AstraZeneca shot ‘safe and effective,’ EU regulator says

LONDON — The European Union’s drug regulatory agency said Thursday that the AstraZeneca vaccine doesn’t increase the overall incidence of blood clots and that the benefits of using it outweigh the possible risks, paving the way for European countries to resume dispensing the shots.

France, Germany and Italy announced they will start using the vaccine again Friday. The Netherlands, Portugal and Spain said they will do so next week, though Spain said it might exclude certain groups to minimize any danger.

More than a dozen nations around the world had suspended their use of the vaccine over the past week following reports of clots in a few dozen of the millions of people across Europe who have gotten the shot. The question was whether the vaccine had anything to do with the clots and whether any action needed to be taken.

The safety committee of the European Medicines Agency “has come to a clear scientific conclusion,” the head of the EMA, Emer Cooke, announced. “This is a safe and effective vaccine.”

However, she said the agency “still cannot rule out definitively a link” between certain rare types of blood clots and the vaccine. The EMA recommended adding a description of these cases to the vaccine leaflets.

The debate raised fears that the safety questions would seriously undermine public confidence in AstraZeneca’s vaccine, which is key to efforts to immunize some of the world’s poorer countries, and further slow the lagging vaccination drive across the 27-nation EU at a moment when infections are rising at an alarming rate.

Europe also relies on Pfizer’s and Moderna’s vaccines.

French Prime Minister Jean Castex said he would be getting an AstraZeneca shot Friday “to show we can have complete confidence” in it. Clots that form in the arms, legs or elsewhere can break free and travel to the heart, brain or lungs, causing strokes, heart attacks or other deadly blockages.

In its findings Thursday, the EMA said the overall number of clotting events of various sorts reported since the rollout is lower than what would be expected in the general population.

But those common clots aren’t the kind causing concern. Instead, the EMA said it will continue to look at two rare types of blood clots. It cited seven reports of a type that appears in multiple blood vessels and 18 reports of a kind called cerebral venous thrombosis, which occurs in a vein that drains blood from the brain.