Continuing Shingrix Vaccine Shortage Challenging Physicians, Patients

Alicia Ault

November 21, 2018

Ever since recombinant zoster vaccine (adjuvanted) (Shingrix) hit the market late last November, GlaxoSmithKline (GSK) has struggled to keep up with runaway demand for the vaccine, which has patients and physicians scrambling to find elusive supplies.

The vaccine has become a victim of its own success — the 90% efficacy rate is a big selling point, said Sandra Fryhofer, MD, an internist in private practice in Atlanta, Georgia, who is a past president of the American College of Physicians and is a liaison to the Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP).

Plus, she said, "people don't want to get shingles." Even though shortages continue, "I think it's great that people are wanting to get vaccinated," Fryhofer told Medscape Medical News.

In its latest quarterly report, GSK said that it was expecting Shingrix sales of £700 to £750 million ($895 to $950 million) for fiscal 2018 and that Shingrix constitutes 99% of the shingles vaccine market.

And demand keeps rising. "Shingrix has been met by unprecedented demand by healthcare providers and patients," said GSK in a statement provided to Medscape Medical News. "Providers are immunizing patients at a rate several times what was previously seen for shingles."

As of October 1, almost 7 million doses of Shingrix had been administered worldwide, with most of the vaccine being administered in the United States. It takes 6 to 9 months to produce Shingrix, and though certain elements were in place before the approval, GSK is still playing catch-up, said the company.

In the third quarter of 2018, GSK distributed as many doses as had been sent out in the first 6 months of the year, but patients and physicians are still encountering empty coffers and wait lists at pharmacies.

According to CVS Health, both its retail pharmacies and MinuteClinic units began offering Shingrix in the spring, but it has not been able to hold on to supplies.

"Due to high demand for this new and highly-effective vaccine, it has become challenging to keep an ample supply across all of our more than 9800 stores and more than 1100 clinics due to supply restrictions from the manufacturer," company spokesman Amy Lanctot told Medscape Medical News. Noting that shipments are intermittent, Lanctot said that patients "are encouraged to call their local store or clinic in advance to find out if they have the Shingrix vaccine in stock."

How to Prioritize?

Fryhofer said that her office is out of vaccine, and has been for a while. GSK's website reports that it is currently filling orders from August and September, she said. "We're just kind of hoping that we'll get some in the mail," said Fryhofer.

In the meantime, she's been sending patients to pharmacies, especially if they need a second dose. The CDC recommends that the second of the two-dose vaccine be administered within 2 to 6 months of the first.

In July, when a patient needed a second dose, Fryhofer urged him to try pharmacies in the community. He found a pharmacy that had Shingrix, and he received his shot. He recently returned for an office visit, and Fryhofer discovered that he'd been given a third dose, because he'd forgotten that he'd already had a second, and the pharmacy (part of a major chain) had not consulted the Georgia Immunization Registry (GRITS).

"I'm very concerned about what happened with this patient," said Fryhofer. She noted that not only had the patient received poor-quality care, but the overtreatment had exacerbated the shortage.

Medicare paid the pharmacy for the second and third doses, she said.

She called the pharmacy and urged the company to change its protocol so that pharmacists consulted GRITS before dispensing.

Fryhofer said she had not been prioritizing patients for Shingrix, "but if this shortage continues, that may be something we have to start thinking about."

Weighing Individual Risk and Benefit

Kenneth Schmader, MD, who was an investigator on both the live-attenuated herpes zoster vaccine (Zostavax, Merck) and Shingrix, said that herpes zoster was not a public health problem. "Your instantaneous risk of developing shingles is pretty low on any given day," Schmader, who is chief of the Division of Geriatrics in the Department of Medicine at Duke University School of Medicine, Durham, North Carolina, told Medscape Medical News.

It is an individual health issue, particularly for older patients who are more likely to develop postherpetic neuralgia, he said. He urged clinicians to be more vigilant about getting vaccine for 70- to 80-year-old patients.

Bone marrow transplant recipients should also be "super-high" on the priority list, because "they are at high risk for really serious complications from reactivation of zoster," said Schmader.

For other transplant recipients, the picture is not as clear. Shingrix is only recommended for immune-competent individuals. The ACIP urges a case-by-case review for those who are immune compromised. "This vaccine has a very powerful adjuvant that stimulates the immune system, and we don't know in certain immune-compromised patients whether that's safe and effective yet," Schmader said.

In addition, the vaccine might not be effective for patients taking immune therapies for cancer, he said. For Shingrix to be effective, the patient's immune system must be active, and those drugs turn off the immune response.

No End in Sight

Because of continuing demand, GSK said it expects "ordering limits to continue throughout 2019."

It says that the company has been regularly shipping large volumes of vaccine every 2 to 3 weeks and that in December, it will move to a twice-monthly shipping schedule. In the next few years, GSK plans to increase capacity so it can supply doses "in the high teens millions, annually," said the company. "We understand that this is a challenging situation to manage and GSK is fully committed to expediting Shingrix resupply throughout 2018."

In the meantime, patients can use GSK's Shingrix Vaccine Locator to find providers or pharmacies that have the vaccine, but the company acknowledges that sometimes supplies disappear faster than the site can be updated.

Schmader said that he had patients who checked back with their pharmacies every 2 or 3 days. Supplies have gotten better in the Raleigh-Durham, North Carolina, area, he added.

"I honestly think it's going to get better over time," said Schmader.

Dr Schmader has received research grants from Merck & Co and GSK.

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