The U.S. Centers for Disease Control and Prevention (CDC) on Monday, October 23, 2023, announced the availability of nirsevimab (Bayfortas, Sanofi), a long-acting monoclonal antibody vaccination approved by the U.S. Food and Drug Administration in July 2023. We have issued a health advisory detailing the limited possibilities. Prevent respiratory syncytial virus (RSV)-related lower respiratory tract disease (LRTD) in infants and young children.1
In August 2023, CDC’s Advisory Committee on Immunization Practices (ACIP) recommended that all infants under 8 months of age born during or beginning the first RSV season, and infants 8 to 8 months of age who are at high risk for severe RSV, Nilsevimab was recommended for infants and children aged 19 months. I am in my second season of RSV infection.2
The manufacturer said unprecedented early demand for the immunization has outpaced the company’s aggressive supply plans, with the 100mg dose prefilled syringe for use in infants weighing 5 kg or more commanding the highest premium.3 The companies said that while the shortage of prefilled syringes with 50 mg doses is not critical, supply is likely to be limited during the RSV season.3 While the CDC is working with the manufacturer on strategies to increase the supply of nilcevimab, the agency has issued some preliminary suggestions to both health care providers and the public on how to adapt to the shortage.1
The recommendation states that for infants weighing less than 5 kg, the original ACIP recommendations remain unchanged.1 Currently, a 50 mg dose is recommended for infants born before October of this year, and within the first week of an infant’s life for infants born during October and for the remainder of the 2023-2024 RSV season. A 50 mg dose of nilsevimab should be administered.1
For infants weighing 5 kg or more, authorities target infants at highest risk for severe RSV-associated LRTD, those younger than 6 months of age, and infants between 6 and 8 months with increasing underlying medical conditions. recommends preferring the 100 mg dose. their vulnerability, and American Indian and Alaska Native infants under 8 months of age.1
The agency recommends that the 50 mg dose not be divided into two doses for infants weighing 11 pounds or more to protect the delivery of the 50 mg dose to infants weighing less than 11 pounds.1 The CDC also warns health care providers that some insurance companies may not cover the cost of two 50 mg doses per infant.1
Palivizumab. The CDC cites guidance from the American Academy of Pediatrics recommending that nilsevimab not be used in the 2023-2024 season for children 8 to 19 months of age who are eligible to receive palivizumab.1 An exception should be made for administering nilsevimab to American Indian and Alaska Native children 8 to 19 months of age who are not eligible to receive pavilizumab.1
Mother’s RSVpreF. As guidance for health care workers and the public, the agency’s recommendations encourage health care workers to discuss concerns about the supply of nilcevimab with pregnant women and suggest that they receive the Pfizer (Abrysvo) RSVpreF vaccine. There is. This vaccine is administered between 32 weeks of pregnancy and 36 weeks/6 days of pregnancy and is effective in protecting newborns from RSV-LRTD. The CDC says vaccination of mothers and newborns is not necessary. One or the other alone is sufficient to protect a newborn.
The agency urges families and communities to follow standard practices to reduce the spread of all respiratory viruses this season, including washing hands regularly, covering coughs and sneezes, disinfecting frequently touched surfaces, and staying home if sick. It is recommended that appropriate infection prevention measures be followed.
“Sanofi is [CDC] To ensure that available doses are equitably distributed through the childhood vaccination program. Our approach to distribution across private marketplaces will be similar,” Sanofi said in a release. “We are considering a number of measures to accelerate additional supplies and expand our manufacturing network, in collaboration with AstraZeneca, our alliance partner responsible for manufacturing.”