AAP publishes guidance on nirsevimab for children
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Key takeaways:
- The AAP recommended that all infants receive nirsevimab to protect against severe RSV.
- The monoclonal antibody was recently approved by the FDA and recommended by the CDC.
The AAP published guidance on the use of nirsevimab, recommending it for all infants aged younger than 8 months to prevent severe disease from respiratory syncytial virus.
The AAP’s guidance aligns with the CDC’s recommendations for the monoclonal antibody, which were made 2 weeks ago.
Nirsevimab was approved by the FDA in July to administer to children during their initial RSV seasons.
RSV surged in the United States last fall, possibly due to waning immunity, and was part of a “tripledemic” of respiratory diseases, alongside COVID-19 and influenza. The common respiratory virus often causes serious disease in young children and older adults, the latter of whom now have access to two RSV vaccines.
Although nirsevimab is not a vaccine, the CDC said it is working on making it available for free for uninsured or underinsured children through the Vaccines for Children program.
The AAP recommends a single dose or nirsevimab for infants younger than 8 months born during or entering their first RSV season, and for infants and children aged 8 through 19 months who are at an increased risk for severe RSV disease and entering their second RSV season, including those recommended by the AAP to receive the monoclonal antibody palivizumab.
The AAP continues to recommend palivizumab for eligible infants who cannot access nirsevimab during the 2023-2024 RSV season but noted that children who have received nirsevimab should not receive palivizumab in the same RSV season.
It published the recommendations in Red Book Online.
“Nirsevimab and palivizumab are both antibody shots that help prepare the immune system to prevent illness,” the AAP said.
RSV activity usually begins in the late fall and extends through spring, the AAP noted.
“Pediatricians are sadly familiar with the dangers of RSV and its devastating consequences for some families,” AAP President Sandy Chung, MD, FAAP, said in a release. “We are eager to offer all infants this protection and urge federal officials to see that it is made available and affordable in all communities.”
Children aged 8 through 19 months who are recommended to receive nirsevimab when entering their second RSV season include those who are severely immunocompromised, have chronic lung disease, cystic fibrosis with manifestations of severe lung disease and American Indian and Alaska Native children, who have been shown to endure high rates of RSV infection.
In July, Chung wrote an open letter to CDC Director Mandy K. Cohen, MD, MPH, and CMS Administrator Chiquita Brooks-LaSure in which she said it is “vital that the administration provide the necessary infrastructure supports to ensure equitable distribution and access” to nirsevimab.
“This infrastructure does not currently exist, and pediatricians and other providers face the prospect of moral injury resulting from having an available product without the ability to administer it given financial and administrative barriers and burdens,” Chung wrote. “Families living in lower-income and under-resourced communities, as well as those with infants at greatest risk for severe RSV illness, may face challenges accessing nirsevimab-alip in the absence of additional infrastructure support.”
References:
- American Academy of Pediatrics recommends medication to prevent RSV be given to all infants and urges equitable access. https://www.aap.org/en/news-room/news-releases/aap/2023/american-academy-of-pediatrics-recommends-medication-to-prevent-rsv-be-given-to-all-infants-and-urges-equitable-access/. Published Aug. 15, 2023. Accessed Aug. 16, 2023.
- Red Book Online. ACIP and AAP recommendations for nirsevimab. https://publications.aap.org/redbook/resources/25379/ACIP-and-AAP-Recommendations-for-Nirsevimab. Accessed Aug. 16, 2023.
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Red Book Online. ACIP and AAP recommendations for nirsevimab. https://publications.aap.org/redbook/resources/25379/ACIP-and-AAP-Recommendations-for-Nirsevimab. Accessed August 16, 2023.
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