Health officials are investigating the “small possible risk” that people getting Johnson & Johnson’s COVID-19 vaccine may develop a rare autoimmune disorder — so it’s only natural that folks would have a lot of questions.
The Centers for Disease Control and Prevention (CDC) reported Monday that 100 people who got the J&J
Janssen shot developed Guillain-Barré syndrome, which can cause muscle weakness and occasionally paralysis. The Food and Drug Administration (FDA) also added a warning about the potential side effect to its fact sheets about the Janssen COVID-19 vaccine.
While this side effect has occurred in just a tiny fraction of the almost 13 million Americans who’ve received the single-dose COVID shot, meaning it’s extremely rare, Google searches for “guillain barre” spiked 2,700% in the U.S. on Tuesday, and “symptoms of guillain-barre syndrome” was also a breakout query on the Alphabet
“People who received the vaccine months ago should not be concerned about this.”
— Dr. Leana Wen
“It’s very important that the CDC and FDA investigate these cases, but I think it’s also very important to put into perspective that those cases are rare,” Dr. Leana Wen, an emergency physician and public health professor at George Washington University, told MarketWatch. “And the FDA has determined that the benefits of the J&J vaccine still outweigh this rare but serious condition.”
“This is the FDA and CDC doing their job. Their job is to identify and present potential side effects of medicines, drugs and vaccines to make the public aware of them with a lot of scientific precision,” agreed Dr. David Putrino, director of rehabilitation innovation for Mount Sinai Health System in NYC. “Until the CDC and FDA make a recommendation to not take the vaccine, there is no cause for concern or alarm.”
So what is Guillain-Barré syndrome (aka GBS) and what should you consider before getting the J&J jab? Here’s what we know so far.
What is Guillain-Barré syndrome?
The CDC describes Guillain-Barré (pronounced Ghee-YAN Bah-RAY) syndrome as a rare autoimmune disorder in which a person’s own immune system damages the nerves, causing muscle weakness, and sometimes paralysis. It is not contagious. There are 3,000 to 6,000 cases of the syndrome in the U.S. per year. Symptoms can last for a few weeks, or sometimes several years. In extreme cases, some people have permanent nerve damage and paralysis. And some people have died.
But GBS is rare, affecting only about 1 in 100,000 people. And in the case of the J&J vaccine, there have only been 100 reported cases among the almost 13 million Americans who have received the shot. While anyone can develop GBS, it is more common in men and adults older than 50. Indeed, the 100 cases being investigated in relation to the J&J vaccine mostly involve men over 50.
What are the symptoms of Guillain-Barré syndrome?
GBS usually presents as weakness or tingling sensations (pins and needles) in both feet and legs, which often spreads to the arms and upper body. Symptoms may escalate until some muscles cannot be used at all, and the person can become paralyzed in extreme cases. The Mayo Clinic reports that symptoms often progressively worsen for about two weeks before reaching a plateau at around four weeks. Recovery can take months, or maybe even years.
The FDA notes in its revised J&J COVID-19 vaccine fact sheet that GBS is most likely to appear within 42 days of vaccination. And in the 100 cases related to the J&J shot that the CDC is investigating, most patients developed GBS within two weeks of getting their shot.
What if you experience Guillain-Barré symptoms?
If you start feeling a tingling or numbing sensation in your feet that quickly spreads upward, seek medical attention ASAP. “I certainly would recommend that they go and see their doctor immediately,” said Putrino, “because there are other more common conditions that it could be, such as stroke, that you would want to see your doctor about if you’re experiencing these sorts of signs or symptoms.”
So what causes Guillain-Barré syndrome?
While the exact cause of GBS remains unknown, it is often triggered by a respiratory or gastrointestinal infection, such as the flu, Epstein Barr or Zika virus. Infection with the Campylobacter jejuni bacteria, which causes gastroenteritis (and symptoms of nausea, vomiting and diarrhea), is one of the most common risk factors for GBS. About two-thirds of people with GBS had a respiratory illness or diarrhea several weeks before developing symptoms, according to the CDC. And, very rarely, people have developed GBS in the days or weeks after receiving certain vaccines, the CDC reports.
It is not contagious, so people don’t spread it to one another. But outbreaks of germs associated with GBS can lead to clusters of people developing GBS.
How is Guillain-Barré syndrome treated?
There is no known cure for GBS, but most people recover. Between 60-80% of people are able to walk independently at six months, the Mayo Clinic reports, but patients may experience lingering effects such as weakness, numbness or fatigue.
