F.D.A. Attaches Warning of Rare Nerve Syndrome to Johnson & Johnson Covid Vaccine

The database shows only one possible death of a recipient of the Johnson & Johnson shot from Guillain-Barre Syndrome. But the man, a 57-year-old Delaware man, had also suffered a heart attack and stroke in the past four years, which raised questions about his April death.

Although it only requires a single dose and is easier to store than Pfizer and Moderna vaccines, Johnson & Johnson vaccination played only a minor role in the US vaccination campaign. One of the reasons for this is that a plant in Baltimore that was supposed to supply most of the cans in the country was closed for three months for violating the law. The factory, operated by Emergent BioSolutions, a subcontractor, was forced to discard the equivalent of 75 million cans on suspicion of contamination, significantly delaying deliveries to the federal government.

At the same time, demand for the shot collapsed after the safety break in April. At that time, 15 women in the United States and Europe who received the Johnson & Johnson injection were diagnosed with the coagulation disorder; three died. The CDC has now confirmed 38 cases of the disorder.

Regulatory authorities and federal health officials warned that women under the age of 50 in particular should be aware of the “rare but increased” risk of clotting. In the nearly three months since the hiatus ended, only about five million people in the U.S. have taken Johnson & Johnson’s recording, and state officials report that people are much more cautious. Millions of cans distributed by the federal government sit unused and expire this summer.

Alex Gorsky, CEO of Johnson & Johnson, said last month he was still confident that the vaccine, which has been used in 27 countries, will help contain the pandemic overseas. The company has pledged up to 400 million cans to the African Union. Regardless, Covax, the global vaccine exchange program, is set to receive hundreds of millions of doses.

Studies have shown that the Johnson & Johnson syringe protects people from more contagious variants of the coronavirus, including the Delta variant, and is highly effective in preventing severe Covid-19, hospitalizations, and death.

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

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