France, Germany, Italy and Spain co-ordinated their decision to temporarily suspend the Oxford/AstraZeneca Covid-19 vaccine, a senior minister said, as the EU drugs regulator reiterated its view that the benefits of the jab outweighed the risks.
Agnès Pannier-Runacher, France’s industry minister, said the countries acted in an effort to help protect public confidence. Speaking hours later, Emer Cooke, head of the European Medicines Agency, said: “We are worried that there may be an effect on the trust [in] the vaccines, but our job is to make sure the products that we authorised are safe and can be trusted by the European citizens.”
The comments came after at least 16 European countries suspended or limited use of the jab because of concerns about possible side-effects, sparked by reported incidents of blood clots.
The EMA is conducting a probe into a series of serious reported events, some fatal, but Cooke reaffirmed the stance the agency had taken in recent days. “We are still firmly convinced that the benefits [of the vaccine] . . . outweigh the risk of these side-effects,” she said. “Thousands of people are dying [of Covid-19] across the EU every day.”
The drugs regulator is reviewing the events on a “case-by-case” basis. “But it needs a scientific evaluation, we need to have the facts first,” she added.
Following the wave of national suspensions, Pannier-Runacher told France Info radio on Tuesday: “You can imagine that we spoke with Italy, we spoke with Spain, we spoke with Germany and it’s no coincidence if these four countries, on the same day, announced the same decision.”
Sweden became the latest European country to take action on Tuesday after days of insisting the shot was safe to use. “There is good knowledge about this vaccine, but it is still important that we pause the vaccination until the EMA has investigated whether these events could be linked to the jabs,” said state epidemiologist Anders Tegnell.
No cases of severe blood clots have been reported in Sweden. But neighbouring Norway and Denmark have each reported one death, with authorities in both countries worried about the unusual combination of blood clots and low platelet counts in younger, seemingly healthy people who had received the vaccine. Spanish and German authorities have also expressed concern over the rare adverse-event combination.
In a sign of the co-ordination between some European capitals, Italian prime minister Mario Draghi and German chancellor Angela Merkel spoke on Monday afternoon before Italy announced its own suspension of the vaccine, people familiar with the matter said. Italy had previously halted the use of a single batch of the vaccine, ABV 2856, but allowed other injections to continue.
“It is important that there is not distrust in the population,” said France’s Pannier-Runacher. “If you see decisions being made in other countries, the risk is that a mistrust of the vaccine could develop. Our intention is to be perfectly transparent . . . and [show] that every time that there is an alert, we treat it as professionally as possible.”
Ursula von der Leyen, European Commission president, announced on Tuesday that BioNTech/Pfizer would bring forward some deliveries and provide the bloc with an extra 10m doses in the second quarter, as the EU appeared to be moving to shore up other supplies.
AstraZeneca has defended the safety and efficacy of its vaccine. Ann Taylor, the company’s chief medical officer, said on Sunday that about 17m people in the EU and the UK had received the jab, with cases of blood clots “lower than the hundreds of cases that would be expected among the general population”.
“The nature of the pandemic has led to increased attention in individual cases and we are going beyond the standard practices for safety monitoring of licensed medicines in reporting vaccine events, to ensure public safety,” Taylor said.
The EMA is expected to report further findings on Thursday at the latest. The World Health Organization, which has also stressed the vaccine is safe to use, is conducting its own review of whether any causal links exist between the shot and the serious adverse events.
Additional reporting by Daniel Dombey in Madrid