The Food and Drug Administration (FDA) added a new warning to the Johnson & Johnson COVID-19 vaccine information. The warning is about a possible link to Guillain-Barré syndrome, a rare neurological condition that can cause paralysis.
This new warning comes after the FDA received 100 preliminary reports of people developing Guillain-Barré syndrome after getting the Johnson & Johnson vaccine, the Washington Post reports. For context, that’s out of 12.8 million doses of the vaccine administered. The cases appeared around two weeks after vaccination and were more common in men and people older than 50.
The condition “has occurred in some people who have received” Johnson & Johnson COVID-19 vaccine, according to the new FDA information. “In most of these people, symptoms began within 42 days following receipt of the [vaccine]. The chance of having this occur is very low.” The warning directs people who experience the symptoms of Guillain-Barré syndrome to seek medical attention.
It’s not clear yet whether or not the vaccine directly caused the condition, but the Centers for Disease Control and Prevention (CDC) told CNN there is a “small possible risk” for the condition associated with the vaccine. Experts are expected to discuss that potential risk at a meeting of the CDC’s Advisory Committee on Immunization Practices later this week.
Guillain-Barré syndrome occurs when the body’s immune system damages its own nerve cells, which can cause muscle weakness and tingling sensations in the arms, hands, feet, ankles, wrists, face, and legs, the Mayo Clinic explains. As it progresses, the condition can cause difficulty with walking, facial movements, chewing, and speaking. It can also cause double vision and difficulty with bowel and bladder control. When it becomes even more severe, Guillain-Barré syndrome can cause paralysis. (There are actually three forms of Guillain-Barré syndrome, the Mayo Clinic says, which are similar but usually start in different parts of the body.)
Experts don’t know exactly what causes the condition, but it can develop after a gastrointestinal or respiratory illness, including Zika virus and COVID-19, the Mayo Clinic explains. People who develop Guillain-Barré syndrome typically require hospitalization. Although there’s no cure for the condition, treatment including immunoglobulin therapy, plasma exchange, and physical therapy can help most patients regain mobility and motor strength, the Mayo Clinic says. However, the recovery process can be long, taking up to three years for some patients.
Previously, the FDA added a warning to the Johnson & Johnson COVID-19 vaccine about a link between the vaccine and cerebral venous sinus thrombosis, a type of rare blood clot in the brain. Both of these new potential side effects are obviously scary, but it’s important to remember just how rare they are—and that in the majority of cases, the potential benefits of getting the vaccine outweigh the risks. With cases rising again in the U.S. and the delta coronavirus variant spreading, it’s crucial for those who can get vaccinated to do so—to protect themselves and those around them.