FDA Issues Rare Nerve Syndrome Warning to Johnson & Johnson

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The database shows only one possible death of a Johnson & Johnson recipient vaccinated from Guillain-Barré syndrome. But the 57-year-old Delaware man has also suffered a heart attack and stroke over the past four years, raising questions about what caused his death in April.

Despite requiring only one dose and easier to store than Pfizer and Moderna’s vaccines, Johnson & Johnson’s vaccine played only a minor role in the US vaccination campaign. This is partly because a plant in Baltimore The company, which was supposed to supply most of the doses in the country, was shut down for three months due to regulatory violations. Operated by a subcontractor, Emergent BioSolutions, the factory discarding the equivalent of 75 million doses Due to suspected contamination, it significantly delays deliveries to the federal government.

Same time, withdrawal request dropped After the security pause in April. Then, 15 women People who received the Johnson & Johnson vaccine in the United States and Europe were diagnosed with a coagulation disorder; three people died. The CDC has now confirmed 38 cases of the disease.

Regulators and federal health officials have warned that women under the age of 50 should be especially careful about this. “rare but increased” risk of clotting. In the nearly three months since the pause ended, about five million people in the United States alone have injected Johnson & Johnson, and state officials are reporting that people are much more wary of it. The millions of doses distributed by the federal government are waiting unused and ends this summer.

Alex Gorsky, CEO of Johnson & Johnson, said last month that he is still hopeful that a vaccine will be found. Used in 27 countrieswill help contain the pandemic overseas. The company has promised doses up to 400 million doses to the African Union. Separately, the global vaccine sharing program Covax take hundreds of millions of doses.

Studies have shown that Johnson & Johnson vaccine protects people against more contagious coronavirus variantsIt is highly effective in preventing severe Covid-19, hospitalizations and deaths, including the Delta variant.

The Food and Drug Administration shares jurisdiction over vaccines with the CDC, but it is solely responsible for issuing product warnings. The agency said the Guillain-Barré cases will be discussed at the upcoming meeting of a committee of outside experts advising the CDC.

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