Summary
A Food and Drug Administration (F.D.A.) advisory panel has recommended approval for a monoclonal antibody shot designed to prevent respiratory syncytial virus (R.S.V.) in infants and vulnerable toddlers. Sanofi and AstraZeneca are the developers of the treatment, which will be the second one approved for the prevention of R.S.V. in very young children.
The 21-member panel unanimously voted in favor of giving the treatment to infants born during or just before their first R.S.V. season, while 19 out of the 21 advisers voted for giving the shot to children up to 24 months old, who remain vulnerable to severe disease.
Importance of the R.S.V. Shot
Respiratory syncytial virus (R.S.V.) is a leading killer of infants globally, and while many people experience the virus as a common cold, it can be severe in young infants and older adults. According to the Centers for Disease Control and Prevention (CDC), up to 80,000 children below the age of 5 are hospitalized annually, and 300 die due to the virus. This winter’s “tripledemic” of flu, Covid-19, and R.S.V. contributed to filling children’s hospitals, and for adults above 65 years, as many as 160,000 hospitalizations are linked to R.S.V with around 10,000 deaths. Recently, vaccines for older adults have been approved.
Safety of the Shot
The F.D.A. will carefully monitor the shot’s safety, having reviewed studies of over 3,200 infants who received the antibody shot from the drugmakers. It should be noted that another recommended maternal R.S.V. vaccine has raised concerns among some advisers over data and a slight increase in preterm births.
What Next?
The CDC is expected to review the use of the new treatments later this month if the F.D.A. approves it. As it is forecasted to become available in fall, around the same time Pfizer’s R.S.V. vaccine given during pregnancy called Abrysvo hits the market, health providers are expected to recommend the best treatment depending on factors such as the timing of a child’s birth and the winter R.S.V. season. Notably, the F.D.A. has not conducted any studies of the risks or benefits of maternal R.S.V. vaccine while also administering the antibody shots to infants.
