EU regulator declares AstraZeneca vaccine safe, but experts fear damage has been done

The European Union’s medicines regulator has concluded that the Oxford-AstraZeneca Covid-19 vaccine is safe to use after several EU countries suspended their rollouts following reports that it could be linked to blood clots.

The European Medicines Agency (EMA)’s executive director Emer Cooke said the agency had “come to a clear scientific conclusion: this is a safe and effective vaccine.”

Cooke said the group did not find that the vaccine causes clotting, though it could not rule out definitively a link to a rare blood clotting disorder, of which seven cases have been reported out of several million doses given. She said the benefits of using the vaccine outweighed the risk.
The committee “concluded that the vaccine is not associated with an increase in the overall risk of thromboembolic events, or blood clots,” Cooke said.

The agency’s decision comes after more than a dozen European countries halted their use of the vaccine, citing reports of a handful of patients across Europe who developed clotting after being inoculated.

Most of the countries said they would await the EMA’s green light before resuming rollouts, but concerns remain about the impact of the suspensions on vaccine hesitancy across the continent.

“I want to reiterate that our scientific position is this: this vaccine is a safe and effective option to protect citizens against Covid-19,” Cooke said at a press conference Thursday.

“It demonstrated that at least 60% efficacy in clinical trials and preventing coronavirus disease, and in fact the real world evidence suggests that the effectiveness could be even higher than that.”

The group said it recommended raising awareness of blood clot reports so that they could be further analyzed. But they said those reports were rare, and that more than 7 million people have received the vaccine in the EU.

Virtually all of western Europe had temporarily stopped using the shot in recent days, even amid a third wave of coronavirus infections across the region, after a small number of reports of clots emerged.

The death of a person in Austria, a woman in Denmark and a third patient in Norway sparked the suspensions. But the decisions were criticized by much of the medical community, and other countries continued to back the use of the vaccine — including the UK, which has given out more than 11 million AstraZeneca doses so far.

In the EU, leaders will now face the question of how to rebuild any trust in the AstraZeneca vaccine that has been lost over the past week. The bloc’s rollout of the jab has stumbled from one obstacle to another since it was approved for use in January, with governments scrambling to secure limited supplies of the jab while simultaneously casting doubts over its efficacy and safety.

Italy said it will resume AstraZeneca vaccinations on Friday, and other countries are expected to follow. Milan’s largest vaccine center told CNN it would overbook appointments in an attempt to make up for the shortfalls of the past few days. Ireland’s Prime Minister had earlier told CNN he hoped his country could “catch up fairly quickly” once the vaccination program resumed.

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sourche: 

https://jonnac4t.cookpad-blog.jp/articles/581014

http://www.shadowville.com/board/general-discussions/eu-regulator-declares-astrazeneca-vaccine-safe-but-experts-fear-damage-has#p470709