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Post by Abacus Sat Dec 19, 2020 10:57 pm

(December, 2005) The Public Readiness and Emergency Preparedness Act (PREPA)
passed by the United States Congress and signed into law by President of the United States George W. Bush in December 2005,
is a controversial tort liability shield intended to protect vaccine manufacturers from financial risk
in the event of a declared public health emergency. The act specifically affords to drug makers immunity
from potential financial liability for clinical trials of avian influenza vaccine
at the discretion of the Executive branch of government.
PREPA strengthens and consolidates the oversight of litigation against pharmaceutical companies
under the purview of the secretary of Health and Human Services (HHS).


(July 30, 2020) AstraZeneca to Be Exempt From Coronavirus Vaccine Liability Claims in Most Countries
"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. Dobber would not name the countries.
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.

(August 21, 2020) Japan to shoulder COVID vaccine liability risks
TOKYO -- Japan's government plans to cover compensation for any health problems
that may arise here from coronavirus vaccines, seeking to ensure a stable supply
from foreign manufacturers as global competition intensifies, Nikkei has learned.
Japan has signed contracts with Pfizer and with AstraZeneca for 120 million doses each of their experimental vaccines.
The safety and efficacy of vaccines can vary depending on patients' ethnic background,
and vaccines that have undergone widespread testing in Europe and the U.S. could cause unexpected problems in Japan.
Having a vaccine approved and brought to market normally takes five to 10 years, or even longer.
For COVID-19, the goal is to compress this timeline to about a year.

(August 21, 2020) Drugmakers Shielded from COVID Vaccine Liability But Funds for Injury Claims in Doubt
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.
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.
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.

(August 21, 2020) Coronavirus: Belgian experts ‘shocked’ as AstraZeneca seeks liability waiver for vaccine
As it enters the final stages of human trials in the development of a vaccine against the new coronavirus,
drugmaker AstraZeneca has introduced several requests to be protected from future claims of liability.
Thierry Vansweevelt, professor of medical law at the University of Antwerp
called the request “very exceptional” and even “slightly shocking,”
in light of existing EU regulations on companies’ liability for what they put on the market.
“There is a European directive on product liability,” Vansweevelt said.
“Any producer who places a defective product on the market is responsible for that without exceptions.
You can’t escape that.” But, Ruud Dobber, an AstraZeneca executive, told Reuters that most countries
with whom it had signed procurement deals had already granted its request, but refused to name the countries in question.

(September 24, 2020) Europe Indemnifies COVID-19 Vaccine Makers in Case of Side Effects
Sue Middleton, president of the executive board of Vaccines Europe, said in a European Parliament hearing that,
under the advance purchase agreements in place, the commission or EU member states would “essentially indemnify the companies
against the cost of legal action” arising from claims of adverse events.
Although vaccines may cause certain known side effects,
unexpected side effects of vaccines are relatively rare, Middleton said.
However, she noted that some did occur in previous mass vaccination campaigns,
such as for measles, mumps and rubella. A commission spokesperson acknowledged
that EC agreements with vaccine suppliers provide for EU “member states to indemnify the manufacturer
of certain liabilities incurred under specific and strict conditions,” but she declined to elaborate what those conditions are.

(October 25, 2020) A Federal Coronavirus Vaccine Contract Released At Last, But Redactions Obscure Terms
Overall, there is a lack of disclosure around the terms of the federal contracts
with companies involved in the crash program to make COVID-19 vaccines.
Most of the contracts haven’t been released.
While the publicly posted Moderna contract includes previously unknown details, extensive redactions leave the public in the dark
about some of the company’s obligations as well as the extent of protections for taxpayers.
It’s 53 pages long, but only 14 of them are free of redactions.
Some of the redactions obscure information that has already been disclosed.
The value of the contract, for example, is blacked out with a note
that it isn’t disclosable under public records law because it is a trade secret.

(October 26, 2020) Coronavirus document disclosure motion could ‘jeopardize’ vaccine for Canadians
Procurement Minister Anita Anand says if opposition parties approve a parliamentary probe
of the government’s handling of the coronavirus pandemic — including some of its sensitive contracts —
then suppliers for coronavirus vaccine candidates and protective gear could “walk away.”
“I do not want to be back here to explain to Canadians that because of the disclosure we were forced to make,
we were not able to secure vaccines or PPE for Canadians because our supplies chose to walk away,”
she said during a press conference on Monday morning.
“I am seriously saying our contracts – vaccines, PPE, rapid test kits – are in jeopardy.”
Pharmaceutical giant Pfizer Canada is among those raising concerns about the motion, set to be voted on in the House of Commons Monday.

(December 3, 2020) Coronavirus vaccine: Pfizer given protection from legal action by UK government
The UK government has granted pharmaceutical giant Pfizer a legal indemnity protecting it from being sued,
enabling its coronavirus vaccine to be rolled out across the country as early as next week.
The Department of Health and Social Care has confirmed the company has been given an indemnity
protecting it from legal action as a result of any problems with the vaccine.
Ministers have also changed the law in recent weeks to give new protections to companies such as Pfizer,
giving them immunity from being sued by patients in the event of any complications.

