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 there will be no proof that the shot is to blame.
AstraZeneca’s is just one of three vaccines in use on the continent. But the growing number of countries raising the alarm is yet another setback to the European Union’s vaccination campaign, which is plagued by shortages. and other obstacles and is far behind the campaigns in Great Britain and the US.
The EU drug regulation agency convened a meeting on Thursday to review experts’ findings on the AstraZeneca vaccine 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 suspend shots until at least Tuesday afternoon. The Italian drug regulator announced a temporary ban less than 24 hours after he said the “alarm” about the vaccine was “unjustified”. And Spain said it will stop using the vaccine for two weeks as experts assess its safety.
AstraZeneca said there are 37 reports of blood clots from more than 17 million vaccinated people in the 27 countries of the European Union 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 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.
AstraZeneca injection has become a key tool in European countries’ efforts to boost their slow vaccine launchesIt is also a pillar of a UN-backed project known as COVAX that aims to bring COVID-19 vaccines to poorer countries.
The Pfizer and Moderna vaccines are also in use on the European continent, and the Johnson & Johnson single-use vaccine is approved but not yet delivered.
In the US, which is dependent on the Pfizer, Moderna and J&J vaccines, AstraZeneca is expected to seek approval in the coming weeks.
Denmark became the first country to temporarily discontinue use of the AstraZeneca vaccine last week. One person was said to develop clots and died 10 days after receiving at least one dose. The other countries are Ireland, Thailand, the Netherlands, Norway, Iceland, Congo and Bulgaria.
Great Britain and Canada are provisionally behind the AstraZeneca vaccine.
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, said of the decision to suspend AstraZeneca’s shot: “The most important thing for trust is transparency.” He said both the first and second doses would be affected by the suspension.
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.
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 head of the Spanish Medicines Agency, Maria Jesús Lamas, said Spain discovered its first case of blood clots last Saturday. She said the ban was “not an easy decision” as it further slows down the national vaccination campaign, but it was the “most cautious” approach.
Nearly 940,000 people in Spain have received the AstraZeneca recording.
Europe, meanwhile, is again imposing restrictions in an effort to prevent a resurgence of infections, many of which come from 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.
Sylvie Corbet in Paris, Maria Cheng in London and Frances D’Emilio in Rome contributed to this report.
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