BERLIN A large 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 believe there is no evidence that the shot it is not. resent.
AstraZeneca’s formula is one of the three vaccines used on the continent. But the growing concern is another setback for the vaccination of the European Union, which is plagued by shortages and other obstacles and lagging behind in the campaigns in Britain and the US.
The EU Drugs Agency has convened a meeting for Thursday to examine the findings of experts on the AstraZeneca shot and decide whether action should be taken.
The upset comes as Europe tightens restrictions on schools and businesses amid serious cases of COVID-19.
German 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 investigation into seven cases of blood clots in the brain of people who have been vaccinated.
“Today’s decision is a pure precaution,” said Jens Spahn.
French President Emmanuel Macron has said his country will also stop issuing 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 recent days include Denmark, which was the first, as well as Ireland, Thailand, the Netherlands, Norway, Iceland, Congo and Bulgaria. Canada and Britain are standing by the vaccine for the time being.
In the coming weeks, AstraZeneca is expected to apply for US approval for its vaccine. The US now relies on vaccines manufactured by Pfizer, Moderna and Johnson & Johnson.
AstraZeneca said there were 37 reports of blood clots from more than 17 million people vaccinated in the 27-nation EU and Britain. The drugmaker said there was no evidence that the vaccine had an increased risk of blood clots.
In fact, it said that the incidence of blood clots is much lower 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 oversaw 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 did not see a signal in any trial,'” he said. Cameron Wolfe, an infectious disease expert at Duke, said. “With such a large number of people, there are going to be people who get big side effects by big coincidence, for example blood clots. [or] many different natural problems we may encounter.
“I think we have to be really careful to understand if it was pure coincidence and if it really happened due to a vaccine,” Wolfe added.
Dr Graham Snyder, medical director of WakeMed, said vaccines had never been known to cause blood clots.
“If you break a large bone in your leg, it can absolutely lead to a blood clot. If you have your leg 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 jab – that would not contribute.”
The World Health Organization and the European Medicines Agency (EU) also said that the data did not indicate that the vaccine had caused the blood clots and that people still needed to be vaccinated.
“Many thousands of people develop blood clots in the EU every year for various reasons,” the European Medicines Agency said. The incidence of vaccines is apparently not higher than in the general population. ‘
The agency said that, while the investigation is ongoing, “the benefits of the AstraZeneca vaccine to prevent COVID-19, with the associated risk of hospitalization and death, outweigh the risks of side effects.”
Blood clots can move through the body and cause heart attacks, strokes and fatal 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 blood clots in the lungs.
The AstraZeneca shot has become an important tool in the efforts of European countries to promote their sluggish vaccination. It is also a pillar of a UN-backed project known as COVAX, which aims to deliver COVID-19 vaccines to poorer countries. The program continues regardless of the European suspension.
Pfizer and Moderna vaccines are also used on the European continent, and J & J’s one-vaccine has been approved but not yet delivered.
Dr Michael Head, a senior research fellow in global health at the University of Southampton in England, said there was no data yet that could justify the suspension of the AstraZeneca vaccine, calling the decision ‘staggering’.
“The cessation of vaccination of vaccines during a pandemic has consequences,” Head said. “This leads to delays in protecting people, and the possibility of increased hesitation against vaccines, due to people seeing the headlines and becoming understandable.”
Spahn, the German health minister, defended the country’s decision, saying “The most important thing for 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 it has been administered so far, compared to nearly 7 million of the Pfizer shot and about 285,000 of Moderna.
German authorities have urged everyone who feels increasingly ill more than four days after receiving the shot – for example, with persistent headaches or spots in the form – to seek medical help.
The head of the Spanish Medicines Agency, Maria Jesús Lamas, said that Spain had detected its first case of blood clots on Saturday. She said the ban was “not an easy decision” because it further delayed the country’s vaccination campaign, but it was the “most sensible” approach.
Nearly 940,000 people in Spain received the AstraZeneca shot.
Some European countries have meanwhile begun to reintroduce restrictions in an effort to stem a revival of infections, many of which are variants of the original virus.
In Italy, 80% of children nationwide could not attend classes after stricter rules took effect in more regions on Monday. In Poland, stricter restrictions have been applied to two other regions, including Warsaw. Paris could close within a few days because intensive care units are overcrowded with COVID-19 patients.
And there is a call in Germany to pull the emergency brake in regions where cases are increasing.
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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.