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The United States Food and Drug Administration (FDA) announced on July 12 that it would add a warning label to Johnson & Johnson’s COVID-19 vaccine indicating that it was linked to a rare neurological disorder known as of Guillain-Barré syndrome (GBS), while J&J confirmed it is “in discussion” with federal agencies.
“FDA Announces Revisions to Vaccine Recipient and Vaccine Provider Information Sheets for the Johnson & Johnson (Janssen) COVID-19 Vaccine to Include Information Related to an Observed Increased Risk of Guillain-Barré Syndrome (GBS) after vaccination, ”an FDA spokesperson told The Epoch Times on July 12.
The benefits of the vaccine outweigh the risks, according to the agency.
This decision was made “based on an analysis of vaccine adverse event reporting (VAERS) data” which found “that there were 100 preliminary reports after vaccination with the Janssen vaccine after approximately 12, 5 million doses administered, ”said the spokesperson. “Of these reports, 95 were serious and required hospitalization. “
At present, the FDA has noted, although the available data suggests that 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 do not pose a similar risk.
Meanwhile, a CDC spokesperson told The Epoch Times that the federal health agency is monitoring GBS reports.
“Each year in the United States, an estimated 3,000 to 6,000 people develop GBS,” a CDC spokesperson said, adding that “it is usually triggered by a respiratory or gastrointestinal infection. Most of people recovering completely 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, explains the Mayo Clinic, which has noted that most people with the condition require hospitalization.
J&J, in a statement released Monday, confirmed that it “has been in talks with the United States Food and Drug Administration and other regulators about rare cases of the neurological disorder, Guillain-Barré syndrome, which have been reported following vaccination with the Janssen COVID-19 vaccine. “
“The risk of this happening is very low,” the statement added, “and the rate of reported cases slightly exceeds the background rate.”
GBS has been linked as a rare side effect to various vaccines, including one that was developed to fight swine flu in 1976, according to the UK National Health Services website.
Earlier this year, the CDC and the FDA recommended stopping use of the J&J vaccine after reports of blood clots emerged in some people who had received it. Weeks later, the two agencies said the vaccine could be used again, but with an FDA warning.
“This break was critical to our ability to educate the public, educate physicians, and acquire more data for presentation and analysis,” said Dr. José Romero, chair of the CDC’s Vaccinations Committee, in April. The vote was 10 to 4 in favor of recommending the vaccine to adults 18 years of age or older. There was one abstention.
COVID-19 is the disease caused by the virus of the CCP (Chinese Communist Party).
J&J did not respond to a request for comment at press time.
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