The US Food and Drug Administration (FDA) amended the label on Johnson & Johnson’s coronavirus vaccine on Monday to warn of an elevated risk of Guillain Barre syndrome, a rare neurological complication.

While the FDA stated that there was no evidence that the vaccine caused the syndrome, it did identify an increase in reports of the sometimes paralyzing disease.

“Today, the FDA is announcing revisions to the vaccine recipient and vaccination provider fact sheets for the Johnson & Johnson (Janssen) COVID-19 Vaccine to include information pertaining to an observed increased risk of Guillain Barre Syndrome (GBS) following vaccination,” it said in a statement.

“Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of Guillain Barre syndrome during the 42 days following vaccination,” the updated label reads.

“Although the available evidence suggests an association between the Janssen vaccine and increased risk of GBS, it is insufficient to establish a causal relationship. No similar signal has been identified with the Moderna and Pfizer-BioNTech COVID-19 vaccines,” the label adds.

What is Guillain Barre syndrome

Out of 12.8 million Janssen vaccines administered, the FDA said 100 early complaints of Guillain Barre syndrome had been filed with the US government’s Vaccine Adverse Reporting System.

“Guillain Barre syndrome (a neurological disorder in which the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis) has occurred in some people who have received the Janssen COVID-19 Vaccine,” the FDA says in the label update for patients and caregivers.

“In most of these people, symptoms began within 42 days following receipt of the Janssen COVID-19 Vaccine. The chance of having this occur is very low,” it adds.

The FDA advises people to seek medical assistance if they have symptoms such as weakness or tingling in their arms and legs after taking a vaccine, especially if the symptoms worsen.

Other warning signs include trouble walking, speaking, chewing, or swallowing, double vision, and bowel or bladder control issues.

According to the FDA, 95 of the 100 GBS complaints involved persons who required hospitalization, and one person died.

“Each year in the United States, an estimated 3,000 to 6,000 people develop GBS. Most people fully recover from the disorder,” the agency added.

“GBS has also been observed at an increased rate associated with certain vaccines, including certain seasonal influenza vaccines and a vaccine to prevent shingles.

Johnson & Johnson vaccine

Johnson & Johnson confirmed it was talking to the US Centers for Disease Control and Prevention and FDA about the issue.

“We have been in discussions with the U.S. Food and Drug Administration and other regulators about rare cases of the neurological disorder, Guillain barre syndrome, that have been reported following vaccination with the Janssen COVID-19 vaccine,” the company said in a brief statement.

“The chance of having this occur is very low, and the rate of reported cases exceeds the background rate by a small degree,” it added.

Even if the vaccine does raise the risk of the syndrome, it’s still better to get vaccinated against the coronavirus, the CDC stressed.

The CDC and FDA keep an eye out for Guillain Barre syndrome.

“GBS is a neurological disorder in which the body’s immune system damages nerve cells, causing muscle weakness or, in the most severe cases, paralysis. Each year in the United States, an estimated 3,000 to 6,000 people develop GBS; it is typically triggered by a respiratory or gastrointestinal infection. Most people fully recover from GBS,” a CDC spokesperson said.

“Reports of GBS after receipt of the J&J/Janssen COVID-19 Vaccine in the Vaccine Adverse Event Reporting System (VAERS) are rare, but do likely indicate a small possible risk of this side effect following this vaccine,” the spokesperson added.

The spokesperson said the CDC’s Advisory Committee on Immunization Practices would discuss the matter in an upcoming meeting.

“In the United States, nearly all COVID-19 hospitalizations and deaths are now occurring in unvaccinated people. The risk of severe adverse events after COVID-19 vaccination remains rare. Everyone age 12 years and older is recommended to receive a COVID-19 vaccine,” the statement said.

A setback for the J&J vaccine

It’s yet another setback for the J&J vaccine, which has been bedeviled by problems.

The CDC and FDA temporarily suspended use of the Johnson & Johnson vaccine earlier this year due to a risk of a rare form of blood clotting issue, but lifted the suspension in April after deciding that the risk was minimal and the illness was curable. The vaccine’s label has been changed to warn of the danger.

Manufacturing was slowed by a mix-up at an Emergent BioSolutions contract vaccine plant in Baltimore earlier this year, which wasted millions of potential Johnson & Johnson doses.

After Pfizer’s and Moderna’s, J&J’s Janssen vaccine was the third to receive FDA emergency use authorisation.

According to the CDC, 84.6 million Americans have received both doses of Pfizer’s vaccine; 62 million have received both doses of Moderna’s vaccine, and 12.7 million have received J&J’s one-dose regimen.

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