Johnson & Johnson vaccine linked to rare neurological disorder: Here’s what doctors say

• The Johnson & Johnson vaccine has been linked to 100 cases of an extremely rare neurological disorder called Guillain–Barré syndrome.

• The label on the J&J vaccine has been updated and now warns of a possible side effect — usually seen two weeks after the one-shot dose is received.

• The FDA has not made an announcement about pausing J&J vaccine distribution, which they did in April after six recipients of the vaccine developed a rare blood-clot disorder.

There’s a major development in COVID-19 vaccine news: The FDA has released a label warning that Johnson & Johnson’s one-shot vaccine could lead to the increased risk of Guillain–Barré syndrome, a rare neurological condition.

So far, 100 cases of the syndrome have been reported out of the 12.8 million people vaccinated by Johnson & Johnson, according to CNN. Usually, symptoms appear within the 42-day period following the shot, according to the FDA. The agency noted that the shot does not cause Guillain–Barré, but there is a higher chance — three to five times more likely — that a person who received the shot could develop the syndrome.

“Although the available evidence suggests an association between [J&J’s] 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 updated label from The FDA adds.

What is Guillain–Barré syndrome?

Guillain–Barré syndrome is a rare neurological disorder in which the immune system mistakenly attacks the peripheral nervous system. Early symptoms include body weakness and tingling in your feet that then spread to your upper body and arms. Those sensations can spread throughout the body leading to balance and reflex problems and in a few cases, full-body paralysis. However, paralysis is usually temporary.

There is no cure for Guillain–Barré but most people do make a full recovery with up to 80% who were paralyzed being able to walk again after six months. Most people also will not die from it. There is a 4% to 7% mortality rate, according to The Mayo Clinic.

Weakness and tingling can be long-term symptoms for some people.

Guillain–Barré and other vaccines

This isn’t the first time Guillain–Barré has been associated with a vaccine. There were cases of the condition after a vaccine for Swine flu was dispensed in 1976, and in extremely rare cases, it has been seen with people who received the flu shot.

Dr. Vivek Cherian, an Internal Medicine physician with the University of Maryland Medical System, told Ladders, “Realize this is not completely unique to the J&J vaccine (assuming there truly turns out to be an association.) Take the seasonal flu, for example, the data on an association between seasonal influenza vaccine and GBS have been variable from season to season. When there has been an increased risk, it has consistently been in the range of one to two additional GBS cases per million flu vaccine doses administered. Studies suggest that it is more likely that a person will get GBS after getting the flu than after vaccination.”

As for the likelihood that you will develop this side effect, Cherian is very skeptical. “In the grand scheme of things, this does not change anything.  Individuals who are unvaccinated remain at the greatest risk so they should take any vaccine that is available to them.  So far the data suggest an association, however, there is no definitive causal relationship. Most things in medicine involve weighing the benefits versus the risks, and there is no question that the benefits of being vaccinated greatly outweigh any potential risks, and the risks of contracting COVID-19 far outweigh the minuscule chance of having a more severe side effect from the vaccine.”

Previous Johnson & Johnson side effects

This isn’t the first time the Johnson & Johnson vaccine has been in the news because of its side effects. In April, distribution had to be paused for 10 days because six recipients of the single vaccine dose developed a rare blood clot disorder called cerebral venous sinus thrombosis within two weeks of vaccination.

As of May of this year, there were 28 cases of the blood-clot disorder seen in recipients and one person died as a result. Women ages 30 to 39 years old were the biggest risk group for cerebral venous sinus thrombosis as a result of the J&J shot.

Does this mean the Johnson & Johnson vaccine will be paused?

There has been no announcement made about pausing the distribution of the J&J vaccine as of mid-July. Dr. Frederick Lepore, a neuro-ophthalmologist at Robert Wood Johnson University Hospital in New Jersey who saw a patient in early June with the syndrome after receiving the vaccine in May, told Ladders, “I’m not an epidemiologist/policy wonk but I think the likelihood of a pause is high. FDA and CDC paused the vaccine from April 13 to April 23 after only SIX cases of dural sinus thrombosis. We are now being told of around 100 cases of Guillain-Barré post-vaccination so I think that another pause is likely.” [Full disclosure: Dr. Lepore is the father of the author of this piece.]

What does this mean for vaccine approval?

This week White House chief medical advisor Dr. Anthony Fauci told CNBC he fully expects the Pfizer, Moderna, and Johnson & Johnson vaccines to receive full approval from U.S. drug regulators. None of the vaccines have received full approval from The FDA yet.

As of now, 184 million people in the U.S. are partially inoculated against Covid and almost 160 million people are fully vaccinated.*