EU regulator: Clot a rare side effect of J&J vaccine
EU’s drug regulatory agency links Johnson & Johnson’s Covid-19 vaccine to rare blood clots, wants warning to be added to label
Blood clots should be listed as a “very rare” side effect of the Johnson & Johnson coronavirus vaccine but its benefits still outweigh the risks, the EU’s drug watchdog said on Tuesday. The European Medicines Agency (EMA) said in a statement that it had found a “possible link” between the jab and the clots, following eight such cases in the US, one of which was fatal. “The cases reviewed were very similar to the cases that occurred with the Covid-19 vaccine developed by AstraZeneca, Vaxzevria,” the EMA statement said. The eight cases in the US, out of some seven million people who had received the vaccine, all involved people under the age of 60, the majority of whom were women, it said. Johnson & Johnson last week delayed the rollout of its single-shot jab across Europe pending the result of the EMA probe. The US regulator suspended the Johnson & Johnson vaccine and was set to announce its decision on Friday.
LONDON/AUCKLAND: The EU’s drug regulatory agency said on Tuesday that it found a “possible link” between Johnson & Johnson’s Covid-19 vaccine and rare blood clots, and that a warning should be added to the label. Experts at the agency reiterated that the vaccine’s benefits outweigh the risks.
The European Medicines Agency (EMA) made the determinations after a small number of blood clot cases in people who had received the vaccine were reported in the US. The agency said a warning about the clots should be added to labels for the J&J vaccine and that the disorders should be considered “very rare side effects of the vaccine”.
The EMA also recommended a label change for AstraZeneca’s Covid vaccine after finding a link between it and rare blood clots.
Last week, J&J halted its vaccine’s European roll-out after US officials recommended a pause in its use when they detected six clot cases among almost 7 million people vaccinated.
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