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.
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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.