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Post by Abacus on 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 on 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 on 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 on 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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