- THE EPOCH TIMES - JULY 12, 2021 - JACK PHILLIPS -
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.
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