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Nirsevimab: A Review
1Department of Pediatrics, Good Samaritan University Hospital, West Islip, New York, USA.
Insights
New RSV prevention tools offer hope for infants and older adults. Nirsevimab, a long-acting antibody, is recommended for infants, while vaccines are available for older adults and pregnant women.
Area of Science:
- Pediatrics
- Immunology
- Public Health
Background:
- Respiratory syncytial virus (RSV) is a leading cause of infant hospitalization in the U.S.
- RSV causes severe lower respiratory tract infections across all age groups.
- Recent advancements in 2023 have introduced novel prevention strategies.
Purpose of the Study:
- To review the recent FDA approvals of new RSV prevention tools.
- To highlight the role of nirsevimab, a monoclonal antibody, for infant protection.
- To discuss recommendations for nirsevimab administration in infants and at-risk children.
Main Methods:
- Review of FDA approvals and recommendations from ACIP and AAP.
- Focus on nirsevimab (Beyfortus™) for RSV prevention in vulnerable populations.
- Analysis of vaccine approvals for older adults and pregnant women.
Main Results:
- FDA approved three new RSV prevention tools in 2023.
- Nirsevimab (Beyfortus™) approved for infants and young children.
- Vaccines (Arexvy™ and Abrysvo™) approved for adults 60+ and pregnant women.
Conclusions:
- Nirsevimab is recommended for all infants under 8 months and high-risk children aged 8-19 months.
- New RSV vaccines and monoclonal antibodies significantly advance prevention efforts.
- These tools aim to reduce severe RSV disease and hospitalizations in infants and the elderly.
Abstract:
Respiratory syncytial virus (RSV) is a major cause of lower respiratory tract infections in people of all ages and is the leading cause of hospitalization among infants in the United States. The year 2023 was exciting for RSV prevention. The Food and Drug Administration (FDA) approved 3 new tools for preventing severe lower respiratory tract RSV infections in infants, young children, and elderly persons. In May 2023, the FDA approved 2 vaccines, RSVpreF3 (Arexvy™, GSK) and RSVpreF (Abrysvo™, Pfizer), for adults ages 60 years or older to be given as a single-dose intramuscular injection. July 2023 brought the approval of the first long-acting monoclonal antibody nirsevimab (Beyfortus™, Sanofi and AstraZeneca) for the prevention of RSV disease in infants and young children. Then in August, the FDA approved a vaccine (Abrysvo™, Pfizer) to be given to pregnant women to protect their newborns through passive immunity. This article focuses on nirsevemab that has been recommended by the Advisory Committee on Immunization Practices (ACIP) and American Academy of Pediatrics (AAP) to be administered for all infants <8 months of age and for children 8 to 19 months of age who are at increased risk for severe RSV disease.
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