The AstraZeneca Covid-19 vaccine is “safe and effective” – and its benefits outweigh any risks, the European Medicines Agency (EMA) has concluded.
However, the European regulator said it “cannot rule out definitively” a link between “a small number of cases of rare and unusual but very serious blood clotting disorders” and the vaccine, though investigations were ongoing.
Emer Cooke, EMA executive director, said this situation was not unexpected, adding that “when you vaccinate millions of people” such reports of rare events will occur.
The EMA has concluded there is no overall increase in the risk of blood clots with the vaccine, and in fact it is likely to reduce the overall risk of clots.
Ms Cooke told a 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.”
It comes after it emerged five men in the UK have suffered an “extremely rare” blood clot problem after having the AstraZeneca coronavirus vaccine, though no causal link with the jab has been established.
More than a dozen European countries halted their use of the vaccine after the reported blood clots.
Spain, Germany, France and Italy were all among the countries to temporarily halt the rollout earlier this month.
However, the head of the EMA’s Pharmacovigilance Risk Assessment Committee (Prac) has said they had concluded that there was no overall risk of blood clots with the AstraZeneca vaccine.
Dr Sabine Straus said the number of blot clots reported after vaccination was “lower than expected in the general population”.
She said: “Prac has concluded that there is no overall increase in the risk of blood clots with this vaccine.”
Because the vaccine was effective in preventing coronavirus – which itself can lead to blood clots – she said it “likely reduces” the risks of clots overall.