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US issues new warning on Johnson & Johnson’s Covid vaccine for rare neurological disease-News

US issues new warning on Johnson & Johnson’s Covid vaccine for rare neurological disease-News



According to the FDA, the initial report of GBS among 100 vaccinators included 95 severe cases requiring hospitalization and one death report.

The U.S. Food and Drug Administration added a warning to Johnson & Johnson’s Covid-19 vaccine fact sheet on Monday, saying that the data indicate an increased risk of rare neurological diseases within six weeks of 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 US swine flu outbreak in 1976, and decades later related to the vaccine used during the 2009 H1N1 flu pandemic.

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.

This warning is another setback of 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 needs to be injected once, and compared to Pfizer or Pfizer, storage The requirements are not so strict. 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 vaccines outweigh the risks of clotting problems.

The Washington Post first reported the warning on Monday.






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