No indication AstraZeneca vaccine causes blood clots, says regulator
A number of European nations, including Germany, France, Italy and Sweden, have suspended use of the Oxford/AstraZeneca covid‑19 vaccine over blood clot concerns.
The World Health Organization and the European Medicines Agency (EMA) have both emphasised that there is currently no evidence linking the vaccine to blood clots and recommend that countries continue using it. Emer Cooke, director of the EMA, reiterated in an online press conference today that the agency remains firmly convinced that the benefits of the vaccine outweigh any risks.
Both organisations are performing a thorough analysis of all the available data and the EMA will be making a statement with its conclusions on Thursday 18 March.
Among 17 million people who have received the vaccine in the EU and the UK, 15 cases of deep-vein thrombosis (DVT) and 22 cases of pulmonary embolism have been reported as of 8 March, AstraZeneca said in a statement on 14 March. DVT is a blood clot in a vein, which has the potential to travel to the lungs, causing a blockage, or what is known as a pulmonary embolism.
“Many thousands of people develop blood clots annually in the EU for different reasons,” the EMA said in a statement. The number of blood clotting incidents in vaccinated people “seems not to be higher than that seen in the general population”.
In Germany, the Paul Ehrlich Institute, which advises the government on covid-19, said it had recommended the temporary suspension of the vaccine following a “noticeable increase” in cases of cerebral venous sinus thrombosis (CVST), a blood clot in a major brain vessel, soon after vaccinations.
Germany’s health minister, Jens Spahn, said at a press conference on 15 March that there had been seven reported cases that may be related to CVST out of 1.6 million vaccinations in Germany. Estimates of how many incidences of CVST you might expect in the general population over a year vary from two to five cases per million people to more than 15 cases per million, depending on the study.
“There is absolutely no data that supports [the German government’s] decision,” says César Muñoz-Fontela at the Bernhard Nocht Institute for Tropical Medicine in Germany. He says that older people and people with pre-existing health conditions, who are more at risk of blood clots generally, have been prioritised for the vaccine, which may have skewed the apparent side effects. He would like to see a comparison with a control group that has the same characteristics as the people so far vaccinated.
The International Society on Thrombosis and Haemostasis recommends that all eligible adults continue to receive their covid-19 vaccinations. “At this time, the small number of reported thrombotic events relative to the millions of administered COVID-19 vaccinations does not suggest a direct link,” it said in a statement.
“In weighing up the merits of a medical intervention, it’s really important to consider both sides of the argument: how risky is it for someone to have it versus how risky is it for them not to,” says Lucy Walker at University College London. “An increased risk of thrombosis is one of the known complications of [coronavirus] infection. The vaccines we have are incredibly good at preventing the illness caused by this virus. They will therefore prevent people from having thrombosis associated with the infection itself.”
The decision to halt use of the vaccine could have wider consequences, Walker adds. One is that it could lower vaccine uptake in general by increasing vaccine anxiety. To get the upper hand with the coronavirus, we also need to vaccinate people as quickly as possible to suppress the evolution of dangerous variants. “To have stocks of a safe, effective vaccine not being used, through an abundance of caution, potentially hinders this mission,” she says.
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Italy and France fold over AstraZeneca jabs: Mario Draghi and Emmanuel Macron vow to 'quickly resume' using vaccine
The leaders of Italy and France today committed to 'quickly' resume inoculations of the Oxford-AstraZeneca vaccine once the European regulator gives the all-clear.
Italian PM Mario Draghi and French President Emmanuel Macron appeared to roll the pitch for an imminent climbdown.
On a call the two leaders agreed they were ready to resume using the jab 'quickly' if the European Medicines Agency (EMA) gives the green light on Thursday.
'The preliminary statement today from EMA was positive,' a statement from Draghi's office said.
They are among a host of EU nations to have suspended use of the jab after some people it was administered to suffered blood clotting problems.
Boris Johnson, the UK's medical regulator the MHRA and the World Health Organisation have insisted the vaccine is safe and continues to roll it out at pace.
