AstraZeneca’s Covid-19 vaccine approved by the EU after concerns about blood clots

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

Many European countries, including Germany, France and Italy, stopped using the vaccine in the past week following reports that people who had received it were developing rare blood clots and some had died, further advancing the already slow roll-out of vaccinations in Europe. was delayed.

Those reports amplified the delays and uncertainties surrounding a drive the EU has left far behind the US and UK in vaccinating its citizens.

As a sign of the impatience of European leaders, Italian Prime Minister Mario Draghi said after the EMA announcement that the country would start giving AstraZeneca vaccinations again on Friday.

EMA’s safety committee found the vaccine “safe and effective in preventing Covid-19, and its benefits outweigh the risk,” said committee chair Sabine Straus. Dr. Straus said that since blood clots are associated with Covid-19 by inoculating people against the disease, the vaccine “likely reduces the risk of thrombotic events in general.”

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

Dr. Straus said the EMA had determined that a predominance of the blood clots found was in women, especially in younger women. She said it “remains premature to conclude” whether this is related to greater risk among the groups or to the makeup of the populations receiving the vaccine.

EMA Director Emer Cooke said the experts have found a limited number of blood clots that require further investigation and the agency “still cannot definitively rule out a link.”

The EMA therefore recommended “awareness raising” by including a warning with the vaccination and informing the public. Such a campaign could help people receiving the AstraZeneca vaccine know what to look for after receiving the injection.

Ms. Cooke had expressed concern on Tuesday that doubts raised about it could hurt public confidence in vaccines. When she was asked at a press conference on Wednesday if she would personally receive the AstraZeneca injection, she said, “If it were me, I would be vaccinated tomorrow, but I would like to know that if anything happened to me,” which I had to do.

Ms Cooke noted that many EU countries had suspended the use of the AstraZeneca vaccine pending the EMA’s evaluation, saying the conclusions should give them “the information they need to make an informed decision. take on the use of the AstraZeneca vaccine in their vaccination campaigns. ”

So far, around 7 million people in the EU, and 11 million in the UK, have received the vaccine, Ms Cooke said.

The analysis of the vaccine gained additional urgency this week after the Paul Ehrlich Institute, Germany’s drug regulator, recommended on Monday that the roll-out of the vaccine be suspended pending further investigation.

The institute’s president, Klaus Cichutek, defended the recommendation, saying his experts in Germany identified seven cases of cerebral vein thrombosis, a serious brain disorder, and that three of the people died. The German Ministry of Health said that, based on the number of vaccinations given, it would have expected as many as 1.4 cases of cerebral vein thrombosis, and the seven cases deserved a break.

The EMA collected reports from all over Europe, giving it a much larger data set 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 scientists at the University of Oxford, relies heavily on the vaccine for its relatively quick vaccination campaign. British politicians have criticized their EU counterparts for discontinuing the use of the vaccine against expert advice.

The AstraZeneca Injection is the world’s most widely used Covid-19 vaccine.

Many medical experts in Europe and beyond criticized politicians’ decisions to stop vaccinations, saying that the known risks of the coronavirus outweigh the potential risks of AstraZeneca shots. German officials said their suspension was deserved because they urge citizens to take the vaccine, as opposed to other drugs, such as contraceptives, which are a personal choice.

European officials who stopped vaccinations saw their decisions as a precautionary measure. But based on the available data and the Covid-19 risks, “The cautious approach would be to proceed with vaccination,” said Prof David Spiegelhalter, an expert on statistics and risk at the University of Cambridge. “Doubt – permanent doubts – about the safety of the vaccines is not a precaution.”

—Jenny Strasburg and Giovanni Legorano contributed to this article.

Write to Daniel Michaels at [email protected]