BERLIN – Officials in several European countries pushed back Friday against decisions by others to pause use of AstraZeneca’s coronavirus vaccine following sporadic reports of blood clots, despite a lack of evidence the shot was responsible.
German Health Minister Jens Spahn said that while the country takes reports of possible harmful effects from vaccines “very, very seriously,” both the European Medicines Agency and Germany's own vaccine oversight body have said they have no evidence of an increase in dangerous blood clots in connection with the shots.
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“I regret that on the basis of the knowledge, as of Friday morning, some countries in the European Union have suspended vaccinations with AstraZeneca,” Spahn told reporters in Berlin.
Denmark was the first to temporarily halt use of the AstraZeneca vaccine Thursday after reports of blood clots in some people. The Nordic nation's health authority said the decision was “based on a precautionary principle” and that one person who developed a blood clot after vaccination had died.
Norway, Iceland and Bulgaria followed suit and suspended use of the Anglo-Swedish company's vaccine, which was developed with the University of Oxford.
“Until all doubts are dispelled and experts guarantee that it holds no risk for people, we are stopping immunization using that vaccine,” Bulgarian Prime Minister Boyko Borissov told a Cabinet meeting. He said that the suspension will last until the European Medicines Agency issues a written statement that it is safe.
The regulator has said it is looking into the reports — but that vaccinations should continue in the meantime.
Thailand and Congo have also delayed use of the vaccine, pending an investigation, while Italy and Romania stopped using shots from one particular batch. Austria has also halted use of doses from a single, but different, batch.
That decision followed the death from blood clots of a 49-year-old 10 days after she had been vaccinated, and the hospitalization of a 35-year-old woman. Experts concluded neither complication was related to the vaccine, and Austria's chancellor said Friday that he, himself, would be willing to receive the shot “to show that I have trust in this vaccine.”
“Experts here have a clear opinion and this vaccine is being used in many countries around the world, and it is already being used by tens of millions,” Sebastian Kurz said.
In fact, nearly every country that issued a suspension acknowledged that it had no evidence the vaccine had caused the blood clots. Health experts have pointed out that the people most likely to currently be receiving COVID-19 vaccinations are also more likely to have other health problems, which could put them at higher risk for blood clots.
France, Poland and Nigeria, meanwhile, said they would continue using the AstraZeneca shot even as national regulators investigate.
“At this stage, the benefit of vaccination is judged superior to the risk,” said France’s health minister, Olivier Veran.
The suspensions were the latest trouble for AstraZeneca, which had a public spat with the European Union earlier this year over supply delays and which also faced concerns about its efficacy in older adults. While EU regulators approved it for use in all adults, some countries have set age restrictions — though many are now lifting those. The trouble also comes as many EU countries have struggled to quickly ramp up vaccinations.
Despite the bumpy rollout, the vaccine is still expected to be critical to the global inoculation program because it’s cheaper and easier to store than many others — and because the global initiative to get vaccines to poorer countries known as COVAX relies heavily on the vaccine.
Italy’s precautionary ban came after what it said were “serious adverse events.” It didn’t elaborate, but Italian media reported at least two suspect deaths of military and law enforcement officers were being investigated.
The union representing members of the Italian Air Force confirmed one of its members had died and urged further clarification from the government.
Italy's ban affects a lot of 500,000 AstraZeneca doses that had been delivered across the country.
The European Medicines Agency, which authorized the shot for use across the 27-nation EU, Iceland, Liechtenstein and Norway in January, said “the vaccine’s benefits continue to outweigh its risks and the vaccine can continue to be administered” while a closer evaluation of the blood clot cases continues.
“There is currently no indication that vaccination has caused these conditions,” the regulator said Thursday. It said the number of people with blood clots in vaccinated people was no higher than those who hadn’t been inoculated.
The World Health Organization said the same, but added that it would asses the reports though it didn’t expect any changes to recommendations based on current evidence.
Britain’s medicines regulator also said it had not received any reports of blood clots in people that were caused by the AstraZeneca vaccine. More than 11 million doses of AstraZeneca have been administered in the U.K.
“Reports of blood clots received so far are not greater than the number that would have occurred naturally in the vaccinated population,” the agency said.
The EU drug regulator did say, separately, that product information for the AstraZeneca vaccine should be updated to note that cases of severe allergic reactions have been reported.
The suggested update is based on a review of 41 reported cases of anaphylaxis, or severe allergic reactions, that were identified among 5 million people who received the AstraZeneca vaccine. In a statement on Friday, the Amsterdam-based agency said it concluded that “a link to the vaccine was likely in at least some of these cases.”
Such allergic reactions are a recognized rare side effect to numerous vaccines and have been reported for other COVID-19 shots, including the one made by Pfizer and BioNTech.
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Associated Press journalists in Africa, Asia and Europe contributed to this report.
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