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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 fatal autoimmune disorder in which the body attacks and damages the nerves, according to the Centers for Disease Control and Prevention (CDC).
Everywhere between 3,000 and 6,000 people develop Guillain-Barré syndrome each year. CDC. For some people, a full recovery just takes a few weeks; for others, it may take a few years.
“Reports of adverse events following the use of the Janssen COVID-19 vaccine during authorization for emergency use suggest an increased risk of Guillain-Barré syndrome during the 42 days after vaccination,” the FDA said in an updated fact sheet for the Johnson & Johnson vaccine. (also known as the Janssen vaccine).
However, the FDA notes that there is not enough data to prove that the vaccine actually is causes Guillain-Barré syndrome. While the Moderna and Pfizer BioNTech COVID-19 vaccines have not been linked to Guillain-Barré syndrome, other common vaccines have. Here is everything experts want you to know about the condition.
Backup: 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 the first onset of symptoms, the CDC says. However, symptoms of GBS can develop until some muscles cannot be used at all. In severe cases, a person may experience permanent nerve damage, become paralyzed or even die from the condition.
The cause of Guillain-Barré syndrome is not fully understood, but it often develops when 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 respiratory illness before they begin to experience symptoms. Gets infected with Campylobacter jejuni, a bacterium that leads to diarrhea, is a common risk factor for the condition, but people can also develop GBS after becoming ill from infections such as 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, as they stimulate the immune system,” explains Lewis Nelson, MD, professor and president of emergency medicine at Rutgers New Jersey Medical School. “In Guillain-Barré syndrome, the immune system fails and identifies certain nerve proteins as foreign and generates a response against them.”
Video: FDA warns of Johnson & Johnson COVID vaccine and risk of Guillain-Barré syndrome – here’s what it means (Health.com)
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Guillain-Barré syndrome is rare, but it has been a side effect associated with other vaccines.
Guillain-Barré syndrome can occur after different types of vaccinations, but the flu vaccine has been particularly linked to the condition in rare situations, says infectious disease expert Amesh A. Adalja, MD, senior researcher at the Johns Hopkins Center for Health Security.
As early as 1976, there was a small increased risk of Guillain-Barré syndrome after people were vaccinated against swine flu. The National Academy of Medicine examined and found that the increased risk was around an additional case of Guillain-Barré syndrome for every 100,000 people who received the swine flu vaccine.
Because of this, the CDC monitors Guillain-Barré syndrome during each flu season, noting that the data on the link between seasonal flu vaccine and Guillain-Barré syndrome have been “consistent” between one and two additional cases of Guillain-Barré syndrome. pr. 1 million influenza vaccine doses.
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 like the Johnson & Johnson vaccine, there is not enough evidence that the Shingrix vaccine actually causes Guillain-Barré syndrome. “Overall, the benefits of vaccination with Shingrix outweigh this small risk,” said Prathit Kulkarni, MD, assistant professor of infectious disease medicine at Baylor College of Medicine.
That said, experts do not understand why some people develop the condition while others have no problems after vaccination, says Jeffrey Carson, MD, a prominent professor of medicine at Rutgers Robert Wood Johnson Medical School and lead researcher at Rutgers to Johnson & Johnson trial. .
Should you be concerned 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 these cases – 95% – were considered serious and required patients to be admitted, New York Times reports.
Dog ca. 12.8 million people have received the Johnson & Johnson vaccine. “It seems that this is an extremely rare event, and where the risk of inflammation still favors the vaccine,” says Dr. Adalja. “I suppose in the coming days and weeks we will learn more about the strength of this connection and risk factors for the reaction.”
However, if you are still nervous, it is important to remember that you have other options if you have not yet been vaccinated, says Richard Watkins, MD, an infectious disease physician and professor of internal medicine at Northeast Ohio Medical University. “There does not appear to be an increased risk with the mRNA vaccines – the Moderna and Pfizer BioNTech vaccines – which are newer technology,” he says.
Therefore, he urges people to carefully weigh all their options. “There is a much greater risk to your health and life by catching COVID-19 than from anything that can happen from the vaccine,” says Dr. Watkins. “Over 606,000 people have died from COVID-19 in the United States”
Dr. Nelson agrees. “There is no doubt that the risk of harm from the COVID vaccine – or any vaccine – is far lower than the risk of the disease that 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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