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AstraZeneca (Oxford Jenner Institute, vaccine AZD1222 (ChAdOx1 nCoV-19), CEPI, BARDA, GAVI )

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AstraZeneca (Oxford Jenner Institute, vaccine AZD1222 (ChAdOx1 nCoV-19), CEPI, BARDA, GAVI ) Empty AstraZeneca (Oxford Jenner Institute, vaccine AZD1222 (ChAdOx1 nCoV-19), CEPI, BARDA, GAVI )

Post by Abacus Wed Dec 23, 2020 7:43 pm

History:
AstraZeneca was founded in 1999 through the merger of the Swedish Astra AB and the British Zeneca Group
(itself formed by the demerger of the pharmaceutical operations of Imperial Chemical Industries in 1993).
Since the merger AZN has been among the world's largest pharmaceutical companies and has made numerous corporate acquisitions,
including Cambridge Antibody Technology (in 2006), MedImmune (in 2007), Spirogen (in 2013) and Definiens (by MedImmune in 2014).
Also since the merger, the combined company has been embroiled in numerous controversies over illegal marketing, product safety, anticompetitive behavior and tax avoidance.
In 2013, AstraZeneca moved its headquarters to Cambridge, United Kingdom, and concentrated its R&D in three sites: Cambridge; Gaithersburg, Maryland, USA (location of MedImmune)
for work on biopharmaceuticals; and Mölndal (near Gothenburg) in Sweden, for research on traditional chemical drugs.

(January 2018) Google’s parent firm invests in UK company developing first ever universal flu vaccine
A private UK company developing a vaccine that would be the first in the world to fight all types of flu
has raised £20m from investors including GV, the venture capital arm of Google parent Alphabet.
Vaccitech, a spin-out founded by scientists at Oxford University’s Jenner Institute,
said on Monday the cash would help fund its vaccine through a two-year clinical trial involving more than 2,000 patients,
as well as expand other projects. The group is also running clinical studies on an experimental shot to prevent Middle East Respiratory Syndrome (Mers)
and a therapeutic prostate cancer vaccine for use with an immunotherapy drug.
Vaccitech’s new vaccine works by using proteins found in the core of the virus rather than those on its surface.
Surface proteins stick out like pins from the virus and change all the time, while those in the core are stable.
The vaccine also stimulates T-cells rather than antibodies – an approach that has yet to convince existing flu vaccine manufacturers such as Sanofi, GlaxoSmithKline and CSL’s Seqirus.
Vaccitech’s latest financing round was also supported by Sequoia China and Oxford Sciences Innovation.

(July 11, 2018) AstraZeneca, 4D team up to develop lung disease gene therapies
AstraZeneca and 4D Molecular Therapeutics have joined forces to develop gene therapies against chronic lung diseases.
The collaboration will use 4D’s adeno-associated virus (AAV) vectors
to create therapies that insert genes that code for therapeutic proteins into human cells.
AstraZeneca’s MedImmune and 4D are setting out on a path they hope will lead to such therapies.
4D is taking the lead on early steps in the process that are in its wheelhouse, such as vector discovery and engineering,
optimization and process development. MedImmune will take over early in clinical development,
enabling it to leverage AstraZeneca’s vast experience in respiratory diseases to power the programs forward.

(September 29, 2018) Vaccitech licenses MERS rights to Oxford University
CEPI (the Coalition for Epidemic Preparedness Innovations) today announced a collaboration with The Jenner Institute
at the University of Oxford and Janssen Vaccines & Prevention B.V.—part of the Janssen Pharmaceutical Companies of Johnson & Johnson
—through which they will receive funding to advance the development and manufacture of a vaccine against Middle East Respiratory Syndrome Coronavirus (MERS-CoV).
Oxford has already initiated clinical development of the MERS-CoV vaccine,
with funding from the UK Department of Health and Social Care, and a phase 1 clinical trial of the vaccine is underway in the UK.
Under the terms of the Framework Partnering Agreement for the collaboration, Oxford and Janssen will receive $14.6 million from CEPI
to support manufacturing of a phase 2 batch and preparation for stockpiling of a MERS-CoV vaccine candidate.
Oxford will undertake phase 2 testing of the vaccine, in partnership with the King Abdullah International Medical Research Centre (KAIMRC) in Riyadh,
Kingdom of Saudi Arabia, and the Kenya Medical Research Institute (KEMRI)-Wellcome Trust Research Programme at Kilifi, Kenya.

(May 22, 2019) AstraZeneca joins with BenevolentAI for drug discovery
Strategic partnership between AstraZeneca and BenevolentAI to use artificial intelligence and machine learning to identify new kidney and lung drugs.
Pharma giant AstraZeneca has announced a new long-term collaboration with artificial intelligence experts BenevolentAI.
The collaboration aims to combine AstraZeneca’s world-leading clinical data with BenevolentAI’s machine learning capabilities
and artificial intelligence to discover new drugs for chronic kidney disease (CKD) and idiopathic pulmonary fibrosis (IPF).
As a recent study in Respiration shows, CKD and IPF are two of the most fatal and prevalent age-associated diseases.

(July 4, 2019) Machine Learning is Transforming Drug Discovery at AstraZeneca
AstraZeneca has been experimenting with machine learning across all stages of research and development, and most recently in pathology
to speed up the review of tissue samples. AstraZeneca uses Amazon SageMaker Ground Truth
—a machine learning-powered, human-in-the-loop data labeling and annotation service—to automate
some of the most tedious portions of this work, resulting in reduction of time spent cataloging samples by 50 percent.
“We want to unlock all the hidden potential in the data and research we’re already doing,” says Goodwin.
“It’s the start of a broad change in our business—using all of this imaging and molecular data along with AI to develop a holistic approach,
one that lets our scientists interact and interpret the data in ways that have never been possible.”

Abacus
Guest


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AstraZeneca (Oxford Jenner Institute, vaccine AZD1222 (ChAdOx1 nCoV-19), CEPI, BARDA, GAVI ) Empty Re: AstraZeneca (Oxford Jenner Institute, vaccine AZD1222 (ChAdOx1 nCoV-19), CEPI, BARDA, GAVI )

Post by Abacus Wed Dec 23, 2020 7:49 pm

(April 30, 2020) AstraZeneca Joins U. of Oxford and Spinout to Develop COVID-19 Vaccine
AstraZeneca will oversee global development, manufacturing, and distribution of the COVID-19 vaccine
candidate that was created by researchers at University of Oxford, and is now being studied in a human clinical trial
launched last week, the partners said today. AstraZeneca, the University, and its spinout company Vaccitech
which has joint rights to the platform technology behind the vaccine candidate, ChAdOx1 nCoV-19—said
they will start work immediately while hammering out final terms of their collaboration agreement.
According to AstraZeneca, vaccines made from the ChAdOx1 virus
have been given to more than 320 people to date and have been shown
to be safe and well tolerated—although they can cause temporary side effects
such as a temperature, flu-like symptoms, headache or sore arm, the company acknowledged.

(May 21, 2020) U.S. Raises Ante in Vaccine Race With $1.2 Billion for Astra
The U.S. threw its weight behind one of the fastest-moving experimental solutions
to the coronavirus pandemic, pledging as much as $1.2 billion to AstraZeneca Plc
to help make the University of Oxford’s Covid vaccine.
The U.K. drugmaker received the money from the U.S. Biomedical Advanced Research and Development Authority (BARDA)
and said it has secured capacity to make 1 billion doses. Astra has identified supply chains in the U.S. and U.K., according to Soriot.
Soriot said Astra is working with groups including the World Health Organization,
the Coalition for Epidemic Preparedness Innovations(CEPI) and Gavi, the Vaccine Alliance,
on making sure the vaccine is allocated fairly so that poorer countries have access.
The company has supply agreements for 400 million doses.

(May 28, 2020) AstraZeneca locks up COVID-19 vaccine supply with Oxford BioMedica production deal
AstraZeneca is on the hook for millions of doses of the University of Oxford's front-runner COVID-19 vaccine candidate,
assuming it proves effective. To fill those orders, the British drugmaker has agreed to a short-term manufacturing deal
that will help it bridge the gap. AstraZeneca and Oxford BioMedica inked a one-year deal covering "multiple batches" of the University of Oxford's adenovirus-based
COVID-19 vaccine candidate, AZD1222 (ChAdOx1 nCoV-19), as part of a consortium aimed at speeding production of the shot.
The vaccine, developed by the University of Oxford’s Jenner Institute, contains the genetic material of the SARS-CoV-2 spike protein.

