A Food and Drug Administration advisory panel recommended approval of a monoclonal antibody injection aimed at preventing a potentially deadly pathogen, respiratory syncytial virus, or RSV, in infants and vulnerable toddlers.
The treatment, dubbed Beyfortus by developers Sanofi and AstraZeneca, would be the second therapy the FDA has allowed to give to very young children to prevent RSV, which is a leading killer of babies and toddlers worldwide. A similar treatment approved more than 20 years ago is given in multiple doses and is only approved for high-risk infants.
The 21-member panel voted unanimously to give the treatment to babies born during or starting their first season of RSV. The advisers voted 19 to 2 to give the shot to children up to 24 months old who remain vulnerable to serious illness.
Why it matters: RSV is a global killer of babies.
While many people experience this common virus as a common cold, it can be serious in young babies and older adults. According to the Centers for Disease Control and Prevention, up to 80,000 children under age 5 are hospitalized with the virus each year, and up to 300 die. RSV played a role in filling children’s hospitals during this winter’s “triplemy,” which also included the flu and Covid-19 were involved.
For adults age 65 and older, as many as 160,000 hospitalizations are attributed to RSV and about 10,000 deaths. Vaccines for older adults have also recently been approved.
Background: The safety of the shot is monitored.
More than 3,200 babies received the antibody shot during studies provided to the FDA by the drug companies, including one that found that after six months, the efficacy against very severe RSV requiring medical attention was 79 percent.
A separate agency panel has recommended approval for an RSV vaccine for the mother, which is also under review. Some advisers expressed concern about the data for that vaccine, and for another similar vaccine that suggested a small increase in preterm births.
If the antibody therapy is approved, the FDA said it would continue to monitor the treatment for safety using various data sources. AstraZeneca said it would also conduct periodic safety assessments using global data.
What’s Next: The CDC will review maternal and infant admissions.
If the agency approves the new shot, it will likely become available in the fall — around the same time that the Pfizer RSV vaccine given during pregnancy, called Abrysvo, hits the market.
The CDC is expected to advise health care providers on how to use the new treatments later this month. Families and their doctors could then choose a course of treatment that would take into account, among other things, the timing of a birth and the RSV winter season.
The FDA said there was no research on the risks or benefits of women taking the mother’s RSV vaccine and giving the antibody shots to their babies.