Emer Cooke, the Executive Director of the European Medicines Agency (EMA), has confirmed the safety and efficacy of the Covid-19 vaccine produced by the Anglo-Swedish firm AstraZeneca on Thursday 18 March, following a preliminary scientific analysis undertaken by the Pharmacovigilance Risk Assessment Committee (PRAC). However, the Director did not definitely rule out the possibility of a potential risk between receiving the vaccine and the occurrence of serious adverse events.
“The committee has come to a clear scientific conclusion: this is a safe and effective vaccine”, she told a press briefing, adding that the risks of the disease are greater than the risks of inoculating with the vaccine.
As for serious cases of thrombosis concomitant with the vaccine inoculation, the director remained cautious. "Based on the evidence available, and after days of in-depth analysis of lab results, clinical reports, autopsy reports [...] we still cannot rule out definitively a link between these cases and the vaccine”, she said.
The committee therefore recommends raising public awareness of the potential risk, even though it is rare, she said, before indicating that the EMA was launching a series of further investigations intended to shed light on these serious cases.
In its conclusions, the EMA confirmed just how rare these serious thrombosis cases were. Out of 20 million people vaccinated, only 7 cases of blood clots were reported. This situation has led to the suspension of the vaccination in about 15 EU Member States (see EUROPE 12678/6).
As for the Agency, a causal link to the vaccine has not been proven. This is especially true given that, overall, the number of thromboembolic events reported after vaccination is lower than would be expected from the general population, she noted in her findings.
On Thursday, a few hours before the EMA presented their conclusions, a Norwegian study conducted by the Oslo University Hospital established a link between the vaccine and thrombosis, according to the newspaper Le Monde.
To read the EMA’s findings: http://bit.ly/3eRyPFN
Letter of formal notice for AstraZeneca
On the same day, the European Commission announced that it would send a letter to AstraZeneca to initiate a formal dialogue with the Anglo-Swedish company within the context of the dispute between the two parties regarding the supply of Covid-19 vaccines.
“The dialogue would become more formal in nature and that would be important”, said Eric Mamer, spokesperson for the EU institution. He did not confirm that AstraZeneca will have 20 days to respond to the letter and that if no amicable settlement can be reached, the matter could be referred to the Belgian courts.
The letter, which was being drafted at midday on Thursday, is to be discussed by the 27 EU Member States before it is sent.
The President of the European Commission, Ursula von der Leyen, said the day before that AstraZeneca would only deliver 70 million doses of Covid-19 vaccine to the EU by the end of June, instead of the contracted quantity of 180 million doses (see EUROPE 12680/2). (Original version in French by Pascal Hansens with Mathieu Bion)