FDA, CDC Increase Availability of RSV Monoclonal Antibody for Infants
The federal agencies said that they will continue to work closely with manufacturers to maintain the availability of the vaccines through the end of 2023 and early 2024 to meet the demand during the RSV season.
The Centers for Disease Control and Prevention (CDC), along with the FDA, have announced the availability of more than 77,000 doses of nirsevimab-alip (Beyfortus; Sanofi), which are being immediately distrusted to hospitals and physicians through the Vaccines for Children Program, as well as through commercial channels.
Nirsevimab-alip is a monoclonal antibody approved by the FDA to protect infants against severe respiratory syncytial virus (RSV).
“Helping to ensure the availability of this preventative option to reduce the impact of RSV disease on eligible babies and young children, families and the health care system remains a priority,” said Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, in a press release.1 “We will continue to use all our regulatory tools to help bring safe, effective and high-quality medicines to the public.”
The federal agencies said that they will continue to work closely with manufacturers to maintain the availability of the vaccines through the end of 2023 and early 2024 to meet the demand during the RSV season.
The CDC and FDA are also working with the American College of Obstetricians and Gynecologists, to encourage health care providers to use the RSV maternal vaccine. This immunization can help safeguard infants against RSV prior to birth.
Additionally, the CDC has been urging clinicians to administer the infant vaccine to patients at the highest risk of infection during this shortage period, including infants up to 6 months, as well as American Indian and Alaska Native infants.
“CDC and FDA are committed to expanding access to this important immunization so that more parents have peace of mind during the winter virus season,” said Nirav D. Shah, MD, JD, CDC’s principal deputy director.1
This article originally appeared on Contemporary Pediatrics.
Reference
1. CDC and FDA Expedite the Availability of Additional Doses of New RSV Immunization for Infants. CDC. November 17, 2023. Accessed November 17, 2023. https://www.cdc.gov/media/releases/2023/p1116-rsv-doses.html
