EU drug regulator says up to countries to decide how to use AstraZeneca shots

FILE PHOTO:  Oxford-AstraZeneca vaccine.  (Reuters Photo)
FILE PHOTO: Oxford-AstraZeneca vaccine. (Reuters Photo)

THE EU drugs regulator on Wednesday (8) said European countries should make their own decisions on the usage of the Oxford-AstraZeneca vaccines following reports of rare blood clot events.

Several countries in Europe have restricted the use of the AstraZeneca vaccine in younger people, after link of very rare events of blood clots were reported. Italy, on Wednesday (7) has restricted its use only for those over the age of 60.

But the European Medicines Agency (EMA) did not issue any guidelines, saying countries would have to assess the risks themselves based on local conditions and on the availability of other vaccines.

“We try to provide as much information as possible on the benefits and the risks we have identified, and based on that and the pandemic situation in a member state – the infection rate, the availability of different vaccines – the different member states can take different decisions on who to vaccinate,” EMA executive director Emer Cooke said in a briefing.

Cooke said the risk of dying from Covid-19 was “much greater” than the risk of mortality from rare side effects.

“It is very important that we use the vaccines we have to try and beat this pandemic,” she said.

Sabine Straus, chair of the EMA’s safety committee, said side-effects were not unexpected as vaccines were rolled out on a large scale.

The EMA has received reports of 169 cases of a rare brain blood clot known as cerebral venous sinus thrombosis (CVST), as of April 4, Straus said. That’s out of 34 million doses of the shot administered in the European Economic Area.

There have also been three cases of blood clots with low platelets after the use of the Johnson & Johnson shot, Peter Arlett, head of data analytics and methods task force, said.

Experts told Reuters it was too early to say whether these events were connected to the vaccine.


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