LONDON – For months, European countries have seen AstraZeneca’s vaccine in the midst of craving and ripping, with shot luck rising and falling on supply spats, and the vaccine’s efficacy itself being questioned.
But some concerns have proved disruptive to the rollout of the world’s workhorse vaccine in Europe as reports of very rare blood clots in some recipients. Many countries Responded by stopping the use of shot, Only to start giving again after one All clear from regulators at European Medicines Agency, and then Stopped vaccinating for the second time In some age groups after doctors worry more about the clot.
On Tuesday, those concerns were reinforced again when a top vaccine official at the European Medical Agency said the vaccine was associated with extremely rare, though sometimes fatal, numbers of a small number of blood recipients. This was the first indication from an international regulatory body that clots could be a real if shot’s very unusual, side effect.
Regulators are now considering issuing their first formal warning about possible side effects – not only in continental Europe, which have long been wary of the shot for political and scientific reasons, but also in the UK, with the AstraGena vaccine and long Born from its biggest champion, where new figures have raised concerns as well.
The University of Oxford, which developed the vaccine with AstraZeneca, said on Tuesday that it had suspended a two-month-old vaccine trial in children and adolescents in the UK, while it is awaiting regulatory guidance.
Emerging concerns threaten to ripple across the globe and cloud the global rollout of a cheap and easy-to-store vaccine, which is the best hope for saving lives in the midst of a wide surge in coronovirus cases in many countries. At least 94 countries of varying income levels have administered doses.
Most scientists and health officials say the benefits of the vaccine are still far outweighed by the risk in older people, who appear less susceptible to clotting. Several dozen cases of blood clots, mostly among young people, have been reported among the millions who have received the vaccine in Europe.
But more countries may restrict the use of the vaccine in young people, setting back efforts to vaccinate enough people to reopen struggling economies. The European Medicines Agency said it would consider meeting this week to update its guidance.
That agency and the World Health Organization have stated that no causal link between the vaccine and the clots was proved and it was suggested that suspending the shot could save more lives.
Regulator in Britain, where shot is the backbone of the country Early vaccination program, It has also stressed that the benefits of the vaccine have overcome the risks. He and the company cited a lack of evidence in the UK that tiring events were more common than people who had never been given the AstraZeneca vaccine.
But the evidence changed last week when Britain reported 30 cases of rare blood clots, up from 25 previously. This week, a prominent scientific adviser to the British government said there was “growing evidence” of clots associated with the vaccine.
AstraZeneca made no comment on Tuesday.
However, news reports indicated that British regulators were considering updating their guidance on its use in young people, who are considered more susceptible to side effects.
“No vaccine, no drug, is risk-free,” said Neil Ferguson, a government scientific advisor, Neil Ferguson, an epidemiologist at Imperial College London. He said that British regulators were “urgently considering the matter”.
For the AstraZeneca vaccine, the latest concerns have added a new chapter in Europe. In Germany, health officials initially broke up with European regulators in mid-February and recommended that the shot be given only to adults under 65, citing insufficient clinical trial data on its effectiveness in older people Give. As a result, the first Germans to be vaccinated were medical workers and teachers, many of them women.
This may be one reason that potential side effects soon appeared in Germany and elsewhere in Europe, but also in Britain, where the vaccine was first applied to older people and more recently to younger people.
On 15 March, Germany’s health minister announced that the country was suspending the use of the shot on blood clotting issues. Health officials reversed the course after European regulators determined that the risk was so low that it would be more dangerous to stop the vaccine.
Last week, Germany flopped again, recommending that no one under 60 be vaccinated. Since then, the Netherlands has followed suit. Other countries such as France and Canada have also suspended the use of the vaccine in fewer people. Norway and Denmark have put a total stop on the shot while they investigate.
Considered more common in young women, the case is an uncommon condition in which clots are associated with abnormally low levels of platelets, a disorder that can lead to bleeding.
The vaccine causes an immune response, activating them in which antibodies bind to platelets, a German physician, Andreas Greincher, who leads an investigation at Greifswald University, said at a press conference on Wednesday.
Those platelets were, in turn, triggering the formation of dangerous clots in parts of the body, including veins draining blood from the brain, leading to a rare type of stroke in some cases.
Why the vaccine was giving rise to antibodies was unclear. He said that there is no evidence that pre-existing conditions had dealt with some people for side effects.
“We can clearly say that thrombosis complications are associated with these antibodies,” Dr. Greenachar said referring to the clot.
Doctors and health officials appeared more confident that the blood clots were an actual, though still unclear, response to the AstraZeneca vaccine by very few people.
European regulators were analyzing 44 cases of rare clots in the brain, 14 of which were fatal, with 9.2 million people vaccinated throughout Europe. For people under 60, which accounts in most cases, which translates into a risk of one in 100,000, said Emer Cook, director of the European Medicine Agency.
in Britain, Regulators reported 30 cases of rare blood clots Between 18 million people were given the AstraZeneca vaccine together with fewer platelets. About one case translated into 600,000 recipients of the vaccine.
European countries have different approaches to the vaccine stem from various factors, including vaccine supply and epidemic severity. European Medicine Agency official Marco Cavalleri, who spoke about the link between the vaccine and blood clots, said on Tuesday that those factors would likely remain how countries use the shot.
Scientists said that beyond those factors, countries adopted very different methods for managing risk. Countries that continued to use the shot were more focused on securing the overall health of their citizens. Others were more vigilant with reducing risk for any one person.
“The outlook is more here, ‘get me out of the epidemic,'” said Penny Ward, Visiting Professor in Pharmaceutical Medicine at King’s College London, referring to the British approach. In continental Europe, she said, “there is a great emphasis on personal safety in the population.”
Adriano Mannino, a philosopher at the University of Munich and director of the Solan Center for Policy Innovation in Germany, said that while the collective benefits of the vaccine in Britain were dominating thinking, the Germans were more concerned with the risk of being personally mistaken for injections. Cases. Reflects, partly, the history of Germany with the Nazis, who carried out deadly experiments on the people.
“In many areas where the law has to regulate morally fragile and potentially dangerous things,” he said, “the German state has known for strict restrictions.”
Nevertheless, Germans older than 60 – still being given the AstraZeneca vaccine – have flooded hotlines for book appointments and stood in line for hours in recent days as eligibility restrictions for their age group Was relaxed.
In the northeastern city of Wismar, several hundred people waited for five hours of driving wind and a mixture of rain and snow to receive shots on Tuesday.
“I want there to be better weather,” KRSTIN Weiss, a district official in the Northeast region, told public broadcaster NDR. “But honestly, it’s a sign that people are ready to vaccinate with AstraZeneca.”
Benjamin Muller reported from London and Melissa Eddy from Berlin. Monica Pronczuk and Emma Bubola contributed reporting.