Europe Weighs Caution on AstraZeneca Vaccine Against Covid-19 Threat

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Europe Weighs Caution on AstraZeneca Vaccine Against Covid-19 Threat

Health authorities and scientists threw their weight behind AstraZeneca PLC’s Covid-19 vaccine, but beleaguered European governments that have suspended its use defended their caution.

The European Union’s medicines regulator said Tuesday that the benefits of using AstraZeneca’s vaccine outweigh possible risks, after similar comments Monday by the World Health Organization, despite reports that some people who had received it suffered blood clots and several of them had died.

Germany, France, Italy and Spain on Monday temporarily stopped giving the shots, further slowing the EU’s already sluggish vaccine rollout and threatening the vaccine’s public credibility.

The EU’s European Medicines Agency is assessing information on the vaccine and the blood-clot cases. It plans to report its findings on Thursday.

Politicians in many EU countries that have been battered by the coronavirus pandemic, its resulting economic shock and recent problems launching vaccination campaigns said they are acting from an abundance of caution.

“The governments are waiting for EMA’s opinion on Thursday and we are confident that the elements will emerge to reassure people and allow us to restart the vaccinations,” said Italian Health Minister Roberto Speranza on Tuesday. “This process should increase people’s confidence” in the AstraZeneca vaccine, he said.

France has suspended the shots. A vaccination center in Saint-Jean-de-Luz.

Photo: Bob Edme/Associated Press

But others see danger in politicians’ caution and vacillating positions on a vaccine that is vital to European efforts to stanch the pandemic.

EMA Executive Director Emer Cooke said Tuesday she was “still firmly convinced” of the vaccine’s benefits.

“Trust in the safety and efficacy of the vaccines that we have authorized is paramount for us,” Ms. Cooke said. “We are worried there may be an effect on the trust of the vaccines.”

Denmark, Norway and Iceland last week suspended the vaccine’s use but pressure on politicians rose Monday after a recommendation by the Paul Ehrlich Institute, Germany’s medicines regulator, to suspend the vaccine’s rollout pending further investigation.

Institute President Klaus Cichutek defended the recommendation, saying his experts identified seven cases in Germany of cerebral vein thrombosis, a severe brain condition. Three of those people died, which he said justified the pause.

Six of the seven patients were women, and all were between 20 and 50 years old, the institute added. More than 1.6 million people got the vaccine in Germany.

“I think the citizens want to be able to trust that the vaccines we offer are safe and efficient,” Prof. Cichutek said in a televised interview. He said his experts and EU authorities want to determine whether evidence indicates a random statistical fluctuation or a link to the vaccine.

‘We are worried there may be an effect on the trust of the vaccines.’

— Emer Cooke, executive director, European Medicines Agency

Germany’s healthcare ministry 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 merited a pause. The ministry acknowledged that other medication, such as birth-control pills, caused similar complications and that there could be benefit in continuing vaccination despite the possible severe side effects.

Continental politicians’ caution contrasts with the approach of the U.K., which recently left the EU, and where AstraZeneca developed the vaccine with scientists from University of Oxford. The U.K. has inoculated a greater proportion of its population than almost any large economy, primarily with more than 11 million doses of the AstraZeneca vaccine.

Britain’s Medicines and Healthcare Products Regulatory Agency, the U.K.’s medicines regulator, said Tuesday the frequency of clots among those vaccinated is no different from what would be expected in the absence of vaccination.

An agency spokeswoman said 30 instances of blood clots among those vaccinated with the AstraZeneca shot were reported through last month, and 38 among those receiving the Pfizer Inc. shot.

“Such reports are not proven side effects of the vaccine,” she said. “Blood clots can occur naturally and are not uncommon.”

The U.K. suffered one of the deadliest Covid-19 outbreaks in Europe, with almost 150,000 known deaths linked to the disease. British scientists and government officials have argued the benefits of vaccination against such a dangerous pathogen almost certainly outweigh any risks, and Britons have been eager to get vaccinated. Prime Minister Boris Johnson’s government pushed an aggressive vaccination program.

Ragnar Löfstedt, professor of risk management at King’s College London, said that while the U.K. and its European neighbors face different pressures related to public opinion on vaccines in general and AstraZeneca’s in particular, the U.K. appears more willing to trade off risks against potential benefits.

“There are different risk tolerances out there,” he said.

“Europe has become a severely risk-averse continent,” said Andreas Rödder, the chair for Modern and Contemporary History at the Johannes Gutenberg University Mainz. The contrast with vaccination leaders such as Britain and Israel “could not be starker in this pandemic,” he said.

Medical experts voiced concern that what many see as politicians’ excessive caution could undermine their own vaccination campaigns.

“There is a very high risk that people won’t want to take the AstraZeneca vaccine after this, even if EMA comes out with new data saying it is indeed safe,” said Gavino Maciocco, a doctor and professor of public health at the University of Firenze. “We already saw in Italy that some people weren’t showing up for their appointments after a few lots of the AstraZeneca vaccine were suspended last week.”

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In France, authorities already faced an uphill battle persuading health workers and other groups to take the AstraZeneca vaccine. The country’s population is among the world’s most skeptical of vaccines. On Tuesday, officials said their pause was just precautionary.

“People are not in danger because they have been vaccinated with AstraZeneca,” said Health Minister Olivier Véran, who is a doctor and posed last month getting his first shot of the AstraZeneca vaccine to dispel concerns about it.

Others said such reassurances wouldn’t counteract negative publicity around the vaccine.

“I don’t know examples of medicines that were suspended and then reintroduced that were widely used,” said Jean-Louis Montastruc, head of clinical pharmacology at Toulouse University Hospital and a member of France’s Academy of Medicine.

Some European countries have continued giving the vaccine. “It would be irresponsible to suspend vaccinations with the AstraZeneca vaccine right now,” said Belgium’s health minister, Frank Vandenbroucke, on Monday.

Officials in Australia, India and Egypt have also said they plan to continue using the vaccine. Canada on Tuesday deemed the vaccine safe for adults over age 65, after a scientific review.

Covid-19 Vaccines

Write to Bojan Pancevski at, Eric Sylvers at and Matthew Dalton at

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