The association between vaccination with Shingrix and GBS was evaluated among Medicare beneficiaries aged 65 years or older. This is the largest postmarket study evaluating GBS risk following vaccination with Shingrix. To evaluate this statistical signal, FDA, the Centers for Medicare & Medicaid Services (CMS), and CDC investigated GBS risk following administration of Shingrix in the Medicare claims database. The VSD analyses identified a preliminary statistical signal suggesting an increased risk of GBS among individuals who received Shingrix compared to a historical control group of individuals who had received Zostavax (Zoster Vaccine Live), another FDA-approved vaccine for the prevention of shingles. The Centers for Disease Control and Prevention (CDC) conducted postmarketing safety surveillance of Shingrix in the Vaccine Safety Datalink (VSD) by monitoring prespecified adverse events, including GBS, among individuals 50 years of age and older who received Shingrix. Across the two largest studies, the safety of Shingrix was evaluated by comparing approximately 14,600 individuals who received at least one dose of Shingrix to approximately 14,600 individuals who received saline placebo. Approximately 17,000 adults aged 50 years and older enrolled in these studies received at least one dose of Shingrix. Prior to approval of Shingrix, FDA evaluated safety data from 17 clinical studies. In another clinical trial, compared to placebo, Shingrix reduced the incidence of shingles by 90% in individuals 70 years of age and older. In one clinical trial, compared to placebo, Shingrix reduced the incidence of shingles by 97% in individuals 50 years and older. Shingrix is administered as a two-dose series, with the second dose given anytime between 2 and 6 months after the first dose. Shingrix received FDA approval on October 20, 2017, for prevention of herpes zoster (shingles) in adults aged 50 years and older. In the study, an increased risk of GBS was observed during the 42 days following vaccination with Shingrix. New Warning about Risk for GBS following ShingrixįDA has required a new warning about GBS in the Prescribing Information for Shingrix as a result of new safety data from a postmarketing observational study. Based on this evaluation, FDA has determined that the results of this observational study show an association of GBS with Shingrix, but that available evidence is insufficient to establish a causal relationship. In a postmarketing observational study, an increased risk of GBS was observed during the 42 days following vaccination with Shingrix.įDA evaluated data from a postmarketing observational study that assessed the risk of GBS following vaccination with Shingrix. FDA required GlaxoSmithKline (GSK), the manufacturer of Shingrix, to revise the Prescribing Information to include the following language in the Warnings and Precautions section: Purpose: To inform the public and healthcare providers that FDA has required and approved safety labeling changes to the Prescribing Information for Shingrix (Zoster Vaccine Recombinant, Adjuvanted) to include a new warning about the risk for Guillain-Barré Syndrome (GBS) following administration of Shingrix. FDA Safety Communication - March 24, 2021
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