The European Medicines Agency (EMA) has said there is clear scientific evidence that the AstraZeneca Covid-19 vaccine is “safe and effective” following an investigation into reported side effects.
A number of EU countries, including Ireland, had paused the use of the AstraZeneca vaccine due to concerns that recipients had experienced blood clots after being inoculated.
In a press briefing today, the EMA said: “We cannot rule out a definitive link between these cases and the vaccine”, adding the number of incidents of blood clots after vaccination was lower than would be expected in the general population.
The regulatory body said it was aware that a number of EU countries had been waiting for today’s announcement, adding they could now make an informed decision regarding how they proceed with the use of the AstraZeneca vaccine.
EMA executive director Emer Cooke said over 7 million people in the EU have now been vaccinated using the AstraZeneca vaccine and over 11 million people in the UK.
Ms Cooke told the press briefing: “The committee has come to a clear scientific conclusion.
“This is a safe and effective vaccine. Its benefits in protecting people from Covid-19, with the associated risks of death and hospitalisation, outweigh the possible risks.
“The committee also concluded that the vaccine is not associated with an increase in the overall risk of thromboembolic events, or blood clots.”
Ms Cooke said the AstraZeneca vaccine “demonstrated at least 60 per cent efficacy in clinical trials in preventing coronavirus disease and, in fact, the real world evidence suggests that the effectiveness could be even higher than that”.
“We are very much aware that some (EU) member states have paused vaccinations, waiting for EMA’s outcome of a review.
“Given that thousands of people in the EU die every day – in fact over 2,500 were reported one day last week – it really was crucial for EMA to review rapidly and thoroughly all the available evidence, so we made this review our highest priority.”
She said the EMA had worked closely with European medical experts and the regulator’s UK counterpart the Medicines and Healthcare products Regulatory Agency (MHRA) during their work.
“The scientific conclusions adopted today provide member states with the information they need to take an informed decision regarding the use of the AstraZeneca vaccine in their vaccination campaigns.”
The head of the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), Dr Sabine Straus reiterated the group had concluded there was no overall risk of blood clots with the AstraZeneca vaccine.
She said the number of blot clots reported after vaccination was “lower than expected in the general population”, adding: “PRAC has concluded that there is no overall increase in the risk of blood clots with this vaccine.”
Seeing as the vaccine was effective in preventing Covid-19 – which itself can lead to blood clots – Dr Straus said the shot “likely reduces” the risks of clots overall.
However, she said there were still “some uncertainties” with a few cases where tiny clots had developed in multiple vessels or in vessels draining blood from the brain.
“The evidence that we have is at the moment not sufficient to conclude with certainty whether these events are indeed caused by the vaccine or not,” she said.
Dr Straus said a warning will be added to the AstraZeneca vaccine to raise awareness of possible risks.
Ms Cooke elaborated: “During the investigation and review, we began to see a small number of cases of rare and unusual, but very serious, clotting disorders, and this then triggered a more focused review.
“Based on the evidence available, and after days of in-depth analysis of lab results, clinical reports, autopsy reports and further information from the clinical trials, we still cannot rule out definitively a link between these cases and the vaccine.
“What the committee has therefore recommended is to raise awareness of these possible risks, making sure that they are included in the product information.
“Drawing attention to these possible rare conditions and providing information to health care professionals and vaccinated people will help to spot and mitigate any possible side effects.”