The Centers for Disease Control and Prevention (CDC) on Monday alerted clinicians about the short supply of monoclonal antibody treatment for respiratory syncytial virus (RSV) in infants amid an uptick in demand.
In its health advisory, the CDC recommended using 100 milligram nirsevimab doses for babies weighing 11 pounds and with underlying conditions owing to the “limited supply during the 2023–2024 RSV season.”
The agency also advised doctors to reserve 50-milligram nirsevimab doses for infants weighing less than 11 pounds. It further recommended suspending the use of nirsevimab among infants eligible for palivizumab, which is another monoclonal antibody for RSV.
However, it stated that nirsevimab should continue to be offered to American Indian and Alaska Native children aged 8–19 months who are not palivizumab-eligible and live in remote regions, where transporting children with severe RSV for medical care is more challenging.
Nirsevimab, sold under the brand name Beyfortus, is made 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, Beyfrotus has been proven to reduce the risk of hospitalizations and health care visits for RSV in infants by about 80 percent.
Sanofi said in a statement that it was working with AstraZeneca to expedite additional supply of Beyfortus and explore ways to extend the manufacturing network in order to meet the “unprecedented demand.”
“For the first time in history, health care providers are able to help protect an extraordinary number of infants against respiratory syncytial virus (RSV) disease.
“Despite an aggressive supply plan built to outperform past pediatric vaccine launches, demand for this product, especially for the 100mg doses used primarily for babies born before the RSV season, has been higher than anticipated,” the company said.
Increase in RSV Cases
The CDC warned last month about an increase in RSV cases across some parts of the southeastern United States, which indicated “a continued shift toward seasonal RSV trends observed prior to the COVID-19 pandemic.”“Historically, such regional increases have predicted the beginning of RSV season nationally, with increased RSV activity spreading north and west over the following 2–3 months,” it said in a Sept. 5 health advisory.
From Aug. 5 through Aug. 19, the rate of RSV-related hospitalizations increased from 2 in 100,000 kids aged 4 and younger, to 7 per 100,000, with the majority of those hospitalizations being in babies less than a year old, the CDC said.
In response to the rise in cases, the health agency has urged clinicians to “prepare to implement new RSV prevention options” ahead of the 2023–2024 RSV season, including administering shots of monoclonal antibody products to patients as well as a preventative antibody treatment called nirsevimab.
RSV is a virus that causes acute respiratory infection in individuals of all age groups. Early symptoms of RSV can include a runny nose, a decrease in appetite, coughing, and wheezing.
While most infants and young children exhibit mild, cold-like symptoms, some infants, especially with their first infection, may develop more serious lower respiratory tract conditions such as pneumonia and bronchiolitis, according to the FDA.
More than 58,000 children under the age of 5 in the United States are hospitalized each year owing to RSV, most of whom are infants, and require oxygen and intravenous fluids. About 100 to 300 children below 5 years old die owing to RSV every year, according to the CDC.
RSV is transmitted through close contact with an infected individual. The spread of the virus is seasonal, usually beginning in the fall and peaking in the winter in most regions of the United States.