(June 5, 2020) 2 billion doses of the Oxford coronavirus vaccine will be available after a new deal that included $750m from Bill Gates, AstraZeneca says
The global supply of a potential coronavirus vaccine being developed at Oxford University has been doubled to 2 billion
after a deal including $750 million from the Bill and Melinda Gates Foundation.
The vaccine is being produced by AstraZeneca British drug maker, drawing on work by researchers from Oxford University.
It announced Thursday that it had signed agreements with the Coalition for Epidemic Preparedness Innovations (CEPI) and Gavi
the Vaccine Alliance to boost its supplies. The company has committed to mass-producing the vaccine before it has been proved effective, an unusual
step designed to compress the long timeline of vaccine production.
CEPI and Gavi are both charities supported the Bill and Melinda Gates Foundation and the World Health Organization.
The $750 million agreement with CEPI and Gavi will support manufacturing, procurement and distribution for 300 million of the 2 billion doses.
The statement also said that AstraZeneca struck a licensing partnership with the Serum Institute of India (SII),
the world's largest manufacturer of vaccines by volume, for 1 billion doses of the vaccine earmarked for low- and middle-income countries.

(June 7, 2020) AstraZeneca Approaches Gilead About Potential Merger
AstraZeneca Plc has made a preliminary approach to rival drugmaker Gilead Sciences Inc. about a potential merger,
according to people familiar with the matter, in what would be the biggest health-care deal on record.
The U.K.-based firm informally contacted Gilead last month to gauge its interest in a possible tie-up,
the people said, asking not to be identified because the details are private.
AstraZeneca didn’t specify terms for any transaction, they said.
AstraZeneca, valued at $140 billion, is the U.K.’s biggest drugmaker by market capitalization
and has developed treatments for conditions from cancer to cardiovascular disease.
Gilead, worth $96 billion at Friday’s close, is the creator of a drug (remdesivir)
that’s received U.S. approval for use with coronavirus patients.

(June 11, 2020) Emergent BioSolutions signs deal to make AstraZeneca COVID-19 vaccine
Emergent BioSolutions Inc said on Thursday it signed an $87 million deal to make AstraZeneca Plc's experimental COVID-19 vaccine
in the United States, boosting the British drugmaker's efforts to bring a vaccine to the market.
The deal comes weeks after the United States pledged up to $1.2 billion to secure 300 million doses
of AstraZeneca's vaccine, which is among the first to move into mid-stage trials.
Emergent, which has also signed a deal with Johnson & Johnson
to make its COVID-19 vaccine, said it would reserve some of its large-scale manufacturing
capacity through 2020 for AstraZeneca.

(June 13, 2020) AstraZeneca to deliver 400M vaccine doses to Europe once approved
AstraZeneca announced Saturday that it has reached an agreement with the Inclusive Vaccines Alliance of Europe
to supply as many as 400 million doses of the University of Oxford's COVID-19 vaccine, with deliveries beginning at the end of the calendar year.
"This agreement will ensure that hundreds of millions of Europeans have access to Oxford University's vaccine following approval," said Pascal Soriot,
AstraZeneca's chief executive officer, in a press statement. "With our European supply chain due to begin production soon,
we hope to make the vaccine available widely and rapidly. I would like to thank the governments of Germany, France, Italy and the Netherlands
for their commitment and swift response."
"AstraZeneca recognises that the vaccine may not work but is committed to progressing the clinical programme
with speed and scaling up manufacturing at risk," the company's statement said.

(June 15, 2020) AstraZeneca taps Catalent for COVID-19 vaccine finishing, packaging at Italian plant
British drugmaker AstraZeneca is shooting for the moon with its plan to produce 2 billion doses per year of a potential COVID-19 vaccine.
To reach that lofty goal, AstraZeneca has reached a deal with New Jersey-based Catalent
to help with the final stages of the shot's manufacturing.
Catalent will be tasked with finishing and packaging duties for AstraZeneca and the University of Oxford's COVID-19 vaccine candidate, AZD1222,
at its 305,000-square-foot manufacturing facility in Anagni, Italy, the CDMO said Monday.
As part of their agreement, Catalent will help AstraZeneca produce "hundreds of millions of doses" beginning in August 2020
and potentially running through March 2022, if the vaccine receives full regulatory approval.
Last week, AstraZeneca and Emergent BioSolutions inked an $87 million deal to manufacture doses of Oxford's adenovirus-based COVID-19 shot for U.S. supply.
The accord was part of the Trump administration's Operation Warp Speed initiative
to develop and rapidly scale production of targeted vaccines before the end of 2020.
For its part, Catalent will also work with Johnson & Johnson to help produce its COVID-19 vaccine hopeful.

(June 16, 2020) Cobra Biologics signs supply agreement with AstraZeneca for manufacture of COVID-19 vaccine candidate
Cobra Biologics (Cobra), part of the Cognate BioServices family, an international CDMO for biologics and pharmaceuticals,
today announced it has signed a supply agreement with AstraZeneca UK Ltd. ("AstraZeneca") to provide GMP manufacture of the adenovirus vector-based COVID-19 vaccine candidate AZD1222,
previously known as ChAdOx1 n-CoV-19. The production agreement is part of AstraZeneca's recently announced in-licensed programme with the University of Oxford
to ensure broad and equitable supply of the vaccine throughout the world, at no profit during the COVID-19 pandemic.
Cobra, along with other consortium members, will be manufacturing the vaccine with first deliveries to begin in the UK in September 2020.
Cobra is supported by leading shareholder EW Healthcare Partners, as well as Medivate Partners, a Middle Eastern Sovereign Wealth Fund and Blackrock,
who continue supporting the business and its expansion activities.

(June 16, 2020) AstraZeneca CEO Soriot says fast-tracked COVID-19 shot will protect for just one year
AstraZeneca, advancing a COVID-19 vaccine from the University of Oxford,
is among global frontrunners in the worldwide hunt for a viable vaccine.
Now, the drugmaker’s CEO says the vaccine is expected to provide protection for one year.
“We think that it will protect for about a year,” AstraZeneca CEO Pascal Soriot said on a Belgian radio station, according to reports.
After that protection runs out, it isn’t clear whether recipients would be instructed
to get another dose, or another vaccine, or rely on COVID-19 treatments if they're approved.
So far, Gilead's remdesivir is the only treatment with an emergency use authorization, but research is underway on many other options.
On Tuesday, researchers in the United Kingdom reported that the inexpensive steroid dexamethasone cut deaths by a third for patients on ventilation.
Numerous governments have already signed deals with the drugmaker to order doses,
including an agreement over the weekend from Italy, France, Germany and the Netherlands worth $843 million for 300 million doses.
Before that deal, AstraZeneca agreed to provide doses to the United Kingdom and inked a $1.2 billion agreement with the U.S. government for hundreds of millions of doses.
The company has also struck deals with CEPI and Gavi, the Vaccine alliance—plus the Serum Institute of India—to allow for access in low- and middle-income countries.

(June 29, 2020) AstraZeneca reaches supply deal with Brazilian government to produce millions of doses of COVID-19 shot
AstraZeneca and the government of Brazil have inked a deal valued at $127 million
to produce doses of the University of Oxford's adenovirus-based COVID-19 vaccine candidate, AZD1222,
as the country combats a rising count of new infections.
Brazil—which trails only the U.S. in terms of total reported COVID-19 cases and deaths—will make available around 30 million finished doses
of the vaccine, with roughly half that amount available by December, AstraZeneca said. Brazil has also committed to produce an additional 70 million doses,
with AstraZeneca supplying the unfinished vaccine at no cost.
The vaccine doses will be finished in Brazil by the Oswaldo Cruz Foundation, also known as Fiocruz,
as AstraZeneca does not have a vaccine production suite at its Brazilian manufacturing facility, the drugmaker said.
On Friday, local Japanese drugmaker Daiichi Sankyo said it was piecing together a supply deal with AstraZeneca for Oxford's shot
after the Japanese government agreed to sit down at the negotiating table to discuss a possible deal.
Daiichi Sankyo Biotech, a subsidiary of the Japanese drugmaker, plans to receive Oxford's undiluted vaccine, which it will finish at its own facilities.

