In a statement following a meeting of experts and a week of intense speculation over the safety of the vaccine and an unlikely link to rare blood clotting incidents, Emer Cooke, executive director of EMA said: “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 thromboembolitic events or blood clots.”
The EMA has said it will make changes to the product information labels to warn about a possible risk but it emphasised it did not believe there was any greater risks from the vaccine and that it was likely to still be less risk than contracting Covid.
The decision comes as the UK’s medicines watchdog insisted the jab was safe and there was no evidence that it caused blood clots. The Medicines and Healthcare Products Regulatory Agency said it was investigating five cases of cerebral sinus vein thrombosis, or blood clots in the brain. This included one death.
But the UK body said the five cases amounted to one in a million people vaccinated so far in the UK, and can happen naturally.
Eighteen countries across Europe have suspended use of the Oxford/AstraZeneca vaccine including Germany, France, Sweden, Italy and Spain.
In a statement on Thursday, Ms Cooke said the regulator was satisfied the vaccine was safe but added: “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’re included in the product information, drawing attention to these possible rare conditions and providing information to health care professionals and vaccinated people.
“I want to reiterate that our scientific position is that is that this vaccine is a safe and effective option to protect citizens against Covid-19. 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.”
In a press conference Dr Sabine Straus, chair of EMA’s pharmacovigilance and risk assessment committee (PRAC) added: “As soon as these concerns arose last week, the committee started a comprehensive review of all the available evidence, and working around the clock, making use of all the resources at our disposal.
“This vaccine is safe and effective in preventing Covid-19 and its benefits continue to be far greater than its risks. PRAC has found no evidence of a quality or a batch issue.
“PRAC has concluded that there is no increase in overall risk of blood clots with this vaccine. Moreover, because the vaccine is effective in preventing Covid-19 disease, which in itself is a cause of blood clots, it likely reduces the risks of thromboembolitic events.”
She said that as of Wednesday night, there had been 18 cases of cerebral venous sinus thrombosis, or brain blood clots, out of almost 20 million vaccinated people.
European countries will now decide whether to re-start their vaccination programmes, amid a row over vaccine supplies and deliveries with the EU threatening to restrict exports.