SCHUMER: AS CENTRAL NY PEDIATRICIANS FACE SHORTAGES OF NEW RSV IMMUNIZATION FOR KIDS, SENATOR CALLS FOR ACTION NOW; SCHUMER LAUNCHES TWO-PRONGED PLAN FOR FEDS AND MANUFACTURERS TO GET ALL HANDS-ON DECK TO ADDRESS SHORTAGE AND DELIVER MORE DOSES FOR SYRACUSE & CNY 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 Central 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; Schumer Says Feds And Manufacturers Need To Step Up To Ensure We Stop These Shortages, Fix Supply Chain Issues And Make Sure Hard-Hit Communities Get Support They Need

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

Standing at SUNY Upstate Medical University 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 has launched his two-pronged push in Syracuse 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 Central 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.

“The release of a brand-new RSV vaccine last year was a gamechanger, but with demand for the vaccine currently outpacing supply, doses aren’t getting into the hands of pediatricians that need them most, rightfully worrying Central New York doctors and families. Without additional doses, doctors are concerned RSV cases will spike, landing kids in the ICU and overwhelming nearby children’s hospitals, when access to a vaccine could easily prevent this type of tragic situation,” said Senator Schumer.  “Doctors should never have to make a choice between who gets a shot and who doesn’t, or tell parents they have to wait weeks or months to protect their kid from this potentially deadly virus, which is why the feds need to take action now and release more doses ASAP. 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 Central NY pediatricians on the frontlines.” 

Schumer explained that the shortage has impacted all levels Central New York healthcare, from community health centers to hospitals to private practitioners. According to Syracuse Community Health (SCH), despite ordering hundreds of doses of the children’s RSV immunization over months of procurement efforts, SCH has received 30 total doses. To date, SCH has received a delivery of just 10 doses of the 100 mg formulation, critical for many of the sickest and highest risk children. SCH Interim President and CEO Dr. Ofrona Reid said SCH sees 20-30 babies per day that are in need of the RSV immunization, but SCH’s highly limited supply prevents providers from immunizing all but a select few children. Syracuse-area private practice Pediatric Associates has faced similar difficulty acquiring the 100 mg formulation. Pediatric Associates received 20 doses of the 100 mg formulation early in the respiratory season but has not been able to obtain more since.

Schumer said even providers and hospitals with better luck securing doses of the immunization have been plagued by shortages, including Golisano Children’s Hospital and Crouse Health. Schumer said equitable and widespread access to immunization is critical to ensure that Golisano’s beds, the only pediatric intensive care unit serving a 22-county region, which operate as a regional backstop for the sickest pediatric patients, are not depleted 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”

“As the mother of a child who suffered through Luekemia, Trisomy 21, COVID-19, and RSV over his first three years of life, I have been fighting to protect Gary from RSV for as long as I can remember. When Beyfortus became available for Gary, we leaped at the opportunity. Without it, had Gary contracted RSV again, we’re not even sure he would be with us today,” said Melanie Berry, mother of Gary Berry. “No mother should ever have to watch their baby nearly die from RSV like I did. No mother should have to struggle to access a life-saving treatment for their child like I did. Mothers of sick children need advocates, and it means the world to my family that Senator Schumer is fighting for all the mothers and sick children out there.”

“For over 40 years, Syracuse Community Health’s mission has been to provide high quality healthcare to our patients, particularly to those that are uninsured, underinsured, disadvantaged or otherwise excluded from traditional healthcare. Recognizing the diverse needs of our patients and community, SCH administers healthcare through the lens of equity and social justice. That is why our protracted struggle securing the new children’s RSV immunization is so concerning,” said SCH Interim President and CEO Dr. Ofrona Reid. “SCH routinely sees 30 children a day who need the RSV immunization. Unfortunately, the 30 total doses SCH has received to date pales in comparison to our need, highlighting gross inequity in the distribution of and access to the immunization. On behalf of SCH and the Onondaga County healthcare community, I would like to thank Senator Schumer for fighting to increase access to this critical immunization, and I am proud to support him in this valiant effort.”

“On behalf of the remarkable caregivers, researchers and staff at SUNY Upstate Medical University, including the dedicated professionals at Upstate Golisano Children’s Hospital, we are grateful for Senator Schumer’s consistent leadership in pressing for better availability of treatments that are proven to reduce the incidence and severity of life-threatening pediatric illnesses like RSV,” said Upstate Medical University President Dr. Mantosh Dewan. “We are proud that scientists at Upstate have been part of the international effort to develop these incredible medical breakthroughs, but they only can be effective if parents have reliable access to them.

Onondaga County Executive Ryan McMahon said, "The health and wellbeing of our community, especially our children, is among my top priorities. Onondaga County is fortunate to have a robust medical infrastructure, but in order to successfully serve our community they must have access critical resources like the RSV immunization." McMahon continued, "Thank you to Senator Schumer for his leadership and efforts to ensure that our local pediatricians and hospitals receive more doses of the new RSV immunization as quickly as possible."

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. During clinical trials, the breakthrough RSV immunization was first tested on three babies at Golisano Children’s Hospital by Upstate pediatrician Dr. Joseph Domachowske who spent decades researching RSV interventions. The babies tested at Golisano, which were the only babies in the northern hemisphere to be part of the first phase of clinical trials, all received the actual immunization rather than a placebo and none developed RSV or had adverse reactions.

“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 those have just begun to be distributed, and Schumer said while this is a critical step forward, manufacturers need to do more to get additional 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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