US puts new warning on J&J coronavirus vaccine for autoimmune disease

July 12 (Reuters) – The United States Food and Drug Administration added a warning to Johnson & Johnson’s (JNJ.N) COVID-19 vaccine fact sheet on Monday that the data suggests there is an increased risk of a rare neurological disorder within six weeks after inoculation.

In a letter to the company, the FDA classified the chances of contracting Guillain-Barré syndrome (GBS) after vaccination as “very low.” Still, he said recipients of the J&J vaccine should see a doctor if they experience any symptoms, including weakness or tingling sensations, difficulty walking or difficulty with facial movements.

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

J&J said in a statement that it is in discussions with regulators over the GBS cases. He said the rate of reported GBS cases among J&J vaccine recipients only exceeds the baseline rate to a small extent.

GBS is a rare neurological disease in which the body’s immune system attacks the protective coating of nerve fibers. Most cases follow a bacterial or viral infection. Most people recover completely from GBS.

The disease has been linked in the past to vaccinations – most notably to a vaccination campaign during a swine flu epidemic in the United States in 1976, and decades later to the vaccine used during the H1N1 influenza pandemic of 2009.

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

Last week, European regulators recommended a similar warning for AstraZeneca’s COVID-19 vaccine, which is based on technology similar to that of Johnson & Johnson’s vaccine.

The warning is another setback for the J&J vaccine, which was supposed to be an important tool for vaccinating in hard-to-reach areas and among those who are reluctant to get vaccinated as it only requires one shot and has demands. less stringent storage than the Pfizer or Moderna Vaccines.

But use of the vaccine has previously been linked to a very rare, life-threatening blood clotting disease slowed down by production issues in the main factory where it is made.

U.S. regulators ruled in April that the vaccine’s benefits outweighed the risk of the problem with blood clotting.

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

Reporting by and Michael Erman in New Jersey; Additional reporting by Lisa Lambert in Washington and Trisha Roy in Bengaluru Editing by Chris Reese, Peter Graff and Sonya Hepinstall

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