In a move to enhance the defense against severe respiratory syncytial virus (RSV) disease in infants, the Centers for Disease Control and Prevention (CDC) has revealed the release of over 77,000 additional doses of Beyfortus™ (nirsevimab-alip 100 mg), a long-acting monoclonal antibody.
These extra doses will swiftly reach physicians and hospitals through both the Vaccines for Children Program and commercial channels. This distribution aims to bolster the availability of nirsevimab-alip, particularly for parents with eligible children, especially those at a higher risk of severe illness.
The CDC and the Food and Drug Administration (FDA) have assured ongoing coordination with manufacturers to secure a steady supply until the end of the year and into early 2024, aligning with the increasing demand.
Dr. Nirav D. Shah, CDC’s principal deputy director, emphasized the commitment to expanding access to this vital immunization, providing parents with peace of mind during the winter virus season. Patrizia Cavazzoni, M.D, director of the FDA’s Center for Drug Evaluation and Research, affirmed the agencies' dedication to utilizing regulatory tools to ensure the availability of safe, effective, and high-quality medicines.
To facilitate accessibility, the CDC has simplified the process for doctors to order the immunization through the Vaccines for Children program, benefiting half of America's children. Additionally, collaborative efforts with organizations such as the American College of Obstetricians and Gynecologists aim to encourage more doctors to administer the RSV maternal vaccine. This approach helps protect babies against RSV before birth.
Moreover, the CDC has maintained regular communication with clinicians nationwide, urging them to prioritize nirsevimab-alip for infants at the highest risk. This includes infants up to six months old and specific groups such as American Indian and Alaska Native infants. The collective efforts underscore the commitment to mitigating the impact of RSV disease on vulnerable populations.
