AstraZeneca Covid-19 Vaccine Approved By EU After Blood Clot Concerns

The European Union health agency said the Covid-19 vaccine produced by AstraZeneca PLC was “safe and effective” and did not increase the risk of blood clots, a decision that could clear the way for the resumption of inoculation campaigns that they have stopped. in much of the region.

The European Medicines Agency said a new expert analysis concluded that the benefits of using a Covid-19 vaccine produced by AstraZeneca outweigh its potential risks and inoculations should continue.

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

Many European countries, including Germany, France and Italy, suspended use of the vaccine for the past week after reports that people who had received it developed rare blood clots and some had died, further slowing the already slow launch. of the vaccine in Europe.

Those reports compounded the delays and uncertainties surrounding a campaign that has left the EU far behind the United States and the United Kingdom in vaccinating their citizens.

In a sign of the impatience of European leaders, Italian Prime Minister Mario Draghi said after the EMA announcement that the country would resume administration of the AstraZeneca vaccines on Friday.

The EMA safety committee found the vaccine to be “safe and effective in preventing Covid-19, and its benefits outweigh its 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 incidents overall.”

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


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

Dr. Straus said that the EMA identified a prevalence of blood clots found among women, particularly younger women. He said it is still “premature to conclude” whether this is related to an increased risk between groups or the composition of populations receiving the vaccine.

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

As a result, the EMA recommended “raising awareness” by including a warning with the vaccination and informing the public. Such a campaign could help people who receive the AstraZeneca vaccine know what to look for after receiving the vaccine.

Ms Cooke expressed concern Tuesday that the concerns raised could damage public confidence in vaccines. When 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 what to do if something happens to me.”


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Cooke, noting that many EU countries had suspended the use of the AstraZeneca vaccine pending EMA review, said their findings should give them “the information they need to make an informed decision about the use of the 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, Cooke said.

The vaccine analysis took on additional urgency this week after the Paul Ehrlich Institute, Germany’s drug regulator, recommended on Monday to suspend the launch of the vaccine pending further investigation.

The institute’s president, Klaus Cichutek, defended the recommendation, saying his experts identified seven cases in Germany of cerebral vein thrombosis, a serious brain condition, and three of the people died. Germany’s Health Ministry said that based on the number of vaccines administered, it would have expected up to 1.4 cases of cerebral vein thrombosis, with all seven cases deserving a hiatus.

The EMA compiled reports from across 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 rapid vaccination campaign. British politicians have criticized their EU counterparts for suspending use of the vaccine against expert advice.

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

Many medical experts in Europe and beyond criticized the decisions of politicians to stop vaccines, saying that the known risks posed by the coronavirus are greater than those possible from AstraZeneca injections. German officials said their suspension was deserved because they urge citizens to get vaccinated, unlike other drugs like contraceptives, which are a personal choice.

European officials who stopped the vaccines framed their decisions as precautionary. But based on the available data and the risks of Covid-19, “the precautionary approach would be to continue vaccination,” said Professor David Spiegelhalter, an expert in statistics and risk at the University of Cambridge. “Questioning an enduring doubt about the safety of vaccines is not a precautionary position.”

Write to Daniel Michaels at [email protected]

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