CDC recommends RSV immunization for infants
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Key takeaways:
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CDC advisors unanimously recommended the monoclonal antibody nirsevimab for infants.
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The CDC director signed off on the recommendation and encouraged parents to discuss nirsevimab with their providers this fall.
The CDC has recommended a monoclonal antibody against respiratory syncytial virus in infants. Image: Adobe Stock
The CDC has recommended that infants be immunized with a monoclonal antibody against respiratory syncytial virus.
It was the latest in a series of recent regulatory votes supporting drugs that protect against RSV, a common respiratory infection that can cause serious illness, especially in infants and older adults. The first two RSV vaccines will be available for older Americans this fall.
The monoclonal antibody, nirsevimab (Beyfortus, AztraZeneca and Sanofi), was approved by the FDA last month as an intramuscular injection of 50 mg for infants with a body weight less than 5 kg and 100 mg for infants with a body weight of 5 kg or more.
The CDC’s Advisory Committee on Immunization Practices [ACIP] unanimously voted Thursday to recommend nirsevimab for infants aged younger than 8 months born during or entering their first RSV season, at an intramuscular injection of 50 mg for infants weighing less than 5 kg and 100 mg for infants weighing 5 kg or more.
Children aged 8 to 19 months who are entering their second RSV season and are at an increased risk for severe RSV disease are recommended to receive one dose at 200 mg.
“The [ACIP] work group felt that nirsevimab use among children aged 8 through 19 months entering their second RSV season or at an increased risk of severe disease is probably a reasonable and efficient allocation of resources,” Jefferson Jones, MD, MPH, a medical officer in the CDC’s National Center for Immunization and Respiratory Diseases, said during the meeting.
CDC Director Mandy Cohen, MD, MPH, quickly endorsed the ACIP vote, making it an official federal recommendation.
“This new RSV immunization provides parents with a powerful tool to protect their children against the threat of RSV,” Cohen said in a press release. “RSV is the leading cause of hospitalizations for infants and older babies at higher risk, and today we have taken an important step to make this life saving product available.”
Data from multiple trials have demonstrated that nirsevimab is approximately 80% efficacious against medically attended RSV after a single dose.
“As we head into respiratory virus season this fall, it’s important to use these new tools available to help prevent severe RSV illness,” Cohen said. “I encourage parents of infants to talk to their pediatricians about this new immunization and the importance of preventing severe RSV.”
Although it is not a vaccine, the ACIP voted to make nirsevimab available through the Vaccines for Children program, which provides free vaccines to uninsured or underinsured children. The CDC said it was “currently working to make nirsevimab available through the Vaccines for Children program.”
“Health care providers will be a key partner in CDC’s outreach efforts. Additional clinical guidance and health care provider education material will be provided by CDC in the coming months,” the agency said.
[Editor’s note: This story was updated to clarify that the ACIP is a CDC advisory committee, to note that nirsevimab is approved by the FDA and is under consideration for the Vaccines for Children program.]
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