FDA warns of potential rare nerve complication with Johnson & Johnson coronavirus vaccine

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While the FDA said it has not established that the vaccine can cause the syndrome, it has noted an increase in reports of the sometimes crippling condition.

“Today, the FDA announces revisions to the vaccine recipient and supplier information sheets for the Johnson & Johnson (Janssen) COVID-19 vaccine to include information related to an observed increased risk of Guillain syndrome -Barré (GBS) after vaccination. He said in a statement sent to CNN.

“Reports of adverse events following the use of the Janssen COVID-19 vaccine under emergency use authorization suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination,” says the label put up to date.

“Although the available evidence suggests an association between the Janssen vaccine and an increased risk of GBS, it is insufficient to establish a causal relationship. No similar signal has been identified with the Moderna and Pfizer-BioNTech COVID-19 vaccines” , adds the label.

The FDA said 100 preliminary reports on Guillain-Barré syndrome had been filed with the US government’s Vaccine Adverse Reporting System, out of 12.8 million Janssen vaccines administered.

“Guillain Barré syndrome (a neurological disorder in which the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis) has occurred in some people who have received the Janssen COVID-19 vaccine,” says the FDA in updating the label for patients and caregivers.

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

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People should see a doctor if they notice symptoms such as weakness or tingling in the arms and legs, especially if they spread, after receiving a vaccine, the FDA said.

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

The FDA said 95 of 100 reports of GBS involved people requiring hospitalization, and one person has died.

“Each year in the United States, an estimated 3,000 to 6,000 people develop GBS. Most people recover completely from this disorder,” the agency added.

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

Johnson & Johnson has confirmed that it has spoken to the U.S. Centers for Disease Control and Prevention and the FDA about this.

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“We have discussed with the United States Food and Drug Administration and other regulators rare cases of the neurological disorder, Guillain-Barré syndrome, which have been reported after vaccination with the Janssen COVID-19 vaccine,” a said the company in a brief statement.

“The risk of this happening is very low and the rate of reported cases slightly exceeds the background rate,” he added.

Even if the vaccine increases the risk of the syndrome, it is always better to be vaccinated against the coronavirus, the CDC pointed out.

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“GBS is a neurological disorder in which the body’s immune system damages nerve cells, causing muscle weakness or, in more severe cases, paralysis. Each year in the United States, an estimated 3,000 to 6,000 people develop GBS; it is usually triggered by a breathing problem. or gastrointestinal infection. Most people fully recover 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 possible low risk of this side effect from this vaccine,” the carrier added. word.

The spokesperson said the CDC’s advisory committee on immunization practices would discuss the matter at a future meeting.

“In the United States, almost all hospitalizations and deaths related to COVID-19 now occur in unvaccinated people. The risk of serious adverse events after COVID-19 vaccination remains rare. It is recommended that anyone aged 12 and over receive a COVID-19 vaccine. “, the statement read.

The CDC and FDA briefly halted use of the Johnson & Johnson vaccine earlier this year due to a risk of a rare blood clotting complication, but lifted the hiatus in April after determining the risk was low and that the disease was treatable. The vaccine label has been updated to warn of the risk.

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

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