NEW YORK (Reuters Health) - An analysis of Medicare claims data found an increased risk of Guillain-Barre syndrome (GBS) following receipt of the recombinant zoster vaccine (RZV), confirming the same "signal" from the U.S. Centers for Disease Control and Prevention (CDC) Vaccine Safety Datalink (VSD) surveillance system.
In comparing Medicare beneficiaries who received RZV (Shingrix) versus zoster vaccine live (ZVL, Zostavax), there was a "slightly" increased risk of GBS during the 42-day risk window following RZV vaccination in the Medicare population, with roughly three excess GBS cases per million vaccinations, report Dr. Ravi Goud of the U.S. Food and Drug Administration (FDA) and colleagues.
The researchers caution that the increased risk of GBS after RZV should be considered in the context of the benefits of the vaccine.
"Herpes zoster is associated with substantial morbidity, including possible persistent pain, and disseminated disease," they write.
Before herpes zoster vaccine was available, roughly one million cases of herpes zoster occurred each year in the United States, resulting in about $1.3 billion in medical-care costs and $1.7 billion in indirect costs per year, they point out.
In clinical trials, RZV cut the incidence of herpes zoster by 97% in adults aged 50+ with durable protection through four years after vaccination.
Overall, the data suggest that the risk-benefit balance for RZV "remains favorable, and clinicians should continue to offer and discuss RZV vaccination with their patients," Dr. Goud and colleagues conclude.
The study was funded through an interagency agreement between the FDA and the Centers for Medicare & Medicaid Services (CMS).
SOURCE: https://bit.ly/3nMvTNq JAMA Internal Medicine, online November 1, 2021.
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