Australian Government's AstraZeneca COVID-19 vaccine health warning

 

Australian Prime Minister Scott Morrison, media release, 8 April 2021:

Earlier this evening the Australian Government received advice from the vaccine expert taskforce, the Australian Technical Advisory Group on Immunisation (ATAGI).

The detail of that advice is attached.

The Government accepts the advice from Australia’s medical experts and will move swiftly to ensure Australia’s vaccination program and advice to patients is adjusted accordingly.

The Australian Government places safety above all else, as it has done throughout the pandemic, and will continue to follow the medical advice in protecting Australians.

The ATAGI advice is clear that the AstraZeneca COVID-19 vaccine is highly effective in preventing severe disease caused by COVID-19.

The medical advice to the Government is that the risk of blood clotting side effects from the Astra Zeneca vaccine is four to six in one million people, in the first four to 20 days post the vaccine. This is a rare but serious side effect.

On that basis, the recommendation is that it is preferred that the Pfizer vaccine be provided to adults under the age of 50. The AstraZeneca vaccine should only be given as a first dose to adults under the age of 50 where the benefit clearly outweighs the risk for that individual.

AstraZeneca is recommended for those over the age of 50.

The vaccination program will continue, particularly for the most vulnerable Australians in Phase 1B including those over the age of 70 who are not impacted by this revised advice.

The longer term timeframe for the program is being reviewed following this medical advice.

The Department of Health will provide preliminary, updated advice to general practitioners and health professionals.

The ATAGI advice follows further international evidence including from the vaccinations in Europe and the United Kingdom. ATAGI had already provided updated guidance on 2 April.

The ATAGI advice has today been considered by the Australian Health Protection Principal Committee (AHPPC), which is the Medical Expert Panel led by the Chief Medical Officer, and also comprising all State and Territory Chief Health Officers.

The advice will be provided to National Cabinet tomorrow.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

The Australian Technical Advisory Group on Immunisation (ATAGI) advice on the AstraZeneca COVID-19 vaccine in response to new vaccine safety concerns, excerpts;

“Definitions

 Thrombosis with thrombocytopenia syndrome (TTS) is a rare and new syndrome which hasbeen reported after being given the AstraZeneca COVID-19 vaccine. It may be caused by this vaccine. The condition involves blood clots (occurring in body sites like the brain or abdomen) together with low platelet levels.

 Thrombosis is the formation of a blood clot, which prevents blood flowing normally through the body.

 Thrombocytopenia is a condition in which you have a low blood platelet count. Platelets (thrombocytes) are blood cells that help blood clot. Platelets stop bleeding by clumping and forming plugs in blood vessel injuries.”

“ The AstraZeneca vaccine appears likely to be causally-linked with a risk of this newly recognised thrombosis with thrombocytopenia syndrome.

 There is currently uncertainty in, and different reported rates of risk, for this adverse event.

 Studies have suggested it may occur in approximately 4 – 6 people in every one million people in the 4-20 days after the first dose of vaccine. However, higher rates have been reported in Germany and some Scandinavian countries.

 Some evidence suggests the risk of this condition occurring may be somewhat higher in people of a younger age, however a small number of cases have been reported in people of different ages (including older adults).

 While there have been more reports of TTS in women in some settings, this may be because more vaccine doses have been given to women. In one country the reported rate of TTS (number of cases adjusted for the number of men and women vaccinated) was similar in men and women.

 TTS can cause serious long term disability or death (with death occurring in approximately 25% of reported cases).

 So far no specific biological risk factors or pre-existing medical conditions have been found to modify (i.e. increase or decrease) the risk of TTS occurring after AstraZeneca vaccine.

 We do not yet know to what extent earlier recognition of this syndrome and improved treatments will improve patient outcomes. More cases can be expected to occur, albeit rarely.

 Comirnaty (the Pfizer COVID-19 vaccine) does not appear to carry a risk of TTS. [my yellow highlighting]

NOTE: On 13 July 2020 AstraZeneca shares were worth US$61.10. By 8 April 2021 share price has fallen to US$49.78. 

As if the NSW Northern Rivers doesn't have enough on its plate, here's Pete!

