Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Oct 26;326(16):1606-1613.
doi: 10.1001/jama.2021.16496.

Association of Receipt of the Ad26.COV2.S COVID-19 Vaccine With Presumptive Guillain-Barré Syndrome, February-July 2021

Emily Jane Woo  1 , Adamma Mba-Jonas  1 , Rositsa B Dimova  1 , Meghna Alimchandani  1 , Craig E Zinderman  1 , Narayan Nair  1
Affiliations

Association of Receipt of the Ad26.COV2.S COVID-19 Vaccine With Presumptive Guillain-Barré Syndrome, February-July 2021

Emily Jane Woo et al. JAMA. .

Abstract

Importance: As part of postauthorization safety surveillance, the US Food and Drug Administration (FDA) has identified a potential safety concern for Guillain-Barré syndrome (GBS) following receipt of the Ad26.COV2.S (Janssen/Johnson & Johnson) COVID-19 vaccine.

Objective: To assess reports of GBS received in the Vaccine Adverse Event Reporting System (VAERS) following Ad26.COV2.S vaccination.

Design, setting, and participants: Reports of presumptive GBS were identified in a US passive reporting system (VAERS) February-July 2021 and characterized, including demographics, clinical characteristics, and relevant medical history.

Exposures: Receipt of the Ad26.COV2.S vaccine; the comparator was the background rate of GBS in the general (unvaccinated) population that had been estimated and published based on a standardized case definition.

Main outcomes and measures: Presumptive GBS; the reporting rate was analyzed, including calculation of the observed to expected ratio based on background rates and vaccine administration data. Because of limited availability of medical records, cases were not assessed according to the Brighton Collaboration criteria for GBS.

Results: As of July 24, 2021, 130 reports of presumptive GBS were identified in VAERS following Ad26.COV2.S vaccination (median age, 56 years; IQR, 45-62 years; 111 individuals [86.0%] were < 65 years; 77 men [59.7%]). The median time to onset of GBS following vaccination was 13 days (IQR, 10-18 days), with 105 cases (81.4%) beginning within 21 days and 123 (95.3%) within 42 days. One hundred twenty-one reports (93.1%) were serious, including 1 death. With approximately 13 209 858 doses of vaccine administered to adults in the US, the estimated crude reporting rate was 1 case of GBS per 100 000 doses administered. The overall estimated observed to expected rate ratio was 4.18 (95% CI, 3.47-4.98) for the 42-day window, and in the worst-case scenario analysis for adults 18 years or older, corresponded to an estimated absolute rate increase of 6.36 per 100 000 person-years (based on a rate of approximately 8.36 cases per 100 000 person-years [123 cases per 1 472 162 person-years] compared with a background rate of approximately 2 cases per 100 000 person-years). For both risk windows, the observed to expected rate ratio was elevated in all age groups except individuals aged 18 through 29 years.

Conclusions and relevance: These findings suggest a potential small but statistically significant safety concern for Guillain-Barré syndrome following receipt of the Ad26.COV2.S vaccine. However, the findings are subject to the limitations of passive reporting systems and presumptive case definition, and they must be considered preliminary pending analysis of medical records to establish a definitive diagnosis.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest Disclosures: None reported.

Figures

Figure.
Figure.. Vaccine Administration Data
See this image and copyright information in PMC

Comment in

References

    1. US Food and Drug Administration. Janssen COVID-19 Vaccine. Accessed September 25, 2021. https://www.fda.gov/media/146303/download
    1. Oliver SE, Gargano JW, Scobie H, et al. . The advisory committee on immunization practices’ interim recommendation for use of Janssen COVID-19 vaccine—United States, February 2021. MMWR Morb Mortal Wkly Rep. 2021;70(9):329-332. doi:10.15585/mmwr.mm7009e4 - DOI - PMC - PubMed
    1. US Food and Drug Administration . Fact sheet for healthcare providers administering vaccine (vaccination providers): Emergency Use Authorization (EUA) of Janssen COVID-19 Vaccine to prevent coronavirus disease 2019 (COVID-19). Published February 27, 2021. Revised August 27, 2021. Accessed September 25, 2021. https://www.fda.gov/media/146304/download
    1. Vaccines and Related Biological Products Advisory Committee Meeting: FDA briefing document. Janssen Ad26.COV2.S Vaccine for the prevention of COVID-19; February 26, 2021. Accessed September 25, 2021. https://www.fda.gov/media/146217/download
    1. Zhou W, Pool V, Iskander JK, et al. . Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS)—United States, 1991-2001. MMWR Surveill Summ. 2003;52(1):1-24. - PubMed

Publication types