Senator Schumer ‘May Have It Wrong Regarding Shingrix’
New York Senator Chuck Schumer recently raised red flags regarding the nationwide shortage of GlaxoSmithKline’s (GSK) ultra-popular shingles vaccine, Shingrix.
Since the Food and Drug Administration (FDA) approved Shingrix in October 2017, GSK has faced inventory challenges attempting to meet overwhelming consumer demand.
GSK has responded to this demand by significantly increasing and accelerating shipments of Shingrix.
But in early January 2019, Senator Schumer related Shingrix inventory shortages to the Federal Government shutdown.
Senator Schumer said in a press release on January 14, 2019, that he is ‘calling on the FDA to declare the months-long shortage an "emergency".’
And, Senator Schumer has also called on the FDA to remove any regulatory hurdles preventing Shingrix shipments, if any exist.
The fact is, the Shingrix inventory shortage started well before the Federal Government shutdown.
For several months, GSK has been open about its Shingrix shortage.
On October 31, 2018, GSK’s Chief Executive Officer Emma Walmsley said, "Shingrix continues to have a remarkable start and we have now administered nearly 7 million doses worldwide since the 2017 launch."
Shingrix is indicated for the prevention of herpes zoster (shingles) in adults aged 50 years and older.
GSK’s spokesperson Sean Clements said, ‘The shingles vaccine’s superior efficacy has sparked an “unprecedented” demand for Shringrix.’
A study published on October 26th, 2018, reported that Shingrix might prevent more cases of herpes zoster, than the live attenuated vaccine, Zostavax.
This study said the Shingrix vaccine was nearly twice as effective as the previous shingles vaccine and is available to patients 10 years younger than before, enabling the prevention of this painful, common condition.
Shingles occur when the herpes zoster virus reactivates years or decades after a chickenpox outbreak.
For about 10 to 13 percent of people, shingles leave them with deep, searing nerve pain, which is a condition called post-herpetic neuralgia (PHN).
PHN can last for months or years and has no treatment or cure, says Immunize.org.
Sean Clements, director of external communications at GSK Vaccines, said, “We continue to work closely with health officials at US Health and Human Services, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC).”
“Just last week, the FDA approved one of our existing vaccine facilities in France, enabling us to increase Shingrix production as part of our ongoing strategy to invest in expanding capacity for Shingrix manufacturing.”
“In 2019, we will be increasing the frequency and volume of doses shipped, with deliveries going to customers twice a month. GSK will delay broad consumer education activities like TV commercials until the shortage is resolved,” said Clements.
But, GSK expects the vaccine shortage to continue through 2019, as it ramps up production.
In the meantime, GSK is in regular contact with wholesalers, distributors, HCPs about the availability of Shingrix.
Until this demand-supply imbalance ends, it is best to contact your local pharmacy to schedule a Shingrix vaccination appointment.
Vaccines, like any medicine, can have side effects, says the CDC. Patients are encouraged to report negative side effects of vaccines to the FDA or CDC.