Johnson & Johnson’s Covid-19 jab can cause the rare auto-immune disorder Guillain-Barre syndrome that attacks the nerves and can result in paralysis, the US Food and Drug Administration has warned, adding the new information to the vaccine’s fact sheets for providers and patients, Politico writes.
FDA informed on Monday that Guillain-Barre has been detected in about 100 people who had recently received Johnson & Johnson’s Covid-19 jabs with 95 of those cases requiring hospitalization and one vaccine recipient dead from the disorder.
According to the report, most of the patients were men aged 50 and older, and symptoms developed in most of the cases within 42 days after they were vaccinated against Covid-19. Around 12.8 million Americans have been inoculated with the Johnson & Johnson single-dose shot.
Pointing in a statement that the safety and well-being of the people who use their products is their number one priority, the drugmaker strongly supported raising awareness of the rare events that have surfaced to ensure they can be identified and treated accordingly and in a timely manner.
The company said that the risk of contracting Guillain-Barre after receiving the vaccination is slightly higher than the average occurrence of the disorder.
This is another setback for Johnson & Johnson after its vaccine was temporarily suspended from use in April over concerns that it could cause dangerous blood clots.
The FDA believes the evidence of any link between the vaccine and Guillain-Barre is insufficient to establish a causal relationship and remains on its stand that benefits outweigh any potential risks.
The recipients of the Johnson & Johnson jab are advised in the FDA’s updated fact sheet to immediately seek medical attention if they experience any of the following symptoms: weakness or tingling sensations, especially in the legs or arms; difficulty walking; difficulty with bladder control or bowel function; double vision or inability to move eyes; or difficulty with facial movements, such as speaking, chewing and swallowing.
Johnson & Johnson’s shares in New York Stock Exchange on Monday had traded as high as $171.18 before the warning surfaced, closing 30 cents lower, at $169.48.
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