BERLIN – A cascading number of European countries, including Germany, France, Italy and Spain, suspended the use of the AstraZeneca coronavirus vaccine on Monday for reports of dangerous blood clots in some recipients, although the company and international regulators say there is no evidence that vina.
The AstraZeneca formula is one of the three vaccines used on the continent. But growing concern is another obstacle to the European Union’s impetus for vaccination, which has been plagued by shortages and other obstacles and is far behind the UK and US campaigns.
The EU Drug Enforcement Agency convened a meeting on Thursday to review experts’ findings on the AstraZeneca shooting and decide whether action should be taken.
Anger comes, as much of Europe is tightening restrictions on schools and businesses amid growing cases of COVID-19.
The 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 a further investigation into seven cases of brain clots in people who have been vaccinated.
“Today’s decision is a purely preventive measure,” Jens Spahn said.
French President Emmanuel Macron has said his country will also stop administering 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 the United Kingdom are currently on the vaccine.
In the coming weeks, AstraZeneca is expected to apply for US authorization for its vaccine. The US is now relying 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 EU in 27 countries and the UK. The doctor said there was no evidence that the vaccine had an increased risk of clots.
In fact, he said the incidence of 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 authorized COVID-19 vaccines.
Duke University’s health care system oversaw one of many AstraZENEC 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, I didn’t see a signal in any of the studies,'” said Dr. Cameron Wolfe, an infectious disease expert at Duke. “In such a large number of people, there will be some people who, by huge 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 was actually due to a vaccine,” Wolfe added.
Dr. Graham Snyder, medical director of WakeMed, said the vaccines were never known to trigger blood clots.
“Rupture of a major bone in the leg, which can absolutely lead to the formation of a blood clot. Getting your foot in a car accident, which can lead to the formation of a blood clot,” said Snyder. “The amount of damage or bleeding caused by a vaccine – a fraction of a fraction of jab – that would not contribute.”
The World Health Organization and the EU’s European Medicines Agency also said the data did not suggest the vaccine had caused clots and that people should continue to be immunized.
“Many thousands of people develop blood clots in the EU every year for various reasons,” said the European Medicines Agency. The incidence of vaccinated persons “does not appear to be higher than that observed in the general population”.
The agency said that while the investigation is ongoing, “the benefits of AstraZeneca vaccine in preventing COVID-19, with the 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 embolism or clots in the lungs.
The AstraZeneca blow has become a key tool in European countries’ efforts to intensify their slow vaccine launch. It is also a pillar of a UN-backed project known as COVAX, which aims to provide COVID-19 vaccines to poorer countries. This program remains unaffected by the European suspension.
Pfizer and Moderna vaccines are also used on the European continent, and J & J’s one-shot vaccine has been licensed but not yet delivered.
Dr Michael Head, a senior researcher in global health at the University of Southampton in England, said there was no data yet to justify the suspension of the AstraZeneca vaccine and called the decision “puzzling”.
“Stopping the launch of a vaccine during a pandemic has consequences,” Head said. This results in delays in protecting people and the potential for increased hesitation in the vaccine as a result of people who have seen the headlines and have become understandably concerned.
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 discontinued.
Germany has received just over 3 million doses of AstraZeneca vaccine, and about half of them have been administered so far, compared to almost 7 million Pfizer vaccines and about 285,000 from Moderna.
German authorities have encouraged anyone who feels increasingly ill more than four days after receiving the shot – for example, with persistent headaches or bruises in the form of a spot – to seek medical attention.
The head of the Spanish Medicines Agency, Maria Jesús Lamas, said Spain had detected its first case of clots on Saturday. She said the ban was not an “easy decision” as it further slowed the nation’s vaccination campaign, but was the “most prudent” approach.
Nearly 940,000 people in Spain received the AstraZeneca shot.
Meanwhile, some European countries have begun to impose restrictions on trying to reverse a recurrence of infections, many of them variants of the original virus.
In Italy, 80% of children across the country were unable to attend classes after stricter rules came into force in several regions on Monday. In Poland, strengthened restrictions have been applied in two other regions, including Warsaw. Paris could be closed in a matter of days as intensive care units become flooded with COVID-19 patients.
And calls are growing in Germany to “pull the brakes” 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 the report.