European Medicines Agency backs J&J Covid-19 vaccine despite rare cases of blood clotting issue
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 US, but backed its overall benefits against any risks.
The European Medicines Agency (EMA) safety committee 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 jab produced by Oxford University and AstraZeneca.
The US has paused the rollout of the J&J vaccine due to the very rare link to blood clotting in adults.
The questions over the J&J shot have dealt a further blow to the EU’s vaccination program, which has lagged rollouts in the UK and the US due to supply delays as well as safety concerns. Rising infections caused by more infectious variants have forced France and others to reimpose lockdowns.
This week the EU was forced to order many millions more doses of the Pfizer vaccine to shore up supplies duee to the issues with Astrazeneca and J&J.
The review of a handful of cases prompted a pause in the rollout of the J&J vaccine in Europe and the USs last week, the latest setback to efforts to tackle the pandemic, which has killed more than 3.1m and infected 142m worldwide.
While the EMA said it considers the vaccine safe, it was up to each European Union member state 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 hospitalization 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