IMAGE: realestate.com.au

TV chef and wannabe social media 'influencer' Pete Evans has his two-level Malabar home (left) on the market again.

Word is that he is making his ten hectare Round Mountain Farm, near Pottsville, home base as he prepares to open a healing clinic in Byron Bay now that Channel 7 has apparently tired of his antics.

That's right readers, your eyes didn't deceive you, the man who peddled glorified light shows as preventatives against COVID-19 and was fined more than $25,000 by the Therapeutic Goods Administration (TGA) over false claims he made about the "BioCharger", wants to run an alternative healing business in The Habitat, Byron’s new commercial precinct which has reportedly attracted health and beauty outlets.

The same man who without any scientific or medical training gave alarmingly bad advice to osteoporosis sufferers and was publicly slammed by the Australian Medical Association.

Who promotes 'anti-vaxxer' sites as well as the debunked "Plandemic: Indoctrination" conspiracy film on social media and, suggests putting doTERRA essential oils in your chicken broth - regardless of the fact that these oils are rarely advised to be taken internally.

Finally, this is the man who thinks 'fat shaming' a woman is a fun thing to do on Facebook.

It seems that Evans may have sensed a vacancy, since former tennis coach and "esoteric healer" Serge Benhayon removed himself from the local spotlight after he spectacularly lost a defamation case in 2018 to the tune of an estimated $1.2 million payout to the respondent and then Universal Medicine was stripped of its Lismore Business Awards after a review by the Lismore Chamber of Commerce.

How can you tell when Australian Prime Minister Scott Morrison is spinning voters a line? He opens his mouth and speaks. How do you know when his decision is flawed? He announces it with a flourish.

It's hard to understand why Scott Morrison chooses to lie so often when he must know how easily he is caught out.

It is easier to understand why he is so frequently attracted to dubious characters - he is the type of overly confident self-important man who is often identified by such individuals as an easy 'mark'.

On the morning of Wednesday 19 August 2020……

Australian Prime Minister Scott Morrison, media release, 19 August 2020:

Australians will be among the first in the world to receive a COVID-19 vaccine, if it proves successful, through an agreement between the Australian Government and UK-based drug company AstraZeneca.

Under the deal, every single Australian will be able to receive the University of Oxford COVID-19 vaccine for free, should trials prove successful, safe and effective…..

Scotty From Marketing played dress-ups to make his vaccine announcement
Mask & full lab coat
IMAGE: ABC News, 20 August 2020

ABCNews, 19 August 2020:

Australians are a step closer to accessing a coronavirus vaccine for free, after the Federal Government secured a major international deal to produce a vaccine frontrunner locally, should trials succeed.

Amid rising pressure to lock in supply of a coronavirus vaccine, the Government has signed an agreement with UK-based drug company AstraZeneca to secure the potential COVID-19 vaccine developed by Oxford University, if its trials prove successful.

Prime Minister Scott Morrison said if the vaccine succeeded, the Government would manufacture it immediately and make it free for all Australians.

"The Oxford vaccine is one of the most advanced and promising in the world, and under this deal we have secured early access for every Australian," he said……

In the evening of Wednesday 19 August 2020….

The Daily Telegraph, 19 August 2020: 

"Drug company AstraZeneca says Prime Minister Scott Morrison’s claim he has reached a deal to secure 25 million doses of the Oxford University vaccine is not true."

Then there is the pharmaceutical company Morrison named....

Corporate Research Project, 4 February 2017:

London-based pharmaceutical giant AstraZeneca is the result of the 1999 merger of Britain’s Zeneca, a spinoff of the old Imperial Chemical Industries specializing in cancer medications, and Sweden’s Astra AB, which was best known for the ulcer and heartburn medication Prilosec. Since that deal, the combined company has been embroiled in numerous controversies over illegal marketing, product safety, anticompetitive behavior and tax avoidance. 