It comes as a top European Commission official urged EU governments to stop sitting on their vaccine stockpiles as several countries suspended use of the AstraZeneca vaccine amid blood-clotting fears.
Stella Kyriakides, the health commissioner, said the bloc was in a 'race against time' to rollout out of the vaccine or face several more spikes in infections.
The EU has already seen a disastrous rollout of the vaccine across the continent, with just 8 per cent of adult receiving a jab compared to a third in the UK.
There have been supply problems with both the AstraZeneca and Pfizer jabs, but it was revealed earlier that several countries including Germany are sitting on stockpiles.
'Even with the immense and regrettable challenges around production capacity and deliveries, there are reports of unused reservoirs of vaccines across the EU, said Kyriakides following talks with European health ministers.
'We are racing against time and the rollout of vaccination is more than ever key to decrease the number of infected people as much as possible.'
While Italy has used all of its Pfizer jabs, the country still has 250,000 AstraZeneca vaccines that it banned from going to Australia in storage.
According to The Times, there are some 14.2 million jabs (60 per cent) delivered to EU governments that are yet to be used.
Her comments came shortly after the European Union’s medicines regulator said it was still 'firmly convinced' of the benefits of the Oxford-AstraZeneca vaccine.
Fourteen European countries including 12 EU members have now suspended their use of the shots altogether - with Sweden joining the list today - while another five have black-listed specific batches and a handful of governments outside Europe have also pulled the emergency brake.
EMA safety experts say a 'very small number of people' have come down with blood disorders but there is 'no indication' that these were caused by the jab, which has already been given to 11 million people in the UK.
'We are still firmly convinced that the benefits of the AstraZeneca vaccine in preventing Covid-19 with its associated risk of hospitalisation and death outweigh the risk of these side effects,' said EMA chief Emer Cooke.
Prime Minister Boris Johnson, UK regulator the MHRA and the WHO have all insisted that the vaccine is safe and that there is no evidence of a link to the sporadic blood clots.
This evening, Health Secretary Matt Hancock reiterated the AstraZeneca was safe and urged people to get it when offered.
'The Oxford-AstraZeneca vaccine is safe, we know that over 10million people have had it in this country. That’s what the British regulator says but also the World Health Organisation and even the European regulator,' he said.
'We keep the effects of these vaccines under review at all times and we know the AstraZeneca vaccine is saving lives right now. So if you get the call, get the jab.'
Italy earlier admitted that its suspension of AstraZeneca jabs was a 'political' move while French doctors accused Emmanuel Macron of 'giving in to panic' and a German lawmaker said the ban could cause a 'catastrophe'.
Germany sought to justify its move by saying that one particular kind of blood clot, a 'sinus vein thrombosis', had occurred seven times among the 1.6million people vaccinated when only around one case would be expected. By contrast, only four such cases have been identified in the UK out of 11million doses administered.
Nicola Magrini, the head of Italian medicines regulator AIFA, said politicians had come under pressure to call off the jabs after Germany and France made similar moves in what one Tory MP described as a 'Brexit sulk'.
In Italy's case, the suspension means around 200,000 fewer vaccinations this week, government sources said, expressing confidence that they could make up for the setback.
'We got to the point of a suspension because several European countries, including Germany and France, preferred to interrupt vaccinations... to put them on hold in order to carry out checks. The choice is a political one,' Magrini said in an interview with La Repubblica.
President Macron has previously undermined the efficacy of the jab, declaring it 'quasi-ineffective' for the over-65s - a position he also later rowed back from.
https://www.dailymail.co.uk/news/article-9368883/Italy-France-fold-AstraZeneca-jabs.html
*************************************Paralyzed by Fear? Johns Hopkins Doctor Notices Something Peculiar About the COVID Vaccine Guidelines
Dr. Marty Makary of Johns Hopkins School of Medicine was bold in his projection that we’ll have herd immunity by April. This has been disputed by those who are nowhere near his level of expertise when it comes to public health, but I get the pushback since it shreds the Democratic Party’s COVID lockdown regime. In an op-ed for The Wall Street Journal, Makary says that we’re underestimating natural immunity and with the pace of vaccinations, we’ll reach that critical benchmark towards reclaiming normality by tax season.
