FDA Cautions Public on Autoimmune Disorder Guillain-Barre Related to Johnson & Johnson
Detail of boxes with the U.S. donated Johnson & Johnson vaccine against Covid-19 at Universidad de Baja California on June 17, 2021 in Tijuana, Baja California. After the visit of Vice president Harris to Mexico, US sent a donation of 1.35 million doses of Johnson and Johnson vaccine. Vaccines will be administrated to anyone over 18 in 39 towns from the Mexican side of the border with United States. The aim of the project is to boost vaccination rates to level of the American cities across the border. Francisco Vega/Getty Images

The U.S. Food and Drug Administration issued a new warning on Monday about an increased risk of autoimmune disorder Guillain-Barre linked to the Johnson & Johnson COVID vaccine.

The released warning came after 100 preliminary cases of the rare-neurological disorder were reported among the 12.5 million doses administered, according to an ABC News Go report.

The FDA also reported that the 95 cases were serious and required admission to the hospital, while there was also one death.

The agency said that they have evaluated the available information for Johnson & Johnson COVID vaccine and continue to find the known and potential benefits clearly outweigh the possible risks.

The company also noted that the chance of having the said autoimmune disorder is very low and the rate of reported cases exceeds the background rate by a small degree.

The Centers for Disease Control and Prevention said that it mostly occurred among men 50 and older who have been vaccinated.

Meanwhile, the symptoms usually start showing three weeks after vaccination, according to a Forbes report.

Guillain-Barre

The rare condition makes the body's immune system attacks nerve cells. It can also cause muscle weakness and paralysis, according to The New York Times report.

The condition can also cause permanent nerve damage although symptoms often pass within weeks in some cases.

There are usually 3,000 to 6,000 cases of the syndrome per year in the United States, according to CDC. This is even common in adults over 50.

The cause of the syndrome remains unknown. It is usually followed by another illness or infection, like the flu.

During the swine flu vaccination in 1976, the syndrome was also linked to the vaccination campaign. It caused around one extra case of Guillain-Barre for every 100,000 people vaccinated.

In addition, the seasonal flu shot is also related to the Guillain-Barre syndrome with around one to two additional cases for every million vaccines administered.

Daniel Salmon, the director of the Institute for Vaccine Safety at Johns Hopkins University, said that the data are showing that the flu vaccines cause the syndrome, adding that it is a very small risk.

J & J COVID Vaccine

J & J COVID vaccine requires one dose instead of two and utilizes viral sector technology instead of mRNA, according to a Healthline report.

It also shares common side effects with other vaccines, such as injection site reactions, headaches, and fatigue.

J & J have also reported a small number of serious blood clots after the vaccination, with the risk of these occurring is very low.

Six instances of thrombosis with thrombocytopenia syndrome, which included one death, had been reported at the time of the pause. The blood clot cases involved women between ages 18 and 48 years old. The symptoms started two weeks after receiving the J & J vaccine.

The FDA granted the company an emergency use authorization in February and became the third COVID vaccine in the United States to have a EUA.

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Written by Mary Webber

WATCH: FDA flags small risk of neurological disorder after Johnson and Johnson vaccine - from CBS News