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FDA to announce new warning on J&J Covid vaccine after reports of link to rare autoimmune disease 

The U.S. Food and Drug Administration (FDA) is set to announce a new warning that the Johnson & Johnson COVID-19 vaccine is linked to a rare autoimmune disease.

Four people familiar with the situation told The Washington Post that the shot has caused instances of Guillain-Barré syndrome, a rare disorder in which the immune system attacks the peripheral nervous system, temporarily paralyzing parts of the body.

The Centers for Disease Control and Prevention (CDC) is said to have received about 100 preliminary reports of Guillain-Barré following the one-dose vaccine   

Most the cases have occurred about two weeks after vaccination and mostly in men aged 50 and older. 

With just 100 cases reported out of 12.8 million doses administered, this means the condition is very rare occurring in just 0.000781 percent of cases.

The warning is yet another setback for J&J’s vaccine, which has plagued by pauses, ingredient mix-ups and doses needing to be thrown out.

The FDA is planning to release a new warning that the Johnson & Johnson COVID-19 vaccine is linked to a rare autoimmune disease called Guillain-Barré syndrome. Pictured: A member of the Philadelphia Fire Department prepares a dose of the Johnson & Johnson COVID-19 vaccine, March 2021

Most the cases have occurred about two weeks after vaccination and mostly in men aged 50 and older. Pictured: Ahealth worker gives a man a shot of the J&J COVID-19 vaccine, July 2021

Most the cases have occurred about two weeks after vaccination and mostly in men aged 50 and older. Pictured: Ahealth worker gives a man a shot of the J&J COVID-19 vaccine, July 2021

Guillain-Barré Syndrome is a rare disorder in which the immune system attacks the peripheral nervous system.

It is often triggered by a viral or bacterial illnesses and causes weakness and tingling in the limbs.

As patients’ conditions worsen, this can lead to parts of the body – or in some cases the whole body – being paralyzed.

Guillain–Barré Syndrome is rare, affecting about one in 100,000 annually.

Fewer than 20,000 cases are diagnosed per year, according to the National Institute of Neurological Disorders and Stroke.

After the first symptoms of Guillain-Barré, sufferers’ conditions usually worsen for about two weeks before plateauing around the four-week mark.

Most people recover, but about five percent have residual weakness or a recurrence.

Vaccines from Pfizer-BioNTech and Moderna have been used to fully vaccinate more than 160 million Americans, while J&J's shot has been used to inoculate just 12.8 million

Vaccines from Pfizer-BioNTech and Moderna have been used to fully vaccinate more than 160 million Americans, while J&J’s shot has been used to inoculate just 12.8 million 

According to The Post, the FDA officials are expected to emphasize that the J&J shot is safe and the the benefits of getting vaccinated outweigh the risks. 

‘It’s a real signal but a rare event,’ one of the people familiar with the situation told the newspaper.

Neither J&J nor the FDA immediately replied to DailyMail.com’s request for comment. 

J&J’s vaccine was believed to be a game-changer in the fight against coronavirus because it only requires one shot and does not need to be store at freezing temperatures.

It was expected to be used to inoculate hard-to-serve populations such as people living in rural areas and home bound seniors.

However, as of Monday, vaccines from Pfizer-BioNTech and Moderna have been used to fully vaccinate more than 160 million Americans with their two-dose shots.

Comparatively, just 12.8 million Americans have been vaccinated with the J&J shot due to a number of setbacks for the firm.

In April. the J&J vaccine was paused by the CDC and FDA for 10 days after six women under the age of 50 developed Cerebral Venous Sinus Thrombosis (CVST), a rare blood clot that forms in the venous sinuses in the brain.

The women developed CVST in combination with a low platelet-count condition known as thrombocytopenia. 

This figure was later updated to include 28 people, including one 45-year-old woman who died. 

The pause was lifted and the FDA added a warning to J&J’s coronavirus vaccine that rare blood clotting events might occur, primarily among women under age 50.

The company then face production problems when workers at Emergent BioSolutions, a plant in Maryland, ruined millions of doses of J&J’s COVID-19 vaccine with an ingredient intended for the AstraZeneca vaccine.

J&J was forced to throw out about 75 million doses of the vaccine worth $750 million, according to the contract it signed with the federal government pricing each dose at $10.

This is a breaking news story and will be updated

Read more at DailyMail.co.uk