The Johnson & Johnson vaccine and Guillain Barré syndrome: what to know

When the Food and Drug Administration updated its Johnson & Johnson COVID-19 vaccine fact sheet this week, it included a warning that the vaccine is associated with a “very low” risk of developing Guillain Barré syndrome, a rare neurological disorder.

It’s the latest in a sometimes bumpy rollout of the one-dose vaccine. In April, the Centers for Disease Control and Prevention and FDA recommended a pause in the use of J & J following a handful of cases involving blood clots; lifting the recommendation a few days later.

Here’s what’s known about this week’s warning and what it might mean for those with questions about the J & J vaccine: 

What is Guillain–Barré syndrome?

Guillain-Barré (pronounced gwee-EN-buh-RAY) syndrome is a rare, potentially serious neurological disorder in which the body’s immune system attacks and damages nerve cells, causing muscle weakness and sometimes paralysis. The syndrome often follows infection with a virus or bacteria — and on very rare occasions it can follow a vaccination.

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Most people fully recover from the syndrome but some experience permanent nerve damage. An estimated 3,000 to 6,000 people develop the syndrome in the United States each year.

What are the chances of getting this syndrome if I receive the Johnson & Johnson vaccine?

The risk of developing the syndrome is very low. 

Of the nearly 13 million people who received the Johnson & Johnson vaccine, 100 cases of the syndrome were reported to the federal Vaccine Adverse Event Reporting System, or roughly 1-in-130,000 people. Of those, 95 cases resulted in hospitalization and one person died.

The syndrome has also been associated with contracting COVID-19 itself, according to a study released last summer of hospitalized patients in Italy, before any vaccines were available.

Guillain–Barré also has been identified as a small risk factor in other, previously approved vaccines. For instance, after swine flu vaccinations in 1976, and in people who receive a seasonal flu shot, according to the CDC. When there has been an increased risk, only one to two additional cases of the syndrome per million doses administered were found. It is more likely that a person will get the syndrome after getting the flu than after a vaccination.

The CDC maintains the Johnson & Johnson vaccine is safe and effective and urges people in the U.S. to get whichever of the three approved vaccines is available to them. The two-dose Pfizer and Moderna vaccines have not been associated with Guillain–Barré syndrome and utilize different technology than the Johnson & Johnson vaccine.

What are the symptoms of Guillain–Barré syndrome?

For most people, the symptoms occurred within 42 days of receiving the vaccine. The FDA said recipients of the Johnson & Johnson vaccine should seek medical attention right away if they develop any of the following symptoms:

• Weakness or tingling sensations, especially in the legs or arms, that’s worsening and spreading to other parts of the body
• Difficulty walking
• Difficulty with facial movements, including speaking, chewing, or swallowing
• Double vision or inability to move eyes
• Difficulty with bladder control or bowel function

Is the Johnson & Johnson vaccine safe?

The J&J vaccine remains approved for emergency use in the U.S and the CDC says all three COVID-19 vaccines available in the U.S. are safe and effective. 

Daniel Salmon, the director of the Institute for Vaccine Safety at Johns Hopkins University, said the risk of contracting Guillain–Barré is far outweighed by the danger posed by COVID. The CDC notes, for instance, that nearly all recent deaths in the U.S. attributed to COVID-19 have involved unvaccinated patients. 

“Everything has risks,” Dr. Salmon told the New York Times. “And the key to decision-making is to optimize the benefits and reduce the risks,” noting, “COVID is a pretty nasty disease that’s killed 600,000 people.”

How many people have taken the J & J vaccine in Michigan?

In Michigan, 318,315 people have taken the Johnson & Johnson vaccine as of Wednesday, a small portion of the 4.9 million people who have received at least one dose of a COVID vaccine in the state. Nearly 13 million people have received the J & J vaccine in the U.S.

But deliveries of the Johnson & Johnson vaccine to distributors have decreased as demand for all COVID-19 vaccines decrease. There have not been deliveries of Johnson & Johnson coronavirus vaccines in the state since June 5, according to state data. And before that,  deliveries had been declining since April when the CDC and FDA recommended a pause in use of the Johnson & Johnson vaccine over the blood clotting issue.

Lynn Sutfin, spokesperson for the state health department, said Michigan continues to use the existing supply of Johnson & Johnson that vaccine providers, primarily pharmacies, already have in the state to fill any new orders by reallocating vaccines from one provider to another so doses aren’t wasted.

She also said Michigan is not receiving any new allocations from the CDC due to a backorder with no determined end date. However, there is not a backorder of orders from the state or providers waiting on vaccine doses.