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U.S. Halted J&J Vaccine 'Out of an Abundance of Caution:' FDA Commissioner
Posted
April 13, 2021
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1:16Now PlayingU.S. health officials called for an immediate pause in using Johnson & Johnson’s single-dose Covid-19 vaccine after six women who received it developed a rare and severe form of blood clotting.
The decision comes at a crucial juncture in the U.S. vaccination effort, which has gained speed in recent weeks at the same time a worsening outbreak driven by coronavirus variants grips the upper Midwest. And it is likely to heighten worry about vaccines around the world after similar issues caused delays in distribution of AstraZeneca Plc’s shot.
A type of brain blood clot called cerebral venous sinus thrombosis was seen with low levels of blood platelets in the women, who were all between the ages of 18 and 48, the U.S. Centers for Disease Control and Prevention and Food and Drug Administration said on Tuesday in a joint statement.
“We are recommending a pause in the use of this vaccine out of an abundance of caution,” the CDC and the FDA said in the statement. “This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.”
More than 6.8 million doses of the J&J vaccine have been administered in the U.S. through Monday, the agencies said.
J&J said in a statement that it’s decided to delay the rollout of its vaccine in Europe. Walgreens Boots Alliance Inc. and CVS Health Corp., which have been administering the shot in drugstores, each said they would pause immediately. J&J fell as much as 3.2% as of 9:34 a.m. in New York, its biggest loss since Jan. 29.
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