The Centers for Disease Control and Prevention (CDC) announced on Thursday the official recommendation for the first preventive treatment for Respiratory syncytial virus (RSV) in infants. This recommendation came shortly after an endorsement from the Advisory Committee on Immunization Practices (ACIP).
The CDC Director, Mandy Cohen, adopted the ACIP’s guidance regarding the administration of nirsevimab, also known as Beyfortus. This treatment is now recommended for infants under eight months old who are born during or entering their first RSV season. It is also recommended for infants between eight and 19 months old who are at an increased risk of severe illness and entering their second RSV season. The treatment involves a single injection.
In a statement, Cohen emphasized the significance of this new RSV immunization as a powerful tool for parents to protect their children against the threat of RSV. RSV is the leading cause of hospitalizations for infants and older babies at higher risk, and this recommendation marks an important step in making this life-saving product available.
The CDC highlighted that Beyfortus, co-developed by Sanofi and AstraZeneca, has been proven to reduce the risk of hospitalization and health visits for RSV by 80%. In June, the Food and Drug Administration’s (FDA) antimicrobial drug advisory panel unanimously endorsed Beyfortus, determining its overall benefit-risk assessment to be favorable.
Furthermore, the ACIP also endorsed the addition of Beyfortus to the federal Vaccines for Children (VFC) program, which offers free immunizations to approximately half of the children in the U.S. The CDC is currently working towards making the product available through the VFC.
Despite Beyfortus being a non-traditional vaccine, the CDC had previously deemed it eligible for inclusion in the VFC.
As efforts to ensure access to this new antibody treatment continue, particularly amidst Medicaid disenrollment this year, it is crucial to make it widely available. Recent data indicates that at least 3.8 million individuals have been disenrolled since the initiation of the unwinding process.
With the normal RSV season approaching in a few months, the timing aligns with the recommended administration of Beyfortus. The CDC anticipates that it will be available in the fall.
“As we head into the respiratory virus season this fall, it’s important to utilize these new tools to help prevent severe RSV illness,” stated Cohen. She urged parents of infants to consult with their pediatricians about this new immunization and the significance of preventing severe RSV infections.
This development may help avoid a recurrence of last year’s RSV surge, which overwhelmed several U.S. hospitals with pediatric cases. The surge shed light on the limited options available for preventing and treating RSV.
Aside from ventilator support, the primary treatment options for RSV are monoclonal antibodies administered post-infection, reserved for higher-risk cases.
In June, the CDC recommended an RSV vaccine for seniors over the age of 60. Additionally, an RSV vaccine for infants developed by Pfizer and administered to pregnant mothers was endorsed by an FDA panel earlier this year.
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