Short supplies mean drugs that can prevent respiratory syncytial virus (RSV) in infants won’t have much of an immediate impact, children’s hospitals say as they brace for a surge in hospitalizations this respiratory disease season.
“Wide access [to the new antibody drug] “This will take time in many departments at children’s hospitals and will not have a significant impact on the number of respiratory patients in the immediate future,” the Children’s Hospital Association said in a statement.
Nilsevimab, sold as Beyfortas, was approved in August. It is a single-dose vaccination that can be given to infants up to 8 months of age and high-risk infants up to 19 months of age.
The drug is a monoclonal antibody rather than a traditional vaccine, meaning infants receive antibodies directly that prevent severe RSV disease, rather than helping them develop their immune systems. This reduces infants’ risk of hospitalization by around 80% and has been hailed as a game changer.
But the Centers for Disease Control and Prevention (CDC) last week urged pediatricians to ration the drug and prioritize infants at highest risk of complications, citing supply constraints.
This includes American Indian and Alaska Native children in remote areas under the age of 8 months, as well as infants born before 29 weeks of pregnancy and infants with severe immunodeficiency.
The agency’s Children’s Vaccines Program, which pays for shots for uninsured and underinsured children, suspended orders for 100-milligram doses earlier this month. A dose of 100 mg is recommended for babies weighing 11 pounds or more up to 8 months of age.
The agency just recently resumed ordering the 50-milligram dose for infants weighing less than 11 pounds. Sanofi said it is temporarily not accepting new orders for the 100-milligram dose but is making current deliveries.
Sanofi, which sells the drug, says demand has far exceeded expectations and it is working with manufacturer AstraZeneca to quickly supply available doses.
A Sanofi spokesperson told The Hill the company does not have any updates.
Drug shortage experts say they are perplexed.
Unlike other generic drugs, there are no known manufacturing interruptions or shortages of raw materials needed to manufacture the drug. Manufacturers simply underestimated demand.
“I don’t know what kind of market research they’ve done, but it’s very easy to look at annual birth statistics to know when. I think it makes sense to use statistics,” said Mike Ganio, senior director of pharmacy operations and quality at the American Society of Health-System Pharmacists.
“We hope this shortage does not lead to another surge in respiratory infections over the winter,” Ganio said.
In an October update, the CDC predicted that “the upcoming fall and winter respiratory disease season will likely result in hospitalizations similar to last season” and higher than pre-pandemic seasons. He said that
Although current RSV levels are low nationally, “a continued increase in RSV activity in the southern United States signals the beginning of the 2023-2024 RSV season, and is now in the mid-Atlantic.” There is also increased activity in the region and areas of the Northeast,” the CDC said.
Last year, large numbers of young children became infected with RSV much faster than usual, overwhelming children’s hospitals and emergency rooms across the country.
“Children’s hospitals are collaborating with community hospitals and other health systems to help manage the supply of pediatric beds, equipment, medicines, and pediatric workforce staffing, but this fall and winter will undoubtedly continue. There will be capacity issues,” said Matt Cook, CEO of the Children’s Hospital Association. statement.
Until this year, there was no drug that could prevent RSV in all infants. But it has not been approved by federal regulators until the end of summer, and public health experts and pediatricians hope to ensure enough doses are on the market before an RSV outbreak begins. I question the wisdom of such a condensed schedule.
A lack of insurance coverage also scuppered the shot’s early rollout.
Pediatricians often have to purchase the drug directly from a supplier or manufacturer, which costs $495 per dose in the private sector. Pediatricians say it’s unclear whether insurance companies will reimburse pediatricians for purchasing and administering the drug.
The federally funded children’s vaccine program pays $395 per dose.
Sanofi said that as of October 1, more than 90% of infant lives were insured.
The company also offers extended payment terms for physicians who purchase directly from Sanofi. This means healthcare providers can order, receive and administer Bayfortas immediately, but will not have to repay Sanofi until later this year, towards the end of the RSV season.
Meanwhile, the CDC recommended that expectant parents consider Abrysvo, a new maternal RSV vaccine recommended for pregnant people to protect newborns during the first six months of life. However, it can only be administered from 32 to 36 weeks of pregnancy.
Contributed by Joseph Choi.
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