FDA officially adds warning of neurological condition to Johnson & Johnson vaccine By Raymond Wolfe for Life Site News
A CDC communications official told Fox News that Guillain-Barré syndrome cases ‘have largely been reported about two weeks after vaccination and mostly in males, many aged 50 years and older.’
The Food and Drug Administration (FDA) announced on Monday that it has added a label to Johnson & Johnson’s COVID-19 vaccine that warns of a risk of Guillain-Barré syndrome (GBS), a rare neurological disorder that can cause paralysis.
The new warning comes in response to 100 preliminary reports of GBS after vaccination with the shot that have been tracked by the Vaccine Adverse Event Reporting System (VAERS), the Epoch Times said. VAERS, a vaccine injury tracking system managed by the FDA and the Centers for Disease Control and Prevention (CDC) is known to underreport cases.
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Of the Guillain-Barré reports submitted to VAERS, 95 were serious and required hospitalization, an FDA spokesperson told the Epoch Times. One death has been recorded so far: that of a 57-year-old Delaware man who had had a heart attack and a stroke in the past four years.
A CDC communications official told Fox News that GBS cases “have largely been reported about two weeks after vaccination and mostly in males, many aged 50 years and older.” Those
vaccinated with the Johnson & Johnson shot are believed to have a three-to-five times greater risk than would typically be observed in the U.S.
The FDA has not yet determined a “causal relationship” between COVID-19 vaccination and Guillain-Barré syndrome, but acknowledged in a statement that “the available evidence suggests an association,” according to Fox News. The Advisory Committee on Immunization Practices (ACIP) of the CDC is slated to review the issue at an upcoming meeting.
The FDA and CDC continue to push experimental COVID-19 vaccines despite a 98-99% survival rate for coronavirus in the U.S.
The revised healthcare provider fact sheet for the Johnson & Johnson vaccine now states that adverse events reports “suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination.” Marion Gruber, PhD, director of the CDC’s vaccine research and review office, confirmed the updates in a letter dated July 12.