Advertising and Marketing Controversies 

In 2003 federal officials announced that AstraZeneca had pleaded guilty to criminal and civil charges relating to the illegal marketing of the prostate cancer drug Zoladex. The company agreed to pay $355 million, consisting of $64 million in criminal fines, a $266 million settlement of civil False Claims Act charges, and a $25 million settlement of fraud charges relating to state Medicaid programs. AstraZeneca, which agreed to enter into a corporate integrity agreement with the Inspector General of the U.S. Department of Health and Human Services, had been accused of giving illegal financial inducements such as grants and honoraria to physicians.

In 2004 a coalition of consumer groups filed suit against AstraZeneca in a California state court, arguing that advertising for the company’s acid reflux drug Nexium misled consumers into thinking that it was superior to AstraZeneca’s Prilosec. The company had introduced Nexium to replace Prilosec as the latter drug was losing its patent protection. The case, along with a related one filed in Massachusetts, is pending. 

Also in 2004, the U.S. Food and Drug Administration (FDA) found that AstraZeneca’s full-page newspaper advertisements defending the safety of its Crestor cholesterol medication were “false and misleading.” The warning letter sent by the agency to AstraZeneca took issue not only with what the company said about the drug but also the way it represented the FDA’s position on Crestor. 

In 2010 the U.S. Justice Department announced that AstraZeneca would pay $520 million to resolve allegations that it illegally marketed its anti-psychotic drug Seroquel for uses not approved as safe and effective by the FDA. Under the terms of the settlement, $302 million of the total was to go to the federal government and $218 million to state Medicaid programs. Among other things, the company was accused of having paid doctors to give speeches and publish articles (ghostwritten by the company) promoting those unapproved uses. AstraZeneca agreed to sign a corporate integrity agreement regarding its future behavior. In 2011 AstraZeneca settled a related Seroquel case brought by state governments by agreeing to pay another $69 million. 

Product Safety 

In 2002 AstraZeneca said it would put a more conspicuous warning label on its lung cancer drug Iressa after several patients in Japan suffered pneumonia and some died. 

In 2003 researchers at the University of Illinois-Chicago released the results of research concluding that AstraZeneca’s Seroquel and two other schizophrenia drugs made by other companies created an elevated risk for diabetes. Subsequently, more than 25,000 lawsuits were filed against the company. In 2010 the company said it would pay a total of $198 million to settle those cases. That same year, the UK’s Prescription Medicines Code of Practice Authority found that AstraZeneca had failed to adequately describe the risks of Seroquel in an advertisement for the drug in a medical journal. 

In 2004 the watchdog group Public Citizen urged the federal government to ban AstraZeneca’s new cholesterol drug Crestor because of evidence linking it to the life-threatening muscle condition rhabdomyolysis. Noting that the company had not submitted timely reports to the FDA on some two dozen serious adverse reactions to Crestor, Public Citizen also called for a criminal investigation of the company. A 2005 study performed at Tufts University found that Crestor users had more serious side effects than those taking other cholesterol drugs. 

Also in 2004, an FDA review of AstraZeneca’s new blood thinner Exanta questioned the safety and effectiveness of the drug.

Pricing and Anticompetitive Behavior

......In 2003 the European Commission accused AstraZeneca of misusing patent rules to shield its ulcer drug Losec (Prilosec in the United States) from generic competitors. The company was charged with having misstated the year the drug was introduced in order to make it eligible for an extension of its exclusivity rights. In 2005 the commission fined AstraZeneca 60 million euros, a penalty which was upheld by the European Court of Justice in 2012.

In 2007 a federal judge ruled in a national class action case that AstraZeneca and two other companies had to pay damages in connection with overcharging Medicare and private insurance companies. The judge singled out AstraZeneca for acting “unfairly and deceptively” in its pricing of prostate cancer drug Zoladex. AstraZeneca was later hit with a $12.9 million judgment. In 2010 AstraZeneca agreed to pay $103 million to settle a national lawsuit accusing the company of overcharging for Zoladex and Pulmicort Respules asthma medication.

In 2009 AstraZeneca was one of four drug companies that entered into a settlement agreement under which they agreed to pay a total of $124 million to settle charges that they violated the federal False Claims Act by failing to provide required rebates to state Medicaid programs. AstraZeneca’s share of the total settlement amount was $2.6 million.....

Read the full history of this company's behaviour here.