Path 27
News

FDA to Warn of COVID Vaccine Link to Rare Nerve Disorder That Can Cause Paralysis

Path 27

The Food and Drug Administration is adding a new warning for Americans who get the Johnson & Johnson coronavirus vaccine based on reports of a rare nerve disease in those who received the shots.

“Reports of adverse events following 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,” the FDA said in a letter dated Monday to Janssen Biotech, the division of Johnson & Johnson that developed the vaccine.

About 100 preliminary reports of Guillain-Barré have been reported, according to the Centers for Disease Control and Prevention, The Washington Post reported.

Of those, 95 were serious and required the patient to be hospitalized, the FDA said. One person has died.

The FDA will stop short of saying the vaccine caused the disease.

Trending:
Olympian's Overzealous Victory Celebration Ends Up Costing Him More Than He Ever Imagined

Existing evidence “is insufficient to establish a causal relationship,” the FDA said, according to The Post.

The FDA said it “continues to find the known and potential benefits clearly outweigh the known and potential risks” of the Johnson & Johnson vaccine.

In its reporting, The New York Times said that incidence of the rare nerve disorder “appear to be three to five times higher among recipients of the Johnson & Johnson vaccine than among the general population in the United States.”

According to the FDA letter sent to Janssen, “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. In most of these people, symptoms began within 42 days following receipt of the Janssen COVID-19 Vaccine. “

The FDA said symptoms of having Guillain-Barré include weakness or tingling sensations, especially in the legs or arms; difficulty walking or with facial movements; and difficulty with bladder control or bowel functions.

Related:
CNN Editor Declares Biden 'Is Having the Worst Week of His Presidency'

Most of those affected have been men aged 50 and older, according to the CDC.

The Post report said no such issues have been found with the Pfizer-BioNTech and Moderna vaccines.

This is the second major stumbling block for the Johnson & Johnson vaccine.

Three months ago, it was put on pause amid concerns the vaccine caused severe blood clots. The pause in its use ended after a warning was attached to the drug.

The Astra Zeneca vaccine, which is given in Europe and has not been approved for use in the U.S., has also been examined for a possible link to Guillain Barré.

Truth and Accuracy

Submit a Correction →



loading

We are committed to truth and accuracy in all of our journalism. Read our editorial standards.

Tags:
, , , ,
Path 27
Jack Davis is a freelance writer who joined The Western Journal in July 2015 and chronicled the campaign that saw President Donald Trump elected. Since then, he has written extensively for The Western Journal on the Trump administration as well as foreign policy and military issues.
Jack Davis is a freelance writer who joined The Western Journal in July 2015 and chronicled the campaign that saw President Donald Trump elected. Since then, he has written extensively for The Western Journal on the Trump administration as well as foreign policy and military issues.
Jack can be reached at jackwritings1@gmail.com.
Location
New York City
Languages Spoken
English
Topics of Expertise
Politics, Foreign Policy, Military & Defense Issues




loading

Conversation