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A Food and Drug Administration advisory panel recommended approval of monoclonal antibody injections for the prevention of respiratory syncytial virus (RSV), a potentially fatal pathogen in infants and vulnerable young children.
The treatment, called Bayfortus by its developers Sanofi and AstraZeneca, is the second treatment approved by the FDA for use in infants to prevent respiratory syncytial virus, a leading cause of death in infants worldwide. becomes. Similar treatments, approved more than 20 years ago, are multiple doses and are approved only for high-risk infants.
A panel of 21 members voted unanimously in favor of treating infants born during or entering their first RSV season. Advisors voted 19 to 2 in favor of vaccinating children up to 24 months, who are still susceptible to serious illness.
Why it matters: RSV is the leading cause of infant mortality worldwide.
Many people experience this common virus as a common cold, but it can be serious in young children and the elderly. Up to 80,000 children under the age of five are hospitalized with the virus each year, and up to 300 die, according to the Centers for Disease Control and Prevention. RSV played a role in filling children’s hospitals during this winter’s “triple demic,” which also included influenza and Covid-19.
Among adults over the age of 65, RSV causes 160,000 hospitalizations and approximately 10,000 deaths. Recently, a vaccine for the elderly has also been approved.
Background: Shot safety is monitored.
More than 3,200 infants were given antibody injections during a study provided to the FDA by a pharmaceutical company. what i found After 6 months, efficacy was 79 percent for very serious RSV requiring medical attention.
Another agency’s committee has recommended approval of a maternal RSV vaccine, which is also under review. Some advisers expressed concern about the vaccine data and similar data suggesting a modest increase in preterm births.
If an antibody therapy is approved, the FDA said it will continue to monitor the safety of the treatment using multiple data sources. AstraZeneca said it also conducts regular safety reviews using global data.
Up next: CDC will review shots of mother and baby.
If the agency approves the new vaccine, it will likely be available in the fall, around the same time that Pfizer’s Abrysvo RSV vaccine, which is given during pregnancy, goes on sale.
The CDC plans to advise health care providers about using the new treatment later this month. This will allow families and their physicians to choose treatment strategies that take into account factors such as the timing of childbirth and the winter RSV epidemic.
The FDA said there have been no studies of the risks or benefits of mothers getting RSV vaccines and inoculating their infants with antibodies.
