FDA warns of possible rare neurological complications with Johnson and Johnson coronavirus vaccine

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While the FDA said it has not proven that the vaccine can cause the syndrome, it has noted an increase in reports of the condition, which sometimes causes paralysis.

“Today, the Food and Drug Administration is announcing reviews of vaccine recipient and provider fact sheets for the Johnson & Johnson (Janssen) COVID-19 vaccine to include information regarding an increased risk of Guillain-Barré syndrome (GBS) after vaccination,” she said in a statement sent to CNN. .

The updated label reads: “Reports of adverse events following use of the Janssen COVID-19 vaccine under an emergency use license indicate an increased risk of Guillain-Barré syndrome within 42 days after vaccination.”

The poster adds: “Although the available evidence suggests an association between Janssen vaccine and an increased risk of GBS, it is not sufficient to establish a causal relationship. A similar indication has not been identified with the Moderna and Pfizer-BioNTech COVID-19 vaccines.”

The US Food and Drug Administration (FDA) said 100 initial reports of Guillain-Barré syndrome have been submitted to the US government’s Vaccine Passive Reporting System, out of 12.8 million Janssen vaccines.

“Guillain-Barré syndrome (a neurological disorder in which the body’s immune system damages nerve cells, sometimes causing muscle weakness and paralysis) in some people who have received the Janssen COVID-19 vaccine,” the Food and Drug Administration says in its patient label update. and caregivers.

“In most of these people, symptoms started within 42 days after receiving the Janssen COVID-19 vaccine. The chance of this happening is very low,” he adds.

The FDA said that people should seek medical attention if they notice symptoms such as weakness or tingling in the arms and legs, especially if it spreads after receiving the vaccine.

Other telltale symptoms include difficulty walking, speaking, and chewing or swallowing. double vision; Bowel or bladder control problems.

The FDA said that 95 of the 100 reports about GBS included people who needed hospital treatment, and one person died.

“Each year in the United States, an estimated 3,000 to 6,000 people are infected with group streptococcus bacteria,” the agency added. Most people recover completely from this disorder.

“GBS has also been observed at an increased rate associated with certain vaccines, including some seasonal influenza vaccines and a vaccine to prevent shingles.

Johnson & Johnson confirmed that it is talking to the US Centers for Disease Control and Prevention and the Food and Drug Administration about the issue.

“We have had discussions with the U.S. Food and Drug Administration and other regulators about a rare case of the neurological disorder, Guillain-Barré syndrome, that has been reported following vaccination with the Janssen COVID-19 vaccine,” the company said in a briefing. statement.

“The chance of this happening is very low, and the rate of reported cases exceeds the background rate by a small degree,” she added.

The CDC stressed that even if a vaccine increases the risk of developing the syndrome, it is still best to get vaccinated against the coronavirus.

“GBS is a neurological disorder in which the body’s immune system damages nerve cells, causing muscle weakness or in the most severe cases paralysis. Each year in the United States, approximately 3,000 to 6,000 people develop GBS; it is usually triggered by the respiratory or gastrointestinal infection. Most people recover completely from GBS,” a CDC spokesperson told CNN.

“Reports of GBS after receiving the J&J/Janssen COVID-19 vaccine in the Vaccine Adverse Event Reporting System (VAERS) are rare, but likely indicate a small potential risk for this side effect after this vaccine,” the spokesperson added.

The spokesman said the Centers for Disease Control and Prevention’s Immunization Practices Advisory Committee will discuss the matter at an upcoming meeting.

“In the United States, nearly all hospitalizations and deaths from COVID-19 occur in people who are not immunized. The risk of severe adverse events after COVID-19 vaccination remains rare. The COVID-19 vaccine is recommended for everyone 12 years of age or older,” he said. Statement “.

The CDC and the Food and Drug Administration briefly halted use of the Johnson & Johnson vaccine earlier this year due to the risk of developing a rare type of blood-clotting complication, but lifted the suspension in April after determining the risk was low and the condition was treatable. The vaccine label has been updated to warn of the risks.

The title of this story has been updated to reflect that this is a rare complication.

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