The Centers for Disease Control and Prevention (CDC) has recently announced the release of more than 77,000 additional doses of Beyfortus™ (nirsevimab-alip (100 mg)), a long-acting monoclonal antibody designed to protect infants against severe respiratory syncytial virus (RSV) disease. These additional doses will be immediately distributed to physicians and hospitals through the Vaccines for Children Program and commercial channels.
This move is aimed at improving the availability of nirsevimab-alip for parents seeking to protect their eligible children, particularly those at the highest risk of severe illness. The CDC and the Food and Drug Administration (FDA) have pledged to maintain close contact with manufacturers to ensure the availability of additional doses through the end of this year and into early 2024 to meet demand.
“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 Dr. Nirav D. Shah, CDC’s principal deputy director.
Patrizia Cavazzoni, M.D, director of the FDA’s Center for Drug Evaluation and Research, echoed this sentiment, stating, “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 healthcare system remains a priority.”
The CDC has taken measures to make the immunization more accessible for doctors to order through the Vaccines for Children program, which provides vaccines to half of America’s children.
Additionally, the CDC and FDA have been engaging with groups such as the American College of Obstetricians and Gynecologists, encouraging more doctors to use the RSV maternal vaccine. This can help ensure babies are protected against RSV before they are born.
Furthermore, the CDC has been in regular contact with clinicians across the country, urging them to prioritize nirsevimab-alip for infants at highest risk during this period of constrained supply. This includes young infants up to six months old and American Indian and Alaska Native infants, among other groups.
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