Key Takeaways
The Food and Drug Administration (FDA) on Monday added anew warningfor the Johnson & Johnson COVID-19 vaccine, saying it may trigger a rare autoimmune disorder called Guillain-Barré syndrome (GBS).
About 100 preliminary cases of the syndrome have been reported after the distribution of nearly 13 million doses of the Johnson & Johnson vaccine in the United States. Of these cases, 95 were serious and required hospitalization and there was one death, per the FDA statement.
Guillain-Barré syndromeis an autoimmune disorder that affects the peripheral nervous system. It can cause full-body paralysis and can lead to death, though most people fully recover. Most of the cases in people vaccinated with the Johnson & Johnson shot were reported within 42 days of vaccination and were mostly in men aged 50 and older.
“Although the available evidence suggests an association between the Janssen vaccine and increased risk of GBS, it is insufficient to establish a causal relationship,” FDA said.
The warning is another setback for the shot, which is the only single-dose vaccine approved for use in the United States.
“We strongly support raising awareness of the signs and symptoms of rare events to ensure they can be quickly identified and effectively treated,” Johnson & Johnsonsaid in a statementyesterday. The company reiterated that despite the warning, its vaccine remains important in the effort to create immunity to COVID-19. Nearly all COVID-19 deaths and hospitalizations in the U.S. are among unvaccinated people, theWhite House saidlast week.
“A single-shot vaccine that provides this level of protection represents an important tool in the global fight against COVID-19, as we strive to help end this deadly pandemic,” the company said.
What This Means For YouThe chance of developing GBS is very low and vaccination remains the most effective tool in protecting yourself from COVID-19. If you received the single-dose Johnson & Johnson shot, seek medical attention if you experience weakness or tingling sensations that spread through your body, difficulty walking, difficulty with facial movements, or double vision or inability to move your eyes.
What This Means For You
The chance of developing GBS is very low and vaccination remains the most effective tool in protecting yourself from COVID-19. If you received the single-dose Johnson & Johnson shot, seek medical attention if you experience weakness or tingling sensations that spread through your body, difficulty walking, difficulty with facial movements, or double vision or inability to move your eyes.
What to Know About Guillain-Barré Syndrome
GBS is an autoimmune disorder in which the immune system attacks the nervous system outside the brain and spinal cord. The disorder is rare—there are 300,000-600,000 cases in the U.S. each year.
Early symptoms include weakness and tingling in the extremities. In mild cases, people may experience brief muscle weakness. In extreme cases, these sensations can develop into full-body paralysis, limiting a person’s ability to breath independently or walk.
Most people, even those who have extreme symptoms, fully recover with only lingering muscle weakness. At six months, about 60-80% of people are able to walk. The mortality rate is between 4% and 7%.
The Link Between GBS and Vaccines
Last week, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee recommended a similar warning label for the AstraZeneca COVID-19 vaccine. The U.S. has yet to authorize the vaccine. So far, there is no strong evidence that the vaccine triggers the condition.
“At this stage the available data neither confirms nor rules out a possible association with the vaccine,” the EMAsaid.
In general, when vaccination is linked with triggering GBS, there are typically only one to two additional GBS cases per million vaccine doses delivered, according to the CDC.
“In the big scheme of things, I personally think trying to protect oneself from COVID-19 and getting a vaccination is certainly the safer option,” Dyck says.
What This Means for the Johnson & Johnson Vaccine
The warning presents another set-back for the vaccine. In April, regulators placed atemporary pauseon the rollout after the shot was linked to reports of a rare blood clot.
The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit ourcoronavirus news page.
4 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
National Institute of Neurological Disorders and Stroke.Guillain-Barré Syndrome Fact Sheet.
Barbi L, Coelho AVC, Arraes de Alencar LC, et al.Prevalence of Guillain-Barré syndrome among Zika virus infected cases: a systematic review and meta-analysis.The Brazilian Journal of Infectious Diseases. Mar-Apr 2018;22(2):137-141. doi: 10.1016/j.bjid.2018.02.005.
Centers for Disease Control and Prevention.Guillain-Barré Syndrome and Vaccines.
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