EU drug regulator says up to countries to decide how to handle AstraZeneca

EU drug regulator says up to countries to decide how to handle AstraZeneca

European countries should make their own decisions about how to handle the risk of rare blood clots from AstraZeneca’s Covid-19 vaccine, based on prevailing infection rates and the availability of alternative vaccines, the EU drugs regulator said on Wednesday.

Several countries in Europe have announced restrictions on the use of the AstraZeneca vaccine in younger people, after a link was found to very rare blood clots, mostly in women under 60 years of age within two weeks of vaccination.

But the European Medicines Agency (EMA) held back from issuing guidelines, saying countries would have to assess the balance of risks themselves, based on local conditions that vary widely across the bloc.

“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 told 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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