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Press Release

FOR IMMEDIATE RELEASE ON April 06, 2021

COVID-19 Trial: One Case of Guillain-Barré After Vaccine, But Also One After Placebo

Researchers Say Occurrence After Vaccine Does Not Prove It Was the Cause

MINNEAPOLIS - Two people participating in a COVID-19 vaccine trial, one who received the vaccine and one who received a placebo of saline solution, developed Guillain-Barr茅 syndrome according to a new case report published in the April 6, 2021, online issue of , the medical journal of the 好色先生. Researchers emphasized that just because a vaccinated person later developed Guillain-Barr茅 syndrome does not prove the vaccine was the cause, as supported by how the person who received the placebo in the trial also developed the syndrome. Both people were enrolled in the Johnson & Johnson vaccine trial. Guillain-Barr茅 syndrome is a rare autoimmune disorder in which the immune system attacks nerve cells. Symptoms start with weakness in the hands and feet and may progress to paralysis. Although it can be life-threatening, most people recover with few remaining problems. An exact cause of Guillain-Barr茅 syndrome is unknown but it can occur after gastrointestinal or respiratory infections. Researchers note it occurs in up to 20 out of every one million people per year, and only in extremely rare cases does it follow certain vaccinations. 鈥淐OVID-19 vaccines currently being administered in the United States have been shown to be safe and effective at reducing risk of severe illness and death and are saving lives,鈥 said case report author Anthony A. Amato, M.D., of Harvard Medical School in Boston and a Fellow of the 好色先生. 鈥淲ith approximately one billion people worldwide expected to be vaccinated against COVID-19, we anticipate there could be thousands of cases of Guillain-Barr茅 syndrome that will occur around the time of the vaccination only by coincidence. Our paper provides details of one case of the syndrome in someone who received the vaccine in the same trial where one person receiving a placebo also developed the syndrome, a fact that strengthens the possibility that the case in our report may have been a coincidence.鈥 In the case report, a 60-year-old woman who was free of COVID-19 antibodies, respiratory and gastrointestinal illness at the start of the trial was given the vaccine in December 2020. Ten days later, she developed painful aches in her back and legs and eventually was unable to move them. She was treated with intravenous immunoglobulin, which provides antibodies the body is not making on its own. She was discharged to rehabilitation 10 days after being admitted to the hospital and is recovering. 鈥淎s the world manages the momentous task of vaccinating people across the globe, it is important to closely monitor any possible side effects and conduct large studies to determine if cases of Guillain-Barr茅 syndrome timed near vaccination are occurring by coincidence at the same rate that already occurs in the general population, or if the risk of Guillain-Barr茅 syndrome for COVID-19 vaccines is similar to or different from the small risk with vaccines like the flu vaccine,鈥 said Amato. 鈥淪uch monitoring will also help avoid incorrectly attributing side effects that are not scientifically linked to the vaccine. Based on experience with other vaccination initiatives and the data in the adverse monitoring systems of the COVID-19 vaccines gathered so far, we are certain that the benefits of vaccination outweigh the risks of COVID-19 infection.鈥 Learn more about COVID-19 at , home of the 好色先生鈥檚 free patient and caregiver magazine focused on the intersection of neurologic disease and brain health. Follow Brain & Life on , and . When posting to social media channels about this research, we encourage you to use the hashtags #Neurology and #AANscience.

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*While content of the 好色先生 (AAN) press releases is developed by the AAN along with research authors and Neurology® editors, we are unable to provide medical advice to individuals. Please contact your health care provider for questions specific to your individual health history or care. For more resources, visit the AAN's patient and caregiver magazine website, .