SCHUMER: AS UPSTATE NY PEDIATRICIANS FACE SHORTAGES OF NEW RSV IMMUNIZATION FOR KIDS, SENATOR CALLS FOR ACTION NOW; SCHUMER PUSHES HIS TWO-PRONGED PLAN FOR FEDS AND MANUFACTURERS TO GET ALL HANDS-ON DECK TO ADDRESS SHORTAGE AND DELIVER NEEDED DOSES FOR ROCHESTER & FINGER LAKES PEDIATRICIANS AND FAMILIES TO COMBAT RSV

Letter

Dear Director Cohen:

I am writing with concerns about the persistent shortages of pediatric immunizations for respiratory syncytial virus (RSV). In preparation for a new release of doses of nirsevimab, or Beyfortus, I urge the Centers for Disease Control & Prevention (CDC) to coordinate with all federal partners to take action and avoid future shortages of this important immunization. I also call on the CDC to ensure equitable distribution of the new doses of Beyfortus to ensure that pediatricians have the tools they need to keep families across New York and the country safe.

The Food and Drug Administration (FDA) first approved the immunization, Beyfortus, in July 2023 in preparation for the 2023-2024 respiratory virus season. Throughout the fall of 2023 there were widespread reports of pediatricians unable to order Beyfortus.[i] Total RSV cases peaked in 2023 at the end of October and early November, following weeks of reported shortages.[ii] At the end of October 2023, the manufacturers of the Beyfortus, Sanofi and AstraZeneca, issued a statement acknowledging that unprecedented demand had outstripped supply and caused the shortages.[iii]

The recognition that the available supply of nirsevimab was not sufficient to protect all eligible children led to interim recommendations to limit who was eligible to receive the RSV immunization, frustrating pediatricians and parents alike. While we were glad to see the CDC and FDA announcement to expedite availability of 77,000 additional doses of Beyfortus in mid-November, it soon became clear that this step was not enough.[iv] In New York, pediatricians have been forced to make challenging decisions about providing the immunization, which has left many families feeling like they have nowhere to turn to protect their families from RSV.[v],[vi]

We appreciate the efforts of the manufacturers in partnership with the CDC and FDA to address the issue, particularly by the release of an additional 230,000 doses of the RSV immunization for infants.[vii] These forthcoming doses are an opportunity to provide peace of mind to thousands of families. The CDC’s updated guidelines around who should receive the immunization will also put increased strain on overall supply.[viii] I urge you to closely track the distribution process through the Vaccines for Children program to guarantee that communities are receiving the doses they need. Especially, as the recent severe winter weather and snowstorms have put communities across the Northeast, like those in Upstate New York, at increased risk for respiratory viruses, it is critical that doses be distributed equitable to help hard hit communities ensure the safety of our children.

Moreover, it’s imperative that manufacturers work closely with the CDC and FDA develop a proactive strategy to anticipate the possibility of future immunization shortages and distribution vulnerabilities. Anticipating spikes in demand will enable manufacturers to adequately prepare to ramp up supply. Such coordination is essential for manufacturers to streamline their supply chain and facilitate effective distribution. Pediatricians and hospital systems are predicting that RSV cases will remain high along with COVID-19 and influenza following the holidays.[ix] Immunization is recognized as the best protection against pediatric RSV, and we can’t let this important tool go unused. I look forward to working with you to support work to mitigate pediatric RSV shortages and other important immunizations. Thank you for your commitment to this issue.

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