The Food and Drug Administration (FDA) issued a warning Monday that the Johnson & Johnson COVID-19 vaccine could be linked to a rare neurological condition called Guillain-Barré syndrome.
FDA regulators found that recipients of the J&J shot may be three-to-five times more likely to develop the disorder than the general population. A new warning has been added to fact sheets distributed to both vaccine recipients and healthcare providers by the agency.
1/ J&J COVID vaccine linked VERY RARELY to Guillain-Barré syndrome (GBS). https://t.co/2JV9S5ssob
– 100 prelim reports of GBS out of 12.8M doses (0.0008%)
– about 2 weeks after vaccination
– mostly in men
– mostly in 50+ years-old
— Céline Gounder, MD, ScM, FIDSA (@celinegounder) July 12, 2021
Regulators discovered about 100 suspected cases of Guillain-Barré, 95% of which required hospitalization, according to The New York Times. The agency said it cannot yet confirm that the relationship between the syndrome and the vaccine is “causal.”
The cases were largely present in men aged 50 years and older about two weeks after they were vaccinated, according to the Centers for Disease Control. (RELATED: Dr. Fauci Tells People Hesitant About The Vaccine To ‘Just Get Over It’)
Guillain-Barré syndrome causes the body’s immune system to attack its nervous system. The initial symptoms are often a feeling of weakness and tingling in extremities, and severe cases can result in paralysis and a need for hospitalization.
Only eight percent of fully vaccinated Americans have been vaccinated with the Johnson & Johnson shot. While it is easier to store than the mRNA alternatives from Moderna and Pfizer, and only requires one shot instead of two for full vaccination, the J&J offering has been plagued by safety and production issues. (RELATED: Poll: Americans No Longer Confident In Johnson & Johnson Vaccine After CDC Pause)
This is the second side-effect red flag that has been raised for the J&J shot, after its use was briefly paused in April after it was linked to occurrences of rare blood clots in some recipients. In March, millions of doses of the jab were ruined by errors at a manufacturing plant in Baltimore.