01.14.19

SCHUMER REVEALS: IN MIDST OF SHUTDOWN, CENTRAL NEW YORK IS EXPERIENCING ALARMING SHINGLE SHOT SHORTAGE THAT LEFT UNSOLVED COULD SICKEN MANY & SPREAD CHICKENPOX VIRUS THIS WINTER; SENATOR URGES EMERGENCY FDA STAFF TO STEP IN, HELP REMEDY SHORTAGE WITH MANUFACTURER & IMPROVE COMMUNICATION WITH LOCALS NOW IN DARK

Despite Government Shutdown, FDA Has Essential Staff That Senator Says Can Help Alleviate Area Shortage Of Shingles Vaccine—Shingrix—Which is Extremely Effective Against Virus; CNY Pharmacies Like Burnet Pharmacy Are Totally Out Of Vaccine

Schumer Says FDA Should Consider Shortage An Emergency, Expedite Regulatory Hurdles To Address It & Urge Prioritized Shipments To States Like NY, Where Population Can Increase Risk Of Virus Spread Faster

Schumer: Shingle Shot Shortage Is A Public Health Crisis We Should Be Able To Avert In CNY

In the midst of a needless government shutdown that has forced the federal Food and Drug Administration (FDA) to shutdown, with the exception of essential staff, U.S. Senator Charles Schumer revealed today that Central New York is experiencing an alarming shortage of the Shingles vaccine, that left unsolved, could result in many people getting Shingles or spreading the chickenpox virus to others this winter.

“To think that in the midst of a shingle shot vaccine shortage across Central New York, that the FDA is shutdown, is a worrisome thought and a problem that must be addressed,” said Senator Schumer. “The shingle shot shortage across Syracuse and Central New York is a two-pronged worry because not only does a shortage mean more people might suffer the painful and harmful shingles virus itself, but it means that young people, particularly babies and children, even those with compromised immune systems who have never had chickenpox themselves, are at a greater risk to communicate the bug. That’s why I am urging the FDA to go above and beyond, to do whatever it can, amidst this needless shutdown and pull out all the stops to step in and help remedy this shortage before it becomes a full-on crisis.”

Schumer, today, publicly pushed emergency FDA staff still working amidst the shutdown to:

1)     Consider this shortage an emergency.

2)     Step in more directly and work as a go-between between the manufacturer and others to ensure locals know when new shipments will arrive, and how to best publicize the news.

3)     Expedite any and all regulatory hurdles that might prevent shipments of the already-approved vaccine from making its way to the U.S. as fast as possible.

4)     Prioritize shingles vaccine shipments to New York and other states with higher populations because the risk of spreading the communicable chickenpox virus which emerges through the shingles virus is highest among populated states, including New York.    

Schumer said that this Shingle shot shortage warrants some of the FDA’s essential agency staff to step in and help remedy the problem with the manufacturer, and most importantly, improve communication with locals who are currently in the dark in terms of when new shipments of the vaccine will arrive locally. The Senator was joined by pharmacists, doctors and residents waiting on the vaccine.

The Senator and local officials and residents further detailed the impacts of the shortage and the risks as they made the case for the FDA to go above and beyond in helping to rectify the situation.  

The vaccine, Shingrix, approved last year to prevent shingles, has been in high demand since GlaxoSmithKline (GSK), the manufacturer of the vaccine, came out with its shingles vaccine that is 90% effective, while others were much less effective, as low as 40%. There is a shortage of GlaxoSmithKline (GSK) shingles vaccine because not enough was produced to meet the high demand for the uniquely effective vaccine.

Many people, especially older adults, do not understand the seriousness of shingles and the complications that could arise with the virus, especially in the spread of the communicable chickenpox virus. The shingles vaccine, which reduces the chances of an older adult getting shingles, and reduces the severity of complications and spread of chickenpox, is recommended for most people over 50. However, people are finding it extremely difficult to get in Syracuse and Central New York.

"The Pharmacists Society of the State of New York applauds Senator Schumer for his continued focus on the Shingrix shortage.  The shortage is very concerning.  Orders are placed, allocations to pharmacies are cut or shipments are not received.  Shingrix is a two-dose vaccine and due to the shortage many patients have been unable to receive the second vaccination.  The shortage causes healthcare costs to increase as patients are forced to repeat the regimen.  We are concerned about the elderly and also children because of the risk of spreading the virus," said Debbi Barber, Pharmacist Society of the State of New York President.  

“The Pharmacists Society of the state of NY applauds Senator Schumer for his focus on the Shingrix vaccine shortage. This is concerning since pharmacies will place orders, and they are either cut, allocated, or shipments are not received at all. Shingrix requires two injections, so the shortage makes it difficult for the pharmacist and patient to coordinate the second injection.  Timing is important, so the patient gets the most effective coverage from their vaccination.  Shingles can be very painful and debilitating to patients, especially with lowered immunity,” said Roxanne Hall Richardson, RPh Onondaga County Pharmacists Society Chairwoman.

“Due to the federal government shutdown, the FDA has only 60% of their staff working and thus, cannot meet the demands for more Shingrix vaccines. This two-dose vaccine's effectiveness is almost double the older version of the shingles vaccine: Zosatavax. Shingrix prevents the onset of herpes zoster or shingles, a painful disease. This is especially important in those over 50, such as the baby boomer generation, because they are more vulnerable to the virus reactivating. As a health care provider, I hope resolution is reached regarding the federal government shutdown for the benefit of public health and our citizens,” said Ahmad Hamad, RPh, Owner Burnet Pharmacy.

Schumer explained that the lack of communication between pharmacies, doctors’ offices, and the manufacturer of the vaccine, GSK, could be better, which leaves patients, doctors, and pharmacies alike in the dark about when the next shipment of Shingrix will arrive. Reports indicate that the wait time for the vaccine may depend on where you live and other factors such as large pharmacy chains’ ability to move supply around. But even in Syracuse, finding the vaccine proves far more difficult than it should.   

Shingles is an extremely painful and debilitating rash that can lead to even more severe complications. The virus (also called herpes zoster) occurs when the varicella-zoster virus (VZV)—the same virus that causes chickenpox—is reactivated in the body. The varicella-zoster virus remains in the body for life and older people are more susceptible to shingles because their immunity to the virus declines at the cellular level. Aside from the painful rash, shingles can produce typical virus symptoms including chills, fever, upset stomach or headache and also spread communicable chickenpox.  

The Centers for Disease Control and Prevention has stated that there is a shortage of GSK’s Shingrix vaccine due to high levels of demand. As a result of this shortage, GSK has implemented order limits and providers have experienced shipping delays. The CDC has reported that order limits and shipping delays are likely to continue throughout 2019. Schumer explained that this uncertainty regarding the timing of shipments is extremely concerning to the adults at risk of contracting the virus and spreading the communicable VZV chickenpox virus to those who have never had the ailment or have a compromised immune system.  

While GSK plans to make even more doses available in the US in 2019, the communication between all entities needs to be improved immediately, Schumer argues. The CDC has issued a message to protect older adults from shingles by providing “did-you-know?” facts regarding the disease.

These facts include:

  • There are about a million new cases of shingles each year in the United States.
  • Anyone who has had chickenpox can get shingles. That means 95% of adults are at risk.
  • While you cannot spread shingles, one can spread the chickenpox virus at the same time.
  • Approximately one-third of the U.S. population will get shingles. The risk rises after 50 years of age. Half of people living to age 85 have had or will get shingles.
  • Among those who get shingles, more than one-third will develop serious complications. The risk of complications rises after 60 years of age.

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