(July 17, 2020) AstraZeneca and R-Pharm announce agreement to manufacture and export COVID-19 vaccine
AstraZeneca and R-Pharm announce a collaboration for the manufacturing of COVID-19 vaccine, AZD1222
aimed at preventing infection from the SARS-CoV-2 virus in Russia.
Under the agreement, R-Pharm will provide technological capabilities for the implementation of the project.
The vaccine vector was transferred to Russia, it is planned to produce the finished dosage form.
At the same time Russia will become one of the hubs for the production and supply of vaccines to international markets.
AstraZeneca is confident that, together with R-Pharm, will be able to provide millions of people with the vaccine in the most efficient way.
AstraZeneca recognises that the vaccine may not work but is committed to progressing the clinical programme with speed and scaling up manufacturing at risk.

(July 27, 2020) AstraZeneca pledges $174M to ramp up coronavirus vaccine supply deal with Emergent
With a $174 million manufacturing pact signed Monday, Maryland-based Emergent BioSolutions
will help produce bulk drug substance for AstraZeneca and Oxford's adenovirus-based COVID-19 shot starting this year.
The agreement follows a separate $87 million deal the companies inked in early June
to reserve space at Emergent's Baltimore Bayview facility for three years of commercial production.
The partnership now totals $261 million through 2021, with an option to expand in future years, Emergent said in a release.
AstraZeneca and Emergent's original deal in June reserved large-scale manufacturing capacity for Oxford's shot, dubbed AZD1222,
through at least 2020 with the possibility for more based on a "flexible capacity deployment model."

(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 6, 2020) AstraZeneca takes COVID-19 vaccine to China with BioKangtai deal for 200M-dose capacity by 2021
AstraZeneca reached a licensing deal with Chinese firm BioKangtai
to help provide its adenovirus vector-based COVID-19 vaccine candidate, created by the University of Oxford, to China,
AstraZeneca said (Chinese) in a social media post on Thursday. The pair will also explore the possibility of producing the vaccine for other markets.
Under the pact, AZ grants exclusive clinical development, production and commercialization rights
to the vaccine in China to BioKangtai, which will in return reserve enough capacity to make at least 100 million doses
of the shot by the end of 2020 and expand to 200 million doses per year
by the end of 2021. Financial terms were not disclosed.
AZ’s shot is only the third foreign COVID-19 vaccine candidate to have looped in China.
Fosun Pharma holds China rights to BioNTech’s mRNA program through a licensing agreement worth up to $135 million.
The pair just kicked off a phase 1 trial in China with the goal to enroll 144 healthy volunteers.
Outside of China, BioNTech and its partner Pfizer launched their 30,000-subject phase 3 efficacy trial last week.
In addition, Inovio previously teamed up with Beijing Advaccine Biotechnology for work on its DNA vaccine candidate, INO-4800.

(August 8, 2020) Brazilian billionaire Jorge Lemann leads initiative to build Covid-19 vaccine factory
Brazilian billionaire Jorge Lemann’s foundation and other business interests will fund the building of factory
to produce the COVID-19 vaccine being developed by Oxford University and pharmaceutical company AstraZeneca PLC.
The Lemann Foundation said in a statement on Friday that the 100 million reais ($18 million) factory
will be donated to Brazil’s premier biomedical research and development lab, the Oswaldo Cruz Foundation, or Fiocruz.
It said the factory will be ready to produce 30 million doses of the vaccine per month as of the beginning of 2021.
The Oxford/AstraZeneca vaccine is being tested on Brazilian volunteers in a study led by the Federal University of São Paulo that is also funded by the Lemann Foundation.
Other donors to the initiative to ensure Brazil can absorb the technology
to produce the potential vaccine include Brazilian brewer Ambev SA, Itaú Unibanco, the Votorantim Institute and the Behring Family Foundation.

(August 11, 2020) AstraZeneca bumps up vaccine deal with Brazil to $360M with more doses, licensing rights
Brazilian President Jair Bolsonaro ordered $360 million set aside last week for a supply and licensing deal with AstraZeneca for at least 100 million doses
of the University of Oxford's adenovirus-based COVID-19 vaccine.
An AstraZeneca spokesman said the new agreement "builds on" the drugmaker's earlier deal
with Brazil in June to supply around 30 million unfinished doses of the vaccine at a price tag of $127 million.
Brazil also committed to produce an additional 70 million doses, with AstraZeneca supplying the unfinished vaccine at no cost.
The vaccine doses were set to be finished and filled at Fiocruz
as AstraZeneca does not have a vaccine production suite at its Brazilian manufacturing facility.
The expanded Brazil deal comes as AstraZeneca looks to lock up manufacturing capacity to reach its stated goal of 2 billion doses produced annually.

(August 15, 2020) AstraZeneca concludes agreement with European Commission for supply of up to 400 million doses of AZD1222 COVID-19 vaccine
AstraZeneca has concluded an agreement with the European Commission (EC) to supply up to 400 million doses of the AZD1222 COVID-19 vaccine.
Pascal Soriot, chief executive officer, said: “This first vaccine agreement with the European Commission will ensure that millions of Europeans have access to the AZD1222 vaccine
following its approval. With production in our European supply chain soon to be started, we hope to make the vaccine available widely and rapidly,
with the first doses to be delivered by the end of 2020.
AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech.
It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus)
that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein.
After vaccination, the surface spike protein is produced,
priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.

(August 19, 2020) CSIRO welcomes Australian agreement with AstraZeneca to provide access to Oxford’s COVID-19 vaccine
CSIRO welcomes the Australian Government’s agreement with pharmaceutical company AstraZeneca,
to give Australians access to the University of Oxford’s COVID-19 vaccine,
should it prove successful, safe and effective. CSIRO also welcomes the news that the Australian Government is working with CSL and AstraZeneca
to assess whether it is possible to provide local manufacturing support for the vaccine,
should it prove successful. As Australia’s national science agency, CSIRO is playing a critical role
in the global efforts to develop a COVID-19 vaccine. In March this year, the Coalition for Epidemic Preparedness Innovations (CEPI) engaged CSIRO
to undertake a preclinical trial of Oxford’s vaccine candidate at the Australian Centre for Disease Preparedness (ACDP).
ACDP is CSIRO’s high-containment biosecurity facility, the only lab of its kind in the southern hemisphere.
CSIRO has shared early data from the preclinical trial with CEPI and Oxford University,
which enabled the vaccine candidate to progress on to phase 3 clinical (human) trials.

(August 21, 2020) Coronavirus: Belgian experts ‘shocked’ as AstraZeneca seeks liability waiver for vaccine
“In the US it is common for firms to cover for themselves in this way, but, in Europe, it is exceptional,”
Stefaan Callens, university professor of medical law at KU Leuven, told HLN.
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.
Dobber said that AstraZeneca could “simply not take the risk” of being faced with liability claims if “in four years the vaccine is showing side effects.”

(August 21, 2020) 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.
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.
The government said “a final formal agreement will include distribution, timing and price of the vaccine”
but those details are not yet ironed out.

(August 24, 2020) Catalent Signs Agreement with AstraZeneca to Expand Manufacturing Support for COVID-19 Vaccine AZD1222
SOMERSET, N.J.--(BUSINESS WIRE)--Catalent, Inc. (NYSE: CTLT), the leading global provider of advanced delivery technologies,
development, and manufacturing solutions for drugs, biologics, cell and gene therapies,
and consumer health products, today announced that Catalent Cell & Gene Therapy will provide drug substance manufacturing to AstraZeneca
for the University of Oxford’s adenovirus vector-based COVID-19 vaccine, AZD1222,
at Catalent’s commercial gene therapy manufacturing facility located in Harmans, Maryland.
Catalent will prepare the Harmans facility, close to Baltimore-Washington International (BWI) airport,
to enable multiple production trains to run in parallel to produce the vaccine candidate drug substance commencing late in the third quarter of 2020.
This agreement expands Catalent’s support of the AZD1222 program following the announcement in June
that Catalent’s facility in Anagni, Italy, will provide large-scale vial filling and packaging of AZD1222.

(August 30, 2020) Australian Religious Leaders Criticize ‘Immoral’ COVID-19 Vaccine Deal
SYDNEY, AUSTRALIA - A coronavirus deal signed by Australia with an international drug company is raising ethical concerns among prominent church leaders.
Australia has signed a deal with the pharmaceutical company AstraZeneca to produce and distribute a vaccine being developed by Britain's Oxford University...
if the treatment works. But three of Australia's most senior archbishops have written to Prime Minister Scott Morrison urging him to reconsider the agreement,
saying the use of "fetal tissue” in the research is “deeply immoral.”
“To use that tissue then for science is reprehensible,” said Glenn Davies, Anglican Archbishop of Sydney.
“Once I know something that is morally compromised, it is my job to speak out about it.”
The Oxford University study uses embryonic kidney cells harvested from a female fetus in the Netherlands in 1973.

