The Food and Drug Administration (FDA) announced on July 12 that it is updating the label on the Johnson & Johnson COVID-19 vaccine to include a warning about the risk of developing Guillain-Barré syndrome, (GBS) a rare and sometimes deadly autoimmune disorder in which the body attacks and damages nerves, according to the Centers for Disease Control and Prevention (CDC).
Anywhere between 3,000 and 6,000 people develop Guillain-Barré syndrome each year, per the CDC. For some people, a full recovery just takes a few weeks; for others, it can take a few years.
“Reports of adverse events following use of the Janssen COVID-19 vaccine under emergency use authorization suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination,” the FDA says in an updated fact sheet for the Johnson & Johnson vaccine (also known as the Janssen vaccine).
However, the FDA notes there isn’t enough data to prove that the vaccine actually causes Guillain-Barré syndrome. While the Moderna and Pfizer-BioNTech COVID-19 vaccines have not been linked with Guillain-Barré syndrome, other common vaccines have. Here’s everything experts want you to know about the condition.
Back up: What are the symptoms of Guillain-Barré syndrome?
People who have GBS often feel weakness or tingling sensations in both legs first, according to the CDC, and this sensation can spread to the arms and upper body. Weakness usually peaks within the first two weeks after symptoms first start, the CDC says. However, symptoms of GBS can progress until some muscles can’t be used at all. In severe cases, a person can experience permanent nerve damage, become paralyzed, or even die of the condition.
The cause of Guillain-Barré syndrome isn’t fully understood, but it often develops after someone has been infected with a virus or bacteria. The CDC says about two-thirds of people with Guillain-Barré syndrome will have diarrhea or a respiratory illness before they start to experience symptoms. Becoming infected with Campylobacter jejuni, a bacteria that leads to diarrhea, is a common risk factor for the condition, but people can also develop GBS after becoming sick from infections like the flu, Zika virus, or Epstein Barr virus.
“Guillain-Barré syndrome is generally accepted to be due to immune stimulation, and for this reason it is often associated with infections and vaccines since they stimulate the immune system,” explains Lewis Nelson, M.D., professor and chair of emergency medicine at the Rutgers New Jersey Medical School. “In Guillain-Barré syndrome, the immune system misfires and identifies certain nerve proteins as foreign and generates a response against them.”
Guillain-Barré syndrome is rare, but it has been a side effect tied to other vaccines.
Guillain-Barré syndrome can happen after different types of vaccinations, but the flu vaccine has notably been tied to the condition in rare situations, says infectious disease expert Amesh A. Adalja, M.D., senior scholar at the Johns Hopkins Center for Health Security.
Even back in 1976, there was a small increased risk of Guillain-Barré syndrome after people were vaccinated against the swine flu. The National Academy of Medicine investigated and found that the increased risk was about one additional case of Guillain-Barré syndrome for every 100,000 people who got the swine flu vaccine.
Because of this, the CDC monitors for Guillain-Barré syndrome during each flu season, noting that the data on the link between the seasonal flu vaccine and Guillain-Barré syndrome has “consistently” been between one and two additional cases of Guillain-Barré syndrome per every 1 million flu vaccine doses given.
The FDA also released a warning in March 2021 about the risk of Guillain-Barré syndrome with the Shingrix vaccine, which helps prevent shingles. But much like the Johnson & Johnson vaccine, there isn’t enough evidence to say that the Shingrix vaccine actually causes Guillain-Barré syndrome. “Overall, the benefits of vaccination with Shingrix are considered to outweigh this small risk,” says Prathit Kulkarni, M.D., assistant professor of medicine in infectious diseases at Baylor College of Medicine.
That said, experts do not understand why certain people develop the condition while others have no problems following vaccination, says Jeffrey Carson, M.D., a distinguished professor of medicine at Rutgers Robert Wood Johnson Medical School and principal investigator at Rutgers for the Johnson & Johnson trial.
Should you be worried about the Johnson & Johnson vaccine?
FDA officials have identified 100 suspected cases of Guillain-Barré syndrome through the Vaccine Adverse Event Reporting System (VAERS) in people who have received the Johnson & Johnson vaccine. The vast majority of those cases—95%—were considered serious and required the patients to be hospitalized, The New York Times reports.
However, about 12.8 million people have received the Johnson & Johnson vaccine. “It appears that this is an extremely rare occurrence and one in which the risk benefit ratio still strongly favors the vaccine,” says Dr. Adalja. “I suspect in the coming days and weeks we will learn more about the strength of this linkage and risk factors for the reaction.”
But if you are still nervous, it’s important to remember you have other options if you have not yet been vaccinated, says Richard Watkins, M.D., an infectious disease physician and professor of internal medicine at the Northeast Ohio Medical University. “There doesn’t appear to be an increased risk with the mRNA vaccines—the Moderna and Pfizer-BioNTech vaccines—which are newer technology,” he says.
That’s why he urges people to carefully weigh all of their options. “There is a much greater risk to your health and life from catching COVID-19 than from anything that can happen from the vaccine,” Dr. Watkins says. “Over 606,000 people have died from COVID-19 in the U.S.”
Dr. Nelson agrees. “There is no question that the risk of harm from the COVID vaccine—or any vaccine—is far lower than the risk of the disease the vaccine is intended to prevent,” he says. “Even when added to the other small risks of the various vaccines, the benefits still far outweigh the potential harm.”
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