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Australia Rise in rare clotting cases drove ‘difficult' call on AstraZeneca vaccine

23:37  18 june  2021
23:37  18 june  2021 Source:   brisbanetimes.com.au

NSW woman's blood clot death linked to AstraZeneca vaccine

  NSW woman's blood clot death linked to AstraZeneca vaccine A woman in New South Wales has died of a rare blood clotting disease after receiving the COVID-19 vaccine, the Therapeutic Goods Association has reported.A woman in New South Wales has died of a rare blood clotting condition after receiving the AstraZeneca COVID-19 vaccine, the Therapeutic Goods Administration has reported.

Concern about a rising number of non-fatal instances of a rare clotting disorder in Australians in their 50s led to the “ difficult ” decision to limit the AstraZeneca vaccine to those over 60. Vials of the AstraZeneca COVID-19 vaccine . Credit:Alex Ellinghausen. The group’s co-chair, Professor Christopher Blyth, said the expert advisory group had felt compelled to make the difficult call following weeks of “robust debate” among committee members. “This was not a small or whimsical decision, it was very hard,” the paediatric infectious diseases specialist said.

The cases were first reported in EudraVigilance, a European database of suspected adverse reactions to medicines. The PRAC is now investigating if Vaxzevria can cause the condition. As with the J&J vaccine , the EMA will decide whether further action is necessary based on the committee’s Previously, the PRAC was reviewing blood clot cases tied to Vaxzevria. It determined that the condition accompanied with low levels of blood platelets should be listed as “very rare ” side effects of the vaccine . The EMA warned that people could develop these conditions within two weeks of getting

Clinical staff draw up AstraZeneca COVID-19 vaccines at the Claremont Showgrounds Covid-19 Vaccination Clinic in Perth, Australia © Getty Clinical staff draw up AstraZeneca COVID-19 vaccines at the Claremont Showgrounds Covid-19 Vaccination Clinic in Perth, Australia

The federal Health Minister's top immunisation advisers say the decision to limit the AstraZeneca vaccine to over-60s was made because of the concerning number and severity of non-fatal cases of a blood clotting condition in people in their 50s and came after weeks of difficult deliberations.

Experts on the Australian Technical Advisory Group on Immunisation told The Age that the move to change the clinical advice, another major disruption to the nation's lagging vaccine rollout, came after analysing months of local and international data.

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The AstraZeneca vaccine has not yet been authorized for use in the United States. "This is, in my opinion, rock-solid evidence," said Andreas Greinacher, MD, head of the Institute of Immunology and Transfusion Medicine, University Hospital Greifswald, Germany, who was among the first scientists in the world to link the Greinacher said that he believes the mechanism linking the vaccine with the rare clotting reactions is likely to apply to other vaccines that also use adenoviruses to ferry instructions for making the virus's spike protein into cells. "My assumption is, and that's a hypothesis, that this is a

Extremely difficult job. Clinics, popups everywhere in the US are opening for the day right now. They either wanted to stop the vaccine in time for that or they really mismanaged this. All I know is nurses are probably about to have a really, really shitty day. Federal health agencies on Tuesday called for an immediate pause in use of Johnson & Johnson’s single-dose coronavirus vaccine after six recipients in the United States developed a rare disorder involving blood clots within about two weeks of vaccination .

The group's co-chair, Professor Christopher Blyth, said the expert advisory group had felt compelled to make the difficult call following weeks of "robust debate" among committee members.

"This was not a small or whimsical decision, it was very hard," the paediatric infectious diseases specialist said.

"There is significantly more than deaths to talk about. We've got some people who have had significant medical complications from this and so that's why we need to have a program which is balanced."

Although the rate of deaths due to the rare complication called thrombosis (blood clots) with thrombocytopenia (low platelets) could even be lower than had been forecast, multiple ATAGI members who spoke to The Age said they had become increasingly concerned by the number and severity of the non-fatal cases that were being reported in people in their 50s.

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There's been multiple cases of an incredibly uncommon (and very severe/fatal) type of blood clot that has not been seen in the UK at all. I'm very sure this is not an issue with the vaccine itself, but there may be some distribution or storage issues going on the EU that is causing this. When analyzing the new data, the experts at the Paul Ehrlich Institute now see a noticeable increase in a special form of very rare cerebral vein thrombosis (sinus vein thrombosis) in connection with a lack of blood platelets (thrombocytopenia) and bleeding close to vaccinations with the COVID-19 vaccine AstraZeneca .

Astrazeneca is a freely given out vaccine by the gouvernement. The government killing its own citizens. Corona killing random people. The risk of developing a rare brain clot from Covid-19 is about eight times greater than vaccination with the AstraZeneca - Oxford jab, according to a new study. This condition, where a patient presents abnormally low levels of platelets, has been detected alongside CVT in the cases of concern reported to date.

The head of the National Centre for Immunisation Research and Surveillance, Kristine Macartney, who has been a member of the group for almost 20 years, said they also calculated the probable number of future cases in those aged 50 to 59, and were uncomfortable with what that revealed.

Professor Macartney said it was initially thought that the rate of thrombosis with thrombocytopenia was about 1 in every 100,000 or 1 in every 200,000 for those in their 50s.

