The Centers for Disease Control and Prevention's advisory committee voted unanimously to recommend the use of an injectable Respiratory Syncytial Virus (RSV) drug for two groups of infants. This decision marks a significant step forward in protecting vulnerable infants from severe RSV disease.
The drug, known as Beyfortus, acts like a vaccine, delivering antibodies directly into the bloodstream via passive immunization. With up to 80,000 hospitalizations and 300 deaths each year among children under age 5 due to RSV, this new measure offers hope for reducing the impact of the virus on infants.
Beyfortus Approved for High-Risk Infants
According to CNN, the advisory committee's recommendation comes as a ray of hope for parents of infants born during or entering their first RSV season, usually starting in October.
The first group recommended to receive the RSV shot includes babies up to 8 months old. The second group consists of infants aged 8 to 19 months who are at heightened risk of severe RSV disease and are entering their second RSV season.
Newborns born shortly before or during the RSV season should ideally receive the shot in their first week of life. RSV is a prevalent cause of respiratory illness in infants and leads to yearly outbreaks affecting children of all age groups.
According to the CDC, each year, a considerable number of young children, particularly infants, are admitted to hospitals across the country due to RSV infection, with estimates ranging from 58,000 to 80,000.
These hospitalizations often necessitate interventions such as oxygen therapy, intravenous fluids, or mechanical ventilation. Tragically, RSV claims the lives of approximately 100 to 300 children under the age of 5 annually.
Beyfortus, a novel long-acting monoclonal antibody product, has demonstrated remarkable success in reducing the risk of RSV-related hospitalizations and healthcare visits in infants by an impressive 80%.
By introducing this immunization, infants can receive the protective benefits of antibodies, safeguarding them against severe RSV disease.
Road to CDC's Formal Recommendation
The injectable RSV drug Beyfortus, manufactured by AstraZeneca and marketed by Sanofi, was approved by the Food and Drug Administration (FDA) last month.
According to NBC News, the drug is already available in Europe, Canada, and the United Kingdom, and it is expected to be available in the United States before the onset of the 2023-2024 RSV season.
A study of nearly 1,500 infants revealed that Beyfortus significantly reduces the risk of developing an RSV-related respiratory illness, necessitating a doctor's visit by nearly 75% for at least five months.
This represents a pivotal advancement in mitigating the impact of the virus, which remains the primary cause of hospitalization among infants in the United States.
Despite the positive development, concerns have been raised about the cost of the RSV shot. The expected price for Beyfortus is $495, which has garnered criticism from some experts.
However, the CDC's Vaccines for Children Program will cover the shot, ensuring accessibility for uninsured, underinsured, Medicare-eligible, American Indian, or Alaska Native children.
RSV is known to cause lower respiratory illness, which is generally mild but can lead to severe conditions like pneumonia or bronchiolitis, particularly among older adults and infants under 6 months old.
While RSV-specific drugs and vaccines have been limited in the U.S. until now, the recent approval of Beyfortus and other RSV vaccines for older adults signals progress in combating this virus.
