The EU drugs regulator reiterated its view that the benefits of the Oxford/AstraZeneca vaccine outweighed the risks, as it emerged that France, Germany, Italy and Spain had co-ordinated their decision to temporarily suspend the jab.
Agnès Pannier-Runacher, France’s industry minister, said the countries acted in a joint effort to help protect public confidence. But speaking later on Tuesday, Emer Cooke, head of the European Medicines Agency, said there was still no evidence of a link between the shot and the reported incidents of blood clots, as she confirmed the EMA was continuing to investigate.
“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,” she added.
The comments came after at least 16 European countries suspended or limited use of the jab because of concerns about possible side-effects.
“We are still firmly convinced that the benefits [of the vaccine] . . . outweigh the risk of these side-effects,” Cooke said. The drugs regulator was reviewing the events on a “case-by-case” basis. “But it needs a scientific evaluation. We need to have the facts first,” she added.
Sweden was the latest European country to take action on Tuesday after days of insisting the shot was safe to use. 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.
Spain and Germany have also expressed concern over rare adverse events. In a statement on Tuesday, Germany’s health ministry said it had recorded three new cases of cerebral venous thrombosis (CVT) since Friday, bringing the total to seven cases, including three deaths, out of 1.6m AstraZeneca vaccinations so far.
Seven cases of CVT was “above average”, the health ministry said, adding that between 1 and 1.4 cases would normally be expected in that population in the 14 days after vaccination and that young people and especially young women were particularly affected. “This illness is so serious . . . that it would not be responsible to continue vaccinating without an investigation,” it added.
In a sign of the co-ordination between 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.
Pannier-Runacher said the French government had also co-ordinated its decision. “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,” she told France Info radio.
“If you see decisions being made in other countries, the risk is that a mistrust of the vaccine could develop,” Pannier-Runacher said. “Our intention is to be perfectly transparent . . . and [show] that every time that there is an alert, we treat it as professionally as possible.”
The French Elysée said the pause was needed to maintain public trust but that it hoped the AstraZeneca vaccination campaign would be able to restart after the EMA delivered further findings on Thursday.
As part of its probe, the EMA said it was investigating whether manufacturing defects in specific batches might explain the reported health problems. Given the number of events identified across Europe, it was unlikely that this was a batch-specific occurrence, Cooke cautioned. “But we cannot rule it out.”
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.
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.
Additional reporting by Guy Chazan in Berlin, Daniel Dombey in Madrid and Leila Abboud in Paris