(September 3, 2020) AMRI Selected to Support AstraZeneca in Delivery of COVID-19 Vaccine
ALBANY, N.Y.--(BUSINESS WIRE)--Albany Molecular Research, Inc. (AMRI), a leading global provider of advanced drug development
and manufacturing solutions, today announced that it has signed a supply agreement with AstraZeneca
to support the manufacture of AstraZeneca’s COVID-19 vaccine candidate AZD1222, intended to protect against the SARS-CoV-2 novel coronavirus.
On May 21, 2020, AstraZeneca announced it had received more than $1B from the U.S. Biomedical Advanced Research and Development Authority (BARDA)
for the development, production and delivery of the COVID-19 vaccine it is developing in cooperation with University of Oxford.
AMRI has been chosen to contribute to the supply of the vaccine candidate through sterile fill/finish of AZD1222 at AMRI’s drug product manufacturing facility in Albuquerque, New Mexico.

(September 3, 2020) AstraZeneca's COVID-19 vaccine to be tested at military sites
Five Department of Defense facilities will participate in the Phase 3 trial of a COVID-19 vaccine, the Pentagon announced Thursday.
According to the Department of Defense, researchers are still seeking volunteers
for the next phase of testing for AZD1222, a COVID-19 vaccine candidate under development by AstraZeneca.
The upcoming trial will take place at
- Naval Medical Center in San Diego,
- Joint Base San Antonio,
- Wilford Hall Ambulatory Surgical Center in San Diego,
- Walter Reed National Military Medical Center in Bethesda, Md.,
- and Fort Belvoir Community Hospital in Fort Belvoir, Virginia.

"The Department of Defense continues to play a key role in the development of a potential COVID-19 vaccine,"
Tom McCaffery, assistant secretary of defense for health affairs, said in a statement.
The vaccine is the result of a partnership between AstraZeneca and Oxford Vaccine Group,
with funding from the Biomedical Advanced Research and Development Authority,
a branch of the U.S. Department of Health and Human Services, as well as the British government.

(September 9, 2020) AstraZeneca Vaccine Tests Face Delay After Patient Gets Ill
AstraZeneca Plc stopped giving shots of its experimental coronavirus vaccine after a person participating in one of the company’s studies got sick,
a potential adverse reaction that could delay or derail efforts to speed an immunization against Covid-19 for the world.
The pause stemmed from a standard review of the company’s vaccine trials after one person developed an unexplained illness (transverse myelitis, inflammation of the spinal cord)
AstraZeneca said in a statement. The move was intended to give researchers time to examine safety data
while maintaining the integrity of the trials, the company said.
Paul Offit, a pediatrician and vaccine expert at the Children’s Hospital of Philadelphia,
said the AstraZeneca shot involves giving large doses of a monkey adenovirus engineered
so it can’t replicate. It is therefore important for researchers to investigate
whether the adverse event wasn’t somehow being triggered by a reaction to that large viral dose, he said.
“When you have that kind of viral load, you can have side effects,” said Offit.

(September 12, 2020) AstraZeneca Resumes Its COVID-19 Vaccine Trials In The U.K.
Drugmaker AstraZeneca announced Saturday that its COVID-19 vaccine studies have resumed in the United Kingdom,
though not yet in the United States. The vaccine trials had been placed on hold
around the world earlier in the week after a U.K. participant in one of the studies developed a neurological illness.
AstraZeneca said it cannot disclose further medical information because it is the study sponsor,
but added in its statement, "All trial investigators and participants will be updated with the relevant information,
and this will be disclosed on global clinical registries, according to the clinical trial and regulatory standards."
In late July, results of a preliminary safety and effectiveness study found that more than two-thirds
of the people who received the experimental vaccine reported fatigue and headache after inoculation.
Muscle aches and fever were also common. In May, the Trump administration awarded the AstraZeneca
effort up to $1.2 billion from the Biomedical Advanced Research and Development Authority as part of Operation Warp Speed,
the administration's push to have a widely available coronavirus vaccine by January.

(September 17, 2020) Italy could have AstraZeneca COVID-19 shots by end November, IRBM biotech says
Italy could have its first shots of British drugmaker AstraZeneca's potential COVID-19 vaccine by the end of November,
the managing director of IRBM told Reuters. Biotech firm IRBM, whose lab is based south of Rome,
is cooperating with AstraZeneca in developing a vaccine
for the disease which has caused more than 35,600 deaths in Italy.

(October 13, 2020) AstraZeneca secures federal backing for investigational monoclonal antibody COVID-19 therapy
The Department of Health and Human Services (HHS) and Department of Defense (DoD)
have awarded a contract of $486 million
to AstraZeneca’s late-stage development and large-scale manufacturing of the AZD7442
investigational treatment for COVID-19, according to a press releases.
AZD7442 is a cocktail of two monoclonal antibodies
that may help treat or prevent infection with SARS-CoV-2.
AstraZeneca will receive approximately $486 million under Operation Warp Speed
for two Phase 3 clinical trials and related development activities,
including a large-scale manufacturing demonstration project and supply of AZD7442 doses in the U.S.

(October 21, 2020) Patient death casts a shadow on AstraZeneca's COVID-19 trial: report
A patient has died in the global study of AstraZeneca and the University of Oxford’s COVID-19 vaccine,
Brazil’s health authority, Anvisa announced on Wednesday. But despite the death, the study will carry on as normal,
Reuters reports. The person who died was Brazilian,
said the Federal University of Sao Paulo,
which is helping coordinate the trial in Brazil,
the news service said. It's not yet clear whether the death was related to the vaccine candidate.
"We cannot comment on individual cases in an ongoing trial of the Oxford vaccine as we adhere strictly to medical confidentiality
and clinical trial regulations, but we can confirm that all required review processes have been followed,” an AstraZeneca spokesperson said in an email.
The news comes a month after AstraZeneca, along with partner Oxford University, paused the study because a patient developed transverse myelitis,
or inflammation of the spinal cord that can be triggered by infections.
AstraZeneca isn't the only COVID-19 vaccine maker that's hit a roadblock. Just last week, Johnson & Johnson
suspended its own study because a patient developed an "unexplained illness."
Like AstraZeneca, J&J did not immediately know if the patient had received the vaccine candidate or placebo.

(October 23, 2020) AstraZeneca's U.S. COVID-19 trial is back on track after 45-day hold
It’s been a minute, but AstraZeneca has gotten the FDA’s all-clear to restart the U.S. study of its COVID-19 vaccine.
The British pharma slammed the brakes on the program in early September when a patient in the U.K. developed an inflammatory side effect.
The pause came just one week after the 30,000-patient U.S. trial had kicked off.
Now, the FDA has finished that review and told AstraZeneca it can restart the U.S. trial, the pharma giant confirmed Friday.
On Wednesday, Brazil’s health authority Anvisa announced a patient participating in the study had died but that the trial would carry on.

(October 27, 2020) Stevanato Group, Catalent Partner to Expedite Equipment Installation
Stevanato Group, a producer of glass primary packaging and capabilities for drug delivery systems,
has expanded its longstanding collaboration with Catalent to include the provision and accelerated delivery
of advanced visual inspection systems to help with potential vaccines and biologics to address the pandemic.
Catalent has ordered Plus 400 LKD automatic and PWL semi-automatic visual inspection machines from Stevanato
and will install the equipment at its sites in Bloomington, IN, and Anagni, Italy, to support various customer programs.

(November 21, 2020) Israel Says Agreed With AstraZeneca on COVID Vaccine Rations for 5 Million People
Israel said Friday it is in advanced stages of negotiations with British drug maker AstraZeneca
to secure the supply of a coronavirus vaccine for five million people.
Under to the agreement, AstraZeneca would provide some 10 million vaccine doses,
with its vaccine requiring two doses per person.
The initial supply of AstraZeneca vaccines would arrive in Israel in the first half of 2021
subject to regulatory authorities in Europe, the United States and Israel.
This deal would include the biggest supply of vaccines Israel has secured so far.
The talks to seal the deal are held on the order by Prime Minister Benjamin Netanyahu and Health Minister Yuli Edelstein.

