EMA recommends clot warning for J&J vaccine, says benefit still positive

The European Medicines Agency’s safety committee concluded that a warning about “unusual blood clots with low blood platelets” should be added to the product information for Johnson & Johnson’s COVID-19 Vaccine. The safety committee also concluded that “these events should be listed as very rare side effects of the vaccine.” The agency said, “In reaching its conclusion, the Committee took into consideration all currently available evidence including eight reports from the United States of serious cases of unusual blood clots associated with low levels of blood platelets, one of which had a fatal outcome. As of 13 April 2021, over 7 million people had received Janssen’s vaccine in the United States. All cases occurred in people under 60 years of age within three weeks after vaccination, the majority in women. Based on the currently available evidence, specific risk factors have not been confirmed…The cases reviewed were very similar to the cases that occurred with the COVID-19 vaccine developed by AstraZeneca (AZN), Vaxzevria.” The EMA confirmed that the overall benefit-risk remains positive for Johnson & Johnson’s vaccine.

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