Can a recombinant herpes zoster vaccine cause Guillain-Barré syndrome in older adults?

A slightly increased risk of Guillain-Barré syndrome (GBS) was observed in Medicare beneficiaries during the 42-day period after recombinant herpes zoster (Shingrix) vaccination. Despite this risk, however, researchers suspect that the benefits of the vaccine likely outweigh the risks associated with the varicella zoster virus itself. This is evident from study results published in JAMA Internal Medicine.

GBS is a rare disease that causes muscle weakness and paralysis that affects 3,000 to 6,000 people in the United States each year. This autoimmune disease has also been reported after certain vaccinations, such as the recombinant herpes zoster vaccine. The aim of the current study was to assess the risk of GBS after vaccination with the herpes zoster vaccine using Medicare data.

The study was a case series that included Medicare beneficiaries aged 65 years or older who received either the recombinant herpes zoster vaccine (n = 849,397; mean age 74.8 years) or the live herpes zoster vaccine (n = 1,817,099; Mean age 74.3 years). A self-controlled case series analysis included events from 2,113,758 eligible beneficiaries who were vaccinated with recombinant zoster who were 65 years of age or older.

Continue reading

The researchers compared the relative risk of GBS in the days after the recombinant and the live zoster vaccine and also performed claims-based and file-based self-controlled case series analyzes to assess the risk of autoimmune disease during days 1 to 42 after vaccination vs with a control window after Vaccination consisting of days 43 to 183.

Compared with the live zoster vaccine group, there was an increased risk of GBS in people who received recombinant zoster vaccines (rate ratio [RR], 2.34; 95% CI, 1.01-5.41; P = .047). In the self-controlled analyzes, 24 cases and 20 cases of GBS occurred during the risk and control period, respectively. In the primary analysis of the self-controlled case series analysis, the researchers found an increased risk for the disease in the 42-day risk window after vaccination compared to the control window (RR 4.30; 95% CI 1.76-10.53; P = .001) .

In the claims-based analysis, the researchers identified an increased risk of GBS in the risk window compared to the extended control window (RR, 2.84; 95% CI, 1.53-5.27; P = 0.001). There was an attributable risk of 3 per million recombinant herpes zoster vaccine doses (95% CI, 0.62-5.64). When comparing the incidence in the risk and control windows in the medical records-based analysis, the researchers again found an increased risk of GBS (RR, 4.96; 95% CI, 1.43-17.27; P = 0.01).

They found that the analyzes had not been adjusted for previous illnesses or other time-varying confounding factors, which could limit the results. The researchers also stated that the risk window after the recombinant herpes zoster vaccination is “not as well defined as the risk window” after the flu vaccination, and they are also unable to determine an ideal risk window with scan statistics. In addition, the study only included people aged 65 and over, which could limit the generalizability of the results to all patients eligible for vaccination.

The researchers wrote in their study “despite the observed increased risk of GBS” that both clinicians and patients “should be aware of the risk of GBS and consider the benefits of avoiding herpes zoster with an effective vaccine”.


R. Goud, B. Lufkin, J. Duffy et al. Risk of Guillain-Barré Syndrome after recombinant herpes zoster vaccination in Medicare beneficiaries. JAMA Intern Med. Published online on November 1, 2021. doi: 10.1001 / jamainternmed.2021.6227

Related Articles