(November 25, 2020) UK’s Johnson speaks with Mohammed bin Salman on phone call
British Prime Minister Boris Johnson spoke to Saudi Crown Prince Mohammed bin Salman
on the phone on Tuesday afternoon after the Kingdom hosted the Group of 20 virtual summit at the weekend.
In a statement, a Downing Street representative said Mr Johnson congratulated Saudi Arabia for hosting the summit
and for the “productive meetings” it brought about on the global recovery from the pandemic and tackling climate change.
“They discussed recent positive progress on the vaccine being developed by the University of Oxford and AstraZeneca
and the importance of ensuring global access to coronavirus vaccines,” the representative added.

(December 8, 2020) HALIX, AstraZeneca Ink Commercial COVID-19 Vax Mfg. Pact
HALIX B.V. signed an agreement with AstraZeneca for large-scale commercial drug substance manufacture of AZD1222, the adenovirus vector-based COVID-19 vaccine.
HALIX will provide commercial manufacturing of drug substance at its cGMP facility at the Leiden Bio Science Park in the Netherlands.
To meet the increased demand, HALIX has expanded with two additional viral vector production lines.
HALIX continues its key role as one of the original partners in the University of Oxford’s consortium
for the manufacture of AZD1222. The vaccine was co-invented by the University of Oxford and its spin-out company Vaccitech.

(December 11, 2020) Australia secures 20 M extra Astra Zeneca vaccines doses
The Australian Government has secured an additional 20 million doses of the "promising" AstraZeneca COVID-19 vaccine,
strengthening Australia’s position for whole-of-population vaccination.
This will mean a total delivery of 53.8 million Astra Zeneca vaccine doses in 2021,
covering the whole of population requirements. The extra 20 million doses
of the Astra Zeneca vaccine will be produced within Australia by CSL.
In addition, a further 11 million doses of the Novavax vaccine will be purchased,bringing the total for this vaccine to 51 million.
A purchasing agreement is also in place for the Pfizer/BioNTech COVID-19 vaccine, with 10 million doses scheduled for early 2021.
The Australian Government is also part of the international COVAX Facility which allows the purchases of over 25 million doses of a range of other potential vaccines.

(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.

(December 22, 2020) Malaysia inks agreement with AstraZeneca to procure 6.4 Million doses of COVID-19 vaccine
KUALA LUMPUR – The government has just signed an agreement with pharmaceutical company AstraZeneca
for the procurement of an additional 10 per cent or 6.4 million doses of the COVID-19 vaccine,
Prime Minister Tan Sri Muhyiddin Yassin announced. He said this meant that the government had secured 40 per cent
guarantee of vaccine supply through joint agreements with COVAX, Pfizer and AstraZeneca.
The government has previously signed preliminary agreements with Covax and Pfizer
for the procurement of the COVID-19 vaccine to secure a vaccine supply of 30 per cent of the population.
“The government is also in final negotiations with Sinovac, CanSino and Gamaleya
to secure a vaccine supply increase of more than 80 per cent or 26.5 million
of the country’s total population,” he said in a video on the recent development of COVID-19 vaccine for Malaysians today.

(December 23, 2020) Australia’s vaccine agreements
Australia has entered into 4 separate agreements for the supply of COVID-19 vaccines.
The Australian Government has invested more than $3.3 billion through these 4 agreements.
Astrazeneca:
- Australia has secured 53.8 million doses of this vaccine
- 3.8 million doses will be delivered to Australia in early 2021
- 50 million doses will be manufactured in Australia in monthly batches.
- CSL will manufacture these doses on behalf of AstraZeneca
Novavax:
- 51 million doses will be made available in Australia during 2021
Pfizer/BioNTech:
- 10 million doses will be available from early 2021
- these doses will be manufactured offshore
- Australia will have the option to purchase additional doses where supply is available.
COVAX Facility:
The Australian Government has made 2 financial commitments to Gavi’s COVAX Facility for the supply of safe and effective COVID-19 vaccines:
- An upfront payment of $123.2 million to allow the purchase of over 25,000,000 doses of COVID-19 vaccines for the Australian population.
- This would be sufficient for 50 percent of the population to receive a 2 dose regimen.
- A further $80 million to support vaccine access for up to 94 lower-income countries through the Facility’s Advanced Market Commitment.



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Post by Abacus Thu Dec 24, 2020 11:29 pm

(December 24, 2020) New Zealand secures AstraZeneca & Novavax COVID-19 vaccines
The new agreements secure access to 7.6 million doses from AstraZeneca — enough for 3.8 million people,
and 10.72 million doses from Novavax — enough for 5.36 million people.
Both vaccines require two doses to be administered.
The four pre-purchase agreements secured to date are:

- 750,000 courses from Pfizer/BioNTech;
- 5 million courses from Janssen;
- 3.8 million courses from the University of Oxford/AstraZeneca; and
- 5.36 million courses from Novavax.

Medsafe, the New Zealand Medicines and Medical Devices Safety Authority, has agreed to allow pharmaceutical companies
to make rolling applications for their COVID-19 vaccines, which means they may submit their data as it is completed and ready
for assessment to speed up the process. Pfizer and BioNTech and Janssen have already started to submit data for Medsafe's approval.
Medsafe is in close contact with its Australian counterpart throughout.

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Post by Abacus Sat Dec 26, 2020 9:56 pm

(December 26, 2020) Developers of Oxford-AstraZeneca Vaccine Tied to UK Eugenics Movement
Analysis by: Jeremy Loffredo and Whitney Webb

..For instance, mainstream media has had little, if anything, to say about the role of the vaccine developers’ private company – Vaccitech – in the Oxford-AstraZeneca partnership,
a company whose main investors include former top Deutsche Bank executives, Silicon Valley behemoth Google and the UK government.
All of them stand to profit from the vaccine alongside the vaccine’s two developers, Adrian Hill and Sarah Gilbert, who retain an estimated 10% stake in the company.

Yet, arguably most troubling of all is the direct link of the vaccine’s lead developers to the Wellcome Trust and, in the case of Adrian Hill, the Galton Institute,
two groups with longstanding ties to the UK Eugenics movement. The latter organization, named for the “father of eugenics” Francis Galton, is the re-named UK Eugenics Society,
a group notorious for its promotion of racist pseudoscience and efforts to “improve racial stock” by reducing the population of those deemed inferior for over a century.

The ties of Adrian Hill to the Galton Institute should raise obvious concerns given the push to make the Oxford-AstraZeneca vaccine he developed with Gilbert
the vaccine of choice for the developing world, particularly countries in Latin America, South and Southeast Asia and Africa,
the very areas where the Galton Institute’s past members have called for reducing population growth..

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Post by Abacus Sun Dec 27, 2020 10:16 pm

(December 26, 2020) UK scientists trial instant immunity antibody drug treatment for Covid-19
The University College London Hospitals NHS Trust (UCLH) said that the researchers in the Storm Chase study
believe a Long Acting AntiBody (LAAB) known as AZD7442, developed by AstraZeneca, may offer immediate and long-term protection
to people who have been recently exposed to the SARS-CoV-2 coronavirus and prevent them developing Covid-19.
UCLH said its new vaccine research centre is running two clinical trials testing a LAAB combination treatment to protect against Covid-19.
The second Provent study is looking at the use of AZD7442 in people who may not respond to vaccination,
for instance where someone has a compromised immune system or are at increased risk of Covid-19 infection due to factors such as age and existing conditions.
Antibodies are protein molecules that the body produces to help fight infections.
Monoclonal antibodies are artificially produced in a laboratory and designed as possible medical treatments.
They are designed to be injected directly into the body, unlike vaccines which “train” the immune system itself to produce antibodies.

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Post by Abacus Wed Dec 30, 2020 6:02 pm

(December 30, 2020) Covid-19: Oxford-AstraZeneca vaccine approved for use in UK
The Oxford-AstraZeneca vaccine has been approved for use in the UK, with the first doses due to be given on Monday.
The UK has ordered 100 million doses of the new vaccine - enough to vaccinate 50 million people.
The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised two full doses
of the Oxford vaccine, with the second dose to be given four to 12 weeks after the first.
Prime Minister Boris Johnson has hailed the latest vaccine development as "a triumph"
for British science, adding: "We will now move to vaccinate as many people as quickly as possible."

