Guillain-Barre Syndrome: FDA Indicates “Low” Risk J&J jab | Coronavirus pandemic News

U.S. health officials are warning people about the rare neurological reaction to a single Johnson-Johnson vaccine.

U.S. regulators have added a new warning to Johnson & Johnson’s COVID-19 vaccine about the links that could have a strange and dangerous neurological reaction.

The Food and Drug Administration (FDA) announced a new warning on Monday, denouncing reports of Guillain-Barre syndrome, a disorder of the immune system that can lead to muscle weakness and occasional paralysis. Health officials said the side effect was “low potential risk” for those who received the shot.

The new warning will be included in pamphlets given to people who were shot by Johnson & Johnson. Regulators said they should seek medical attention if they experience symptoms such as tingling sensations, gait problems and double vision.

The action came after the FDA and the Centers for Disease Control and Prevention (CDC) reviewed reports of about 100 people who develop the syndrome after receiving a single-dose vaccine. Almost all were hospitalized and one person died, the FDA said.

Guillain-Barre syndrome occurs when the body’s immune system mistakenly attacks some of its nerve cells, causing muscle weakness and sometimes temporary paralysis. According to the CDC, there are between 3,000 and 6,000 people in the United States who develop the syndrome each year.

The number of cases related to Johnson & Johnson’s vaccine is a small fraction of the nearly 13 million people in the U.S. who have received the jab. Most cases were given in men — most of whom were 50 years of age or older — and usually two weeks after vaccination.

Johnson & Johnson said in a statement that the report has been discussed with the FDA and other health regulators around the world.

The CDC said it will ask the jury, made up of external vaccine experts, to look into the matter at upcoming meetings.

The government has said the most widely used vaccines in the U.S., made by Pfizer and Modern, show no risk of mixing after more than 320 million doses have been given.

Vaccines have historically provided extensive protection with little risk, but they do have occasional side effects as with other medications and medical therapies. The three COVID-19 vaccines used in the U.S. have been tested on tens of thousands of people, but even such horrific research cannot rule out rare side effects.

The CDC and the FDA have monitored reports of side effects sent by doctors, pharmacists, and patients to a federal vaccine safety database.

Some Guillain-Barre infections can cause infections, including the flu, cytomegalovirus, and Zika virus. But there have been rare cases where people get the disorder when they take a few vaccines and develop it in a few days or weeks.

Johnson & Johnson’s vaccine was highly anticipated for its “definitive” formulation and easy-to-pack refrigerator. But in the beginning, it was associated with another strange danger (blood clots), and the company was unable to produce as many as expected, at the Baltimore plant that helps make the shooting.

The news continues that the demand for COVID vaccines in the U.S. continues to decline, with about 430,000 shots a day being administered. The seven-day average peak was around 3.5 million in April.

Cases are growing rapidly in states that do not have a vaccine in the west and south of the country, as the predominantly highly contagious Delta variant.