Rome. Days after the safety of the AstraZeneca vaccine was announced, Italian Health Minister Roberto Speranza called his German counterpart on Monday and learned that Germany was “quite concerned” about stopping the use of some serious blood clots in one of the vaccine recipients.
That call could not have been worse for Italy and its neighbors.
Their vaccine withdrawals were already lagging behind due to lack of և they were encouraging people to get the shots that were available. Just days ago, Prime Minister Mario Draghi reassured Italians who had been warned about the AstraZeneca vaccine. “There is no clear evidence, no clear correlation, that these events are related to the use of the vaccine,” he said.
But when Germany ended the pause, pressure was exerted on other governments to do the same so that public opinion would not punish them if they seemed useless in comparison to the united European front.
The German decision caused a domino effect of vaccine deficiency. A cascade of countries – Italy, France and Spain – soon joined the decision to suspend AstraZeneca, dealing a major blow to Europe’s already shaky vaccine engine, despite clear evidence that the vaccine could cause harm.
On Tuesday, the EU’s top drug lord backed down on fears of a shooting, saying there was no sign of causing dangerous problems, that its rescue benefits “outweighed the risk of side effects”. The European Medicines Agency is still investigating the matter, said its chief executive, Emer Cook, adding that “there is no indication that the vaccine has caused these conditions.”
It is becoming increasingly clear that suspensions have as much to do with political considerations as they do with scientific ones.
“There is an emotional upheaval to this incident that started in Germany,” Giorgio Pallio, president of the Italian Drug Agency, said on Tuesday. He said. “There is no danger. At the epidemiological level, there is no correlation. “
The director of the agency was clearer.
“It was a political choice,” director Nicola Magrin told La Repubblica on Monday, adding that Italy had suspended the AstraZeneca vaccine because other European countries had decided to do so.
On Tuesday, some governments were already rewriting their decisions as a step towards gaining confidence in vaccines: sort, regrouping, restless efforts. But for now, the suspensions seem to have had the opposite effect, further delaying Europe’s temptation, perhaps endangering hundreds or thousands of lives.
Analysts say the delays make it extremely difficult for any European country to achieve its goal of vaccinating 70% of its population by September, and put pressure on governments to provide vaccines that have not yet been approved by alliance regulators.
France said in a statement on Tuesday that President Emanuel Macron and Italian Prime Minister Draghi had discussed the decision to discontinue the AstraZeneca vaccine, adding that comments made by European health regulators on Tuesday were “encouraging”.
The suspension of the vaccine is a “temporary warning” as countries await the assessment of the European Medicines Agency, the statement said. “Emanuel Macron և Mario Draghi are ready to resume vaccination campaigns with the AstraZeneca vaccine very soon, if further research by the EMA is positive,” the statement said.
But Monday’s decision could already push back the vaccination campaign in Europe at the height of the epidemic as the continent faces a third wave of infections due to new variants.
Clinical trials of other AstraZeneca: vaccines have been large enough to raise alarms about any common side effects, scientists say. But the rare occurrences were most likely to occur only when mass vaccinations began.
No causal link has been found between the vaccine, blood clots or heavy bleeding, the European Medicines Agency said, adding that the vaccine should be used. Health officials in Europe said on Tuesday that concerns had less to do with less clotting problems than with unusual manifestations, especially at a young age.
But there are worrying problems with the vaccine in Europe.
At first, countries like Austria reported rare but serious cases of blood clots. European regulators, however, say those conditions are no more common in vaccinated people than in any other. And they are more common in older people who have been the target of vaccination campaigns.
As those concerns dissipated, some countries began to report a small number of other, unrelated issues. Patients in Norway with low platelets, receiving a vaccine component of blood clotting. German patients were under the age of 50, raising concerns among health officials.
It is not yet known whether these conditions were related to vaccines.
Some cases of immune thrombocytopenia, a disorder characterized by a lack of platelets, have also been reported in people in the United States who have received the Pfizer or Moderna vaccine.
