FDA Adds New Warning to Johnson & Johnson Vaccine

johnson & johnson vaccine, fda warning

Warning: The FDA released a warning this week on the Johnson & Johnson vaccine. In rare cases, the vaccine could be linked to Guillain-Barré Syndrome (GBS). GBS is a neurological disorder in which the immune system attacks the body’s nervous system. 

The cases of someone getting GBS after the vaccine are rare — 100 in over 12 million people thus far. Most of those 100 cases were men in age 50 and older who developed GBS around two weeks after getting the vaccine.

The FDA noted that while there is an association between the Johnson & Johnson vaccine and GBS, evidence is “insufficient to establish a causal relationship.”

Even so, the FDA has added a warning label to the vaccine that reads: “Guillain-Barré Syndrome Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination.”

Other vaccines have been associated with the development of GBS as well, including the flu shot and the shingles vaccine

The symptoms of Guillain-Barre syndrome can include numbness in the extremities, major muscle weakness, unsteadiness and lack of coordination, and paralysis. Patients usually recover. 

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