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U.S. puts new warning on J&J coronavirus vaccine for autoimmune disorder

CoronavirusJul 13, 2021 12:47AM ET
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© Reuters. FILE PHOTO: A box of Johnson & Johnson's coronavirus disease (COVID-19) vaccines is seen at the Forem vaccination centre in Pamplona, Spain, April 22, 2021. REUTERS/Vincent West/File Photo

By Michael Erman

(Reuters) -The U.S. Food and Drug Administration on Monday added a warning to the fact sheet for Johnson & Johnson (NYSE:JNJ)'s COVID-19 vaccine saying that data suggests there is an increased risk of a rare neurological disorder in the six weeks after inoculation.

In a letter to the company, the FDA classified the chances of getting Guillain-Barré syndrome (GBS) after vaccination as being "very low." Still, it said J&J vaccine recipients should seek medical attention if they have symptoms including weakness or tingling sensations, difficulty walking or difficulty with facial movements.

Around 12.8 million people have received J&J's one-dose vaccine in the United States. The FDA said 100 preliminary reports of GBS in the vaccine recipients include 95 serious cases that required hospitalization and one reported death.

J&J said in a statement that it was in discussion with regulators about the cases of GBS. It said the rate of reported cases of GBS in J&J vaccine recipients exceeds the background rate only by a small degree.

GBS is a rare neurological condition in which the body's immune system attacks the protective coating on nerve fibers. Most cases follow a bacterial or viral infection. Most people fully recover from GBS.

The condition has been linked in the past to vaccinations - most notably to a vaccination campaign during a swine flu outbreak in the United States in 1976, and decades later to the vaccine used during the 2009 H1N1 flu pandemic.

According to a statement from the U.S. Centers for Disease Control and Prevention (CDC), most of the cases were in men, many of whom were 50 or older. It did not find higher than expected cases of GBS in recipients of the mRNA-based vaccines from Pfizer (NYSE:PFE) Inc/BioNTech SE and Moderna (NASDAQ:MRNA) Inc.

Last week, European regulators recommended a similar warning for AstraZeneca (NASDAQ:AZN)'s COVID-19 shot, which is based on a similar technology as Johnson & Johnson's vaccine.

The warning is another setback for the J&J shot, which was supposed to be an important tool for vaccinating in hard-to-reach areas and among those hesitant to be vaccinated because it requires only one shot and has less stringent storage requirements than the Pfizer or Moderna vaccines.

But use of the vaccine has already been linked to a very rare, potentially life threatening blood clotting condition and slowed by production problems at the main plant where it is being made.

U.S. regulators decided in April that the vaccine's benefits outweighed the risk from the blood clotting issue.

The warning was first reported by the Washington Post on Monday.

U.S. puts new warning on J&J coronavirus vaccine for autoimmune disorder
 

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Comments (5)
Martin Lewis
Martin Lewis Jul 13, 2021 1:42AM ET
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Welcome to socialism (like other socialist nations, China/North Korea/N.az.i Germany (H.itt.leer was a democratic socialist)/Soviet Union)...Biden is sending door-to-door gestapo to try and coerce people into taking a vaccine that is not even approved by the government and has a growing number of adverse events. There are more adverse events and deaths reported in the VAERS (vaccine adverse event reporting system) just the past year related to the COVID-19 vaccine than are present in the entire VAERS from every other vaccine combined since the development of the VAERS.
Martin Lewis
Martin Lewis Jul 13, 2021 1:41AM ET
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Welcome to socialism (like other socialist nations, China/North Korea/N.az.i Germany (H.itt.leer was a democratic socialist)/Soviet Union)...Biden is sending door-to-door gestapo to try and coerce people into taking a vaccine that is not even approved by the government and has a growing number of adverse events. There are more adverse events and deaths reported in the VAERS (vaccine adverse event reporting system) just the past year related to the COVID-19 vaccine than are present in the entire VAERS from every other vaccine combined since the development of the VAERS.
Martin Lewis
Martin Lewis Jul 13, 2021 1:35AM ET
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So the same government that is coercing the population - including low risk individuals such as children - to get an experimental vaccine that is not even approved by the government (i.e. still no FDA approval) is adding all these warning labels about things like clots, heart inflammation, now autoimmune disorders. Democrats/leftists are truly cult members drinking the koolaid. MSM should be disgusted at themselves for pushing the globalist agenda, they are more dangerous than the virus.
Felipe Daniel
Felipe Daniel Jul 13, 2021 12:53AM ET
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To be expected, in line with rushed vaccine that did not go through usual 2 years of clinical trials with animals before it ever touches humans.
Bob Collins
Bob Collins Jul 12, 2021 11:20PM ET
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The Nuremberg Code (1947) Permissible Medical Experiments • The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion … • The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury. • The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment. For more information see Nuremberg Doctor's Trial, BMJ 1996;313(7070):1445-75.
 
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