Russian roulette (noun) the practice of loading a bullet into one chamber of a revolver, spinning the cylinder, and then pulling the trigger while pointing the gun at one’s own head. An activity that is potentially very dangerous.
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Officials have no answers about legal liabilities for vaccine’s potential side-effects FULL STORY HERE: https://www.4cmitv.com/2020/08/23/2020-aug-23-the-fine-print-australia-astrazeneca-exempt-from-coronavirus-vaccine-liability-claims-vaccine-wont-be-the-end-of-covid-19/
The government’s signing of a letter of intent with Britain’s AstraZeneca to secure the Oxford University vaccine has raised questions over the exact nature of the agreement, with finer details around numbers and rollout not yet announced.
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Prime Minister Scott Morrison promised “every single Australian” would get the vaccine for free under the “deal” with AstraZeneca.
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Vaccine won’t be the end of COVID-19: WHO [WHO Europe’s regional director Hans Kluge on Thursday urged people to prepare to live with the COVID-19 virus, and not rely on a vaccine to bring an end to the pandemic.]
The government said “a final formal agreement will include distribution, timing and price of the vaccine” but those details are not yet ironed out.
“The next step will be to conclude other contractual agreements, including arrangements with a selected manufacturer who can produce the vaccine locally,” an AstraZeneca spokeswoman told The New Daily.
“We look forward to confirming the next steps with the Australian government and other critical partners shortly.”
But neither Department of Health officials nor the company itself would shed light on whether Australia had agreed – or would agree – to conditions around indemnification for AstraZeneca against potential legal liability for side-effects of the vaccine.
Reuters reported last month that Ruud Dobber – AstraZeneca executive vice-president, and president of its biopharmaceuticals business unit – said “we as a company simply cannot take the risk if in … four years the vaccine is showing side effects.”
“In the contracts we have in place, we are asking for indemnification,” he said, according to Reuters.
The New Daily has put questions to the office of the federal Health Minister Greg Hunt.
In a written response, the federal Department of Health would only say that details of negotiations with AstraZeneca “are commercial in confidence.”
In a press conference on Thursday, deputy chief medical officer Professor Michael Kidd was unable to comment.
“I am sorry, I have not seen the letter of intent that has been signed so I am unable to provide any advice on its content,” he said in response The New Daily‘s question.
AstraZeneca also declined to comment on the indemnification claims or the comments of the company’s executive but did not deny the report.
“We are still in the early stages of our discussions with the Australian government to continue to ensure broad and equitable access to the vaccine to as many countries as possible, should clinical trials prove to be successful,” a company spokeswoman said.
“We are committed to doing this at no profit during the pandemic. Safety of the vaccine is the most utmost importance to us and development continues in late-stage trials globally assessing safety, efficacy and immunogenicity.”
“We are not able to comment further on the details of the Australian agreement at this stage.”
Dr Kerryn Phelps, former president of the Australian Medical Association and former federal Member for Wentworth, said she and other doctors hoped more details about a potential vaccine agreement would be made public.
“The medical profession would like to know what is in this ‘letter of intent’. There are well in excess of 100 vaccines in development, and right now we don’t know which will be most effective or the safest,” she told The New Daily.
“Hearing this announcement about a ‘deal’, and not knowing what’s in the letter of intent, makes me, as a doctor, feel a bit anxious about what’s been agreed between the government and this pharmaceutical company and whether it limits our access to potentially better vaccines.”
Dr Phelps said the most effective forms of some vaccines, such as one for shingles, were not available to Australians while they were available to Americans – and that she didn’t want to see Aussies blocked from accessing the most potent coronavirus vaccine due to limitations in manufacturing or obligations under a previous deal.
“Given taxpayers are the ones to be paying for it, we deserve to know what’s been agreed.”
Dr Phelps went as far as to say that Australia should not rush to sign up to a potentially unproven vaccine, calling for patience and commitment to current social distancing and hygiene measures instead.
“A new vaccine is not something you can rush. It’s better to continue all of the other preventive community measures like wearing masks, regular hand washing, physical distancing, avoiding crowds,” she said.
“It’s far better than the alternative of letting the virus run – but also better than lining Australians up for a mass immunisation program without rigorous testing.”
Original Source: Date-stamped: 2020 AUG 21 | Time-stamped: 6:00 am | Author: Josh Butler | Article Title: The New Daily AU: Officials have no answers about legal liabilities for vaccine’s potential side-effects | Article Link: thenewdaily.com.au
REUTERS HEADLINES: AstraZeneca to be exempt from coronavirus vaccine liability claims in most countries
AstraZeneca has been granted protection from future product liability claims related to its COVID-19 vaccine hopeful by most of the countries with which it has struck supply agreements, a senior executive told Reuters.
With 25 companies testing their vaccine candidates on humans and getting ready to immunise hundred millions of people once the products are shown to work, the question of who pays for any claims for damages in case of side effects has been a tricky point in supply negotiations.
“This is a unique situation where we as a company simply cannot take the risk if in … four years the vaccine is showing side effects,” Ruud Dobber, a member of Astra’s senior executive team, told Reuters.
“In the contracts we have in place, we are asking for indemnification. For most countries it is acceptable to take that risk on their shoulders because it is in their national interest,” he said, adding that Astra and regulators were making safety and tolerability a top priority.
EU officials told Reuters this week product liability was among contentious points in European efforts to secure supply deals for potential COVID-19 vaccines from Pfizer, Sanofi and Johnson & Johnson.
The United States, however, already has a law to exclude tort claims from products that help control a public-health crises in the form of the 2005 Public Readiness and Emergency Preparedness, or PREP Act.
AstraZeneca, Britain’s second-largest drugmaker, has pledged to supply a total of more than 2 billion doses at no profit in agreements with the United States, Britain and European countries, among other nations and organisations.
To back its claim to forgo profits from the $1.2 billion collaboration in the United States, Astra has even granted the government access to financial accounts related to the venture, according to Dobber.
“There are very clear milestones before they are going to pay. Because we made the promise to manufacture the vaccine at no profit, auditors of the U.S. administration will get free access to our accounting books,” he said.
Original Source: Date-stamped: 2020 JUL 30 | Time-stamped: 9:22 PM | Author: Ludwig Burger, Pushkala Aripaka | Article Title: AstraZeneca to be exempt from coronavirus vaccine liability claims in most countries | Article Link: uk.reuters.com
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The New Daily AU: Officials have no answers about legal liabilities for vaccine’s potential side-effects: Australian health officials and drug maker AstraZeneca have declined to comment on whether the pharma company is seeking indemnification against potential liability arising from any side effects of its vaccine candidate.
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