France has said only people aged 55 and over should receive the AstraZeneca Covid-19 vaccine, and three Scandinavian countries have reserved judgment until next week, a day after Europe’s health regulator declared the shot safe and effective for all age groups.
As politicians launched an urgent effort to convince citizens of the vaccine’s safety, the French health regulator said the shot’s use should resume “without delay”. France was among more than a dozen EU states to suspend the shot this week.
But Dominique Le Guludec, the head of the regulator, said it should be provisionally reserved for people aged 55 and over until further information was available, on the basis of rare but serious cases of a brain blood clot disorder known as cerebral venous sinus thrombosis (CVST).
Le Guludec said 25 people who had received the AstraZeneca shot had fallen ill with the disorder in Europe, and nine aged under 55, most of them women, had died. The cases needed further investigation, she said.
Norway, whose expert panel said on Thursday it was “convinced” of a link between the shot and the rare brain blood clots, Sweden, which reported one death from clotting and heavy bleeding, and Denmark said they needed more time before making a decision. Finland said it was suspending the use of the jab while it investigates two possible cases of blood clots.
Italy has said people who decline the AstraZeneca vaccine will be given an alternative later on, with the government reportedly devising an advertising campaign featuring high-profile people, including the footballer Francesco Totti, to encourage take-up.
The continuing hesitancy around the Oxford/AstraZeneca shot, given to 11 million people in the UK and 7 million elsewhere in Europe, comes after several European countries initially said it should be used only on people under 65 because of a lack of trial data.
France was joined by Germany, Spain, Italy, the Netherlands, Portugal, Lithuania, Latvia, Slovenia and others on Thursday in announcing early resumptions after three-day suspensions, which authorities said had been decided on out of an abundance of caution and to retain trust. Ireland said on Friday it planned to resume using the jab in the coming days.
Many experts fear the suspensions may have the opposite effect, undermining public confidence in the shot, further delaying the continent’s already sluggish vaccine programme and, with multiple countries now entering a third wave of the pandemic, costing lives.
National vaccination campaigns in the EU lag far behind those in Britain and the US, dogged by supply shortages and slower implementation. According to Our World in Data, the UK has delivered nearly 40 shots for every 100 people, the US 34 and the EU 12.
The EMA on Thursday echoed the UK regulator, MHRA, in saying it had reached a “clear scientific conclusion” that the benefits of the AstraZeneca shot far outweighed the risks. But while they found the shot was not associated with an increase in the overall risk of blood clots, the agencies said a link between the rare clotting disorder and the vaccine could not be definitively ruled out.
They will update their guidance on the AstraZeneca vaccine to include an explanation for patients about the rare potential risks alongside information for healthcare professionals to help them prevent and mitigate possible side-effects.
On Friday the World Health Organization’s vaccine safety panel said data it had reviewed did not point to any overall increase in clotting conditions but it would continue to monitor its effects.
Germany’s health minister, Jens Spahn, said it had been right to pause the shot “until the clustering of this very rare type of thrombosis had been examined” and France’s Europe minister, Clément Beaune, said it had been “necessary in order to coordinate and remove the doubts”.
But some health experts worry the AstraZeneca suspensions may have done lasting harm. “Stopping the AstraZeneca maximises the damage to its image that has plagued the German vaccination strategy from the beginning,” said Ulrich Weigeldt, of the German association of general practitioners.
One poll in France this week suggested confidence in the AstraZeneca shot had fallen to 20%. Enrico Bucci, an Italian biologist and scientific data analyst, said the pause was an “unrepairable communications disaster”. The EMA had never recommended halting vaccinations, he noted: “Governments made political and emotional decisions”.
There are also fears that the European suspensions of the AstraZeneca shot, which is among the cheapest Covid vaccines available and easier to store and transport than some others, would harm its rollout in developing countries, where it will be vital.
“Unfortunate events” in Europe would “clearly not be helpful … in building public confidence on the use of that particular vaccine and other vaccines, for sure,” said John Nkengasong, the director of the Africa Centers for Disease Control and Prevention.
The WHO’s director general Tedros Adhanom Ghebreyesus exhorted the world on Friday to keep administering the jab, telling reporters that it was especially important because it accounts for more than 90% of the vaccines being distributed through Covax, the WHO-led global vaccine-sharing scheme.
The episode has highlighted a generally more cautious approach to the benefit-risk calculation on the continent. Germany’s health ministry said explicitly it risked facing legal consequences if it failed to follow its national health agency’s advice.
“Exercising precaution is one way in which policymakers manage risk, and it’s more prevalent in European countries than the US or UK where the emphasis is more on weighing risks and benefits,” said Stephan Lewandowsky, a cognitive psychologist at the University of Bristol, who described it as “a difficult issue”.
He suggested that since the European public was generally more risk averse, the suspension and careful examination of the AstraZeneca shot “may help maintain public trust in the vaccination process, even though it may also mean that more people will get sick from Covid-19 than if vaccinations had continued.”