virus for adults age 60 and older. According to the CDC, the virus is associated with 60,000 hospitalizations and up to 10,000 deaths per year in people age 65 and older. year; the number was nearly 25,000 before Pfizer’s shot.
Agency advisers who considered the antibody injection for infants voted unanimously in June to approve the treatment for infants. More than 3,200 babies received the injection in studies that Sanofi and AstraZeneca submitted to the FDA. A six-month study found efficacy against very severe RSV requiring medical attention was 79 percent.
FDA advisers were more cautious about a Pfizer RSV injection intended for pregnant women. In May, a panel voted 10 to 4 that the vaccine was safe, reflecting concerns about slightly increased rates of preterm birth in 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 preterm birth. The agency has yet to make a decision on that Pfizer maternal vaccine, called Abrysvo, though a company spokeswoman said approval was expected in the coming weeks.
