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EU regulator says warning labels should be added to J&J vaccine
LONDON — The agency that regulates drugs for the European Union says a warning about rare blood clots should be added to labels for Johnson & Johnson’s COVID-19 vaccine.
The European Medicines Agency says these rare blood disorders should be considered as “very rare side effects of the vaccine.”
Last week, Johnson & Johnson halted its European roll-out of the vaccine after U.S. officials recommended a pause in the vaccine, when they detected six very rare blood clot cases among nearly 7 million people who had been vaccinated.
European officials say they considered all currently available evidence from the U.S. of the rare blood clots associated with low blood platelets, including one death.
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