FDA Combines Johnson & Johnson Covid Vaccine with Rare Nervous Syndrome Warning
The database shows only one possible death of a Johnson & Johnson stroke recipient 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.
Although it requires only one dose and is easier to maintain than the Pfizer and Moderna vaccines, Johnson & Johnson’s goal has played only a small role in the inoculation campaign in the US. This is partly because a plants in Baltimore which was supposed to supply most doses in the country was closed for three months due to regulatory violations. The plant, operated by Emergent BioSolutions, a subcontractor, has been forced to discard the equivalent of 75 million doses due to suspected contamination, significantly delaying deliveries to the federal government.
In the same time, demand for purpose fell after the security break in April. In that time, 15 gra in the United States and Europe who had received the Johnson & Johnson stroke were diagnosed with clotting disorder; three died. The CDC has now confirmed 38 cases of the disorder.
Federal health regulators and officials warned that women under the age of 50, in particular, should be aware of this. Risk of clotting “rare but increased”. In the nearly three months since the break, only about five million people in the United States have shot Johnson & Johnson, and state officials report that people are much more wary of him. The millions of doses that have been distributed by the federal government have been reduced unused and voluntarily expires this summer.
Alex Gorsky, chief executive of Johnson & Johnson, said last month that he was still hoping the vaccine, which has been used in 27 countries, would help contain the pandemic overseas. The company has promised the African Union up to 400 million doses. Separately, Covax, the global vaccine-sharing program, is supposed to take hundreds of millions of doses.
Studies have shown that Johnson & Johnson shot protects people from the most contagious variants of the coronavirus, including the Delta variant, and is very effective in preventing severe Covid-19, hospitalization and death.
The Food and Drug Administration shares jurisdiction over 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.