BERLIN – A tiered number of European countries, including Germany, France, Italy and Spain, suspended 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 to blame.
AstraZeneca’s formula is one of three vaccines in use on the continent. But the escalating concern is another setback for the European Union’s vaccination campaign, which has been plagued by shortages and other hurdles and falls far short of the campaigns in Britain and the US.
The EU drug regulation agency convened a meeting on Thursday to review experts’ findings on the AstraZeneca shooting and decide whether to take action.
The furor is now hitting much of Europe as restrictions on schools and businesses are tightening amid the rising cases of COVID-19.
Germany’s health minister said the decision to suspend AstraZeneca shots was taken on the advice of the country’s vaccine regulator, the Paul Ehrlich Institute, which called for further investigations into seven cases of blood clots in the brains of vaccinated people.
“Today’s decision is purely a precautionary measure,” said Jens Spahn.
French President Emmanuel Macron said his country will also stop providing the vaccine until at least Tuesday afternoon. Italy also announced a temporary ban, as did Spain, Portugal and Slovenia.
Other countries that have done this in recent days include Denmark, which was the first, as well as Ireland, Thailand, the Netherlands, Norway, Iceland, Congo, and Bulgaria. Canada and Great Britain are currently behind the vaccine.
AstraZeneca is expected to seek US approval of its vaccine in the coming weeks. The US now relies on vaccines manufactured by Pfizer, Moderna and Johnson & Johnson.
AstraZeneca said there are 37 reports of blood clots from more than 17 million vaccinated people in the 27 countries of the EU and Great Britain. The medicine man said there is no evidence that the vaccine poses an increased risk of blood clots.
In fact, it said the incidence of clots is much lower than would naturally be expected in a general population of this size and comparable to that of other approved COVID-19 vaccines.
The Duke University Health 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 said, ‘Look, we haven’t seen a signal in any of the studies,'” said Dr. Cameron Wolfe, infectious disease expert at Duke. ‘With such a large number of people, there will be people who will have enormous side effects by an enormous coincidence, for example blood clots. [or] many different natural problems that we may encounter.
“I think we have to be really careful to understand if that was just a coincidence or if it really happened because of a vaccine,” Wolfe added.
Dr. Graham Snyder, WakeMed’s medical director, said vaccines have never been known to cause blood clots.
“Breaking a big bone in your leg can absolutely lead to a blood clot. If your leg gets crushed in a car accident, it can lead to a blood clot,” Snyder said. “The amount of damage or bleeding from a vaccine – a fraction of a fraction of a shot – that wouldn’t contribute.”
The World Health Organization and the European Medicines Agency of the EU have also said the data does not suggest that the vaccine caused the blood clots and that people should be immunized.
“Many thousands of people get blood clots every year in the EU for various reasons,” said the European Medicines Agency. The incidence in vaccinated people “does not appear to be higher than in the general population.”
The agency said that while the investigation is underway, “the benefits of the AstraZeneca vaccine in preventing COVID-19, with the associated risk of hospitalization and death, outweigh the risks of side effects.”
Blood clots can travel throughout 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 lung.
The AstraZeneca injection has become an important tool in European countries’ efforts to boost their slow vaccine launches. It is also a pillar of a UN-backed project, known as COVAX, which aims to deliver COVID-19 vaccines to poorer countries. That program is unaffected by the European suspension.
The Pfizer and Moderna vaccines are also in use on the European continent, and J & J’s one-time vaccine is approved but not yet delivered.
Dr. Michael Head, a senior research fellow in global health at the University of Southampton in England, said there is as yet no data to justify the suspension of the AstraZeneca vaccine, calling the decision “mind-boggling”.
“Halting the rollout of vaccines during a pandemic has consequences,” said Head. “This results in delays in protecting people and the potential for greater vaccine reluctance as a result of people seeing the headlines and understandably becoming concerned.”
Spahn, Germany’s health minister, defended the country’s decision, saying, “The most important thing to trust is transparency.” He said both the first and second doses would be suspended.
Germany has received just over 3 million doses of the AstraZeneca vaccine, and about half of them have been administered to date, compared to nearly 7 million from the Pfizer injection and about 285,000 from Moderna.
The German authorities have encouraged anyone who feels progressively sicker more than four days after the injection – for example, with persistent headaches or point bruises – to seek medical attention.
The head of the Spanish Medicines Agency, Maria Jesús Lamas, said Spain discovered its first case of blood clots on Saturday. She said the ban was “not an easy decision” as it further slows down the country’s vaccination campaign, but it was the “most cautious” approach.
Nearly 940,000 people in Spain have received the AstraZeneca recording.
Some European countries, meanwhile, have begun to re-impose restrictions in an effort to stop a flare-up of infections, many of them by variants of the original virus.
In Italy, 80% of children across the country were unable to attend classes after tougher rules came into effect in more regions on Monday. In Poland, reinforced restrictions were applied to two more regions, including Warsaw. Paris can be shut down in a few days as the intensive care units are overrun with COVID-19 patients.
And in Germany, the demand to “pull the emergency brake” is growing in regions where the number of cases is increasing.
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.