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AstraZeneca's coronavirus vaccine plausibly linked to rare brain clots, European regulators say

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BERLIN — Europe’s medical regulator on Wednesday said that it is “plausible” than an immune response is causing rare but occasionally deadly blood clots among a few of those inoculated with AstraZeneca’s coronavirus vaccine.

The European Medicines Agency said it is reminding health-care professionals and people receiving the vaccine to “remain aware” of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within two weeks of vaccination. It said the rare blood clots should be listed as possible side effects.

So far, most of the cases reported have occurred in women under 60 years of age, it said.

The vaccine produced by AstraZeneca and Oxford University has been under intense scientific scrutiny since early last month, when a 49-year-old nurse died of complications due to blood clots following her vaccination in Austria. Other cases followed across Europe, leading some countries to suspend their use of the vaccine until scientific reviews were done.

Concerns center on a rare condition called cerebral venous sinus thrombosis, or CVST, a clot that stops blood from draining from the brain. Regulators have said it is occurring among those vaccinated at a rate above what they’d expect to see in the normal population.

Wednesday’s announcement is the latest blow for the vaccine that was touted as a key tool in leading the world out of the pandemic. Cheap and easier to store than others on the market, there are plans to roll it out in more than 140 countries through a program designed to ensure equitable distribution.

Cases of concern are small in number. Britain has documented the serious clots in about 1 in 500,000 shots. But higher rates in countries that began using AstraZeneca’s vaccine only among younger people have spurred debate as to whether the risks might be higher for certain age groups or for women. The EMA has estimated the risk to those under 60 to be about 1 in 100,000.

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