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

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The database indicates only one possible death of a recipient of the Johnson & Johnson shot from Guillain-Barré syndrome. But the man, a 57-year-old from Delaware, had also had a heart attack and a stroke in the past four years, raising questions about what led to his death in April.

Even though it requires only one dose and is easier to store than Pfizer’s and Moderna’s vaccines, Johnson & Johnson’s shot has played only a minor role in the U.S. inoculation campaign. That is partly because a plant in Baltimore that was supposed to supply most of the doses in the country was shut down for three months because of regulatory violations. The factory, operated by Emergent BioSolutions, a subcontractor, has been forced to throw out the equivalent of 75 million doses because of suspected contamination, significantly delaying deliveries to the federal government.

At the same time, demand for the shot plummeted after the safety pause in April. At that time, 15 women in the United States and Europe who had received the Johnson & Johnson shot were diagnosed with the clotting disorder; three died. The C.D.C. has now confirmed 38 cases of the disorder.

Regulators and federal health officials warned that women younger than 50, in particular, should be aware of the “rare but increased” clotting risk. In the nearly three months since the pause ended, only about five million people in the United States have taken Johnson & Johnson’s shot, and state officials report that people are much more wary of it. Millions of doses that have been distributed by the federal government are sitting unused and will expire this summer.

Alex Gorsky, Johnson & Johnson’s chief executive, said last month that he was still hopeful that the vaccine, which has been used in 27 countries, would help contain the pandemic overseas. The company has promised up to 400 million doses to the African Union. Separately, Covax, the global vaccine-sharing program, is supposed to receive hundreds of millions of doses.

Studies have showed that the Johnson & Johnson shot protects people against more contagious coronavirus variants, including the Delta variant, and is highly effective at preventing severe Covid-19, hospitalizations and death.

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