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Post by Abacus Wed Dec 23, 2020 7:26 pm

(December 20, 2020) SII calls for protection against “frivolous” lawsuits
The chief executive officer of the Serum Institute of India, Adar Poonawalla,
has said the government should provide vaccine makers indemnity against lawsuits,
saying such legal challenges will “ or distract them if they have to just all-day fight lawsuits
and explain to the media what is happening”. SII is expected to get approval
for distributing the vaccine developed by the Oxford University and AstraZeneca;
it also has a deal to make the Novavax vaccine.

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Post by Abacus Tue Dec 29, 2020 9:48 pm

(December 21, 2020) COVID-19 vaccination in the EU: Are the contracts with the companies publicly available?
Contracts are protected for confidentiality reasons, which is warranted by
the highly competitive nature of this global market. This is in order
to protect sensitive negotiations as well as business related information,
such as financial information and development and production plans.
Disclosing sensitive business information would also undermine
the tendering process and have potentially far-reaching consequences
for the ability of the Commission to carry out its tasks as set out in the legal instruments
that form the basis of the negotiations. All companies require that such sensitive business
information remains confidential between the signatories of the contract.

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Post by Abacus Tue Dec 29, 2020 10:32 pm

(December 17, 2020) You can’t sue Pfizer or Moderna if you have severe Covid vaccine side effects. The government likely won’t compensate you for damages either
If you experience severe side effects after getting a Covid vaccine, lawyers tell CNBC there is basically no one to blame in a U.S. court of law.
The federal government has granted companies like Pfizer and Moderna immunity from liability if something unintentionally goes wrong with their vaccines.
You also can’t sue the Food and Drug Administration for authorizing a vaccine for emergency use,
nor can you hold your employer accountable if they mandate inoculation as a condition of employment.
In February, Health and Human Services Secretary Alex Azar invoked the Public Readiness and Emergency Preparedness Act.
The 2005 law empowers the HHS secretary to provide legal protection to companies making or distributing
critical medical supplies, such as vaccines and treatments, unless there’s “willful misconduct” by the company. The protection lasts until 2024.
HHS declined CNBC’s request for an interview.

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Post by Abacus Sat Feb 06, 2021 5:12 pm

(February 3, 2021) (South African) Treasury has indemnified two vaccine producers
Finance minister Tito Mboweni has granted indemnity to two vaccine manufacturers to date,
the Serum Institute of India, which will supply SA with the AstraZeneca vaccine, and Pfizer,
the Treasury confirmed on Tuesday. Governments across the world are being required
to take liability in the event of serious adverse events that arise from Covid-19 vaccination.
businesslive.co.za/bd/national/2021-02-03-treasury-has-indemnified-two-vaccine-producers/



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Post by Abacus Tue Feb 23, 2021 8:45 pm

(February 23, 2021) If you die from the COVID-19 vaccine in Japan, the government will give your family over ¥44 mil
Japan began distributing the COVID-19 vaccine on Feb 17. While a little behind other developed countries, they seem to be trying
to do it in as organized fashion as possible, staggering vaccinations to medical staff, the elderly, people with health conditions,
and everyone else in that order. It’s not without its challenges, however, and one of them remains the Japanese people’s general skittishness when it comes to vaccines.
However, some who fear that the prevention might be worse than the disease may be swayed by a recent report that the Ministry of Health, Labour and Welfare will award a lump sum of 44,200,000 yen
to the surviving family of any person who dies as a result of the COVID-19 vaccine and even cover funeral costs up to 209,000 yen.
It doesn’t even matter if there was negligence on the part of medical staff or the vaccine producer. In other words, there’s no strings attached.
japantoday.com/category/features/health/If-you-die-from-the-COVID-19-vaccine-in-Japan-the-government-will-give-your-family-over-%C2%A544-mil

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Post by Abacus Tue Feb 23, 2021 9:36 pm

(February 18, 2021) Duterte certifies indemnity fund bills for Covid-19 vaccines as urgent
President Rodrigo Duterte has certified as urgent the proposed measures seeking to ensure availability of funds to compensate Filipinos
in case they die or suffer from severe side effects after receiving Covid-19 vaccines.
An indemnification law is expected to hasten the delivery of Covid-19 vaccines in the country,
since it is among the requirements of vaccine manufacturers to exempt them from liability
should their products cause serious adverse effects to vaccine takers.
tribune.net.ph/index.php/2021/02/18/duterte-certifies-indemnity-fund-bills-for-covid-19-vaccines-as-urgent/

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Post by Abacus Tue Mar 23, 2021 9:28 pm

(March 23, 2021) President Rodrigo Duterte questions indemnity clause in vaccine contracts
MANILA – President Rodrigo Duterte on Monday questioned the demand
of vaccine manufacturers for the national government to shoulder liability
for adverse effects of Covid-19 vaccines procured by the private sector.
Duterte, a lawyer and former prosecutor, said he found “holes” under the indemnity clause
in vaccine procurement contracts that require government to assume liability for private sector-procured vaccines.
“The government cannot guarantee much less give you an immune status na (that) you are freed of any and all liability.
I think we cannot even do that even if we wanted to yung assumption of liability,” he said in a pre-recorded public address.
pna.gov.ph/articles/1134533


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Post by Abacus Mon Mar 29, 2021 9:44 pm

(March 29, 2021) Pfizer Demands South African Ministers Personally Sign Vaccine Pact
Pfizer Inc. is demanding that South Africa’s health and finance ministers
personally sign a Covid-19 vaccine-supply agreement so that it is indemnified
from any claims made against it in the country regarding the shot.

