“The AstraZeneca vaccine is safe, effective and the benefits outweigh the risks” as reiterated by the European Medicines Agency EMA, which sees no links to blood clot problems. The agency’s risk assessment committee in an extraordinary meeting has reached the same conclusion as during its first assessment. The only change for the EMA would be that the risk of blood clots should be included in the vaccine insert because it also recognizes that there have been rare cases of clots combined with platelet loss and bleeding.
The agency has explained that they will continue to investigate these thrombus events that, it repeats, are less frequent than those observed in the general population and recalls that the coronavirus itself is capable of causing circulation problems of this type.
The EMA explains that these cases have occurred more frequently in young women, while the United Kingdom has used it often in older people, although it also recalls that it is too early to draw conclusions.
The announcement took place at a press conference that has generated unusual expectations for the until recently discreet regulatory body.
The EMA’s ruling was highly anticipated at a time when the European Union, in the midst of a vaccine shortage, is storing millions of doses of this vaccine developed by the British-Swedish company AstraZeneca that could have ended up in the trash.
Several European Union countries, including Germany, Italy and France, have chosen to suspend distribution of the vaccine due to unconfirmed reports of an increased rate of blood clots among patients who received the vaccine.
Others have stopped only the distribution of a suspicious batch, the now famous ABV2856.
So far, the EMA and the World Health Organization have said there is no proof that the vaccine is the culprit.
EMA Director Emer Cook said Tuesday that the regulatory body remained “firmly convinced” that the benefits of continuing to use AstraZeneca’s COVID-19 vaccine outweighed the risks.
Cooke said this is not an “unexpected” situation when millions of people are being vaccinated and thousands develop blood clots each year.
“Our role at the EMA is to evaluate them, to make sure that any suspected adverse reaction is quickly investigated so that we can find out if it is a real side effect of the vaccine or a coincidence,” he said.
The EMA could also issue an “additional warning” for the use of the vaccine, Cooke said, as has ultimately been the case.
It now remains to be seen whether European governments that rushed to suspend vaccination are so quick to resume it after the agency’s verdict.
EU countries are looking for a quick unlock
Even before the European watchdog’s announcement on Thursday, the president of the European Commission made it clear that the AstraZeneca vaccine will remain a pillar of the EU’s vaccine strategy.
“I trust AstraZeneca, I trust vaccines,” said Ursula von der Leyen.
Almost as soon as the French president froze the vaccines on Monday, French health officials and politicians began to worry about the impact on public opinion in a country where many already considered the AstraZeneca vaccine second-class.
The government now expects to announce the resumption of vaccinations as early as Thursday.
French Prime Minister Jean Castex, who at 55 and with no known underlying health problems is still unable to get vaccinated, said on national television Tuesday night that “it would be prudent for me to get vaccinated very quickly, as soon as the suspension be, I hope, raised “.
Castex said he wants to show his fellow citizens “that vaccination is the way out of this crisis.” Shortly before President Emmanuel Macron announced the suspension, Castex had defended the AstraZeneca vaccine, causing some confusion in opinion.
Italy follows a similar line. The Minister of Health, Roberto Speranza, affirms that the European countries hope that the EMA will offer on Thursday “the necessary clarifications and guarantees” to be able to resume the administration of the AstraZeneca vaccine “without hesitation”.
In Germany, where eight cases of blood clots are being investigated, authorities defended the decision to suspend vaccinations pending further investigation, but appeared ready to resume them soon. Health Ministry spokesman Hanno Kautz said: “It is clear that the EMA decision is binding and of course we will also follow it.”
Lithuania’s president criticized his Health Minister’s decision to suspend vaccines, saying it causes “enormous damage to the entire vaccination process.”
Amós García, president of the Spanish Vaccination Association, said that it will be difficult for governments to regain confidence in the general vaccination program against the coronavirus, regardless of what the EMA announces.
“The problem when a vaccine is questioned is not that it affects that vaccine, but that it affects the entire vaccination world,” he said.
“Possibly there has been an excess of zeal” among governments that, like Spain, suspended vaccinations, he said. But he praised European vaccine surveillance systems for quickly identifying and investigating blood clot problems. Spain is examining three such cases.
The Spanish Minister of Health, Carolina Darias, defended the decision to suspend the AstraZeneca vaccine, stating that it is necessary to “continue building confidence” in the efforts to fight COVID-19.