But whatever it was, the scientists said the disorders were so rare, even in vaccinated people, that continuing to get the vaccine would save the most lives.
“We need to do something that reduces the overall risk burden in the community,” said Naor Bar-Ze, a public health specialist at the Hopkins Bloomberg School of Public Health. “At this stage, it means continuing the vaccination, but making sure we have the available data quickly, very thoroughly, as well as possible analysis.” European countries have not considered the decision on vaccinations. Their concerns are centered on AstraZeneca, a company with which they had a toxic relationship as it drastically reduced its projected supply of vaccines in early 2021.
That spit prompted the EU to tighten rules on the export of those shots and others from factories within the bloc. And it deepened the long-standing mistrust of some European health officials about the vaccine. The alliance was slow to approve the vaccine, waiting a month for Britain to do so.
Even after European regulators allowed it, a number of member states restricted the use of the vaccine at a younger age, citing insufficient clinical trial data on its use in the elderly.
That decision may return to the European legislators. Britain, which has given the vaccine to all adults, has since shown that the first dose significantly reduces the risk of COVID-19 in the elderly.
Just as EU member states broke the bloc’s central regulator by initially restricting the vaccine to younger people, they parted ways with regulators for a second time this week, ending the operation. Analysts say this reflects a growing impatience with the bloc’s bureaucracy amid a catastrophically slow spread of vaccines.
“It has dealt a terrible blow to Europe’s self-confidence, I would say in the international arena,” said Johan Norberg, a Swedish historian who writes about the continent’s epidemic response. “We always have this tendency to retreat from our national policy.”
In recent days, these political considerations have spread across the continent after someone in Austria who was vaccinated with AstraZeneca died of a blood clot. Unnoticed, however, it prompted the country to discontinue the vaccine in early March. Other countries soon followed suit, alerting to any new reports of blood clots, however rare they may be.
In recent days, Spanish Health Minister Carolina Dorians has spoken to her counterparts around the continent, according to a ministry official, who asked not to be named because the discussions were private. A thrombosis case was reported in Spain last weekend, with some regions halting the distribution of AstraZeneca vaccines for safety reasons.
But the main motive was political.
France, too, seems to have succumbed to pressure to act in unison with its powerful neighbors. It relied on the AstraZeneca vaccine to get the vaccine after the glacial launch, և French Health Minister Olivier Veran said just days ago that “there is no reason to stop.”
But after Germany made its intentions clear, Macron made the choice to follow suit or not be a salesman. And so, on Tuesday, Veran changed his tone. France, he told parliament, had to “listen to Europe, listen to all European countries.”
It was something that Speranza, Italy’s health minister, expected to happen after he spoke to his German counterpart after learning about it from an Italian official during a discussion.
When Speranza raised the issue with Prime Minister Draghi, he noted that the unbearable pressure of Italian society could be met if only he could use a vaccine that was considered too dangerous for Europe.
European Union champion Draghin settled in Berlin with Chancellor Angela Merkel and decided to suspend AstraZeneca with Speranza until the European Medicines Agency clarified everything.
As the damage to Tuesday’s delays became clear, European officials sought to mitigate the disruption. They said they were only waiting for European regulators to complete the problems quickly before they could start vaccinating people with AstraZeneca shots.
Italy even claimed that when European regulators made their proposal on Thursday, it would quickly implement the 200,000 vaccines lost due to the suspension, in part, the government said, with the help of the Pfizer vaccine.
For many European scientists, this is a tortured argument, and suspensions are a devastating miscalculation. “It’s the right regulators to study safety signals,” said Michael Head, a senior global health researcher at the University of Southampton. “But stopping the spread of vaccines during an epidemic, when there is a lot of COVID-19 around, makes a pretty drastic decision. I do not see why you are going to do that.”
And for the European Union, which preaches the virtues of staying together throughout the epidemic, even as it slows down their vaccination campaign, the decisions have shown the pitfalls of being blocked.
“It’s a panic attack,” said Natalie Tocchi, director of the Italian Institute of International Affairs and an adviser on EU foreign policy.