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FDA Adds New Warning to Johnson & Johnson’s COVID-19 Vaccine Fact Sheet

The federal government database has identified 100 suspected cases of Guillain-Barre syndrome (GBS) among the 12.8 million who received the Johnson & Johnson vaccine. GBS is a rare condition in which the body’s immune system attacks nerve cells. It most commonly begins with tingling and weakness in the feet and legs, spreading to the upper body. If GBS progresses, muscle weakness can evolve into paralysis. Most people with GBS fully recover, though some patients will experience lingering effects.  

As most hospitalizations and deaths linked to COVID are occurring among unvaccinated people, the Centers for Disease Control and Prevention (CDC) states that the benefits of the Johnson & Johnson vaccine outweigh the risks from the vaccine.

This isn’t the first warning to surface for the Johnson & Johnson vaccine. In April 2021, the U.S. Food and Drug Administration (FDA) and CDC paused the Johnson & Johnson vaccine. The pause came out of an abundance of caution after a small number of people who received the Johnson & Johnson vaccine developed Thrombosis with Thrombocytopenia syndrome (TTS), a blood-clotting disorder. After a thorough review of all available vaccine data, the CDC and FDA have concluded that the Johnson & Johnson vaccine’s known benefits outweigh its known and potential risks.

Who is at risk?

Experts aren’t sure who, specifically, is at higher risk of developing GBS or TTS as a vaccine side effect. Most instances of GBS identified in the federal database were seen in males ages 50 and older. Most people who developed TTS blood clots were women between 18 and 49. But the side effect has also been seen in men.

Should I still get the COVID-19 vaccine?

The COVID-19 vaccines are a proven way to avoid serious illness and hospitalization from the virus. Plus, the vaccine is our greatest hope for ending the pandemic. But like all big decisions, it’s yours to make. It’s good to have as much information as possible when making decisions.

Side effects from any of the vaccines authorized in the United States have been rare, and they are different depending on the vaccine. Based on all available data to date, the rare side effects that come with the Johnson & Johnson vaccine have not occurred in recipients of other authorized COVID-19 vaccines. And the Johnson & Johnson vaccine has not been reported to cause heart inflammation, a rare side effect impacting young men who received the Pfizer and Moderna vaccines.

If you’re concerned about your risk, it’s always a good idea to discuss your health concerns with your doctor before getting vaccinated.