U.S. issues new warning on coronavirus vaccine for Johnson & Johnson’s autoimmune disease Reuters

Michael Urman

(Reuters)-The U.S. Food and Drug Administration added a warning to Johnson & Johnson’s (NYSE:) COVID-19 vaccine fact sheet on Monday, stating that the data indicated that six people have rare neurological diseases The risk increases. A few weeks after vaccination.

In a letter to the company, the FDA classified the risk of Guillain-Barré syndrome (GBS) after vaccination as “very low.” However, it said that if the Johnson & Johnson vaccine vaccinators experience symptoms such as weakness or tingling, difficulty walking or facial movement difficulties, they should seek medical attention.

In the United States, approximately 12.8 million people have received a single dose of Johnson & Johnson’s vaccine. According to the FDA, the initial report of GBS among 100 vaccinators included 95 severe cases requiring hospitalization and one death report.

Johnson & Johnson said in a statement that it is discussing the GBS case with regulators. It said that the reported GBS case rate among Johnson & Johnson vaccinators was only slightly higher than the background rate.

GBS is a rare neurological disease. The body’s immune system attacks the protective coating on nerve fibers. Most cases are caused by bacterial or viral infections. Most people fully recover from GBS.

This situation used to be related to vaccination-most notably the vaccination campaign during the 1976 US swine flu outbreak, and the vaccine used during the 2009 H1N1 flu pandemic decades later.

According to a statement from the Centers for Disease Control and Prevention (CDC), the majority of cases are men, and many of them are 50 years of age or older.It has not found higher-than-expected cases of GBS among mRNA-based vaccine recipients Pfizer (New York Stock Exchange:) Inc/BioNTech SE and Modern (NASDAQ:)Company

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

This warning is another setback for Johnson & Johnson Injection. It should be an important tool for vaccination in hard-to-reach areas and those who do not want to be vaccinated, because it only requires one injection and the storage requirements are not as good as Pfizer or modern vaccines.

But the use of the vaccine has been linked to a very rare and potentially life-threatening blood clotting condition and has slowed down due to production problems in the main factories producing the vaccine.

US regulators decided in April that the benefits of the vaccine outweigh the risk of clotting problems.

The Washington Post first reported the warning on Monday.