BERLIN (AP) – Germany, France, Italy and Spain became the last countries on Monday to suspend the use of AstraZeneca’s COVID-19 vaccine due to reports of dangerous blood clots in some recipients, although the company and European regulators have said that there is no evidence that the shot is to blame.
AstraZeneca is just one of three vaccines in use on the continent. But the cascading number of nations that raise the alarm represents another setback for the European Union’s vaccination campaign, which has been plagued by scarcity and other obstacles and is far behind campaigns in Britain and the USA
The EU drug regulatory agency convened a meeting on Thursday to review the experts’ conclusions about the AstraZeneca vaccine and decide if any action needs to be taken.
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The furor comes as much of Europe is increasing restrictions on schools and businesses amid increasing cases of COVID-19.
Germany’s health minister said the decision to suspend AstraZeneca vaccines was taken on the advice of the country’s vaccine regulator, the Paul Ehrlich Institute, which called for a more in-depth investigation into seven cases of clots in the brains of people who were vaccinated .
“Today’s decision is a purely precautionary measure,” said Jens Spahn.
French President Emmanuel Macron said his country would also stop shooting until at least Tuesday afternoon. Italy’s drug regulator announced a temporary ban, less than 24 hours after saying that the “alarm” about the vaccine “was not justified”. And Spain has said it will stop using the vaccine for two weeks, while experts review its safety.
AstraZeneca said there were 37 reports of blood clots in more than 17 million people vaccinated in the 27 countries of the European Union and Britain. The drugmaker said there is no evidence that the vaccine increases the risk of clots.
In fact, he said the incidence of clots is much less than would be expected to occur naturally in a general population of this size and is similar to that of other licensed COVID-19 vaccines.
The World Health Organization and the European Medicines Agency of the EU also said that the data does not suggest that the vaccine caused the clots and that people should continue to be immunized.
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“Many thousands of people develop blood clots annually in the EU for different reasons,” said the European Medicines Agency. The incidence in vaccinated persons “does not appear to be greater than that observed in the general population”.
The agency said that, while the investigation is ongoing, “the benefits of the AstraZeneca vaccine in preventing COVID-19, with its associated risk of hospitalization and death, outweigh the risks of side effects.”
Blood clots can travel through the body and cause heart attacks, strokes and deadly blockages in the lungs. AstraZeneca has reported 15 cases of deep vein thrombosis, or a type of clot that often develops in the legs, and 22 cases of pulmonary embolisms or clots in the lungs.
The AstraZeneca injection has become a key tool in European countries’ efforts to drive the slow release of vaccines. It is also the pillar of a UN-supported project known as COVAX, which aims to bring COVID-19 vaccines to the poorest countries.
Vaccines from Pfizer and Moderna are also used on the European continent, and the Johnson & Johnson one-shot vaccine has been authorized, but has not yet been distributed.
In the US, which depends on the Pfizer, Moderna and J&J vaccines, AstraZeneca should apply for authorization in the coming weeks.
Denmark last week became the first country to temporarily suspend the use of the AstraZeneca vaccine. He said that a person developed clots and died 10 days after receiving at least one dose. The other countries include Ireland, Thailand, the Netherlands, Norway, Iceland, Congo and Bulgaria.
Britain and Canada are defending the AstraZeneca vaccine for the time being.
Dr. Michael Head, senior researcher in global health at the University of Southampton, England, said there was no data yet to justify the suspension of the AstraZeneca vaccine and called the decision “disconcerting”.
“Stopping the launch of a vaccine during a pandemic has consequences,” said Head. “This results in delays in protecting people and the potential for increased hesitation to the vaccine, as a result of people who saw the headlines and were concerned”
Spahn, the German health minister, said of the decision to suspend the injection of AstraZeneca: “The most important thing for trust is transparency”. He said that both the first and second doses will be affected by the suspension.
German authorities have encouraged anyone who feels increasingly sick more than four days after receiving the injection – for example, with persistent headaches or bruises in the form of stitches – to seek medical attention.
Germany received just over 3 million doses of the AstraZeneca vaccine, and about half of them have already been administered, compared with almost 7 million doses of the Pfizer vaccine and about 285,000 from Moderna.
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The head of the Spanish Medicines Agency, Maria Jesús Lamas, said that Spain detected its first case of clots last Saturday. She said the ban “was not an easy decision” because it further slows down the national vaccination campaign, but it was the “most prudent” approach.
Almost 940,000 people in Spain received the AstraZeneca injection.
Meanwhile, Europe is re-imposing restrictions in an attempt to stem the resurgence of infections, many of which are variants of the original virus.
In Italy, 80% of children across the country were unable to attend classes after stricter rules in more regions came into effect on Monday. In Poland, tightened restrictions were applied to two more regions, including Warsaw. Paris can be confined in a matter of days because intensive care units are filling up with patients with COVID-19.
Sylvie Corbet in Paris, Maria Cheng in London and Frances D’Emilio in Rome contributed to this report.