The demand is contained in a March 24 letter from South Africa’s Health Minister Zweli Mkhize
to his finance counterpart Tito Mboweni, seen by Bloomberg and confirmed by the National Treasury.
Pfizer was not satisfied by assurances that the signature of the country’s health director general was sufficient to guarantee the indemnity, Mkhize said.
bloomberg.com/news/articles/2021-03-29/pfizer-demands-s-african-ministers-personally-sign-vaccine-pact


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Post by Abacus Thu Apr 15, 2021 9:27 pm

(April 11, 2021) No legal risk for GPs administering AstraZeneca vaccine: Health Minister
With a Sydney Morning Herald report from Sunday morning indicating many GPs are refusing to offer the AstraZeneca
COVID vaccine to people under 50 ‘until the Federal Government urgently clarifies legal liability
if patients suffer serious or fatal side effects’,

the Federal Health Minister was resounding in his message later in the day.
‘I want to make something very, very clear,’ Greg Hunt told reporters. ‘Australia already has vaccine indemnity agreements in place.
The AMA and [Royal Australian] College of General Practitioners have clear advice in writing from the Government to that effect,

and they also have updated informed consent material, so no doctor need worry.
racgp.org.au/newsgp/professional/no-legal-risk-for-gps-administering-astrazeneca-va

(April 12, 2021) US covid contract details are a “trade secret”—according to the contractors
After reporting on the struggles of the US’s $44 million vaccine management system,
we requested documents related to the CDC’s no-bid contracts for the underlying software, awarded to consulting giant Deloitte.
The records we got back had significant redactions—including the company’s costs, the identities of those who worked on the project,
and even Deloitte’s explanation for why it was qualified to do the job.

All the redactions cite a rule in the Freedom of Information Act commonly referred to as Exemption 4,
which allows companies to hide “commercial information” such as trade secrets from the public.
The contractor, rather than the government, decides what is considered sensitive information.
When a government agency receives a request for records, it sends that request to the contractors, who mark what they want to keep secret.

Companies have essentially free rein to call contract details “confidential business information,” thanks to a 2019 decision by the Supreme Court.
Before that, companies had to explain why releasing the information would cause “substantial harm” to their business.
“Now all the agency has to do is get an affidavit from someone at the company that says, ‘We treat this as confidential business information.’ Period.
technologyreview.com/2021/04/12/1022460/us-covid-contract-redaction-deloitte/

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Post by Abacus Wed Apr 21, 2021 9:28 pm

(April 18, 2021) The ‘secret’ contracts for Pfizer and Moderna vaccines: the exclusive of “Report”
The European Union has kept them hidden for months: first it refused to publish them, then it covered sensitive data with a series of omissions.
The transmission of Rai 3 came into possession of the contracts and published in full the first contracts
for the purchase of the anti-Covid vaccines stipulated by Brussels at the end of 2020 with Pfizer and Moderna.

The figure of € 15.50 per dose for the Pfizer-Biontech vaccine which has been talked about for months, in fact, is not exactly correct.
That’s just the average between two different prices agreed with the pharmaceutical company.
The contracts also confirm that, in the event of damage from side effects, the compensation will fall almost exclusively on the states.

Patents, on the other hand, remain in private hands, despite the indemnity and public funding.
ruetir.com/2021/04/18/the-secret-contracts-for-pfizer-and-moderna-vaccines-the-exclusive-of-report/

(April 21, 2021) SA's vaccine compensation fund could cost R250m in first year - Mkhize
Cape Town - The government's compensation fund to cover potential injuries from Covid-19 vaccines could cost around R250 million in the first year,
the health minister said in response to questions in Parliament. The African country hardest-hit by the coronavirus pandemic in terms of infections
and deaths told vaccine manufacturers Johnson & Johnson and Pfizer it would set up the fund during negotiations to buy shots.

Mkhize said the potential cost was based on an estimate of between 800 and 2 000 successful claims
and included the administrative costs of the fund. He said a committee
of experts would develop a vaccine injury table to assess compensation applications.

The minister said last week that the government had agreed to fully indemnify J&J and Pfizer
against third-party claims and that vaccine manufacturers had made "difficult and sometimes unreasonable" demands
during negotiations including non-refundable downpayments.
iol.co.za/news/politics/sas-vaccine-compensation-fund-could-cost-r250m-in-first-year-mkhize-47a42070-14c4-4738-a21a-c3bff070f385

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