Safety Signal for Guillain-Barre With J&J COVID-19 Shot Confirmed in Surveillance Data

By Reuters Staff

October 14, 2021

NEW YORK (Reuters Health) - Data from the vaccine adverse event reporting system (VAERS) show a potential "small but statistically significant safety concern" for the development of Guillain-Barre syndrome (GBS) after receipt of the Janssen/Johnson & Johnson COVID-19 vaccine.

The researchers with the U.S. Food and Drug Administration (FDA) emphasize, however, that the absolute risk of GBS following vaccination is "extremely small and far lower" than the risk of COVID-19.

Within the VAERS, 130 cases of presumptive GBS were reported from February 2021 to July 2021, Dr. Emily Jane Woo and colleagues report in JAMA. The median age of presumptive GBS cases was 56 years and 59.7% were men.

The median time to GBS onset after vaccine administration was 13 days. Most cases began within 21 days after vaccination and nearly all began within 42 days. The majority of cases were "serious" and there was one death.

With more than 13 million doses of the J&J vaccine administered to adults in the U.S. from the emergency use authorization through July 26, 2021, the estimated crude GBS reporting rate was one case per 100,000 doses administered, the researchers report.

The overall estimated observed-to-expected-rate ratio was 4.18 (95% confidence interval, 3.47 to 4.98) for the 42-day window, corresponding to an absolute rate increase of 6.36 per 100,000 person-years compared with a background rate of about two cases per 100,000 person-years.

The researchers caution, however, that 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."

"Additional medical record collection, review, and analyses to determine whether the cases meet the Brighton Collaboration criteria for GBS8 are in progress," they say.

The FDA is conducting continuous safety monitoring for adverse events after all vaccines, including the J&J COVID-19 vaccine.

Both FDA and the European Medicines Agency added Guillan-Barre to the product information factsheets for the J&J vaccine in July (https://bit.ly/3DG4pPI, https://bit.ly/3v9LeuA).

SOURCE: https://bit.ly/3v08Z8D JAMA, online October 7, 2021.

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