Johnson & Johnson’s Covid-19 vaccine linked to blood clots, says EU regulator
A possible link between Johnson & Johnson’s Covid-19 vaccine and rare blood clots has been found by European medicines regulator. The body however stressed that the overall benefits of vaccine outweigh the risks it is exhibiting.
The development has thrown another towel for the company Janssen that had developed J&J vaccine. It was banned last week in the United States of America, and with finding by EU regulator questions are raised on Europe’s vaccine rollout.
The European Medicines Agency (EMA) has concluded that “a warning about unusual blood clots with low blood platelets should be added to the product information” about the Johnson & Johnson vaccine being given to patients. EMA added that all evidence available has been analyzed which includes 7 instances of serious blood clot formation found in the US.
EMA said, “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 agency noted “the combination of blood clots and low blood platelets is very rare, and the overall benefits of Covid-19 Vaccine Janssen in preventing Covid-19 outweigh the risks of side effects.”
Following the assessment announcement by EMA (European Medicines Agency), Johnson & Johnson said of resuming shipments of the Covid-19 vaccine to the European Union, Norway and Iceland. The company said it will include information of how to diagnose, assess and manage the blood clots in its vaccine information leaflet.
Dr. Paul Stoffels, chief scientific officer at Johnson & Johnson said, “We appreciate the rigorous review of the PRAC and share the goal of raising awareness of the signs and symptoms of this very rare event to ensure the correct diagnosis and appropriate treatment.”