THE European Medicines Agency (EMA) has said the Oxford/AstraZeneca jab is ‘safe and effective’.
The EMA said the benefits of the vaccine outweigh the risks.
The regulator’s executive director Emer Cooke said the jab is not associated with an increase in the overall risk of blood clots.
“The committee has come to a clear scientific conclusion: this is a safe and effective vaccine,” Cooke said.
“The committee also concluded that the vaccine is not associated with an increase in the overall risk of thromboembolic events or blood clots.”
Thirteen EU member states, including Ireland, suspended the vaccine over concerns of a link to blood clots in a small number of people.
Today’s announcement by the EMA paves the way for the rollout of the vaccine to resume.
The information leaflet will be revised to create awareness of potential risks.
Cooke said, after days of analysis, they cannot rule out a link between these cases and the vaccine.
She said: “Me, I would be vaccinated tomorrow but I would want to know what to look out for.
“Our expert committee on the safety of medicines has now come to a conclusion on the review of cases of blood clots in people vaccinated with AstraZeneca Covid-19 vaccine.
“What the committee has therefore recommended is to raise awareness of these possible risks to making sure that they include it in the product information and attention to these possible rare conditions and providing information to health care professionals.
“We are also launching additional investigations to understand more about these rare cases and we are conducting targeted observational studies.”Tags: