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(Reuters) – The United States Food and Drug Administration is expected to announce a new warning on Johnson & Johnson’s coronavirus vaccine linked to rare autoimmune disease, The Washington Post reported on Monday, citing four people familiar with the matter .
According to the Post, around 100 preliminary reports of Guillain-Barré syndrome (GBS) have been detected in the United States following vaccination with J&J shot, mostly in men, many of whom were 50 years of age or older. About 12.8 million people have received the single dose vaccine in the United States.
J&J and the FDA were not immediately available for comment.
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.
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.
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.
A warning would be another setback for the J&J vaccine, which was supposed to be an important tool for vaccinating in hard-to-reach areas and the vaccine hesitant because it only requires one shot and has less stringent storage requirements than the two-dose vaccines. by Pfizer Inc / BioNTech SE and Moderna Inc.
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 decided in April that the vaccine’s benefits outweighed the risk of the problem with blood clotting.
(Reporting by Lisa Lambert in Washington and Michael Erman in New Jersey, editing by Chris Reese and Peter Graff)
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