Europe’s drug regulator has found a possible link between Johnson & Johnson’s COVID-19 vaccine and rare blood clotting issues in adults who received doses in the United States, but backed its overall benefits against any risks.
The European Medicines Agency (EMA) said on Tuesday its safety committee had concluded that a warning about unusual blood clots with low platelets must be added to the vaccine’s labels, just as has also been required of rival shot maker AstraZeneca.
The questions over the J&J shot have dealt a further blow to the EU’s vaccination programme, which has lagged rollouts in Britain and the United States due to supply delays as well as safety concerns.
Rising infections caused by more infectious variants have forced France and others to reimpose lockdowns.
While the regulator said it considers the vaccine safe, it was up to the European Union’s member states to decide how to use it, taking a similar stance to that with AstraZeneca.
“I have to stress again (the cases) are very rare and in the vast majority of cases these vaccines are going to prevent death and hospitalisation from COVID-19,” EMA executive Director Emer Cooke said in a briefing.
“We have to balance the benefits of the vaccine with the risks.”
Several nations have suspended or limited the use of AstraZeneca’s vaccine over possible blood clots.
Note: U.S. authorities will meet on Friday to discuss whether to resume using the J&J vaccine.