BERLIN – A large number of European countries, including Germany, France, Italy and Spain, suspended the use of the AstraZeneca coronavirus vaccine on Monday due to reports of dangerous blood clots in some recipients, although the company and international regulators say that there is no evidence that the injection is to blame.
AstraZeneca’s formula is one of three vaccines in use on the continent. But growing concern is 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 United States.
The EU drug regulatory agency called a meeting on Thursday to review the experts’ conclusions about the injection of AstraZeneca and decide whether action should be taken.
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 distributing the vaccine until at least Tuesday afternoon. Italy has also announced a temporary ban, as have Spain, Portugal and Slovenia.
Other countries that have done so in the past few days include Denmark, which was the first, as well as Ireland, Thailand, the Netherlands, Norway, Iceland, Congo and Bulgaria. Canada and Britain are defending the vaccine for now.
In the coming weeks, AstraZeneca is expected to apply for US authorization for its vaccine. The United States now depends on vaccines produced by Pfizer, Moderna and Johnson & Johnson.
AstraZeneca said there were 37 reports of blood clots in more than 17 million people vaccinated in the 27 EU countries 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 Duke University Health System supervised one of the many AstraZeneca clinical trials to test the vaccine, and none of the nearly 180 participants developed blood clots.
“I think it’s worth knowing that AstraZeneca said, ‘Look, we didn’t see a sign in any of the tests,'” said Dr. Cameron Wolfe, an infectious disease specialist at Duke. “In any number of people, there will be some people who, by a great coincidence, will have enormous side effects, for example, blood clots [or] many different natural problems that we can face.
“I think we really need to be careful to understand whether this was pure coincidence or whether it really happened because of a vaccine,” added Wolfe.
Dr. Graham Snyder, medical director at WakeMed, said vaccines have never been known to trigger blood clots.
“Breaking an important bone in your leg, which can absolutely lead to a blood clot. Being your leg crushed in a car accident can lead to a blood clot,” said Snyder. “The amount of damage or bleeding from a vaccine – a fraction of a fraction of an injection – that would not contribute.”
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.
“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 provide COVID-19 vaccines to the poorest countries. This program remains unchanged by the European suspension.
Pfizer and Moderna vaccines are also used on the European continent, and J&J’s unique vaccine has been authorized, but has not yet been distributed.
Dr. Michael Head, a senior researcher in global health at the University of Southampton, England, said there is still no data 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, understandably, were concerned.”
Spahn, the German health minister, defended the country’s decision, saying: “The most important thing for trust is transparency.” He said the first and second doses would be suspended.
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.
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.
The head of the Spanish Medicines Agency, Maria Jesús Lamas, said that Spain detected its first case of clots on Saturday. She said the ban “was not an easy decision” because it further slows down the country’s vaccination campaign, but it was the “most prudent” approach.
Almost 940,000 people in Spain received the AstraZeneca injection.
Meanwhile, some European countries have begun to re-enforce 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.
And orders are growing in Germany to “pull the emergency brake” in regions where cases are on the rise.
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WRAL reporter Keely Arthur and AP reporters Sylvie Corbet in Paris, Maria Cheng in London, Jamey Keaten in Geneva and Frances D’Emilio in Rome contributed to this report.