BERLIN – A cascading number of European countries, including Germany, France, Italy and Spain, suspended the use of AstraZeneca’s coronavirus vaccine on Monday due to reports of dangerous blood clots in some recipients, although the company and international regulators say there is no evidence of guilt.
AstraZeneca formula is one of three vaccines used on the continent. But growing concern is another setback for boosting European Union vaccination, which has been hit by shortages and other hurdles and lags far behind campaigns in Britain and the United States.
The EU drug regulatory agency convened a meeting on Thursday to review experts’ findings on AstraZeneca’s shooting and decide whether action should be taken.
The rage comes as much of Europe is tightening restrictions on schools and businesses amid growing cases of COVID-19.
The German Minister of Health said that the decision to suspend the shooting of AstraZeneca was taken on the advice of the country’s vaccine regulator, the Paul Ehrlich Institute, which called for an additional investigation into seven cases of clots in the brains of people who had been vaccinated.
“Today’s decision is a purely preventative measure,” Jens Spahn said.
French President Emmanuel Macron said his country would stop dispensing the vaccine at least until Tuesday afternoon. Italy also announced a temporary ban, as did Spain, Portugal and Slovenia.
Other countries that have done so in recent days are Denmark, which was the first, as well as Ireland, Thailand, the Netherlands, Norway, Iceland, Congo and Bulgaria. Canada and Britain are currently on the vaccine side.
In the coming weeks, AstraZeneca is expected to apply for US authorization of its vaccine. The US now relies on vaccines produced by Pfizer, Moderna and Johnson & Johnson.
AstraZeneca said there have been 37 reports of blood clots from more than 17 million people vaccinated in the EU and Britain from 27 countries. The drug maker said there is no evidence that the vaccine carries a higher risk of clots.
In fact, he said the incidence of clots is much lower than expected to occur naturally in a general population of this size and is similar to that of other licensed COVID-19 vaccines.
Duke University’s health care system oversaw one of 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 has said, ‘Look, we haven’t seen any signs in any of the trials,'” said Dr. Cameron Wolfe, Duke’s infectious disease expert. there will be some people who, by coincidence, have huge side effects, for example, blood clots [or] many different natural problems we may encounter.
“I think we really need to be careful to understand if this was pure coincidence or if this really happened because of a vaccine,” Wolfe added.
Dr. Graham Snyder, medical director of WakeMed, said vaccines have never been known to cause blood clots.
“Breaking a major bone in the leg, which can absolutely lead to a blood clot. Crushing the leg in a car accident, which can lead to a blood clot,” Snyder said. “The amount of damage or bleeding from a vaccine (a fraction of a puncture fraction) that would not contribute.”
The World Health Organization and the European Medicines Agency of the EU have also said that the data do not suggest that the vaccine has caused clots and that people should continue to be vaccinated.
“Many thousands of people develop blood clots annually in the EU for different reasons,” the European Medicines Agency said. The incidence in vaccinated people “does not seem to be higher than that seen in the general population.”
The agency said that while the investigation continues, “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 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 shooting of AstraZeneca has become a key tool in the efforts of European countries to increase their weak vaccine implementation. It is also the mainstay of a UN-backed project known as COVAX that aims to supply COVID-19 vaccines to the poorest countries. This program continues to be affected by the European suspension.
Pfizer and Moderna vaccines are also used on the European continent and the only J&J vaccine has been authorized but has not yet been delivered.
Dr Michael Head, a senior researcher in global health at the University of Southampton in England, said there was still no data to justify the suspension of the AstraZeneca vaccine and called the decision “baffling”.
“Stopping a deployment of vaccines during a pandemic has consequences,” Head said. “This translates into delays in protecting people and the potential for increased hesitation, as a result of people who have seen the headlines and who, understandably, care.”
Spahn, the German health minister, defended the country’s decision and said: “The most important thing for trust is transparency.” He said the first and second doses would be suspended.
Germany has received just over 3 million doses of the AstraZeneca vaccine, and about half of those administered so far, compared to nearly 7 million of those shot with Pfizer and about 285,000 from Moderna.
German authorities have encouraged everyone who feels increasingly ill more than four days after receiving the shot, for example, with persistent headaches or point-shaped bruises, 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. He said the ban “was not an easy decision” as it further slowed the country’s vaccination campaign, but it was the “most prudent” approach.
Almost 940,000 people in Spain have been shot by AstraZeneca.
Meanwhile, some European countries have begun to impose restrictions to try to counteract the resurgence of infections, many of them from variants of the original virus.
In Italy, 80% of children across the country were unable to attend classes after stricter rules became effective in more regions on Monday. In Poland, reinforced restrictions were applied to two more regions, including Warsaw. Paris could close in a matter of days because intensive care units are flooding with COVID-19 patients.
And calls are growing in Germany to “pull the emergency brake” in regions where cases are on the rise.
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WRAL journalist Keely Arthur and AP reporter Sylvie Corbet in Paris Maria Cheng in London Jamey Keaten in Geneva and Frances D’Emilio in Rome contributed to the report.