COVID-19 Resource Center

COVID-19 Resource Center

Perspective from Ahmet Hoke, MD, PhD, FRCPC
Perspective from Dhanashri P. Miskin, MD
Source: FDA. Fact sheet. Accessed July 13, 2021.

July 13, 2021
2 min read
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FDA: Johnson & Johnson COVID-19 vaccine tied to Guillain-Barré syndrome

Perspective from Ahmet Hoke, MD, PhD, FRCPC
Perspective from Dhanashri P. Miskin, MD
Source: FDA. Fact sheet. Accessed July 13, 2021.

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The FDA has said that Johnson & Johnson’s COVID-19 vaccine may lead to an increased risk for Guillain-Barré syndrome.

The New York Times reported on July 12 that officials identified 100 suspected cases of Guillain-Barré syndrome, a neurological condition in which the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis, that were linked to the vaccine. Among them, 95% were deemed “serious and required hospitalization.”

Johnson and Johnson COVID vaccine
The FDA issued a warning about the Johnson & Johnson vaccine.
Photo source: Adobe Stock

According to the FDA, in most instances, the symptoms of Guillain Barré syndrome began within 6 weeks of vaccine receipt. However, the agency also said that the chance of this occurring is “very low.”

The FDA urged patients to call 911 right away if they were administered the Johnson & Johnson vaccine and experience weakness or tingling sensations, especially in the legs or arms, that is getting worse and spreading; problems with walking, facial movements such as speaking, chewing or swallowing and bladder or bowel control; double vision or inability to move eyes; or any allergic reaction.

Previously, two studies published in Annals of Neurology cited small clusters “of an unusual variant of Guillain-Barré syndrome” following receipt of a COVID-19 vaccine. The rate of Guillain-Barré syndrome in these clusters was approximately four to 10 times higher than the anticipated baseline frequency.

An FDA advisory panel voted unanimously this past February to recommend authorizing the Johnson & Johnson vaccine. A day later, the FDA granted the shot an emergency use authorization; the vaccine’s rollout began soon after the FDA’s action.

However, the rollout of the Johnson & Johnson vaccine has not been seamless. In March, the company confirmed that it discarded a batch of COVID-19 vaccine doses following a mishap at a manufacturing site. Then in June, the FDA told Johnson & Johnson that more batches must be discarded, saying the affected batches were “not suitable for use.” In addition, the FDA and CDC temporarily paused rollout of the vaccine after identifying a link between the shot and blood clotting events.

References

Allen CM, et al. Ann Neurol. 2021;doi:10.1002/ana.26144.

FDA. Fact sheet for healthcare providers administering vaccine (vaccination providers) emergency use authorization (EUA) of the Janssen COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19). https://www.fda.gov/media/146304/download. Accessed July 13, 2021.

FDA. Fact sheet for recipients and caregivers emergency use authorization (EUA) of the Janssen covid-19 vaccine to prevent coronavirus disease 2019 (COVID-19) in individuals 18 years of age and older. https://www.fda.gov/media/146305/download. Accessed July 13, 2021.

Lafraniere S, Weiland N. The New York Times. FDA attaches warning of rare nerve syndrome to Johnson & Johnson Vaccine. https://www.nytimes.com/2021/07/12/us/politics/fda-warning-johnson-johnson-vaccine-nerve-syndrome.html. Accessed July 13, 2021.

Maramattom BV, et al. Ann Neurol. 2021;doi:10.1002/ana.26143.