Health officials are reeling back their recommendations about who is eligible for a shot that prevents severe respiratory syncytial virus, or RSV, in infants amid a drug shortage that has coincided with a steady rise in cases.
In August, an advisory panel recommended the monoclonal antibody shot Beyfortus for all infants under 8 months entering their first RSV season. Children 8 to 19 months who are at increased risk of severe disease were also able to get the shot if they were entering their second season.
The Centers for Disease Control and Prevention now recommends prioritizing higher doses for babies younger than six months, and infants who have underlying conditions putting them at risk for severe disease. The agency said parents of children 8 to 19 months should consider getting their babies another monoclonal antibody, palivizumab, if they're eligible.
One of the drug’s makers, Sanofi, blamed “unprecedented demand” in a recent statement and vowed to accelerate the production of additional supply along with the company's manufacturing partner AstraZeneca.
The tightened recommendations came as the CDC reported a spike in RSV cases nationwide. The cases are primarily concentrated in the southeastern U.S. where the agency issued a heath advisory last month. In the U.S., about 58,000 children younger than 5 are hospitalized for RSV each year, and several hundred die annually of the disease.
Before the shortage became apparent, health officials had said babies could get a shot of Beyfortus like a vaccine before the RSV season, which typically runs from fall into winter. Results from clinical trials show the drug prevents RSV lower respiratory tract disease in infants and children entering or during their first RSV season.
The monoclonal antibody is the first of its kind to be widely available to everyone beyond a small population of immunocompromised children. The other option – palivizumab – is recommended only for high-risk infants born severely premature at 29 weeks or earlier. That drug requires monthly injections.
Health officials are urging doctors to encourage pregnant patients to get a new vaccine designed to protect newborns from RSV. Babies who receive that drug in utero, don't require followup shots of the antibody vaccine.
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