USA— The U.S. Centers for Disease Control and Prevention (CDC) advisory panel has announced its endorsement of the utilization of Sanofi in collaboration with AstraZeneca’s antibody therapy of Beyfortus (nirsevimab) to mitigate the risk of respiratory syncytial virus (RSV) in infants and toddlers.
This breakthrough immunization marks a pivotal advancement in combating respiratory syncytial virus (RSV) disease in newborns, a respiratory ailment notorious for its impact on young children.
Resonating with this significant stride, Mandy Cohen, CDC Director, affirmed, “This new immunization provides parents with a powerful tool to protect their children against the threat of RSV.”
Beyfortus is the first product of its kind to offer comprehensive protection to newborns against RSV, a virus notorious for causing lung-related complications and becoming the leading cause of hospitalization among infants under a year old.
The prevalence of cases tends to surge during the fall and winter months, and its effects can be particularly perilous for younger infants, making it challenging for them to breathe due to mucus buildup in their delicate lungs.
The recent approval of Beyfortus by the FDA marks a watershed moment. It has gained the green light for preventing RSV lower respiratory tract disease in newborns and infants born during or entering their first RSV season.
It has also been approved for children up to 24 months of age who remain susceptible to severe RSV disease through their second RSV disease season.
Expected to be available this fall, the long-acting monoclonal antibody will be priced at US$495 per dose.
However, it will be offered at a reduced rate of US$395 through the US government’s Vaccines for Children program.
The ACIP, convening on August 3, delivered unanimous votes of approval for routine Beyfortus usage in specific age groups.
The committee recommended its use for newborns and infants below 8 months of age born during or entering their first RSV season, as well as for children aged 8 to 19 months who are at an elevated risk of severe RSV disease and entering their second RSV season.
While the votes marked a significant milestone, they were not without certain concerns. Some committee members raised questions about the cost and logistical challenges of deploying Beyfortus, particularly in rural areas.
Unlike traditional vaccines, which stimulate the body’s immune system to produce antibodies, Beyfortus represents a form of passive immunization.
This novel approach entails introducing protective antibodies into the body, ready to tackle the virus upon exposure.
Michael Greenberg, North America Medical Head of Vaccines at Sanofi, elucidated, “This allows for a lot of flexibility and timing so it can be given according to when the RSV season starts… and is designed to last through that and to be able to protect babies through that first RSV season.”
The significance of Beyfortus goes beyond medical advances; it addresses healthcare disparities, as certain racial and ethnic groups are disproportionately affected by RSV.
Recognizing this, the CDC recommended a second shot for American Indian and Alaska Native children who face significantly higher hospitalization rates due to RSV.
Nirsevimab, the long-acting antibody holds the potential to redefine infant care. It is not a vaccine but rather a protein designed to neutralize RSV and prevent its entry into cells. This marks a pioneering advancement in infant immunization strategies.
The ACIP’s endorsement also extends to the federally funded Vaccines for Children Program, ensuring equitable access to this groundbreaking immunization.
Along with the approval of Beyfortus, the FDA recently authorized vaccines from GSK and Pfizer to prevent lower respiratory tract disease caused by RSV in people ages 60 years and older.
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