AstraZeneca’s Covid-19 vaccine cleared by EU after blood clots

EU authorities hope the EMA’s statement could put a troubled vaccination campaign back on track, although it remains to be seen whether the new analysis will overcome the distrust of the AstraZeneca shot among many Europeans.

Many European countries, including Germany, France and Italy, have suspended use of the vaccine in recent weeks following reports that people who received it have developed rare blood clots, and some have died, delaying Europe’s already sluggish vaccination.

These reports exacerbated the delays and uncertainties surrounding the EU’s struggle to vaccinate citizens far behind the EU and the UK.

In the wake of impatience from European leaders, Italian Prime Minister Mario Draghi said after the EMA announcement that the country would resume vaccinations with AstraZeneca on Friday.

The EMA’s safety committee found that the vaccine ‘is safe and effective in preventing Covid-19, and its benefits outweigh the risks,’ ‘said committee chair Sabine Straus. Dr. Straus said that since blood clots are associated with Covid-19, the vaccine is likely to vaccinate people against the disease, “probably reducing the risk of thrombotic incidents.”

Health officials have noted that blood clots are widespread for a variety of reasons. Blood clots have also been observed in people receiving other Covid-19 vaccines and can be caused by medicines that are as common as birth control pills.

Dr Straus said the EMA has a consideration of the blood clots found among women, especially younger women. According to her, it remains ‘premature to decide’ whether it is associated with greater risk among the groups or the composition of the population receiving the vaccine.

Emer Cooke, executive director of the EMA, said the experts had found a limited number of blood clots that needed to be further investigated, and the agency still could not definitively rule out a connection. ‘

The EMA therefore recommended ‘raising awareness’ by including a warning at the vaccination and informing the public. Such a campaign could help people receiving the AstraZeneca vaccine know what to look for once they have the chance.

Mrs Cooke on Tuesday expressed concern that doubts about it could jeopardize public confidence in vaccines. At a news conference on Wednesday whether she would shoot the AstraZeneca in person, she said: ‘If I were, I would be vaccinated tomorrow, but I would like to know that if I had something to overcome, what to do.

Mrs. Cooke, noting that many EU countries have suspended the use of the AstraZeneca vaccine pending the EMA’s investigation, said the conclusions “should give them the information to make an informed decision about the use of the AstraZeneca vaccine”. AstraZeneca vaccine in their vaccination campaigns. “

So far, about seven million people in the EU and 11 million in the UK have received the vaccine, Ms. Cooke said.

The analysis of the vaccine became extra urgent this week after the Paul Ehrlich Institute, the medical regulator of Germany, on Monday recommended suspending the explosion of the vaccine pending further investigation.

Institute President Klaus Cichutek defends the recommendation, saying that his experts have identified seven cases in Germany of cerebral arterial thrombosis, a serious brain condition, and three of the people have died. The German Ministry of Health said that, based on the number of vaccinations given, it would have expected up to 1.4 cases of cerebral arterial thrombosis, and that the seven cases deserved a break.

The EMA collected reports from across Europe, which gave it a much larger dataset to analyze.

Some EU countries, including Greece and Belgium, have continued to use the vaccine, as have Australia, Canada and India.

The UK, where AstraZeneca developed the vaccine with Oxford University scientists, relies heavily on the vaccine for its relatively rapid vaccination campaign. British politicians have criticized their European counterparts for suspending the use of the vaccine against expert advice.

The AstraZeneca shot is the most widely used Covid-19 vaccine in the world.

Many medical experts in Europe and beyond have criticized politicians’ decisions to stop vaccinations, saying that the known risks posed by the coronavirus are greater than possible through AstraZeneca shots. German officials said their suspension was deserved because they were asking citizens to take the vaccine, unlike other medicines such as contraceptives, which are a personal choice.

European officials who interrupted vaccinations drafted their decisions as precautionary measures. But based on available data and Covid-19 risks, “is the cautionary approach to continue vaccination,” said prof. David Spiegelhalter, an expert in statistics and risk at the University of Cambridge, said. “Doubts about the safety of the vaccines – lasting doubt – are not a precautionary position.”

—Jenny Strasburg and Giovanni Legorano contributed to this article.

Write to Daniel Michaels by [email protected]