AstraZeneca's coronavirus vaccine plausibly linked to rare brain clots, European regulators say
Source: Washington Post
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.
Read more: https://www.washingtonpost.com/world/europe/astrazeneca-blood-clots-europe/2021/04/07/ca5ef1dc-9792-11eb-8f0a-3384cf4fb399_story.html
There was quite a bit of speculative Euro media discussion about what was going to be announced today, so this is the announcement.
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By Benjamin Mueller, Monika Pronczuk and Matina Stevis-Gridneff
April 7, 2021, 10:20 a.m. ET
Britain said on Wednesday that it would offer alternatives to the AstraZeneca vaccine for adults under 30 as European regulators described a “possible link” with rare blood clots, a setback for the world’s most widely used vaccine and a blow to the more than 100 countries relying on it to save lives amid a global surge in coronavirus cases. The European regulator, the European Medicines Agency, stopped short of advising that use of the vaccine be curbed in the 27 European Union countries, saying that it was up to the national authorities to decide who should receive which vaccine.
Until the announcement, Britain had never wavered in its use of the vaccine, making it a holdout in Europe even as many countries detected unusual, sometimes fatal, blood clots in some recipients. But evidence has mounted that very small numbers of Britons had also been afflicted, forcing the country to reduce the use in younger people of a vaccine that is the backbone of its world-beating inoculation program.
The concern over the blood clots has threatened the pace of vaccinations far beyond Europe. At least 111 countries of varying income levels have administered doses of AstraZeneca’s shot, making it international aid groups’ most potent weapon in the battle to reduce deaths in the vaccine-starved global south. British and European regulators both said it was possible that the clots were linked to the vaccine, but that more investigation was needed. European regulators described the cases as a serious but “very rare” side effect.
The agency reiterated that the overall benefits of the vaccine still outweighed the risks, but urged that health professionals and recipients of the shot be cautious about symptoms like shortness of breath, chest pain or leg swelling. Many European countries have restricted use of the vaccine in younger people because some scientists believe they are at higher risk of developing the rare blood clots. They are also at lower risk of severe Covid-19, raising the safety bar for any vaccine being given to younger people. But the regulator said that it had not concluded that age or gender were a specific risk and that it would further investigate the issue.
https://www.nytimes.com/2021/04/07/world/astrazeneca-blood-clots.html
