The European Medicines Agency (EMA) has deemed AstraZeneca’s Covid-19 vaccine “safe and effective” after an extensive review of possible blood clot risks, the agency’s chief said on Thursday.
Blood clot reports from several countries prompted governments around the world to halt inoculations with the AstraZeneca jab. This slowed down already sluggish inoculation campaigns in the European Union.
The EMA, which had approved the jab in January, launched a review of the risks.
“The committee has come to a clear scientific conclusion,” the agency’s chief Emer Cooke said when presenting the findings.
“This is a safe and effective vaccine. Its benefits in protecting people from Covid-19, with the associated risks of death and hospitalization, outweigh the possible risks,” Cooke said.
The agency’s committee concluded that the vaccine was not associated with an increase in the overall risk of thromboembolic events or blood clots. “When you vaccinate millions of people, it’s inveitable that rare or serious incidences or illnesses will occur in the time immediately following vaccination,” she said.
However, the agency could not definitively rule out a link between cases of rare, very serious clotting disorders and the vaccine, and said it launched additional investigations to understand the issue.
The EMA therefore recommended issuing warnings by including the risks in the product information.
The World Health Organization has also recommended the continued use of the vaccine.
These assessments now clear the way for countries to take up their AstraZeneca vaccine campaigns again. Before the announcement of the results, some governments indicated that they would follow the EMA’s advice.
But while AstraZeneca’s jab received backing from the EU medicines agency, the company itself remains at loggerheads with the European Commission.
The commission – the bloc’s executive body – announced earlier on Thursday that it is preparing a formal letter to the pharmaceutical giant amid delivery delays, taking a first step in a dispute resolution process.
“We have the intention to send a letter to AstraZeneca, a letter that will permit us to engage in a dialogue with the company in the framework of a dispute resolution process,” commission spokesperson Eric Mamer told reporters.
The EU countries would still have to give their input to the letter, he said.
Within 20 days of notice, the chiefs of both sides – the company and the commission – would have to meet “and attempt to resolve the dispute by good-faith negotiations,” according to their agreement.
The commission maintains that AstraZeneca under-delivered on its promises, while the company argues that the contract only stipulates it has to make the best possible effort to deliver on envisaged doses. According to European Commission President Ursula von der Leyen, the company would only deliver 70 million of a promised 180 million doses in the second quarter of the year.
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