AstraZeneca Covid-19 vaccine eliminated by EU after blood clot concerns

EU authorities hope that the EMA statement could bring back a troubled vaccination campaign, 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 vaccine use in recent weeks following reports that people who have received it have developed rare blood clots and some have died, further slowing the already slow launch of vaccination in Europe.

These reports have exacerbated delays and uncertainties over an impetus that left the EU and the UK long behind in vaccinating its citizens.

As a sign of impatience for European leaders, Italian Prime Minister Mario Draghi said after the EMA announcement that the country will resume the administration of vaccinations against AstraZeneca on Friday.

The EMA’s safety committee found the vaccine “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 by inoculating people against the disease, the vaccine “probably reduces the risk of thrombotic events in general.”

Health officials have noted that blood clots are spreading for several reasons. Clots have also been observed in people receiving other Covid-19 vaccines and may be caused by medicines as common as birth control pills.

Dr. Straus said the EMA identified a predominance of blood clots found among women, especially younger women. She said it remained “premature to conclude” whether this was related to a higher risk among groups or the structure of the populations receiving the vaccine.

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

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

Ms Cooke expressed concern on Tuesday that doubts about it could affect public confidence in vaccines. Asked at a news conference on Wednesday if she would personally receive the AstraZeneca shot, she said: “If it were me, I would be vaccinated tomorrow, but I would like to know if something happens to me,” what to do.

Ms Cooke, noting that many EU countries have suspended the use of the AstraZeneca vaccine pending the EMA review, said her findings should provide them with “the information they need to make an informed decision on the use of the AstraZeneca vaccine in their vaccination campaigns ”.

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

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

The president of the Institute, Klaus Cichutek, defended the recommendation, saying that his experts identified seven cases in Germany of cerebral vein thrombosis, a severe brain condition and three of the people died. The German Ministry of Health said that, based on the number of vaccinations administered, up to 1.4 cases of cerebral vein thrombosis would have been expected, and the seven cases deserved a break.

The EMA has collected 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 Oxford University, relies heavily on the vaccine for its relatively rapid vaccination campaign. British politicians have criticized their EU 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 the known risks of coronavirus are greater than those of AstraZeneca vaccines. German officials said their suspension was deserved because it urged citizens to get the vaccine, unlike other drugs, such as contraceptives, which are a personal choice.

European officials who stopped vaccinations have expressed their decisions as a precaution. But based on available data and the risks of Covid-19, “the precautionary approach would be to continue vaccination,” said Prof. David Spiegelhalter, an expert in statistics and risk at the University of Cambridge. “Doubting – long-standing doubts – about the safety of vaccines is not a precautionary position.”

—Jenny Strasburg and Giovanni Legorano contributed to this article.

Write to Daniel Michaels at [email protected]