DCR Health: AstraZeneca’s coronavirus vaccine plausibly linked to rare brain clots, according to European regulators.☕☕☕

Ayyyeee… What’s Goodie Everyone. So I got some tea and it involves the coronavirus vaccine and a unfortunate link.

Medical regulators in Britain and the European Union said it was “plausible” that the Oxford-AstraZeneca’s coronavirus vaccine is linked to rare but sometimes deadly blood clots.

The European Medicines Agency stressed that the benefits of vaccination still outweigh the risks, as thousands of people die of the coronavirus across the continent each day and British officials advised that adults under 30 be offered alternative vaccines, noting that the calculus is different for young and otherwise healthy people who are at relatively low risk of serious covid-19. Italy and Belgium also put new restrictions on the vaccine for people under 60 and 55 respectively, bringing them in line with other European countries, including Germany and France.

The new guidelines marked a notable shift for the United Kingdom, where the government has wholeheartedly backed its homegrown vaccine even as other European countries raised concerns. British newspapers had pounced on initial pauses of AstraZeneca inoculations in Europe as being more about politics than safety, while members of the scientific community had said they were baffled at the decisions.
“This is a course correction,” Jonathan Van-Tam, England’s deputy chief medical officer, said in a televised briefing on Wednesday comparing Britain’s fast moving and relatively successful vaccine campaign to an ocean liner. “If you sail a massive liner across the Atlantic, then it’s not really reasonable that you aren’t going to have to make at least one course correction in that voyage,” Van-Tam said. He called the chances of anyone including the young getting unusual blood clots in relation to the AstraZeneca vaccine “vanishingly small.”

AstraZeneca has listed its shot as “a vaccine for the world.” Cheaper and easier to store than others on the market, there are plans to roll it out in more than 140 countries through Covax, a program designed to ensure equitable distribution. But about half the global population is under 30, according to United Nations figures, and many low income countries have limited ability to diagnose and treat the complicated and potentially serious side effect.

AstraZeneca said Wednesday it has been working with European regulators to update product information and better understand the individual cases of concern.
“Overall, both of these reviews reaffirmed the vaccine offers a high level of protection against all severities of COVID-19 and that these benefits continue to far outweigh the risks,” it said, adding that the regulatory investigations had been unable to identify any specific risk factors, such as age or sex.

A total of 169 cases of CVST have been reported among 34 million people given the AstraZeneca vaccine across continental Europe and Britain as of April 4, the EMA said. In addition, there have been 53 other cases of rare blood clots. Although incident rates have differed from country to country, the regulator said that could reflect different reporting standards and estimated the overall risk to be about 1 in every 100,000 shots, in line with rates seen in Germany. Both E.U. and British regulators said that although the majority of the blood clots have been recorded in younger women, that may reflect who has been getting the vaccine. Asked whether the risks of the vaccine for young women might outweigh the benefits, EMA’s Straus said, “At the moment, that is something that is very difficult to answer.”The oral contraceptive pill, which comes with its own risk of blood clots, does not appear to be a risk factor, the EMA said.

E.U. and British regulators said that although the majority of the blood clots have been recorded in younger women, that may reflect who has been getting the vaccine. Asked whether the risks of the vaccine for young women might outweigh the benefits, EMA’s Straus said, “At the moment, that is something that is very difficult to answer.”The oral contraceptive pill, which comes with its own risk of blood clots, does not appear to be a risk factor, the EMA said.

British officials said that although 51 of the 79 cases they assessed involved women, looking at the numbers as a proportion of people inoculated with AstraZeneca, there was no difference between women and men. Van-Tam said that although the absolute risk might not be higher for younger people, for otherwise healthy people in their 20s, the risk of serious harm from the vaccine slightly outweighed the potential for it to keep them out of coronavirus intensive care wards. Of the more than 20 million people in Britain who had received at least one dose of the AstraZeneca vaccine as of the end of March, 19 people died of rare blood clots and three of those people were under 30 years of age, officials said.

The regulators said that AstraZeneca has been asked to conduct more laboratory tests and to provide data from closed clinical trials in an attempt to get a better idea of risk factors.

Peter Arlett, head of pharmacovigilance at the EMA, said J&J;’s vaccine “uses a similar technology,” but there have been just three cases of blood clots accompanied by low platelet counts among 4.5 million recipients of that vaccine that “have some similarities” to those seen following AstraZeneca.
Regulators emphasized that for most people especially the elderly it is far better to get any safe and effective vaccine than not.
“This vaccine has proven to be highly effective in preventing severe disease and hospitalization, and it is saving lives,” EMA chief Emer Cooke said of AstraZeneca. “Vaccination is extremely important in helping us in the fight against covid-19, and we need to use the vaccines.”

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