On July 12, the Food and Drug Administration issued a warning that the Johnson & Johnson (Janssen) COVID-19 vaccine can increase risk for a rare neurological disease called Guillain-Barre syndrome. 

The risk is low. Out of 12.5 million individuals vaccinated with the J&J vaccine, just 100 were diagnosed with Guillain-Barre. Among those, 95% were hospitalized and one resulted in death. 

Guillain-Barre syndrome is a condition that causes a loss of myelin, the sheath that coats nerves, similar to the rubber coating of a wire, said Dr. Megan Donnelly, a neurologist with Novant Health Neurology & Headache SouthPark. Myelin ensures that messages can travel quickly through nerves. When messages cannot travel quickly, individuals can lose muscular strength.

Guillain-Barre usually starts with numbness and weakness in the toes, gradually traveling up the legs, Donnelly said.  As it travels, it can lead to paralysis of the arms and legs and lead to an inability to breathe. The disease tends to resolve and patients recover, but often requires hospitalization for monitoring and supportive care.

While the J&J vaccine has been flagged, Pfizer and Moderna do not carry the same warning. 

So, is the J&J vaccine safe?

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Dr. Megan Donnelly

Despite the latest warning, Donnelly said she does not believe there should be a hold on the use of the J&J vaccine. 

“I think that using some level of caution is important, and it's why anytime there's new vaccines, they're monitored,” she said.

If it is very important for an individual to only receive one shot as opposed to Pfizer’s and Moderna’s two shots, the chances of developing Guillain-Barre with J&J “is still a fairly low risk, so it might be worth it to them for that reason,” Donnelly said.

This is not the first occasion where the J&J vaccine has been flagged for safety concerns. In April, the FDA paused the administration of the vaccine after the U.S. reported six cases of a rare and severe blood clot in patients who had received J&J. On April 23, the Centers for Disease Control and Prevention and and FDA recommended the use of the vaccine resume, advice which Novant Health followed.

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Where have I heard of Guillain-Barré before? 

Even though Guillain-Barre is extremely rare, you may have been asked if you have the condition before. 

In 1976, there was a small risk of developing the condition after receiving the swine flu vaccine. As a result, administrators of the yearly flu vaccine ask patients: “Do you have a history of Guillain-Barre syndrome?”

Delta variant increasing the need for vaccination

About half of North Carolinians have yet to get a COVID-19 vaccine, according to the NC Department of Health and Human Services. But the Delta variant of the coronavirus is highly transmissible among people who are not vaccinated. The risk of serious illness or death if you contract COVID is higher than your chances of getting a neuromuscular disease, Donnelly said. Add to this the fact that there are still options – the Pfizer and Moderna vaccine – that don’t show a risk of Guillain-Barre, and it’s clear that the most important thing to do is protect yourself from COVID-19.