J&J Coronavirus Vaccine US Puts New Warning

The US Food and Drug Administration on Monday announced that evidence revealed an elevated risk of a rare neurological disease within six weeks following vaccination, according to a warning in the information sheet for COVID-19 vaccine from Johnson & Johnson.

The FDA rated Guillain-Barré Syndrome (GBS) as "extremely low," following the vaccine, in a letter to the firm.

"Still, the J&J receiver has advised that if symptoms include weakness or shivering, difficulties walking or problems with facial motions, he should seek medical treatment

.In the United States, over 12.8 million people were vaccinated with J&J's single dosage. According to the FDA, 100 early GBS reports in vaccination recipients including neuf5 severe and death-related cases.

In a response, J&J stated that it has been discussing the GBS cases with regulators. The rate of GBS recorded in J&J Vaccine beneficiaries is just slightly higher than the background rate.

GBS is a rare neurological disease that affects the protective layer on nerve fibres of the body's immune system. Bacterial or viral infection occurs in most instances. Most people are recovering completely from GBS.

It has previously been associated with vaccines – especially a swine flu-influenza vaccination in 1976, and decades later with an H1N1-influenza pandemic vaccine in the United States.

At the Forem vaccination centre in Pamplona, Spain, April 22, 2021 is seen a box of Johnson & Johnson coronaviral disease (COVID-19) vaccines. Vincent West/Photo of File/REUTERS

The majority of instances were in males, many of them 50 years old or older, as stated by the U.S. Centers of Disease Control and Prevention (CDC). There have been no higher than anticipated GBS cases in Pfizer/BioNTech SE and Moderna mRNA-based vaccines.

Comparable warning to AstraZeneca's COVID-19 injection was suggested last week by European authorities based on similar technology as Johnson&Johnson's.

The warning was yet another setback for the J&J shot, a major tool for vaccination in places that are difficult to access and unwilling to be vaccinated because it just needs one injection and is less storage compatible with the Pfizer or Moderna vaccines.

However, the use of the vaccine has previously been associated with a very uncommon, life-threatening blood clotting disorder and has already been slowed down by production issues at the main factory.

In April the American regulators concluded that the advantages of the vaccination exceeded the danger of blood clotting.

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