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.
“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.”
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.