COVID-19 vaccine by J&J comes with rare nerve syndrome warning. Here's what to know about it
Adrianna Rodriguez, USA TODAY 1 hr ago
Even though the Food and Drug Administration updated the warning label on Johnson & Johnson’s coronavirus vaccine to include an increased risk of a rare neurological disorder, health experts say Americans shouldn’t worry.
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The odds of developing Guillain-Barré syndrome after getting the COVID-19 shot, they say, are less than getting it from other vaccines, bacteria and viruses, including SARS-CoV-2, the virus that causes COVID-19.
The label updated Monday says reports suggest an increased risk of GBS within 42 days after getting vaccinated. In a statement, the FDA said the data “suggests an association,” but not enough “to establish a causal relationship.”
© PIERRE-PHILIPPE MARCOU, AFP via Getty Images A health worker holds a syringe with a vial of the J&J/Janssen Covid-19 vaccine at a vaccination centre at the Wizink Center in Madrid on May 21, 2021.Start the day smarter. Get all the news you need in your inbox each morning.
Experts urge Americans to continue getting their COVID-19 shots, including the Johnson & Johnson vaccine.
What is Guillain-Barré Syndrome?Guillain-Barré syndrome, or GBS, is a rare neurological disorder in which the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis, according to the CDC.
Symptoms range in a spectrum of severity from a tingling sensation in the hands and feet to paralysis, said Dr. Len Horovitz, a pulmonary specialist and internist at Lenox Hill Hospital in New York City.
Other symptoms also include difficulty with eye muscles and vision, swallowing, speaking or chewing, according to the National Institute of Neurological Disorders and Stroke. Patients may also experience coordination problems and unsteadiness, abnormal heart rate or blood pressure and problems with digestion or bladder control.
About 70% of people who are diagnosed with GBS make a full recovery, the NINDS says. Symptoms may persist for years, but Horovitz says most people recover within a few months.
GBS symptoms can spread to other parts of the body – such as the diaphragm muscles – so it’s important to seek medical attention if you’re feeling shortness of breath, said Dr. Vivek Cherian, an internal medicine physician affiliated with the University of Maryland Medical System.
What the FDA says about the J&J vaccine and Guillain-Barré syndromeNearly 13 million doses of the Johnson & Johnson COVID-19 vaccine have been administered in the U.S., compared with 185 million doses of Pfizer’s vaccine and 136 million doses of Moderna’s vaccine.
Out of 13 million doses, the FDA said there have been about 100 preliminary reports of Guillain-Barré syndrome that may be associated with the J&J vaccine. Cases were primarily men in their 50s or older, and symptoms developed within 42 days of injection.
“It’s not completely surprising because we have heard other associations (of Guillain-Barré syndrome), even with the flu vaccine in rare cases,” Cherian said.
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Why experts say Americans shouldn’t worryEach year, the CDC estimates 3,000 to 6,000 people develop GBS in the U.S. from viruses, bacteria and, on rare occasions, other vaccines.
Scientists are working to determine whether the incidence of Guillain-Barré within the vaccinated population is higher than in the unvaccinated population. Although only one case appeared during J&J trials, experts say they expected to see more as vaccination efforts expanded.
“You don’t see these things in the clinical trials because probability-wise, they don’t show up … until you start vaccinating millions of people,” Cherian said.
But 100 cases out of nearly 13 million administered doses is still rare, experts say, and Americans may be more at risk of GBS if they develop COVID-19.
An April 2020 study from Italy published in the peer-reviewed New England Journal of Medicine found five out of the 1,200 COVID-19 patients developed GBS.
“After a person has an infection, there can be an immune system confusion where the immune system attacks the insolation, or myelin sheath, around the peripheral nerves,” said Dr. Robert Fox, staff neurologist at the Cleveland Clinic’s Mellen Center for Multiple Sclerosis.
While GBS symptoms may last a few months, Cherian says a growing population of recovered COVID-19 patients have been experiencing “long COVID” symptoms for more than a year. The risks of getting COVID-19, especially as the highly transmissible delta variant continues to circulate in the U.S., far outweigh the risk of developing Guillain-Barré from the J&J vaccine, experts stress.
“The risk of getting COVID and developing severe disease or long COVID is so much more than your risk of developing a rare syndrome of the vaccine,” Horovitz said. “You should put your arm out and get the shot.”
Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.