The Centers for Disease Control and Prevention (CDC) officially recommended the first preventive Respiratory syncytial virus (RSV) treatment for infants on Thursday, shortly after a key panel endorsed the product.
CDC Director Mandy Cohen adopted the guidance recommended by the Advisory Committee on Immunization Practices (ACIP) on Thursday for the administration of nirsevimab, or Beyfortus.
The treatment has been recommended for infants under eight months old who are born during or are entering their first RSV season as well as infants between eight and 19 months who are at an increased risk of severe illness and are entering their second RSV season. It is administered with one injection.
“This new RSV immunization provides parents with a powerful tool to protect their children against the threat of RSV,” Cohen said in a statement. “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.”
The CDC noted in its announcement that Beyfortus, co-developed by Sanofi and AstraZeneca, has been shown to reduce the risk for hospitalization and health visits for RSV by 80 percent. In June, the Food and Drug Administration’s (FDA) antimicrobial drug advisory panel unanimously endorsed Beyfortus, finding the overall benefit-risk assessment to be favorable.
The ACIP on Thursday also endorsed adding Beyfortus to the federal Vaccines for Children (VFC) program, which provides free immunizations to about half of the children in the U.S. The CDC said it is working to make the product available through the VFC.
Though Beyfortus is not a traditional vaccine, the CDC previously determined that it was eligible for inclusion in the VFC.
Efforts to ensure access to the new antibody treatment will be key, especially as Medicaid disenrollment continues this year. The most recent data suggests at least 3.8 million have been disenrolled since the start of the unwinding.
With the normal RSV season now only a few months away, the timing aligns with the recommended administration, with the CDC saying it expects Beyfortus to be available this fall.
“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 added. “I encourage parents of infants to talk to their pediatricians about this new immunization and the importance of preventing severe RSV.”
This development may serve to help avert a repeat of last year’s RSV surge which saw many U.S. hospitals reach capacity with children. The surge brought heightened attention to the stark lack of options for preventing and treating RSV.
Apart from being placed on a ventilator, one of the only other treatment options is monoclonal antibodies administered post-infection, which is reserved for higher-risk cases.
In June, the CDC recommended an RSV vaccine for seniors over the age of 60. An RSV vaccine for infants from Pfizer, administered to pregnant mothers, was endorsed by an FDA panel earlier this year as well.