FDA warns Johnson & Johnson COVID-19 vaccine is linked to rare neurological reaction

U.S. regulators added new warnings to Johnson & Johnson on Monday Coronavirus disease Regarding the vaccine linked to a rare and potentially dangerous neurological reaction, it is not fully understood that the injection caused the problem.

The U.S. Food and Drug Administration announced a new warning, flagging reports of Guillain-Barré syndrome, a disease of the immune system that can cause muscle weakness and occasional paralysis. Health officials describe this side effect as “the risk that people who get the vaccine may face is very small.”

The action was taken after the FDA and the Centers for Disease Control and Prevention reviewed reports of approximately 100 people experiencing the syndrome after receiving a single dose of the vaccine. The FDA said that almost everyone was hospitalized and one person died.

Guillain-Barre syndrome occurs when the body’s immune system mistakenly attacks certain nerve cells, causing muscle weakness and sometimes temporary paralysis. According to the Centers for Disease Control and Prevention, an estimated 3,000 to 6,000 people develop this syndrome each year.

The number of reported cases related to the Johnson & Johnson vaccine is only a small fraction of the nearly 13 million Americans who received a single injection. Most cases are reported in men—many 50 years and older—usually around two weeks after vaccination.

Johnson & Johnson said in a statement that it has been discussing these reports with the FDA and other health regulatory agencies around the world.

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The CDC said it will ask its external vaccine expert team to review the issue at an upcoming meeting.

The government stated that the most used vaccine in the United States, produced by Pfizer and Moderna, did not show a risk of contracting the disease after vaccinating more than 320 million doses.

The new warning will be included in a pamphlet issued to people who have been given injections by Johnson & Johnson. The FDA stated that if they experience any symptoms, including tingling, difficulty walking, and double vision, they should seek medical attention.

Vaccines have traditionally provided extensive protection with little risk, but like other drugs and medical therapies, side effects occasionally occur. The three COVID-19 vaccines used in the United States have been tested in tens of thousands of people, but even such a large study cannot rule out extremely rare side effects.

The CDC and FDA have been monitoring the side effects reports submitted by doctors, drugmakers, and patients to the Federal Vaccine Safety Database.

Guillain-Barre can be caused by a variety of infections, including influenza, cytomegalovirus and Zika virus. But in rare cases, people will develop the disease days or weeks after receiving certain vaccines.

Johnson & Johnson’s vaccine is highly anticipated because of its disposable formulation and easy-to-transport cold storage. But in the early days, it was related to another rare thrombosis risk. Due to a problem with a factory in Baltimore that helped make the lens, the company’s output failed to meet expectations.