Launch of shingles vaccine hits some roadblocks

A new vaccine to treat shingles has been recognized as highly effective, but its launch earlier this year has not been without problems.

Approved by the FDA in October 2017 for use in patients aged 50 and older, GSK’s Shingrix was voted around the same time as the preferred vaccine for shingles over its predecessor, Zostavax. Trials of vaccine showed 90 percent efficacy across all age groups against the varicella zoster virus (VZV), the same virus that causes chickenpox.

Since its release, however, there have been some demand and administration challenges for the vaccine.

Demand problems

Reports of wait lists for vaccine and national shortages have developed in recent months, with the CDC reporting shortages as early as May 2018. Media reports have highlighted the plight of pharmacies and physicians trying to meet the demands of patients and receiving adequate supplies of the vaccine. The vaccine earned GSK about $150 million in the first quarter of 2018, but supply levels were set using previous shingles vaccine demand levels and demand for the current vaccine has been higher.

What is GSK doing?

Sean Clements, a spokesperson for GSK, acknowledged demand problems, but said the company is working to find solutions.

“We have seen unprecedented demand for Shingrix by patients and healthcare professionals, and responding to that demand, we have significantly increased deliveries and accelerated shipments of doses of vaccine for this year,” Clements said.
He expects that Shingrix will be shipped regularly and available throughout 2018. He said 1.5 million Americans have received the vaccine already.

“When distributing vaccine, we are focused on a fair and equitable allocation plan across all customer segments, to help ensure your patients have the opportunity to complete the two-dose series,” Clements added. “We understand that this is a challenging situation to manage and GSK is fully committed to expediting Shingrix resupply throughout 2018.”

Clements said the company is working with the FDA and CDC to communicate any demand issues.
 

Administration and storage problems

Another bump in the road for Shingrix has been administration and storage errors. According to the CDC’s Vaccine Adverse Event Reporting System (VAERS), the vaccine has been administered by the wrong route-subcutaneously rather than intramuscularly-and to patients who were younger than FDA’s approval allowed. Patients also received education on the wrong vaccine in some cases, or were not provided information on Shringrix’s required second dose. There were also storage and reconstitution errors noted, including administering the vaccine after frozen storage and administering the adjuvant component without reconstitution with the vaccine antigen, according to VAERS.

Resolving errors

Clements said GSK anticipated some initial confusion on administration due to the differences between Shingrix and its predecessor. Shingrix needs only to be refrigerated and not frozen, he noted. Anticipating the confusion, GSK created a provider education portal, and efforts to develop additional support were ramped up once initial reports of problems arose after the vaccine’s launch, Clement said.

“Once we saw the early reports, we increased our efforts and developed additional communications, including a communication to the Immunization Action Coalition (IAC), National Foundation for Infectious Diseases (NFID) and the American College of Physicians (ACP) to request their assistance in educating their membership on proper administration and storage,” Clement said.

GSK will continue to work with FDA and CDC to find ways to resolve these errors, he added.

Cost concerns

There are also some concerns about the cost of the vaccine, at $140 per dose and $280 for the entire series. Some research has shown that traditional shingles vaccination and boosters may be more cost-effective for some patients. A research letter published in the Journal of the American Medical Association in July 2018 suggests that few patients will receive the full two doses that effective vaccination with Shingrix requires, making it less cost-effective than previous interventions. GSK did not offer comment on the report or the suggestion that the vaccine may be too costly, but previously told Medical Economics that it expects payer coverage of the vaccine to become widespread after its release.