“About 1 in 600 Americans has died of Covid-19, which translates to a population fatality rate of about 0.15%. The Covid-19 infection fatality rate is about 0.23%,” Dr. Makary wrote. With those figures, he estimates that two-thirds of the country has already had the infection. We’re rapidly approaching 100 million vaccinations. It’s not an insane projection, but one he says other health experts are afraid to push for fear of impacting the rate of vaccinations. That’s not their job, he argued. Good health news should be disseminated, not buried. There was pushback, and there will be more when he recently wrote about the vaccine protocols.
The good doctor cited an Israeli study that shows those given the Pfizer vaccine are virtually “bulletproof” four weeks after the first dose. That’s the keyword right there. So, we can be returning to normal if the CDC wasn’t so busy peddling exaggerated threats about the virus and being stricken with fear, which Makary noted with their latest guidelines. Is it ‘follow the science’ or ‘be afraid, be very afraid'?
Get the shot, wait a month, and start rebuilding our lives. That’s fair. That seems to be based on the science, which the CDC might be ignoring. You be the judge (via WSJ):
"Parts of the new guidelines are absurdly restrictive. For example, the CDC didn’t withdraw its advice to avoid air travel after vaccination. A year of prevaccine experience has demonstrated that airplanes aren’t a source of spread. A study conducted for the defense department found that commercial planes have HEPA filtration and airflow that exceed the standards of a hospital operating room.
[…]
An unpublished study conducted by the Israeli Health Ministry and Pfizer showed that vaccination reduced transmission by 89% to 94% and almost totally prevented hospitalization and death, according to press reports. Immunity kicks in fully about four weeks after the first vaccine dose, and then you are essentially bulletproof. With the added safety of wearing a mask indoors for a few more weeks or months—a practical necessity in public places even if not a medical one, since you can’t tell on sight if someone’s immune—there is little a vaccinated person should be discouraged from doing.
On a positive note, the CDC did say that fully vaccinated people who are asymptomatic don’t need to be tested. But that obvious recommendation should have come two months ago, before wasting so many tests on people who have high levels of circulating antibodies from vaccination.
In its guidance the CDC says the risks of infection in vaccinated people “cannot be completely eliminated.” True, we don’t have conclusive data that guarantees vaccination reduces risk to zero. We never will. We are operating in the realm of medical discretion based on the best available data, as practicing physicians have always done. The CDC highlights the vaccines’ stunning success but is ridiculously cautious about its implications. Public-health officials focus myopically on transmission risk while all but ignoring the broader health crisis stemming from isolation. The CDC acknowledges “potential” risks of isolation, but doesn’t go into details.
It’s time to liberate vaccinated people to restore their relationships and rebuild their lives. That would encourage vaccination by giving hesitant people a vivid incentive to have the shots.
Throughout the pandemic, authorities have missed the mark on precautions. Hospitals blocked family members from being with their loved ones as they gasped for air, gagging on a ventilator tube—what some patients describe as the worst feeling in the world. In addition to the power of holding a hand, family members coordinate care and serve as a valuable safety net, a partnership that was badly needed when many hospitals had staffing shortages. Separating family members was excessive and cruel, driven by narrow thinking that focused singularly on reducing viral transmission risk, heedless of the harm to the quality of human life."
He added the mental health issues that have exploded due to the lockdown regime that teachers’ unions, Democrats, and the liberal media ignore. Kids are committing suicide. Anxiety and depression have also spiked among students. Loneliness and isolation are going to be the real ‘long haul’ symptom of this pandemic, which could be alleviated partially if our experts actually gave us advice that wasn’t so covered in crap.
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Also see my other blogs. Main ones below:
http://snorphty.blogspot.com (TONGUE-TIED)
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com/ (AUSTRALIAN POLITICS)
http://awesternheart.blogspot.com.au/ (THE PSYCHOLOGIST)
https://heofen.blogspot.com/ (MY OTHER BLOGS)
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