World Health boss admits he has NO idea if Covid vaccine causes blood clots
A Terrible Conundrum for the AstraZeneca Vaccine
For the moment, reports of a very rare, dangerous blood disorder among recipients cannot be ignored.That’s why the past few weeks have felt so catastrophic.
Australia will continue to roll out the AstraZeneca Covid vaccine despite health officials admitting they do not know if it causes potentially deadly blood clots.
In March more than a dozen countries suspended the jab after a handful of European patients suffered brain blockages that can cause strokes.
Germany is still banning the vaccine for under 60s amid fears the clots are more prominent in young people, particularly young women.
European regulators are reviewing the data and on Tuesday Marco Cavaleri, head of vaccines at the European Medicines Agency, said he believes there is a 'causal link' between the vaccine and the clots.
Urgent AstraZeneca Covid vaccine probe lauched after man hospitalised
Australia's medicines regulator has begun an urgent investigation into the AstraZeneca Covid vaccine after a man was hositalised with a rare blood clotting condition. The Therapeutic Goods Administration held talks with British regulators overnight probing whether the 44-year-old's low blood platelets and 22 other similar cases in the UK are linked to the vaccine.Discussions will continue on Saturday between the Australian Health Protection Principal Committee and the Australian Technical Advisory Group on Immunisation.
But Australia's Health Department Secretary Professor Brendan Murphy admitted on Wednesday that he does not know if there is a risk.
'At the moment, we don't have those answers,' he said.
'All I'm saying is that there is a lot of action at the moment analysing the information in Europe and in the UK and we are taking a very close interest in it.'
He said 'the government and the department have taken the view that safety is absolutely paramount'.
'The UK has had so much more experience than we have. They've got the better data,' he said.
'Europe has better data and that's why we're looking at their data to see whether this is a real problem and whether we need to do anything about it. All I'm saying is that this is a very active, ongoing review.'
Decision about AstraZeneca's use in Australia to be make this week
An urgent investigation was launched into the potential side effects of the Covid-19 vaccine after a Melbourne man who received the jab was hospitalised with a rare blood clotting condition. Experts have been holding talks with European regulators to determine whether the 44-year-old's low blood platelets and 22 other similar cases in the UK are linked to the vaccine. The Australian Technical Advisory Group on Immunisation (ATAGI) will convene on Wednesday to weigh up the risks and benefits of AstraZeneca jabs once further information is provided from international discussions.
Last month an investigation was launched after a 44-year-old Melbourne man was hospitalised with blood clots after getting the jab.
Australian health officials have previously said that blood clots happen in general life and any adverse effects suffered after vaccination may be coincidental.
The UK's safety watchdog, the MHRA, has so far spotted 30 rare clotting events in 18.1 million doses – around one in every 600,000. But the EMA believes it may occur in up to one in every 100,000 under-60s.
Last week the UK regulator criticised Germany for suspending the jab in under-60s, arguing there was 'no evidence' to support age-based restrictions.
UK Prime Minister Boris Johnson on Tuesday called on Britons to still get AstraZeneca's jab.
AstraZeneca vaccine: what we know and don't know
A European Medicines Agency (EMA) recommendation Wednesday that a dangerous type of blood clot should be listed as a "very rare side effect" of the AstraZeneca jab stopped just short of saying there is a causal link between the vaccine and the deadly condition. "The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects," theQuestions have persisted for weeks on whether highly unusual blood clots among those getting the AstraZeneca vaccine against Covid-19 were more frequent than in the general population, and what causes them if they were.
'The advice to people is to keep going out there, get your jab, get your second jab,' he said.
EU regulator boss Mr Cavaleri told Italian media there's a clear association between the AstraZeneca vaccine and the dozens of rare blood clots that have been reported worldwide out of the tens of millions of AstraZeneca shots that have been given out.
'It is becoming more and more difficult to affirm that there isn't a cause-and-effect relationship between AstraZeneca vaccines and the very rare cases of blood clots associated with a low level of platelets,' Mr Cavaleri was quoted as saying.
Asked about Cavaleri's comments, the EMA press office said its evaluation 'has not yet reached a conclusion and the review is currently ongoing.'
It said it planned a press conference as soon as the review is finalised, possibly Wednesday or Thursday.
The agency has repeatedly insisted AstraZeneca's jab is safe and the benefits outweigh any risks.
AstraZeneca and Oxford University, which developed the vaccine, announced they were pausing the trial of their jabs in children while British regulators investigate the potential blood clot link in adults.
Young Australians' hopes for an overseas holiday could be dashed
Australia had been aiming to open its international borders beyond New Zealand from the end of October when every citizen was expected to receive at least their first vaccine dose. But that timeline is now almost impossible to meet following Thursday's announcement the AstraZeneca Covid-19 vaccine - which Australia had purchased the most doses of - was no longer recommended for under 50s, only the Pfizer jab.
'Whilst there are no safety concerns in the pediatric clinical trial, we await additional information' from the British regulator, an Oxford spokesperson said in a statement.
In Geneva, the World Health Organization said its experts were also evaluating a possible link between the AstraZeneca vaccine and rare blood clots - and that it might have a 'fresh, conclusive assessment' before Thursday.
After suspending the jab last month, most EU nations restarted on March 19 - some with age restrictions - after the EMA said the benefits of the vaccine outweighed the risks of not inoculating people against COVID-19. At the time, the EMA recommended the vaccine's leaflet be updated with information about the rare clots.
Any further doubts about the AstraZeneca vaccine would be a setback for the shot, which is critical to Europe's immunization campaign and a linchpin in the global strategy to get vaccines to poorer countries.
The AstraZeneca vaccine is cheaper and easier to use than rival vaccines from Pfizer and Moderna and has been endorsed for use in over 50 countries, including by the 27-nation EU and the World Health Organization. U.S. authorities are still evaluating the vaccine.
