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  • Conversation: J&J resumes roll-out of COVID-19 vaccine in EU

    • April 21, 2021 6:59 PM BST
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      J&J resumes roll-out of COVID-19 vaccine in EU

      Johnson & Johnson (J&J) is planning to resume the roll-out of its COVID-19 vaccine in the EU following updated guidance from the European Medicines Agency’s (EMA) safety committee.
      The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed a small number of cases of very rare blood clots in combination with low platelet counts in individuals who have received the J&J vaccine.
      According to J&J, these very rare adverse events can occur within approximately one to three weeks following injection with its COVID-19 vaccine.
      The PRAC has confirmed the overall benefit-risk profile of J&J’s COVID-19 vaccine, although J&J must update the product information for the jab to include information on the diagnosis and management of this type of rare adverse event.
      J&J will now resume shipments of its COVID-19 vaccine in the European Union, Norway and Iceland, with updated EMA and Healthcare Professionals guidance to become available to national healthcare authorities.
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