No evidence for restricting AstraZeneca use, says European Medicines Agency

There is currently no evidence to support restricting the use of the AstraZeneca Covid-19 vaccine to certain age groups, the European Medicines Agency said on Wednesday after Germany joined several countries in limiting its use to older people.

"According to the current scientific knowledge, there is no evidence that would support restricting the use of this vaccine in any population," EMA chief Emer Cooke said, following a review of evidence by the agency.

“The benefits of the vaccine outweigh possible side effects.”

Her comments came after Germany agreed on Tuesday to restrict the use of the vaccine to people aged over 60 due to very rare blood clot cases seen in some people who received the vaccine.

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The EMA has received reports of 44 rare blood clotting cases among 9.2 million people who received the vaccine across the European Economic Area.

Currently there is no evidence the vaccine was the cause of these illnesses, which occur anyway in the population, though Ms Cooke said a link was “possible” and that the investigation would continue.

The blood clots mostly occurred in younger women, who are at a higher risk of such illnesses and who make up the bulk of those who have received AstraZeneca vaccines in the EU. This is linked to the fact the jabs were initially restricted to younger groups by some national regulators, and were therefore particularly given to health workers, who are predominantly female.

Resumed

Most countries have resumed use of the vaccine after several including Ireland suspended its use as a precaution during the EMA’s initial investigation earlier this month.

However, France has chosen to limit its use to people aged over 55 and Canada followed suit on Monday. Norway and Denmark have not yet resumed administering the vaccines, pending further evidence.

The Irish Health Products Regulatory Authority (HPRA) said it is continuing to review “very rare reports of atypical blood disorders, which include blood clots associated with low platelets, in people vaccinated with AstraZeneca’s Covid-19 vaccine”.

No cases of blood clotting similar to those in Germany have been reported in Ireland, it confirmed.

Up to March 30th, about 2,500 reports of suspected adverse reactions associated with the AstraZeneca have been reported to HPRA, of which 12 described individuals who have been diagnosed, or are being investigated for a blood clotting event after vaccination.

“These events describe a typical profile of clotting seen at any time in the general population, such as clots in the lung or legs,” HPRA noted.