People with GBS are often hospitalized. Treatments include plasma exchange (aka plasmapheresis), which removes and replaces the liquid part of the blood (or plasma) to get rid of certain antibodies that may have been causing your immune system to attack your nerves. Patients are also given high-dose immunoglobulin therapy, aka an infusion of healthy antibodies to block the damaging antibodies that may be contributing to GBS.
What’s the connection between Guillain-Barré syndrome and vaccinations?
For reasons that are still unknown, there are rare cases of people developing GBS after getting certain vaccines. The seasonal flu vaccine is associated with roughly one to two additional cases of GBS for every million vaccines given, for example. And the 1976 swine flu vaccination campaign, which was a special flu vaccine for a potential pandemic strain of influenza, also led to a small increase in the syndrome; about one extra case of GBS for every 100,000 people vaccinated at the time. But research suggests that it is more likely a person will develop GBS after getting the flu than after receiving their flu shot.
“All vaccines have some sort of risk of a side effect when you’re triggering the immune system the way that you are,” said Putrino. “There’s always a small risk of side effects of this nature …The numbers are still in your favor. ” But the benefits of the vaccines outweigh the risks of the serious illnesses that they are protecting you against.
So what do we know about the J&J COVID-19 vaccine and Guillain-Barré syndrome?
In the clinical trial for Johnson & Johnson’s COVID-19 vaccine, two patients developed GBS within two weeks of getting injected. One patient had received the placebo, however, while the other had received the vaccine. The study concluded that there wasn’t enough data to determine a cause-and-effect relationship between the vaccine and GBS. The report also noted that “many people will develop GBS by coincidence within a few weeks of vaccination.”
“People get Guillain-Barré syndrome from other things. There are other potential triggers, like other viruses and bacteria, and so that is something else to keep in mind,” said Wen. “This is another rare but serious illness that exists in our world.”
The CDC revealed Monday that it has received reports of 100 people among the almost 13 million Americans who received the J&J vaccine developing GBS. The health agency said it would ask its panel of outside vaccine experts to review the issue at an upcoming meeting, and the FDA also added a warning about the potential side effect to its fact sheets about the Janssen COVID-19 vaccine. Most cases of the side effect were reported in men aged 50 and up about two weeks after vaccination.
“So people who received the vaccine months ago should not be concerned about this,” said Wen.
And the government said the Pfizer
vaccines show no risk of the disorder after more than 320 million doses have been administered. The Pfizer and Moderna shots are mRNA vaccines, while J&J is a viral vector vaccine. The difference: the mRNA shots teach our cells how to make a protein — or even just a piece of a protein — that triggers an immune response inside our bodies to fight the coronavirus, the CDC explains on its site. The viral vector vaccine delivers a modified version of a different virus to help teach our cells how to fight the novel coronavirus.
Should you still get a COVID-19 vaccine?
Absolutely. If there’s one thing health officials agree on, it’s that the benefits of getting vaccinated against COVID far outweigh the extremely small risk of developing Guillain-Barré syndrome from the J&J vaccine. The global tally for the coronavirus-borne COVID-19 illness passed 187.8 million on Wednesday, and more than 4.04 million people around the world have died. The U.S. leads the world with a total of 33.9 million cases and 607,771 deaths and counting — and the highly infectious delta variant is spreading in states with low vaccination rates.
What’s more, millions of people have continued to suffer “long covid” symptoms for months after their initial COVID-19 infection, including extreme fatigue, shortness of breath, memory loss, brain fog, insomnia, chest pain and dizziness. One study found that 30% of COVID-19 survivors reported “persistent symptoms” nine months later. “If you think about 100 people in 13 million developing GBS, that means less than a .001% chance of getting GBS from a COVID-19 vaccine,” said Putrino. “You have a more than 10% chance of getting long covid if you catch COVID-19 while unvaccinated.” And Dr. Anthony Fauci recently reported that more than 99% of U.S. COVID-19 deaths in June were among unvaccinated people.
“The benefits of the vaccine far exceed the risks of the vaccine.”
— Dr. David Putrino
If you have experienced GBS in the past, however, you should speak with your doctor. You may want to consider one of the mRNA vaccines from Pfizer or Moderna if you haven’t been vaccinated against COVID already. But if you only have access to the J&J shot, or if you can only receive a single-dose shot, then health experts say you should feel confident that the J&J jab is safe.
“The benefits of the vaccine far exceed the risks of the vaccine, and if people are extremely concerned about the possibility of getting GBS [from the J&J shot], they can speak to their physician and ask for a different vaccine,” said Putrino. “But not everyone has that luxury, and our recommendation, strongly, would have to be that you get the vaccine that you can get, as opposed to no vaccine at all.”