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Post by Abacus Thu Dec 31, 2020 7:01 pm

(April 13, 2018) Merck and Oxford University announce vaccines partnership
Merck have announced a partnership with Oxford University’s Jenner Institute
to develop more robust and scalable vaccine manufacturing processes.
The aim of the partnership is to make vaccines more affordable and available globally.
Through the collaboration with the Jenner Institute, the partners
will improve the manufacturing process for adenovirus vaccines
(vaccines based on adenovirus, a type of DNA virus, as a carrier) on a real-world feed stream.
Adrian Hill, Director of the Jenner Institute at Oxford University said,
“The newly developed process should match or exceed our existing process in terms of productivity and purity.



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Post by Abacus Fri Jan 01, 2021 10:46 pm

(January 1, 2021) Taiwan secures 10 M doses of AstraZeneca COVID-19 vaccine
Taiwan's Health Minister and Central Epidemic Command Center (CECC)
has announced that the country has purchased 20 million doses of coronavirus vaccines,
including 10 million from AstraZeneca. Taiwan is also developing three of its own domestic vaccines.
Head of CECC, Chen Shih-chung said that the center has negotiated the purchase of 20 million doses of vaccines,
including 4.76 million doses through the COVAX global initiative and 10 million doses of the Oxford/AstraZeneca vaccine.
Chen estimates that the center will begin inoculating Taiwanese residents with these vaccines by March of 2021.
In addition, discussions with several other foreign vaccine makers who have entered Phase III trials are ongoing.

(January 1, 2021) Expert panel approves Serum Institute's (SII) Covid-19 vaccine for emergency use
An Indian regulatory expert panel on Friday recommended emergency use authorization of the AstraZeneca-Oxford vaccine against Covid-19
manufactured by Serum Institute in India - clearing the decks for an unprecedented campaign aimed at vaccinating
30 crore people in the next few months. Sources said the approval for the first Indian Covid-19 vaccine
came from the Central Drug Standards and Control Organisation’s subject expert committee after lengthy presentation
by the company officials and detailed deliberations on the data they shared with the experts. There was no need for an efficacy evaluation
for which the data considered by the UK regulatory authority for the Oxford-Astra vaccine, was perused by the Indian experts.
But there is no clarity at the moment on what the gap between the two shots would be whether the two shots will be administered
four weeks apart as per the protocol or three months apart as decided by the UK government. There is also no clarity on the dosing schedule.
The CDSCO panel also heard a presentation from Bharat Biotech, Hyderabad on the homegrown Covid-19 vaccine but didn’t take a decision.

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Post by Abacus Tue Jan 05, 2021 9:48 pm

(November 1, 2010) Okairos SRL
Okairos SRL is working to commercialize therapies based on viral vectors it acquired
when Merck & Co. Inc. agreed in 2007 to spin out the technology from IRBM, a small subsidiary in Rome, Italy.

(May 30, 2013) GSK buys Swiss-based vaccine developer Okairos for €250 million
GlaxoSmithKline (GSK), one of the world’s leading research-based pharmaceutical and healthcare companies, has acquired Swiss-based, Okairos AG (Okairos),
a specialist developer of vaccine platform technologies for €250 million (approximately £215 million/$325 million) in cash.
Okairos, a private company, has developed a novel vaccine platform technology
which is expected to play an important role in GSK’s development of new prophylactic vaccines
(designed to prevent infection) as well as new classes of therapeutic vaccines (designed to treat infection or disease).
Okairos’ technology complements GSK’s existing vaccine technology and expertise and will enable GSK to continue its work developing the next generation of vaccines.
Under the terms of the transaction, GSK will take full ownership of the company and thus assume ownership of early stage assets for diseases
such as respiratory syncytial virus (RSV), hepatitis C virus (HCV), malaria, tuberculosis, ebola and HIV, supplementing the company’s existing vaccines pipeline.
Okairos was supported by investments from the following life science venture capital firms: BioMedInvest, the Boehringer Ingelheim Venture Fund, LSP, Novartis Venture Funds and Versant Ventures.

(August 30, 2014) International consortium to accelerate multi-site trials of Ebola vaccine candidate soon
An unprecedented international consortium assembled to accelerate collaborative multi-site trials of candidate Ebola vaccine.
A £2.8 million grant from the Wellcome Trust, the Medical Research Council (MRC) and the UK Department for International Development (DFID)
will allow a team led by Professor Adrian Hill, of the Jenner Institute at the University of Oxford,
to start safety tests of the vaccine alongside similar trials in the US run by
the National Institute of Allergy and Infectious Diseases (NIAID, a part of the NIH).
Dr Moncef Slaoui, Chairman of Global R&D and Vaccines at GSK said: “Today’s announcement shows how private and public partners can pull together to respond to this critical public health emergency.
Professor Adrian Hill, Director of the Jenner Institute at the University of Oxford said: “The tragic events unfolding in Africa demand an urgent response.
Dr Jeremy Farrar, Director of the Wellcome Trust, said: “This epidemic has shown how difficult it can be to control Ebola.
The initial safety work we're announcing today with our international partners will hopefully make that possible during this crisis and for inevitable future epidemics.”

(October 17, 2014) GlobalData says public-private partnerships vital to advance ebola treatment pipeline
Daian Cheng, Ph.D., GlobalData’s Analyst covering Infectious Diseases, states that despite a clear need for novel therapeutic approaches to combat Ebola,
the infection has not represented an attractive investment for pharmaceutical companies
due to its low incidence and the occurrence of outbreaks
in countries that cannot afford expensive medicines.
“So far, clinical-stage experimental treatments for Ebola have all been advanced,
at least in part, with the financial support of public entities,
and the contribution of public resources to R&D has only increased as fears of the virus have spread.”

(October 29, 2014) Swissmedic nod for trial on ebola vaccine
Swissmedic, the Swiss regulatory authority for therapeutic products has approved an application for a clinical trial with an experimental Ebola vaccine at the Lausanne University Hospital.
The trial will be conducted among 120 volunteer participants with support from the U.N. World Health Organization, Swissmedic said.
The experimental vaccine is to be initially administered on healthy volunteers who will be sent as medical staff to fight the Ebola epidemic in West Africa.
In a statement, the Bern-based Swiss government agency said the trial continues a series
that began in the United States, Britain and Mali, using a vaccine based on a genetically modified chimpanzee adenovirus.
The vaccine is based on a genetically modified chimpanzee adenovirus ("ChAd-Ebola"; Chimpanzee-Adenovirus chAD3-ZEBOV).
The trial will test the safety of the vaccine and its capacity to induce an immune response.
Developed by the US National Institute of Allergy and Infectious Diseases (NIAID) and pharmaceutical company GlaxoSmithKline,
the vaccine consists of a virus that is rendered harmless and used as genetic carrier for one Ebola protein.


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Post by Abacus Tue Jan 12, 2021 8:16 pm

(January 11, 2021) AMRI Included in BARDA CDMO Network
Albany Molecular Research, Inc. (AMRI), a global provider of advanced contract research, development and manufacturing solutions,
said that its Albuquerque, NM, facility has been approved for inclusion in the Biomedical Advanced Research and Development Authority (BARDA)
contract development and manufacturing organization (CDMO) network.
The network is part of a comprehensive effort by the U.S. government to improve preparedness capabilities.
AMRI’s Albuquerque location includes a large-scale fill and finish facility,
currently supporting COVID-19 vaccine production. Inclusion in the network recognizes AMRI’s pandemic preparedness,
its existing support of COVID-19 vaccine production, experience in government contracting
and its ability to support further BARDA contract work at Albuquerque.

