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 United States, one of which was fatal.
“EMA finds possible link to very rare cases of unusual blood clots with low blood platelets,” the Amsterdam-based agency said in a statement, adding that it “confirms (the) overall benefit-risk remains positive.”
The regulator said its safety committee “concluded that a warning about unusual blood clots with low blood platelets should be added to the product information” for the J&J shot.
Its experts also “concluded that these events should be listed as very rare side effects of the vaccine.”
US health authorities recommended a “pause” Tuesday in the use of the Johnson & Johnson Covid-19 vaccine “out of an abundance of caution” over potential links to a rare type of blood clot, in a blow to the country’s immunization campaign.
Concerns over the vaccine by US pharmaceutical giant Johnson & Johnson and the jab by rival drugmaker AstraZeneca have dampened hopes that vaccines could offer a swift end to the pandemic.
Johnson & Johnson last week delayed the rollout of its single-shot jab across Europe pending the result of the EMA probe.
J&J said earlier Tuesday that it was “very confident” in its vaccine and hopeful for a quick resolution from regulators over its status.