Report: FDA to Announce Warning on Johnson & Johnson Vaccine Related to Disorder

The Food and Drug Administration (FDA) is reportedly set to announce a warning for the Johnson & Johnson coronavirus vaccine saying it has been linked to a serious, although rare, side effect.

The side effect is known as Guillain-Barré syndrome (GBS), the Washington Post reported Monday:

About 100 preliminary reports of Guillain-Barré have been detected after the administration of 12.8 million doses of Johnson & Johnson vaccine in the United States, the Centers for Disease Control and Prevention said in a statement Monday. The cases have largely been reported about two weeks after vaccination and mostly in men, many aged 50 and older.

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Available data do not show a pattern suggesting a similar increased risk with the Pfizer-BioNTech and Moderna vaccines, after more than 321 million doses of those vaccines have been administered in the United States.

According to the Centers for Disease Control and Prevention (CDC) website, GBS is a rare disorder whereby a person’s immune system damages nerves which causes muscle weakness and sometimes paralysis.

“While its cause is not fully understood, the syndrome often follows infection with a virus or bacteria. Each year in the United States, an estimated 3,000 to 6,000 people develop GBS. Most people fully recover from GBS, but some have permanent nerve damage,” the agency noted.

The CDC will ask outside vaccine experts to review the issue during a meeting in the near future, NBC Boston reported.

“The government said the vaccines most used in the U.S., made by Pfizer and Moderna, show no risk of the disorder after more than 320 million doses have been administered,” the outlet stated.

However, the majority of Americans who are still unvaccinated for the coronavirus do not intend to get the shot, according to a recent ABC News/Washington Post survey.

“Sixty percent of those surveyed revealed to have received at least one dose of a coronavirus vaccine, but over one-third, 38 percent, said they have not, and 2 percent refused to answer or did not offer an opinion on the matter,” Breitbart News reported.

According to the Post article, the CDC monitors for GBS during every flu season.