Technicalities on routine vaccinations and administrative timelines for hospital formulary processes could hinder children's protection against respiratory syncytial virus.
During the 2022-23 viral illness season, pediatric RSV cases skyrocketed as many children's hospitals filled to capacity. Nearly every child contracts RSV before the age of 2, but this fall saw an early surge of cases. Most children recover, but more severe cases require weeks of hospitalized care. There's one approved preventive drug, but it's only for a specific population.
Europe approved Sanofi and AstraZeneca's RSV preventive drug in November, but in the U.S., the FDA's decision on the monoclonal antibody most likely won't be announced until late 2023.
This timeline may place the drug's approval before the next RSV season, but there are two potential hiccups. First, the 1993 law clarifying the nation's childhood routine vaccination program does not cite antibody shots, meaning regulatory agencies would have to clear a space for it, according to Kaiser Health News. Also, allowing the use of a newly approved drug at hospitals and health systems can take weeks to months.
After a drug or vaccine is approved, the hospital pharmacy formulary process includes determining risks and benefits, each hospital coming to a decision, each system enacting a rule and then ordering supply. This can last months, according to Aaron Harthan, PharmD, pediatric critical care pharmacist at OSF Healthcare Children's Hospital of Illinois in Peoria.