The European Medicines Agency (EMA) concluded that the AstraZeneca COVID vaccine is “safe and effective” after its safety review of the vaccine after reports of blood clots in some people vaccinated.
“We still cannot rule out definitively a link between these cases and the vaccine,” qualified EMA chief Emer Cooke at a press conference. The safety committee said that they had
The opinion of the EMA is hotly anticipated at a time when the European Union, in the midst of a vaccine shortage, is counting on millions of doses of this vaccine developed by British-Swedish firm AstraZeneca.
A number of European Union countries including Germany, Italy and France have chosen to suspend their rollouts of the shot over unconfirmed reports of an increased rate of blood clots among recipients.
So far, the EMA and World Health Organization have said there is no evidence the vaccine is to blame.
Head of EMA Emer Cook said on Tuesday that the regulator remained “firmly convinced” the benefit of continuing to use the AstraZeneca COVID-19 vaccine outweighed the risks.
Cooke said this was 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 these, to make sure that any suspected adverse reactions are rapidly investigated so we can figure out, is this a real side effect to the vaccine or is it a coincidence,” she said.
The EMA could also issue an “additional warning” for the use of the vaccine, Cooke said.
EU countries seek quick thaw
Even before Thursday’s announcement by Europe’s watchdog, 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 the vaccines,” Ursula von der Leyen said.
Almost as soon as France’s president froze the vaccinations Monday, top French officials started worrying about the impact on public opinion in a country where many already viewed the AstraZeneca vaccine as second-class.
The government now hopes to announce resumed vaccinations as soon as Thursday.
French Prime Minister Jean Castex, who at 55 and with no known underlying health problems is not yet eligible for vaccination, said on national television Tuesday night that “it would be wise that I get vaccinated very quickly, as soon as the suspension is, I hope, lifted.”
Castex said he wants to demonstrate to his fellow citizens “that vaccination is the exit door from this crisis.”
Italy is toeing a similar line. Health Minister Roberto Speranza says European countries are hoping that the EMA on Thursday will deliver “the clarifications and reassurances necessary” to be able to resume administering the AstraZeneca vaccine “without hesitation.”
In Germany, where eight cases of blood clots are under investigation, officials defended the decision to suspend vaccinations pending further investigation, but appeared ready to resume them soon. Health Ministry spokesman Hanno Kautz said, “It’s clear that the EMA decision is binding, and of course we will follow the EMA decision too.”
Lithuania’s president criticised its health minister’s decision to suspend the shots, saying it causes “enormous damage to the entire vaccination process.”
Amós García, president of the Spanish Vaccinology Association, said it will be difficult for governments to rebuild trust in the overall coronavirus vaccination programme, no matter what the EMA announces.
“The problem when a vaccine is put in doubt is not that it affects that vaccine, but that it affects the whole vaccination world,” he said.
“Possibly there has been an excess of zeal” among governments like Spain’s that suspended vaccinations, he said. But he praised Europe’s vaccine surveillance systems for quickly identifying and investigating the blood clot issues. Spain is examining three such cases.
Spanish Health Minister Carolina Darias defended the decision to put a hold on the AstraZeneca vaccine, saying it is necessary to “continue building confidence” in efforts to fight COVID-19.