The EU drug regulator reiterated its position that the benefits of the Oxford / AstraZeneca vaccine outweighed its risks, as it turned out that France, Germany, Italy and Spain had coordinated their decision to temporarily suspend the shot.
Agnès Pannier-Runacher, France’s industry minister, said the countries have acted jointly to help protect public confidence. But later on Tuesday, Emer Cooke, head of the European Medicines Agency, said there was still no evidence of a link between the injection and the reported incidents of blood clots, as she confirmed that the EMA is continuing the investigation.
“We are concerned that there may be an effect on trust [in] the vaccines, but our job is to make sure that the products we have authorized are safe and can be trusted by European citizens, ”she said.
The comments came after at least 16 European countries suspended or restricted use of the injection due to concerns about potential side effects.
“We still firmly believe the benefits[of the vaccine]Outweigh the risk of these side effects, ”said Cooke. The drug regulator assessed 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 last European country to take action on Tuesday after insisting for days that the shot was safe to use. No cases of serious blood clots have been reported in Sweden. But neighboring Norway and Denmark have each reported one death, with authorities in both countries concerned about the unusual combination of blood clots and low platelet counts in younger, seemingly healthy people who received the vaccine.
Spain and Germany have also raised concerns about rare adverse events. In a statement on Tuesday, the German Ministry of Health said it had registered three new cases of cerebral venous thrombosis (CVT) since Friday, bringing the total to seven cases, including three deaths, out of a total of 1.6 million AstraZeneca. vaccinations so far.
Seven cases of CVT were “above average,” said the Ministry of Health, adding that normally between 1 and 1.4 cases are expected in that population in the 14 days after vaccination and that mostly young people and especially young women were hit. “This disease is so serious that it would not be responsible to continue to vaccinate without testing,” he said.
In a sign of coordination between European capitals, Italian Prime Minister Mario Draghi and German Chancellor Angela Merkel spoke Monday afternoon before Italy announced its own suspension of the vaccine, people familiar with the matter said. Italy had previously discontinued use of a single batch of the vaccine, ABV 2856, but continued to inject other injections.
Pannier-Runacher said the French government had also coordinated its decision. “You can imagine we spoke to Italy, we spoke to Spain, we spoke to Germany and it is no coincidence that these four countries announced the same decision on the same day,” she told France Info radio.
“When you see decisions being made in other countries, there is a risk of mistrust in the vaccine,” said Pannier-Runacher. “Our intention is to be perfectly transparent [show] that whenever there is a warning, we handle it as professionally as possible. “
As part of its investigation, the EMA said it was investigating whether manufacturing defects in specific batches could explain the reported health problems. Given the number of events identified across Europe, this was unlikely to be a batch-specific occurrence, Cooke cautioned. “But we cannot rule it out.” The EMA is expected to report further findings on Thursday.
AstraZeneca has defended the safety and efficacy of its vaccine. Ann Taylor, the company’s chief medical officer, said on Sunday that about 17 million people in the EU and the UK had been injected, with blood clot cases “lower than the hundreds of cases expected in the general population.”
“The nature of the pandemic has led to increased attention in individual cases and we are going beyond standard safety monitoring practices of approved drugs when reporting vaccination events to ensure public safety,” said Taylor.
Ursula von der Leyen, President of the European Commission, announced on Tuesday that BioNTech / Pfizer would bring forward some deliveries and provide the block with an additional dose of 10 million in the second quarter as the EU appeared to be moving to support other supplies .
Additional reporting by Guy Chazan in Berlin and Daniel Dombey in Madrid