Guillain-Barre syndrome: FDA flags ‘small’ risk with J&J jab

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Al Jazeera English 13 July, 2021 - 02:43am 54 views

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FDA warns on potential Johnson & Johnson COVID-19 vaccine link to rare disorder

Fox News 13 July, 2021 - 07:46am

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The warning comes after about 100 preliminary reports of Guillain-Barré cases against a backdrop of about 12.5 million Johnson & Johnson doses administered, the FDA said in a statement Monday. Of the total, 95 cases were serious and involved hospitalization, with one reported death. However, the FDA stopped short of pinning a causal relationship between the vaccine and the rare disorder.

"Although the available evidence suggests an association between the Janssen vaccine and increased risk of GBS, it is insufficient to establish a causal relationship," the statement reads, later adding, "Importantly, the FDA has evaluated the available information for the Janssen COVID-19 Vaccine and continues to find the known and potential benefits clearly outweigh the known and potential risks."

The updated warning advises seeking immediate medical attention upon symptoms post-vaccination like "weakness or tingling sensations (especially in the legs or arms) worsening or 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, or difficulty with bladder control or bowel function."

"The chance of having this occur is very low, and the rate of reported cases exceeds the background rate by a small degree," reads the statement from Johnson & Johnson, which also urged awareness over signs and symptoms of rare adverse events for prompt identification and treatment.

A Centers for Disease Control and Prevention (CDC) spokesperson also confirmed to Fox News that the CDC and FDA are monitoring reports of Guillain-Barré Syndrome (GBS) after receiving Johnson & Johnson’s Janssen COVID-19 Vaccine.

"Reports of GBS after receipt of the J&J/Janssen COVID-19 Vaccine in the Vaccine Adverse Event Reporting System (VAERS) are rare, but do likely indicate a small possible risk of this side effect following this vaccine," Kristen Nordlund, health communication specialist and special assistant to the director of communications at CDC, wrote to Fox News in an email. "These cases have largely been reported about two weeks after vaccination and mostly in males, many aged 50 years and older. "

Nordlund and the FDA said available data don't show a similar trend with mRNA vaccines (Pfizer-BioNTech and Moderna), after over 321 million doses were administered in the United States. An independent group of experts advising the CDC plan to discuss the issue at an upcoming meeting, she said, though it is not immediately clear when the meeting will be held.

"Very rarely, people have developed GBS in the days or weeks after receiving certain vaccines," the agency states. The syndrome is estimated to affect about 1 in 100,000 people, and in the U.S. it is more common among men and individuals above age 50. It is not contagious but outbreaks of germs linked to GBS can result in clusters. Treatments include plasma exchange and antibody infusions.

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What to Know About Guillain-Barré Syndrome

NECN 13 July, 2021 - 07:46am

About 100 people who received the Johnson & Johnson COVID-19 vaccine have reportedly developed Guillain-Barré syndrome, according to the Centers for Disease Control and Prevention.

The J&J vaccine may pose a "small possible risk" of the rare immune system disorder that can cause muscle weakness and sometimes temporary paralysis, U.S. health officials said.

GBS is a rare neurological disorder causing the immune system to attack the peripheral nervous system, or the nerves around the brain and spinal cord.

Those who develop GBS may experience tingling in the feet or hands, or pain beginning in the legs or back. After that passes, muscle weakness may set in. Additional symptoms include difficulty with eye muscles and vision; trouble swallowing, speaking or chewing; lack of coordination; an abnormal heart beat/rate; and issues digesting or controlling the bladder.

The CDC estimates only 3,000 to 6,000 people develop GBS every year, with most people fully recovering. Only 100 of the nearly 13 million people who have received the J&J vaccine have reportedly developed it.

Men, many 50 years and older, reported most of the cases, usually about two weeks post-vaccination.

There is no known cure for Guillain-Barré syndrome, according to the National Institutes of Health.

Plasma exchange and immunoglobulin therapies have both shown to have benefits to people with GBS, along with other treatments for specific symptoms and longer term rehabilitative care.

The NIH reports that 70% of patients with GBS eventually recover.

U.S. issues new warning on J&J vaccine | ANC

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U.S. issues new warning on J&J COVID-19 vaccine

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