SCHUMER: MANY UPSTATE NY DOCTORS ARE FACING SHORTAGES OF NEW RSV IMMUNIZATION FOR KIDS, AND WITH RECENT COLD WEATHER INCREASING RISK FOR RESPIRATORY VIRUSES, SAYS WE NEED ACTION NOW; SCHUMER LAUNCHES TWO-PRONGED PLAN TO PUSH FEDS AND MANUFACTURERS TO GET ALL HANDS-ON DECK TO ADDRESS SHORTAGE AND DELIVER MORE DOSES FOR WNY PEDIATRICIANS AND FAMILIES TO COMBAT RSV

Respiratory Syncytial Virus Infection (RSV) Can Be Serious For Young Children, But The Brand New Potentially Lifesaving Medication Released Last Year For RSV Is Seeing Shortages Across Country, Including Western NY

With Respiratory Viruses Like RSV, Flu And COVID Facing Increased Risk During Cold Weather – Now Schumer Is Calling On Feds And Manufacturers To Step Up To Ensure We Stop These Shortages

Schumer: New RSV Immunization Can Be A Life Saver, We Need To Make Sure Pediatricians And Hospitals Have Support They Need To Keep Our Kids Safe  

Standing at Western New York Pediatrics with doctors, who like many across the country have faced shortages of the brand new, potentially lifesaving Respiratory Syncytial Virus Infection (RSV) immunization for kids that was released last year, U.S. Senate Majority Leader Charles E. Schumer today launched his two-pronged push calling on the feds and medicine manufacturers to get all hands on deck to ensure doctors across New York and America have the support they need to keep our kids safe.

In a letter to the Centers for Disease Control & Prevention (CDC), Food and Drug Administration (FDA), Schumer said first it is imperative that as new doses are expected to be released in early 2024 that those vaccines get to pediatricians on the frontlines, like those in Western NY, who have been seeing these shortages ASAP, especially as recent severe cold weather has increased risk for respiratory viruses. Secondly, the senator said it is vital the drug manufacturers work with all levels of the federal government to ramp up supply now, fix supply chain issues so that all those who need the vaccines are able to get it.

“The release of a brand-new immunization for RSV last year was a gamechanger in the fight against this disease that often terrifies new parents and puts our youngest children at risk. But with recent winter weather increasing risk for respiratory viruses, Western New York pediatricians and parents are justifiably nervous as we have already seen supply not able to meet the demand and we need action now,” said Senator Schumer. “Parents and doctors should never have to scramble to ensure our children can get a vaccine from RSV. That’s why I’m calling on the CDC, FDA and drug manufacturers to get all hands-on deck and work overtime to release more doses of this vital treatment, and to ensure all new doses get where they are needed most, like our hard-hit Western NY pediatricians on the frontlines.” 

Schumer added, “As a grandfather to three young children, there is nothing more terrifying than the thought of them getting sick, and a parent should never have to hear there isn’t enough medicine to keep their kid healthy and safe. We must do more to prevent future shortages, and manufacturers need to bolster work with federal partners to optimize their supply chains to make sure families can access this essential vaccine”

"Western New York Pediatrics, within Medical Health Associates of Western New York (MHA), stands at the forefront of pediatric care, covering a vast region and serving a patient roster of 55,000 individuals. As we strive to follow the American Academy of Pediatrics' recommendations for widespread vaccination, our ability to administer only 29% of the recommended doses due to supply issues is deeply concerning”, said Chris Tirabassi, CEO of Medical Health Associates of Western New York. “In this challenging time, we express our gratitude to Senator Charles Schumer for his steadfast advocacy. We urge the CDC to collaborate with manufacturers and expedite the distribution of the RSV vaccine. Swift action is imperative to ensure equitable access and prevent further disruptions in the vaccination process.”

“Due to the limited availability of RSV shots, our staff was placed in the difficult situation of having to decide which babies would have the opportunity to receive the medication”, said Dr. Colleen Mattimore, MD, of Western New York Pediatrics. “It is unfair to have to ration shots for the most at-risk babies when babies are already more susceptible to RSV than most age groups. I have had to send babies to the ER to be treated for respiratory distress due to this shortage. We need to work together to remove this burden from medical practices, medical staff, and parents. Most importantly we need to work together to ensure that there is enough medication available for all eligible babies. We appreciate Senator Schumer coming here today to help advocate for us and our patients.”

Each year, about 1 in 50 infants are hospitalized with RSV before their first birthday, a number of whom end up in an intensive care unit due to the severity of their infection. However, the new preventive antibody treatment is shown to reduce the risk of RSV-related complications by more than 70 percent.

“Before last year, parents of young children – especially children born premature or with respiratory issues – largely had nothing to do except pray their child did not get RSV. If they did, in many cases the result was hospitalization, with their child hooked up to oxygen, doctors monitoring their breathing round the clock,” Schumer said. “Thankfully, the new RSV preventive antibody treatment is shown to significantly reduce the risk of severe RSV by more than 70 percent, and that is why it is critical we ensure it is easily accessible and available across Upstate New York.”

The Biden Administration has already been putting pressure on RSV vaccine makers to address this problem. Last month the White House announced an additional 230,000 more doses of the RSV shot for infants would become available and those are expected to be distributed soon, and Schumer said while this is a critical step forward, manufacturers need to do more to get additional doses out ASAP to the hospitals that are most in need.

A copy of Schumer’s letter to the CDC and FDA appears below and letter to drug manufacturers can be found below:

CC:

Robert Califf, Commissioner, Food and Drug Administration

AstraZeneca

Sanfoi

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.

Sincerely,

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