EMA's Risk Assessment Committee Finds Link Of Rare Cases Between JNJ COVID-19 Shot, Blood Clots

  • The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has concluded a possible link to rare cases of venous thromboembolism (VTE) with Johnson & Johnson's JNJ COVID-19 Vaccine.
  • The PRAC has now reviewed new evidence from the study used to authorize this vaccine and another sizeable clinical study. 
  • The PRAC also reviewed evidence from the post-marketing setting. When taking all evidence into account, the committee concluded that there is a reasonable possibility that rare cases of VTE are linked to vaccination with COVID-19 Vaccine Janssen.
  • Therefore, the committee is recommending listing VTE as a rare side effect of COVID-19 Vaccine Janssen.
  • Related Link: European Medicine Agency Lists Guillain-Barré Syndrome As Rare Side Effect For JNJ COVID-19 Vaccine.
  • The PRAC assessed immune thrombocytopenia (ITP) cases reported following vaccination with Vaxzevria, AstraZeneca Plc's AZN COVID-19 vaccine, and JNJ's jab.
  • A warning statement has been agreed to highlight that cases of very low levels of blood platelets have been reported very rarely, usually within the first four weeks following vaccination with COVID-19 Vaccine Janssen or Vaxzevria.
  • Related: EMA To Add New Side Effects To Janssen, AstraZeneca COVID-19 Shots.
  • The PRAC will continue to monitor for new information and will take any further actions as necessary.
  • Price Action: JNJ stock is up 0.25% at $161.50, and AZN stock is down 1.52% at $59.15 during the premarket session on the last check Friday.
  • Photo by Johaehn from Pixabay
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Posted In: BiotechNewsHealth CareFDAGeneralBriefsCOVID-19 CoronavirusCOVID-19 Vaccine
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