USA – In response to a critical shortage of Beyfortus, a monoclonal antibody developed by Sanofi and AstraZeneca to protect infants from respiratory syncytial virus (RSV), the Centers for Disease Control and Prevention (CDC) has taken swift action.
Late Thursday, the CDC expedited the release of over 77,000 additional doses of the drug, which gained approval in August.
This move is crucial as RSV cases surge in certain regions of the United States just ahead of the holiday season.
Beyfortus is one of the two available treatments in the U.S. designed to safeguard infants from RSV, a leading cause of infant hospitalization nationwide.
The shortage of Beyfortus has posed challenges for hospitals and pediatricians, with Sanofi attributing the supply issues to “unprecedented demand.”
This scarcity, coupled with insurance coverage complications, poses a significant threat, preventing infants from receiving essential protection against RSV.
Respiratory syncytial virus is a common respiratory infection causing mild, cold-like symptoms but can lead to severe cases in children and older adults.
Annually, RSV claims the lives of a few hundred children under 5 and results in 6,000 to 10,000 deaths among seniors, according to CDC statistics.
Additionally, the virus causes 58,000 to 80,000 hospitalizations among children under 5 each year. The expedited release of over 77,000 doses aims to address the immediate demand for the drug.
The CDC announced that the additional doses will be promptly distributed to physicians and hospitals through commercial channels and the Vaccines for Children Program. This program covers the cost of shots for uninsured and underinsured children.
The agency, in collaboration with the Food and Drug Administration (FDA), will maintain close communication with drug manufacturers to ensure a continuous supply of additional doses through the end of 2023 and early 2024.
Dr. Nirav Shah, the CDC’s principal deputy director, emphasized their commitment to expanding access to this critical immunization, providing parents with peace of mind during the winter virus season.
The recent spike in RSV cases, exceeding 5,000 in the week ending Nov. 4, signals a concerning trend. The U.S. experienced an unusually severe RSV season last year as the public relaxed Covid pandemic health measures that had previously kept RSV spread in check.
As hospitals and healthcare providers grapple with the rising demand for RSV treatments, the CDC’s rapid response and the release of additional doses are crucial steps to ensure the protection of infants during a period of heightened risk.
The ongoing collaboration with drug manufacturers and the commitment to meeting demand through early 2024 underscore the significance of addressing this public health challenge.