The CDC Alerts Clinicians About Short Supply of Monoclonal Antibody Treatment for RSV in Infants
The Centers for Disease Control and Prevention (CDC) issued a health advisory on Monday, notifying clinicians about the limited availability of monoclonal antibody treatment for respiratory syncytial virus (RSV) in infants. With an increase in demand, the CDC recommends prioritizing the use of 100-milligram doses of the monoclonal antibody nirsevimab for infants under 6 months old and those with underlying conditions.
In its health advisory, the CDC suggests reserving 50 milligram nirsevimab doses for infants weighing less than 11 pounds. Additionally, the use of nirsevimab should be suspended for infants eligible for palivizumab, another monoclonal antibody for RSV. However, the CDC emphasizes that nirsevimab should still be offered to American Indian and Alaska Native children aged 8–19 months who are not eligible for palivizumab and live in remote regions where accessing medical care for severe RSV is challenging.
Nirsevimab, marketed as Beyfortus, is manufactured by AstraZeneca and marketed by Sanofi. It was approved by the Food and Drug Administration (FDA) in July to prevent RSV disease in infants. According to the CDC, Beyfortus has been proven to reduce the risk of hospitalizations and healthcare visits for RSV in infants by about 80 percent.
Sanofi has acknowledged the unprecedented demand for Beyfortus and is working with AstraZeneca to expedite additional supply and expand the manufacturing network.
Increase in RSV Cases
The CDC recently warned about a rise in RSV cases in certain parts of the southeastern United States, indicating a return to pre-pandemic seasonal trends. Historically, regional increases have preceded a national surge in RSV activity over the following months. From August 5 to August 19, RSV-related hospitalizations increased significantly, particularly among infants under a year old.
In response to this surge, the CDC urges clinicians to prepare for the upcoming RSV season by implementing new prevention options, including administering monoclonal antibody products and nirsevimab as a preventative treatment.
A 1981 electron microscope image of a human respiratory syncytial virus (RSV). (Centers for Disease Control and Prevention via AP)
RSV is a virus that causes acute respiratory infection in individuals of all age groups. While most infants and young children experience mild symptoms similar to a cold, some infants, especially during their first infection, may develop more severe lower respiratory tract conditions such as pneumonia and bronchiolitis. RSV hospitalizes over 58,000 children under the age of 5 in the United States each year, with approximately 100 to 300 deaths in this age group.
RSV is transmitted through close contact with infected individuals and typically spreads seasonally, starting in the fall and peaking in the winter in most regions of the United States.
Katabella Roberts contributed to this report.
What is the significance of the shortage of monoclonal antibody treatment for RSV in infants?
Italization due to severe RSV by 70% in infants.
The shortage of monoclonal antibody treatment for RSV in infants is concerning, especially considering the increased demand for these treatments. RSV is a common respiratory virus that can cause severe illness in infants, particularly those born prematurely or with underlying health conditions. It is important to prioritize the use of available doses to ensure infants at the highest risk receive the necessary treatment.
The CDC’s recommendation to prioritize the use of 100-milligram doses of nirsevimab for infants under 6 months old and those with underlying conditions is based on the efficacy of this treatment in reducing the risk of hospitalization. By reserving 50 milligram doses for infants weighing less than 11 pounds, healthcare providers can ensure the appropriate dosage is given to this specific population.
It is also crucial to suspend the use of nirsevimab for infants eligible for palivizumab, another monoclonal antibody for RSV. This allows for the optimal use of available treatments and prevents potential overdose or adverse reactions. However, the CDC acknowledges the unique circumstances of American Indian and Alaska Native children aged 8-19 months living in remote regions where access to medical care for severe RSV is challenging. In these cases, nirsevimab should still be offered as an alternative preventive measure.
The approval of nirsevimab by the FDA in July was a significant development in the prevention of RSV disease in infants. It provided healthcare providers with an additional tool to protect vulnerable infants from severe illness. The shortage of this treatment raises concerns about the potential impact on infant health and the ability to adequately respond to the rising cases of RSV.
Healthcare organizations, manufacturers, and regulatory bodies should collaborate to address the shortage of monoclonal antibody treatment for RSV. This may involve increasing production capacity, exploring alternative treatment options, and implementing measures to ensure equitable distribution. It is crucial to prioritize the health and well-being of infants by ensuring access to life-saving treatments.
In conclusion, the CDC’s alert regarding the limited availability of monoclonal antibody treatment for RSV in infants highlights the importance of careful allocation and prioritization. Healthcare providers must adhere to the CDC’s recommendations to ensure that infants at the highest risk receive the necessary treatment. Efforts should be made to address the shortage and ensure the availability of these life-saving treatments for all infants in need.
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