FDA: Johnson & Johnson COVID-19 vaccine tied to Guillain-Barré syndrome
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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.”
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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.
Perspective
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Ahmet Hoke, MD, PhD, FRCPC
These cases of Guillain-Barré syndrome among COVID-19 vaccine recipients may be the result of a molecular mimicry whereby a viral protein mimics a host protein in nerves and triggers an autoimmune reaction. However, it is worth noting that anytime an external foreign virus or bacteria is introduced into the body, whether by direct infection or by immunization, there is the risk for this type of reaction.
Individuals should still receive the COVID-19 vaccine, regardless of the risk for Guillain-Barré syndrome. The incidence of the condition before COVID-19 was about two to three cases for every 1 million people, which is extremely low. With these new developments, the incidence of Guillain-Barré syndrome is about eight cases for every 1 million people, which is still very low. With only about 100 cases of Guillain-Barré syndrome reported in over 12 million people who have received the Johnson & Johnson vaccine, increased risk for Guillain-Barré syndrome associated with the vaccine appears very small.
Patients who are still unsure of receiving the COVID-19 vaccine because of these recent reports should probably take the RNA-based vaccines, if they have the option to do so, because we have not seen an increased risk for Guillain-Barré syndrome among those vaccine recipients.
Perspective
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Dhanashri P. Miskin, MD
These new reports may stem from the COVID-19 vaccine stimulating the immune system (as a vaccine is supposed to do), but in the vaccine recipients who now have Guillain-Barré syndrome, the immune system was overstimulated, and mistakenly attacked the peripheral nervous system as being a foreign invader.
Regardless, people should still get the COVID-19 vaccine since the general incidence of Guillain-Barré syndrome has not been greatly increased since these vaccines were rolled out. In my opinion, that slight increase in risk does not outweigh the tremendous benefit of everyone getting vaccinated.
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