"But over time the rate has just steadily climbed. It's now more like one in 35,000 or 40,000," she said.

Professor Macartney said while she wanted to provide assurance to anyone who had recently got an AstraZeneca vaccine that it was still a rare condition, "it also becomes more apparent in the 50 to 59 age group that the cases had tended to be a bit more severe, with clots in both the brain and/or the abdominal blood vessels".

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Two specific clotting disorders have been linked to the AstraZeneca vaccine : cerebral venous sinus thrombosis (CVST), where clots form in the veins that drain blood from the brain, and splanchnic vein thrombosis (SVT), where clots form in the abdominal veins. They’ve coincided with people having So the pandemic may be increasing the baseline risk for these rare blood clots too. It’s also possible that the vaccine might trigger CVST in patients who have an underlying predisposition to developing the condition, meaning that some cases arise after vaccination in patients who would have developed

30 cases of blood clots linked to AstraZeneca 's vaccine were reported in Europe. German researchers found signs of antibodies that attack platelets in the blood. These antibodies destroy the platelets and, to make up for the loss, the body overproduces platelets, causing them to clot . European scientists believe they have an explanation for the blood clots reported in a tiny number of people who received Oxford- AstraZeneca 's coronavirus vaccine . Two separate research teams in Germany and Norway claimed the shot may, in very rare cases , cause the body to attack its own

Doctors are still strongly urging those who have received their first AstraZeneca to go back for their second dose.

Chief Medical Officer Professor Paul Kelly said anyone who had a first dose of AstraZeneca without a problem "should feel very confident to have their second dose, and they should keep that booking."

Data from Britain shows the rare clotting syndrome was far less common for second doses.

Two Australian women, aged 48 and 52, have died from the clotting disorder after receiving the AstraZeneca shot and four million doses of the vaccine have been administered nationwide.

A 52-year-old NSW woman died last week, with the Therapeutic Goods Administration saying she died from a clot in her brain. In April, 48-year-old Genene Norris, also from NSW, died from blood clots likely to be linked to the vaccine.

However, the risk of thrombosis with thrombocytopenia is lower in older groups, with 1.4 cases in every 100,000 AstraZeneca vaccine doses reported for those in their 60s compared with a rate of 2.7 per 100,000 doses in the 50 to 59 age group.

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Murdoch Children's Research Institute vaccine uptake expert Margie Danchin is a non-voting member of ATAGI and said it would be unwise for people aged 60 or over to put off having a vaccine until later in the year as they waited for an alternative to AstraZeneca.

"The last thing we want to do is have a massive outbreak and people turn around and say ‘you said wait and now people are dying from COVID disease'," she said. "That would be an absolute tragedy."

a man looking at the camera: The Age, News. AstraZeneca case study Barry Clearwater Story: Barry has had the first AstraZeneca shot and is happy to have the second shot.Pic Simon Schluter 18 June 2021. © Simon Schluter The Age, News. AstraZeneca case study Barry Clearwater Story: Barry has had the first AstraZeneca shot and is happy to have the second shot.Pic Simon Schluter 18 June 2021.

Melbourne consultant engineer Barry Clearwater, 67, has already had one shot of the AstraZeneca vaccine and sees it as his duty to get his second jab when it's due in August.

"I think we not only have a duty for ourselves … but also a duty to others, [so that others are] able to have an income, such as waiters, chefs and travel people, and we need to get going again," Mr Clearwater said.

While federal health authorities have conceded Thursday's decision will temporarily slow the vaccine rollout as people in their 50s reschedule their first doses, Health Minister Greg Hunt said the call by ATAGI could actually increase uptake overall, as those in their 50s hesitant to get the AstraZeneca vaccine take up the Pfizer jab.

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"What this will do is it will mean, for those potentially up to a million people who were AstraZeneca-hesitant within that age group, they will have access to Pfizer," Mr Hunt said.

Asked how the change in clinical guidance would further slow down the vaccine rollout already beset with delays, Dr Blyth said increasing reliance on Pfizer vaccines would mean "supply will again be challenged" for the next few months.

But he was hopeful constraints on supply would eased later in the year with tens of millions of doses of Pfizer and Moderna vaccines expected to arrive in Australia.

He said a number of mitigation strategies to increase vaccination uptake in Australia were being actively considered by the expert panel.

This included the possibility of widely distributing first doses of the Pfizer vaccine, and delaying the second dose, a strategy that had been used overseas to increase partial protection and immunity quicker.

"All of those things need to be considered in light of this decision, and we're looking hard at that at the moment," he said.

Associate Professor Danchin said experts on the group agonised over the decision to change the preferred vaccine for those in their 50s, concerned about the impact it would have on public confidence.

"It was becoming painfully clear that the severity in that age group, the 50 to 59-year-olds, was unacceptable," she said.

Those aged under 60 are more likely to get severe side effects, with 33 per cent requiring an admission to ICU, compared to 15 per cent for those 60 and over.

"We shouldn't just be talking about two deaths," said Associate Professor Danchin. "We're talking about an increase in severity which is unacceptable in terms of long term complications for some of these people."

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