FDA Warning for Guillain–Barre Syndrome and the Johnson & Johnson COVID-19 Vaccine

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A Statement from the Foundation Global Medical Advisory Board

The Washington Post and New York Times published on July 12, 2021 articles of a report by the FDA regarding cases of purported GBS after receiving the Johnson and Johnson COVID 19 vaccine.  Approximately 100 reports of suspected GBS were experienced by 12.8 million subjects who received this vaccine.  The cases were more common in men and patients above the age of 50.

It is important to understand that the reporting system used was the VAERS system (Vaccine Adverse Event Reporting System). This is a passive reporting system whereby patients, families and health care providers can report a case of GBS.  In past studies, patients were reported as having GBS when the disease was later determined to be another disorder.  Further analysis of the data will be necessary to determine if all of the patients truly developed GBS.

The CDC will be conducting shortly a meeting of their Advisory Committee on Immunization Practice  to analyze the data thoroughly.  The Foundation will be attending this meeting on behalf of the GBS patient community. As this time, the FDA states there is not enough information to establish a causal relationship between the J&J vaccine and cases of GBS.

The FDA has reiterated its stance that the known and potential benefits of the J&J vaccine clearly outweigh the known potential risks of the vaccine.  The GBS/CIDP Foundation supports this stance.   One must keep in mind that the vaccine is highly effective against COVID 19 and the delta variant.  Approximately one third of adults in the United States have not been vaccinated and cases of COVID 19 have increased in several states.

More than 100 million adults in the United States have received the Pfizer and Moderna vaccines and no increased incidence of GBS has been found after those vaccinations.

No data exists to advise patients who have had GBS in the past to avoid the Covid 19 vaccines including the J&J vaccines.  If a patient has received any of the vaccines and developed symptoms of weakness, numbness, or gait difficulty he or she should seek immediate care.