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

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 Upstate NY

Pediatricians Are The First Line Of Defense In Protecting Kids Against RSV, But Without Adequate And Consistent Vaccine Supply, More Infants Could Get Infected; Thanks To Schumer’s Efforts More Doses Were Released Last Month, And Now, Senator Is Continuing His Push Calling On Feds And Manufacturers To Step Up To Ensure We Continue To Close Gap, Fix Supply Chain Issues And Make Sure Hard-Hit Communities Get Support They Need

Schumer: New RSV Immunization Can Be A Life Saver, But We Need To Make Sure Pediatricians Have Doses In Their Hands To Keep Our Kids Safe   

Standing at Rochester Regional Health’s Riedman Health Center 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 just last year, U.S. Senate Majority Leader Charles E. Schumer continued his two-pronged push in Rochester 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) and Food and Drug Administration (FDA), Schumer said it is imperative that with new doses being distributed, those vaccines get to pediatric clinics on the frontlines ASAP, like those in Upstate NY, who have been seeing vaccine shortages. Schumer said it is especially important to get these doses to pediatricians because they are the first line of defense in protecting children and most often where parents go first. 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. Schumer said thanks to his push, the CDC and FDA are working with drug manufacturers to address the shortage. Schumer said more doses went out just last month, but the feds need to continue to take action to work with doctors and make sure these shots get to the hardest hit communities across Upstate New York.

“Thanks to the revolutionary RSV vaccine that was released last year, we can protect our infants from RSV, but because demand for the vaccine is outpacing supply, pediatricians are having to tell concerned parents they don’t have the doses at their disposal to help their children fight this potentially deadly virus. Families are being told they have to wait weeks or months before they can protect their kids from RSV, creating long periods of worry that new parents should never, ever be subject to, while Rochester pediatricians are also rightfully concerned that without additional doses, RSV cases will spike, landing kids in the ICU and overwhelming nearby children’s hospitals,” said Senator Schumer. “Doctors should never have to make a choice between who gets a shot and who doesn’t, especially when a game changing vaccine should be easily at our fingertips. The feds need to continue to take action and release more doses ASAP, which is 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 ensure all new doses get where they are needed most, like our hard-hit Rochester pediatricians on the frontlines.” 

Schumer explained that the shortage has impacted all levels within the Rochester Finger Lakes New York healthcare community, from hospitals and outpatient pediatric center to private practitioners. According to Rochester Regional Health (RRH), despite ordering hundreds of doses of the children’s Beyfortus RSV immunization over months of procurement efforts, RRH only received a very limited supply of 20 initial doses and another 20 doses two weeks ago and 30 doses under the perinatal VFC (Vaccines For Children) program which is a federally funded program that provides vaccines at no cost to children who might not otherwise be vaccinated because of inability to pay.  35 of these doses have been used so far at just the Rochester General Hospital nursery and NICU.  RRH currently has no supply of the Beyfortus vaccine at RRH’s 12 outpatient pediatric clinics.  RRH delivered more 4,000 babies at their hospitals over the past year and all would be eligible for the RSV vaccine, but because of the very limited supply hospital and medical practitioners are being faced with triaging and rationing vaccine for the most needy children.

Schumer said even providers and hospitals with better luck in recently securing doses of the immunization have been plagued by inconsistent availability of the vaccine for months, including University of Rochester Medical Center.  Schumer said equitable and widespread access to the immunization is critical to ensure that Rochester Finger Lakes area health providers have adequate supplies of the RSV vaccine to help insure hospitals are not overwhelmed by RSV patients whose admission could be avoided.

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.”

Terra Keller, mother of 2-year-old Joey Keller said, “We know firsthand how serious and scary this illness can be and the toll it takes on a young family.  Joey and his twin sister were born early and before this vaccine was available and unfortunately Joey contracted a severe case of RSV when he was only 2-months old.  Joey was forced to be hospitalized for four days, and though he recovered, he continues to suffer from other respiratory issues including croup and we wonder if they could be lingering impacts from his RSV infection.  So we appreciate Senator Schumer’s push to make adequate doses of the Beyfortus RSV vaccine available to pediatricians for local children.  No child should have to endure RSV when there is now a vaccine available to safeguard kids from this life-threatening sickness.”

“We are thankful for Senator Schumer’s support and advocacy for some of our youngest patients whose immune systems are often not developed enough to fight an RSV infection,” said Dr. Robert Mayo, Medical Director for Rochester Regional Health.  “Being able to provide these proven treatments that help prevent life-threatening pediatric illnesses is critical to the mission of Rochester Regional Health to ensure equity in access to care through a comprehensive range of wellness, primary care, and specialty services conveniently close to home for our patients and their families.”

“The University of Rochester Medical Center is proud that our researchers have been leaders in the decades-long effort to develop safe and effective vaccines for RSV and other viral respiratory illnesses” said David C. Linehan, MD, CEO of the University of Rochester Medical Center and Dean of the School of Medicine and Dentistry. “We thank Senator Schumer for bringing attention to this important issue and pushing to ensure a consistent supply of monoclonal antibodies, so that all eligible children can be immunized against RSV and avoid unnecessary hospitalizations.” 

Schumer explained that according to Monroe County Health Department, over the past four months alone in Monroe County there have been 4,666 cases of RSV (1,974 of which are kids under 5 years old), with 471 hospitalizations and 9 deaths of individuals over 18 years old.  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 put 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 now those are being distributed. Schumer said while this is a critical step forward, manufacturers need to do more to get the doses out ASAP to the doctors and 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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