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France, Germany, Spain and Italy joined several other European countries in temporarily halting use of the Oxford-AstraZeneca Covid-19 vaccine on Monday, fearing the injections could be linked to an increased risk of blood clots. But experts say no causal link has been identified so far, and they have warned that the suspensions could end up doing more harm than good.
A growing number of European countries have chosen to suspend vaccine deployment after reporting that a small number of patients have developed blood clots after receiving at least one dose.
The World Health Organization said Monday that “there is no evidence that the incidents are caused by the vaccine,” and advised that vaccination campaigns continue while the clotting problems are investigated. Several experts have agreed that without a heavier burden of proof, the suspensions could ultimately lead to future outbreaks – especially because they come at a precarious time for Europe in the pandemic.
“There is still a lot of Covid in Europe, so given that this is a public health emergency, you would need to see a strong enough signal in the data to suspend a vaccination program,” said Michael Head, Senior Global Health Researcher. at the University of Southampton in the UK. “If we have this fear and there is nothing there, will there be more cases and deaths from Covid-19 due to delays in the deployment of the vaccine? Will it increase hesitation about vaccines? “
Head said that while any potential side effects from the vaccine are to be thoroughly investigated, decisions to stop vaccination campaigns must strike a delicate balance between risks and benefits. At the moment, he said, there is no data to suggest that AstraZeneca injections are linked to blood clots.
“I don’t see a strong enough signal to justify withdrawing the vaccine from national deployments,” Head said. “Given that there are still a lot of Covids in Europe and the urgency of the situation, I don’t know why the vaccination programs are being suspended.”
Blood clots are dangerous because they can block blood vessels and cause breathing problems, heart attacks, and strokes. Blood clots can damage organs such as the heart and brain and, depending on their size and location, can be fatal.
German Health Minister Jens Spahn said on Monday the decision to suspend the AstraZeneca vaccine came from the Paul Ehrlich Institute, the country’s vaccine regulatory body, and was based on new reports of blood clots linked vaccine in Germany and Europe. The institute recommended further study of seven cases of thrombosis, or blood clots, in the brain that were detected in people who were vaccinated. In Germany, 1.6 million people have received the AstraZeneca vaccine.
Spahn said the decision to suspend use of the vaccine was “purely preventive.”
Denmark was the first country to halt the AstraZeneca campaign rollout last week after one person developed multiple clots and died 10 days after receiving at least one dose of the vaccine.
Since then, several other countries have added their own suspensions, including Norway, Iceland, the Netherlands, the Democratic Republic of the Congo and Indonesia.
The European Medicines Agency, the continent’s main pharmaceutical regulator, said on Monday that a “rigorous analysis of all data” is underway but added that the reported cases of blood clots in those vaccinated “do not appear to be over. higher than those observed in the general population. “
One serious type of clotting event cited by the German Ministry of Health was cerebral venous thrombosis, a rare stroke caused by blood clots in the brain. Cerebral venous thrombosis affects five in 1 million people each year, according to Johns Hopkins University. In the United States, up to 100,000 people die each year from blood clots such as deep vein thrombosis and pulmonary embolism, according to the Centers for Disease Control and Prevention.
The agency also highlighted the important role the vaccine plays in preventing serious illnesses caused by Covid-19.
“While its investigation is ongoing, the EMA currently remains of the view that the benefits of the AstraZeneca vaccine in preventing Covid-19, with its associated risk of hospitalization and death, outweigh the risks of side effects, “agency officials said in a statement.
The European Medicines Agency said it would meet on Thursday to assess the results of its investigation and decide whether further action is needed.
In a statement released on Sunday, AstraZeneca said there was nothing in the company’s safety data to indicate that the vaccine was associated with an increased risk of blood clots. The drugmaker said there have been 37 reported cases of blood clots in more than 17 million people vaccinated in the European Union and the UK. Fifteen of the reported cases were from deep vein thrombosis and 22 were from pulmonary embolism, according to AstraZeneca.
“This is much lower than one would naturally expect in a general population of this size and is similar for other licensed COVID-19 vaccines,” the company said in its statement.
Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said that with so many doses of the AstraZeneca vaccine already given, scientists should be able to see signs of rare side effects if they occur. . In the UK, for example, around 11 million doses of the AstraZeneca vaccine have been administered, out of the 20 million people vaccinated in the country.
“With the number of people vaccinated in the UK, we are going to be able to detect rare things – on the order of 1 in 100,000,” he said.
Evans said the suspensions appear premature, especially without more information on incidents of blood clotting disorders. Blood clots are, for example, a complication of Covid-19, he said.
“We need to make sure that these cases have not occurred in people with undiagnosed Covid, as people with Covid-19 are at increased risk of thrombosis,” Evans said.
And if safety is to be paramount, Evans said that one of the consequences of stopping vaccine deployment before adequate data becomes available is that it could contribute to vaccine reluctance.
“I think it will hurt confidence in the AstraZeneca vaccine whether it is justified or not,” Evans said. “And that will hurt confidence in Covid vaccines in general, and the vaccines themselves in general.”
Head was also concerned about the effect these actions might have on vaccination campaigns across Europe, adding that not all the information that has been made public so far does not justify the suspension of use of the vaccine.
“This is all a little worrying,” he said, “and it can cause more harm than stopping.”
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