Mr Cavaleri said while EMA was prepared to declare a link, further study was still needed to understand why and how the phenomenon occurs.
It’s Not Over for the J&J Vaccine
A pause is just that—a pause—in which health officials can reevaluate the data at hand.Experts haven’t yet conclusively determined whether J&J’s vaccine is directly causing these strange clots, or how frequently the condition might be occurring, because they’re relying largely on people reporting their health conditions to federal agencies. Roughly 7 million doses of the vaccine have been administered so far in the United States; among them were about 1 million women under the age of 50. “I think it’s reasonable to say it is a rare event, but I don’t think we should go into false precision in this kind of situation,” Saad Omer, a vaccine expert at Yale, told me.
He said the rare blood clots, including some in the brain, coupled with a low level of blood platelets that may make people at risk of serious bleeding, 'seem to be the key event to study further.'
Mr Cavaleri promised more details soon, adding: 'In the coming hours, we will say that the link is there, how this happens we still haven´t figured out.'
Mr Cavaleri said the biological mechanism for how the vaccine might be causing the rare clots was still unknown and if it was linked to how the shot is made, other vaccines with similar technologies might also need to be evaluated.
He stressed the risk-benefit analysis remained positive for the AstraZeneca jab, even for young women who appear to be more affected by the clots.
'Let's not forget that young women also end up in intensive care with COVID. So we need to do very meticulous work to understand if the risk-benefit analysis remains for all ages,' he was quoted as saying.
A TIMELINE OF THE ASTRAZENECA BLOOD CLOT SAGA
March 7: Austria suspended the use of one batch of the vaccine after a woman, 49, who had been given it died of a 'severe coagulation disorder' and a 35-year-old developed a blood clot in her lung.
March 11: Authorities in Denmark, Norway and Iceland suspended all use of the vaccine following a 60-year-old woman in Denmark died of a blood clot after the reports emerged in Austria. Danish health minister Magnus Heunicke said: 'It is currently not possible to conclude whether there is a link.'
March 11: European Medicines Agency's safety committee began an investigation into the cases. It confirms 30 cases of 'thromboembolic events' – clots – were reported after five million vaccines in the EEA.
NSW woman, 48, dies a week after getting Covid-19 vaccine
Daily Mail Australia understands the woman, who was diabetic but otherwise previously in good health, was placed in an intensive care unit and died yesterday. Stock image © Provided by Daily Mail The risk of dying from Covid-19 is significantly higher than the rate of CSVT blood clots, which have not been definitively linked to the vaccines (Based on fatality estimates from Cambridge University and CSVT occurrences in Germany) WHICH COUNTRIES HAVE SUSPENDED THE ASTRAZENECA VACCINE? NOT SUSPENDEDSUSPENDED FOR UNDER-30sSUSPENDED FOR UNDER-55sSUSPENDED FOR UNDER-60sSUSPENDED FOR UNDER-65sSUSPENDED FOR UNDE
March 12: Thailand suspended the use of the vaccine off the back of European worries. Bulgaria also stopped using it.
March 12: The European Medicines Agency, Britain's Medicines and Healthcare products Regulatory Agency, Health Canada, the World Health Organization and AstraZeneca itself, all spoke out to defend the vaccine and say there is no proof it's linked to blood clots.
March 13: The Netherlands, Italy and Ireland temporarily stopped using the vaccine as fears about the cases in Austria and Denmark snowballed.
March 14: Germany and France suspended the vaccine.
March 15: Spain, Portugal and Slovenia suspended use of the jab.
March 15: Professor Andrew Pollard, the Oxford expert who ran the clinical trials of the jab, insisted safety data are 'reassuring' and said 'clearly those blood clots still happen' as often as they would in unvaccinated people.
March 16: World Health Organization officials met to discuss the issue. European Medicines Agency is still investigating.
March 17: Scientists accuse governments of banning the jab on political grounds. AstraZeneca's vaccine has been a flashpoint in the past.
March 18: European Medicines Agency holds a press conference on its investigation and rules that the vaccine is 'safe and effective'. It said there wasn't enough evidence to rule out a link to blood clots, but also not enough to prove one. On balance, it would be safer for countries to keep using the vaccine to stop Covid. The investigation would continue.
March 18: Germany, France and Italy resume use of the jab after the EMA's conclusion.
March 19: Finland suspends the jab after finding blood clot cases in its own population.
March 19: Bulgaria, Cyprus, Ireland, Latvia, Lithuania, Netherlands and Spain all confirm they will start using the jab again. Scandinavian countries did not follow suit and kept the ban in place.
March 22: A study is published that found public trust in the AstraZeneca vaccine collapsed in Europe at the time of the blood clot saga. A YouGov survey found more than half of people in Germany, France, Italy and Spain believed the jab was unsafe.
March 30: Germany bans the vaccine for people under the age of 60 after officials said they had found 31 cases of CSVT after 2.7million vaccinations.
April 2: UK regulators announce a total of 30 blood clots, 22 in the brain, have now been discovered in Britons vaccinated with the AZ jab.
April 5: UK regulators begin reviewing their guidance amid concern the jab is considerably more likely among younger people.
The Blood-Clot Problem Is Multiplying .
So are theories to explain it.The world is now engaged in a vaccination program unlike anything we have seen in our lifetimes, and with it, unprecedented scrutiny of ultra-rare but dangerous side effects. An estimated 852 million COVID-19 vaccine doses have been administered across 154 countries, according to data collected by Bloomberg. Last week, the European Medicines Agency, which regulates medicines in the European Union, concluded that the unusual clotting events were indeed a side effect of the AstraZeneca vaccine; by that point, more than 220 cases of dangerous blood abnormalities had been identified.