The U.S. Food and Drug Administration (FDA) on July 12 said it will add a warning label to Johnson & Johnson’s COVID-19 vaccine that it is linked to a rare neurological disorder known as Guillain-Barré syndrome (GBS), while J&J confirmed it is “in discussions” with federal agencies.
“The FDA is announcing revisions to the vaccine recipient and vaccination provider fact sheets for the Johnson & Johnson (Janssen) COVID-19 Vaccine to include information pertaining to an observed increased risk of Guillain-Barré Syndrome (GBS) following vaccination,” an FDA spokesperson told The Epoch Times on July 12.
The benefits of the vaccine outweigh the risks, the agency said.
That determination was made “based on an analysis of Vaccine Adverse Event Reporting (VAERS) data” which found “there have been 100 preliminary reports following vaccination with the Janssen vaccine after approximately 12.5 million doses administered,” the spokesperson said. “Of these reports, 95 of them were serious and required hospitalization.”
As of now, the FDA noted, although available data suggest there is an association between the J&J vaccine and an increased risk of GBS, this is “insufficient to establish a causal relationship.”
The spokesperson added that the Moderna and Pfizer COVID-19 vaccines don’t present a similar risk.
Meanwhile, a spokesperson for the CDC told The Epoch Times that the federal health agency is monitoring reports of GBS.
“Every year in the United States, an estimated 3,000 to 6,000 people develop GBS,” said a CDC spokesperson, adding that “it is typically triggered by a respiratory or gastrointestinal infection. Most people fully recover from GBS.”
According to the CDC, GBS is a neurological disorder in which the body’s immune system damages nerve cells and causes muscle weakness. In some cases, the disorder can cause paralysis, says the Mayo Clinic, which noted that most people with the condition must be hospitalized.
J&J, in a statement on Monday, confirmed it has “been in discussions with the U.S. Food and Drug Administration and other regulators about rare cases of the neurological disorder, Guillain-Barré syndrome, that have been reported following vaccination with the Janssen COVID-19 vaccine.”
“The chance of having this occur is very low,” the statement added, “and the rate of reported cases exceeds the background rate by a small degree.”
GBS has been linked as a rare side effect to various vaccines, including one that was developed to combat the swine flu in 1976, according to the UK National Health Services website.
Earlier this year, the CDC and FDA recommended halting usage of the J&J vaccine after reports of blood clots emerged among some individuals who had received it. Weeks later, the two agencies said that the vaccine could again be used, but with an FDA warning.
“This pause was essential to our ability to inform the public, inform physicians, and acquire more data for presentation and for analysis,” Dr. José Romero, chairman of the CDC’s Committee of Immunizations, said in April. The vote was 10–4 in favor of recommending the vaccine to adults who are 18 or older. There was one abstention.
COVID-19 is the illness caused by the CCP (Chinese Communist Party) virus.
J&J hasn’t responded to a request for comment by press time.