The Food and Drug Administration made an announcement on Monday about approving a new type of immunization called nirsevimab. This immunization aims to protect babies from respiratory syncytial virus (RSV), which is a common cause of hospitalization in American infants. Medical experts consider nirsevimab to be groundbreaking in the field, and the drug’s safety and effectiveness have been endorsed by a panel of FDA experts. Dr. John Farley, the director of the Office of Infectious Diseases, emphasizes that this approval will greatly benefit children, families, and the healthcare system.
The drug companies AstraZeneca and Sanofi, who will market nirsevimab as Beyfortus, have reported an 83.2% reduction in RSV-related hospitalizations after infants received the antibody injection. Thomas Triomphe, an executive vice president at Sanofi, describes this approval as an unprecedented moment for infant health, as the previous RSV season had a devastating impact. The FDA-approved image of Beyfortus can be seen below.
AstraZeneca and Sanofi
Previously, parents and doctors only had one option to protect some babies from RSV: monthly injections of palivizumab, an antibody drug that is specifically recommended for at-risk infants and young children. Nirsevimab offers a more convenient solution, as it only requires one injection for the season, effectively preventing the first RSV infection until the child is older. While RSV is almost universal among children by age 2, infants who contract the virus during their early months are more likely to require hospitalization, even without underlying medical conditions.
However, the potential cost and the availability of Pfizer’s Abrysvo vaccine, which offers a competing option for protecting babies, may affect the widespread adoption of nirsevimab. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is currently in the process of drafting recommendations on how to navigate these two products. Their goal is to determine the best course of action for parents and doctors based on the effectiveness and cost-effectiveness of each option.
“When considering whether to give both a maternal vaccine and a monoclonal antibody, giving both products was not found to be cost effective,” explains Christopher Jones from the CDC. The work group responsible for making these recommendations is considering limiting the use of nirsevimab to babies whose mothers did not receive Pfizer’s vaccine, with a few exceptions. The CDC panel will meet next month to vote on formal inclusion of nirsevimab. This vote is necessary to cover the shots for uninsured babies through the federal Vaccines for Children program and to establish coverage requirements for private insurers.
Sanofi plans to launch Beyfortus in time for the 2023-2024 RSV season and will disclose the US price of the drug at that time. The FDA and CDC have previously approved Pfizer’s Abrysvo vaccine to protect older adults from RSV and it will be available in about a month for eligible Americans.
Logistical Considerations
The widespread recommendation of nirsevimab for American babies presents logistical challenges for health authorities, as their immunization systems are primarily designed for traditional vaccines rather than antibody drugs. Georgina Peacock from the CDC identifies these challenges and commits to addressing them, given that nirsevimab functions both as a therapeutic and an immunizing agent. One challenge is monitoring the safety of nirsevimab between the FDA and CDC, as adverse events after injections need to be reported through a separate system intended for drugs. This system differs from the databases used to track vaccine side effects. Tracking who has received the injection may also be complicated if some states cannot include nirsevimab in their immunization registries.
“There will be a robust monitoring process in place for nirsevimab, involving collaboration between the CDC and FDA to analyze safety information and data,” reveals Tom Shimabukuro from the CDC.
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