Although the risk appears to be small, the Johnson & Johnson COVID vaccine seems to be linked to the rare neurological disorder Guillain–Barré syndrome.
On July 12, the Food and Drug Administration warned that the vaccine can lead to an increased risk of the condition. The FDA revised the vaccine recipient and vaccination provider fact sheets for the Johnson & Johnson COVID vaccine to include information about the observed increased risk of Guillain–Barré syndrome after receiving the vaccine.
GBS is a disorder in which the body’s immune system damages nerve cells, causing muscle weakness or even paralysis.
An analysis of Vaccine Adverse Event Reporting data showed that there have been 100 preliminary reports of GBS after vaccination with the Johnson & Johnson vaccine. This finding came after about 12.5 million doses of the vaccine had been administered, according to the FDA.
Officials say the syndrome was mostly reported about two weeks after vaccination, primarily in men, many of whom were 50 years or older. Of the 100 reported cases, 95 were serious, requiring hospitalization. There was one reported death.
According to the Centers for Disease Control and Prevention, GBS is deemed rare. Each year in the U.S., about 3,000-6,000 people develop GBS, regardless of whether they have received a vaccine.
GBS has previously been reported at increased rates following other vaccinations, such as seasonal influenza vaccines and a vaccine to prevent shingles. In 1976, a large swine flu vaccination campaign led to a small uptick in cases of GBS, causing roughly one extra case for every 100,000 people vaccinated.
However, the FDA says although there is evidence to suggest an association between the Johnson & Johnson vaccine and an increased risk of GBS, it is “insufficient to establish a causal relationship.”
As stated in the FDA’s revised fact sheet for patients, GBS is most likely to appear 42 days after vaccination. Patients should consult a doctor if they begin to experience weakness or tingling in their arms and legs; double vision; difficulty walking, speaking, chewing, and swallowing; or controlling their bladder or bowels.
The Moderna and Pfizer vaccines have not demonstrated a similar association with GBS.
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