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Post by Abacus Fri Jan 29, 2021 10:16 pm

(January 29, 2021) EMA approves AstraZeneca/Oxford Covid-19 vaccine
The European Union (EU)’s healthcare regulator the European Medicines Agency (EMA) has granted AstraZeneca (AZ)
and the University of Oxford conditional marketing authorisation for their two-dose Covid-19 vaccine.
This brings the total number of emergency-approved Covid-19 vaccines in the EU to three.
The EMA granted conditional marketing authorisation to Pfizer and BioNTech’s and Moderna’s
vaccines in late December and early January respectively. UK regulator
the Medicines and Healthcare products Regulatory Agency has approved the same
three vaccines but approved the AstraZeneca/Oxford jab at the end of December.
pharmaceutical-technology.com/features/ema-approves-astrazeneca-oxford-covid-19-vaccine/

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Post by Abacus Sun Feb 07, 2021 6:41 pm

(January 28, 2021) Coronavirus: Germany recommends AstraZeneca vaccine for under-65s only
dw.com/en/coronavirus-germany-recommends-astrazeneca-vaccine-for-under-65s-only/a-56371850

(January 29, 2021) EMA has recommended granting a conditional marketing authorisation for COVID-19 Vaccine AstraZeneca
to prevent coronavirus disease 2019 (COVID-19) in people from 18 years of age.
ema.europa.eu/en/news/ema-recommends-covid-19-vaccine-astrazeneca-authorisation-eu

(January 30, 2021) Italy agency cautious on AstraZeneca jab for over 55s
medicalxpress.com/news/2021-01-italy-agency-cautious-astrazeneca-jab.html

(February 1, 2021) Austria recommends AstraZeneca vaccine for under-65s only
thelocal.at/20210201/austria-recommends-astrazeneca-vaccine-only-for-under-65s

(February 2, 2021) French Health Body Recommends AstraZeneca Shot up to Age 64
bloomberg.com/news/articles/2021-02-02/french-health-body-recommends-astrazeneca-shot-up-to-age-64-kko8p3ag

(February 2, 2021) Sweden recommends AstraZeneca vaccine only for people aged under 65
thelocal.se/20210202/sweden-recommends-astra-zeneca-covid-vaccine-only-for-people-aged-under-65

(February 3, 2021) Belgium does not recommend AstraZeneca’s vaccine for over 55
euractiv.com/section/politics/short_news/belgium-does-not-recommend-astrazenecas-vaccine-for-over-55/

(February 4, 2021) Dutch latest to limit AstraZeneca vaccine to under-65s
medicalxpress.com/news/2021-02-dutch-latest-limit-astrazeneca-vaccine.html

(February 7, 2021) Spain limits Astra jab to under-55s, latest EU nation to put age curb
health.economictimes.indiatimes.com/news/policy/spain-limits-astra-jab-to-under-55s-latest-eu-nation-to-put-age-curb/80729991

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Post by Abacus Thu Feb 11, 2021 8:26 pm

(February 3, 2021) SII to supply 1.1 billion doses of Covid-19 vaccines to Covax vaccine scheme
India's Serum Institute will supply 1.1 billion doses of COVID-19 vaccines developed by AstraZeneca and Novavax
to the COVAX vaccine scheme as part of a new long-term deal, head of the U.N. Children's Fund said on Wednesday.
They would be produced by Serum under a technology transfer agreement, she said in a briefing.
The COVAX facility is co-led by GAVI, the World Health Organization (WHO),
the Coalition for Epidemic Preparedness Innovations(CEPI) and UNICEF.
hindustantimes.com/india-news/sii-to-supply-1-1-billion-doses-of-covid-19-vaccines-to-covax-vaccine-scheme-101612360625334.html

(February 4, 2021) Switzerland withholds approval for AstraZeneca Covid vaccine citing lack of evidence
Switzerland has said trials of AstraZeneca’s coronavirus vaccine did not produce clear data,
especially around its efficacy in older people, as it withheld approval of the jab.
Drugs regulator Swissmedic called for more efficacy and quality data before it green lights the shot,
which is currently being used in the UK and won approval in the European Union last week.
Switzerland, which has already ordered 5.3 million doses from AstraZeneca,
said it was waiting on results from trials of the shot in North and South America involving tens of thousands of people.
The Swiss government said it had signed a deal with Germany's Curevac and the Swedish government for the delivery of 5 million vaccine doses,
a preliminary pact with US vaccine maker Novavax for 6 million doses, and secured a further 6 million doses from Moderna.
independent.co.uk/news/world/europe/oxford-covid-vaccine-switzerland-astrazeneca-b1797073.html?utm_content=Echobox&utm_medium=Social&utm_source=Twitter#Echobox=1612376197

(February 6, 2021) Daiichi Sankyo enters outsourcing agreement to manufacture AstraZeneca-developed Covid-19 vaccine, AZD1222, in Japan
Daiichi Sankyo Company announced that it recently entered into an outsourcing agreement
with AstraZeneca K.K. to manufacture the AstraZeneca-developed covid-19 vaccine, AZD1222, in Japan.
In order to play a part in the Covid-19 vaccine manufacturing and supply scheme
agreed upon between AstraZeneca and the government of Japan,
Daiichi Sankyo will use undiluted solutions provided by AstraZeneca
to manufacture Covid-19 vaccines in the country, including vial filling and packaging, in accordance with the outsourcing agreement.
pharmabiz.com/NewsDetails.aspx?aid=135335&sid=2

(February 10, 2021) AstraZeneca Plans Higher Covid Vaccine Output For EU
AstraZeneca plans to accelerate production of its Covid vaccine in the second quarter
to support EU needs, the British pharmaceutical giant said Wednesday, announcing a deal with Germany's IDT Biologika.
Beyond the immediate need for more vaccines, the agreement will see both companies invest to increase capacity
at a production site in Dessau, eastern Germany, to produce millions of doses monthly by the end of 2022.
Last week meanwhile saw a separate Anglo-German collaboration announced, with Britain's GlaxoSmithKline and Germany's CureVac
teaming up to develop a vaccine that can potentially counter multiple variants of Covid-19.
barrons.com/news/astrazeneca-says-to-boost-vaccine-manufacturing-for-europe-with-germany-s-idt-biologika-01612968306?tesla=y








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Post by Abacus Tue Mar 02, 2021 10:52 pm

(March 2, 2021) Pressured European officials are trying to drum up support for the AstraZeneca Covid vaccine
LONDON — European officials are coming under increasing pressure to reverse restrictions
on who can receive the AstraZeneca-Oxford coronavirus vaccine, and to drum up support for the shot.
On Monday, France performed a U-turn on previous guidance over who can receive the vaccine,
now recommending the AstraZeneca shot to anyone between 65 and 74 with preexisting health problems.
It had initially said the vaccine was only suitable for the under-65s.
cnbc.com/2021/03/02/eu-tries-to-drum-up-support-for-unpopular-astrazeneca-shot.html

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Post by Abacus Tue Mar 02, 2021 10:53 pm

(March 1, 2021) AstraZeneca sells stake in vaccine maker Moderna for nearly US$1 billion
AstraZeneca sold its stake in rival COVID-19 vaccine maker Moderna for roughly US$1 billion over the course of last year
as the Anglo-Swedish drugmaker cashed in on the meteoric rise in the U.S. company's shares.
London-listed AstraZeneca recorded US$1.38 billion in equity portfolio sales last year,
with "a large proportion" of it coming from the Moderna sale, according its latest annual report.
AstraZeneca began investing in Moderna in 2013, paying US$240 million upfront and by the end of 2019 had built up its stake to 7.65per cent.
That would be worth about US$3.2 billion based on Moderna's 2020 closing stock price of US$104.47, Reuters calculation showed.
channelnewsasia.com/news/business/astrazeneca-sells-stake-in-vaccine-maker-moderna-for-nearly-us-1-billion-14304732

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Post by Abacus Thu Mar 04, 2021 8:23 pm

(March 4, 2021) Germany says AstraZeneca vaccine OK for over-65's after all
Germany's independent Standing Committee on Vaccination (Stiko)
said on Thursday that the AstraZeneca vaccine can be administered to older people.
Germany had originally balked at approving the vaccine for those aged 65 and over due to efficacy concerns.
However, new data — and quite possibly the faltering national attempts to start vaccinating
— caused German health authorities to change their minds.
Stiko also advised waiting 12 weeks between administering the first and second AstraZeneca shots,
after studies showed a longer gap increased the vaccine's efficacy.
France, Belgium and Italy loosened age restrictions for the AstraZeneca vaccine earlier this week.
dw.com/en/germany-says-astrazeneca-vaccine-ok-for-over-65s-after-all/a-56771381

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Post by Abacus Thu Mar 11, 2021 9:40 pm

(March 7, 2021) Austria suspends use of batch of Covid jab after death of nurse
Authorities in Austria have stopped vaccinations with a batch of AstraZeneca's inoculation
against the coronavirus, after one person died and another became seriously ill after receiving their jabs.
A 49-year-old woman died as a result of severe coagulation disorders, an illness related to the blood’s ability to clot.
The woman was admitted to the intensive care unit of Vienna General Hospital last weekend
after initially being treated at a hospital in Lower Austria. A day after being admitted, the woman died.
Meanwhile, a 35-year-old female developed a pulmonary embolism and is now recovering.
A pulmonary embolism is a lung disease that is caused by a dislodged blood clot.
Several local news organization reported that both women were nurses working at the local hospital.
thelocal.at/20210307/austria-suspends-use-of-batch-of-covid-jab-after-death-of-nurse/

