France, Germany, Spain and Italy have joined several other European countries to temporarily suspend the use of the Oxford-AstraZeneca Covid-19 vaccine over concerns that the shots are associated with an increased risk of blood clots. But experts say so far no causal link has been identified, and they warn that the suspensions could do more harm than good.
A growing number of European countries have decided to suspend vaccination of the vaccine after reports that a small number of patients had blood clots after receiving at least one dose.
The World Health Organization said on Monday: “There is no evidence that the incidents are caused by the vaccine”, and advised that vaccination campaigns should continue while the clotting problems are investigated. Several experts agreed that the suspensions without a greater burden of proof could eventually provoke future outbreaks – especially as it comes at a difficult time for Europe in the pandemic.
“There is still a lot of Covid in Europe, so since it is a public health emergency, you will need to see a pretty strong signal in the data to suspend a vaccination program,” said Michael Head, a senior research fellow. in global health, said. at the University of Southampton in the United Kingdom. “If we are so scared and there is nothing, will there be more cases and deaths due to Covid-19 due to delays in the deployment of the vaccine? Will it increase the hesitation of the vaccine?”
Head said all of the possible side effects of vaccines should be thoroughly investigated, decisions to stop vaccinations should find a fine balance between risks and benefits. At present, there is no information to suggest that AstraZeneca shots were linked to blood clots.
“I can not see a strong enough signal to withdraw the vaccine from the national implementation,” Head said. “Since there is still a lot of Covid in Europe and the state of emergency is in the situation, I do not know why the vaccination programs are being suspended.”
Blood clots are dangerous because they can clog blood vessels and cause breathing problems, heart attacks and strokes. Blood clots can damage organs such as the heart and brain, and can be fatal depending on their size and location.
German Health Minister Jens Spahn said on Monday that the decision to suspend the AstraZeneca vaccine came from the Paul Ehrlich Institute, the country’s vaccine regulator, and was based on new reports of blood clots related to the vaccine in Germany and Europe. The institute recommended that further investigation be conducted into seven cases of thrombosis, or blood clots, in the brain detected in people who have been vaccinated. In Germany, 1.6 million people received the AstraZeneca vaccine.
Spahn said the decision to suspend the use of the vaccine was’ merely ‘precautionary’.
Denmark was the first country to suspend the launch of the AstraZeneca campaign last week after one person had multiple blood clots and died ten 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 Congo and Indonesia.
The European Medicines Agency, the main drug regulator on the continent, said on Monday that a “careful analysis of all the data” was under way, but added that the incidence of blood clots in vaccinated people did not appear to be higher than in the general population. . “
One serious type of clotting event cited by the German Ministry of Health was cerebral arterial thrombosis, a rare stroke caused by blood clots in the brain. According to Johns Hopkins University, cerebral arterial thrombosis affects five million people every year. According to the Centers for Disease Control and Prevention, up to 100,000 people in the United States die each year from blood clots such as deep vein thrombosis and pulmonary embolism.
The agency also emphasized the important role that the vaccine plays in preventing serious diseases of Covid-19.
“While the investigation is ongoing, the EMA currently considers that the benefits of the AstraZeneca vaccine to prevent Covid-19, with the associated risk of hospitalization and death, outweigh the risks of side effects,” said agency officials 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 was needed.
In a statement released on Sunday, AstraZeneca said there was no indication in the company’s safety data that the vaccine was associated with an increased risk of blood clots. According to the drugmaker, there were 37 cases of blood clots in more than 17 million people vaccinated in the European Union and in the United Kingdom. According to AstraZeneca, fifteen of the reported cases are deep vein thrombosis and 22 pulmonary embolisms.
“It is much lower than would naturally be expected in a general population of this size and is similar to other licensed COVID-19 vaccines,” the company said in a statement.
Stephen Evans, a professor of pharmaco-epidemiology at the London School of Hygiene & Tropical Medicine, said scientists with as many doses of the AstraZeneca vaccine should already be able to be administered if it occurs. In the UK, for example, about 11 million doses of the AstraZeneca vaccine have been administered, among the 20 million people vaccinated in the country.
“With the number of people being vaccinated in the UK, we will be able to detect scarce things – on the order of 1 in 100,000 people,” he said.
Evans said the suspensions appear premature, especially without further information on the incidents of blood clotting disorders. Blood clots, for example, are a complication of Covid-19, he said.
“We need to be sure that these cases did not occur in people with undiagnosed Covid, because people with Covid-19 have an increased risk of thrombosis,” Evans said.
And while safety should be paramount, Evans said one of the consequences of stopping the deployment of a vaccine before sufficient information is available is that it could contribute to the vaccine’s hesitation.
“I think it will hurt confidence in the AstraZeneca vaccine, whether it is justified or not,” Evans said. “And it will damage confidence in Covid vaccines in general and vaccinations themselves in general.”
Head was also concerned about the impact this action could have on vaccinations in Europe, adding that all the information released so far does not justify suspending the use of the vaccine.
“It’s all a little worrying,” he said, “and it can do more harm than good.”