The FDA on Monday announced it will be adding an advisory to Johnson & Johnson’s Covid-19 vaccine warning about Guillain-Barré Syndrome as a possible adverse side effect.
The warning, regarding the disorder in which the immune system attacks a person’s nerves, will be added after around 100 reports of Guillain-Barré were documented among vaccine recipients in the VAERS (Vaccine Adverse Event Reporting System) database.
“Of these reports, 95 were serious and required hospitalization,” reported the Washington Post, adding, “There was one death,” however neither the CDC or FDA elaborated on the fatality.
“The cases have largely been reported about two weeks after vaccination and mostly in men, many aged 50 and older, according to the CDC.”
Adding to the statement, the CDC said, while rare, the reports “do likely indicate a small possible risk of this side effect following” J&J’s vaccine. However, the FDA still says that “small possible risk” is “insufficient to establish a causal relationship” between the J&J jab and Guillain-Barré.
12.8 million doses of the J&J have already been administered in the US. On Monday, the FDA updated its J&J fact sheet to warn vaccine recipients to be wary of possible signs of Guillain-Barré.
Guillain Barré syndrome (a neurological disorder in which the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis) has occurred in some people who have received the Janssen COVID-19 Vaccine. In most of these people, symptoms began within 42 days following receipt of the Janssen COVID-19 Vaccine. The chance of having this occur is very low. You should seek medical attention right away if you develop any of the following symptoms after receiving the Janssen COVID-19 Vaccine:
• Weakness or tingling sensations, especially in the legs or arms, that’s worsening and spreading to other parts of the body
• Difficulty walking
• Difficulty with facial movements, including speaking, chewing, or swallowing
• Double vision or inability to move eyes
• Difficulty with bladder control or bowel function
“Most people fully recover from Guillain-Barré,” the Post claims.
News of the additional warning is the latest blow for J&J’s already difficult vaccine rollout.
Back in mid-April, the CDC and FDA put a halt on distributing the one-dose Janssen vaccine citing reports of a high risk of blood clots. The shot resumed distribution about ten days later. And just last month, the FDA ordered J&J to destroy over 60 million vials produced in a Boston lab, claiming the unsanitary conditions at the facility could have contaminated the doses.
“The Baltimore plant was shut down in April after federal officials discovered millions of doses had been contaminated with AstraZeneca vaccine, which was also being made there,” reports the Post.