(March 11, 2021) Denmark suspends use of AstraZeneca COVID vaccine
The Danish Health Authority on Thursday halted the use of the AstraZeneca coronavirus vaccine for 14 days.
It follows reports of "serious cases of blood clots among vaccinated people," a statement read.
However, the authority stopped short of saying there was a direct link between the vaccine and the blood clots, "at the time being."
Shortly after Denmark's announcement, Iceland and Norway both halted the rollout of the vaccine.
Italy also moved to ban a batch of the AstraZeneca vaccine following reports "of some serious adverse effects.
dw.com/en/denmark-suspends-use-of-astrazeneca-covid-vaccine/a-56835406












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Post by Abacus Mon Mar 15, 2021 11:03 pm

(March 15, 2021) Germany Joins Growing List of Countries to Suspend Astra Vaccine
Germany suspended use of AstraZeneca Plc’s Covid-19 vaccine amid a growing
health scare that’s creating yet another delay for the European Union’s inoculation campaign.
Germany joins about a dozen places, including Northern Italy, the Netherlands and Ireland,
that have halted use of the product amid reports of serious blood clotting.
bloomberg.com/news/articles/2021-03-15/germany-is-latest-country-to-halt-use-of-astrazeneca-covid-shot

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Post by Abacus Mon Mar 22, 2021 9:30 pm

(March 16, 2021) Future Planet Invests in Vaccitech’s Series B Financing
Future Planet Capital has invested in a $168m Series B financing announced today by Vaccitech Ltd. Future Planet
joins other leading investors including M&G Investment Management, Tencent, Gilead Sciences,
Monaco Constitutional Reserve Fund and fellow existing investor, Oxford Sciences Innovation.
Vaccitech is a clinical stage biopharmaceutical company engaged in the discovery and development
of novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases and cancer; in 2020 it co-invented
a COVID-19 vaccine candidate with the University of Oxford, AZD1222, which is known as the COVID-19 Vaccine AstraZeneca.
bio-itworld.com/pressreleases/2021/03/19/future-planet-invests-in-vaccitech-s-series-b-financing

(March 17, 2021) Daiichi Sankyo begins manufacture of the AstraZeneca COVID-19 Vaccine in Japan
Daiichi Sankyo Company, Ltd announced on March 12, 2021, that it has started manufacturing the AstraZeneca COVID-19 vaccine (AZD1222) in Japan.
The marketing approval application for AZD1222 in Japan was submitted by AstraZeneca K.K. on February 5, 2021.
Daiichi Sankyo is using undiluted solutions provided by AstraZeneca to manufacture AZD1222 in Japan, including the vial filling and packaging,
in accordance with the outsourcing agreement to manufacture AZD1222, which was concluded with AstraZeneca in February 2021.
biospectrumasia.com/news/37/17784/daiichi-sankyo-begins-manufacture-of-the-astrazeneca-covid-19-vaccine-in-japan-.html

(March 22, 2021) Australia approves CSL - Seqirus to manufacture AstraZeneca COVID-19 vaccine
The Therapeutic Goods Administration (TGA) has approved manufacture of the AstraZeneca COVID-19 Vaccine (ChAdOx1-S) in Australia.
This follows on from the 16 February 2021 approval by TGA of the overseas-manufactured AstraZeneca vaccine.
The vaccine is being manufactured at two sites in suburban Melbourne.
CSL-Behring Australia in Broadmeadows are manufacturing the active raw vaccine material,
while the final vaccine doses are being manufactured, vials filled and packaged at Seqirus in Parkville (a CSL company).
biospectrumasia.com/news/37/17808/australia-approves-csl-seqirus-to-manufacture-astrazeneca-covid-19-vaccine.html

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Post by Abacus Tue Mar 30, 2021 8:43 pm

(March 30, 2021) AstraZeneca vaccine fears: Germany bans Oxford jab for everyone under 60
"On the basis of the currently available, but still limited, evidence
and taking into account the current pandemic situation,
the Stiko recommends using the Covid-19 Vaccine AstraZeneca for people over the age of 60," said the body.
They added that inoculation of AstraZeneca jabs to anyone under the age of 60 remained at the "discretion" of doctors across the country.
The decision was taken after Berlin's state hospital groups Charite and Vivantes stopped giving women under the age of 60 shots of AstraZeneca's COVID-19 vaccine,
German daily Tagesspiegel reported on its website, citing a spokeswoman for the hospitals.
express.co.uk/news/politics/1416758/AstraZeneca-vaccine-Berlin-hospital-women-under-55-safety-concerns-stop-using-EU


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Post by Abacus Sun Apr 04, 2021 7:40 pm

(March 30, 2021) AstraZeneca vaccine renamed ‘Vaxzevria’
The coronavirus vaccine produced by the AstraZeneca pharmaceutical company is now called Vaxzevria,
the Swedish medicine agency Läkemedelsverket announced based on data from the European Medicines Agency (EMA).The vaccine itself remains unchanged,
but the Swedish agency considers the new name important, as it is accompanied by other things, such as new labelling and packaging.
The name change to Vaxzevria was approved by the EMA on 25 March, following an application from the company.
brusselstimes.com/news/eu-affairs/162559/astrazeneca-vaccine-now-renamed-as-vaxzevria-ema-european-eu-uk-swedish-lakemedelsverket/

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Post by Abacus Mon Apr 12, 2021 8:43 pm

(April 7, 2021) AstraZeneca’s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets
EMA’s safety committee (PRAC) has concluded today that unusual blood clots
with low blood platelets should be listed as very rare side effects of Vaxzevria (formerly COVID-19 Vaccine AstraZeneca).

In reaching its conclusion, the committee took into consideration all currently available evidence,
including the advice from an ad hoc expert group. EMA is reminding healthcare professionals and people receiving
the vaccine to remain aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets
occurring within 2 weeks of vaccination. So far, most of the cases reported have occurred in women under 60 years of age within 2 weeks of vaccination.

Based on the currently available evidence, specific risk factors have not been confirmed.
People who have received the vaccine should seek medical assistance immediately
if they develop symptoms of this combination of blood clots and low blood platelets (see below).
ema.europa.eu/en/news/astrazenecas-covid-19-vaccine-ema-finds-possible-link-very-rare-cases-unusual-blood-clots-low-blood

(April 11, 2021) A&E departments swamped with patients with AstraZeneca vaccine side-effects
A&E departments are being swamped by people who have developed mild side-effects
from the AstraZeneca vaccine amid concerns the jab causes blood clots.
Emergency doctors told the Health Service Journal (HSJ) that a growing number
of people are presenting to A&E units after having the jab.
Some have been advised to go to hospital by GPs.
standard.co.uk/news/uk/astrazeneca-covid-vaccine-side-effects-a-e-swamped-b928986.html

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Post by Abacus Wed Apr 14, 2021 9:03 pm

(April 14, 2021) Denmark becomes first country in Europe to abandon AstraZeneca's COVID vaccine
Denmark has become the first country in Europe to abandon AstraZeneca's COVID vaccine.
The decision was taken due to the vaccine's link with very rare cases of blood clots, the country's health agency said.
Søren Brostrøm, director of the agency, said despite the World Health Organization and the European Medicines Agency (EMA)
favouring the use of the AstraZeneca jab, Denmark's vaccine campaign would continue without it.
euronews.com/2021/04/14/denmark-becomes-first-country-in-europe-to-abandon-astrazeneca-s-covid-vaccine

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Post by Abacus Fri Apr 16, 2021 11:18 pm

(April 16, 2021) Denmark to consider individual choice over AstraZeneca vaccine
The Danish government has said it is prepared to listen to suggestions the country’s shelved AstraZeneca
Covid-19 vaccines can be given to individuals who consent to take it.
The government is yet to confirm its plans for the approximately 200,000 AstraZeneca vaccines currently in storage in Denmark.
The vaccine is still officially approved for use in Denmark but has been withdrawn from the Covid-19 vaccination calendar.
A lack of clarity also exists as to liability in the case of serious side effects, and how compensation would be given.
thelocal.dk/20210416/denmark-to-consider-individual-choice-over-astrazeneca-vaccine/

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Post by Abacus Tue Apr 20, 2021 7:55 pm

(April 15, 2021) Norwegian Institute of Public Health's recommendation about AstraZeneca vaccine
Calculations have been performed based on Norwegian data where the risk of dying from COVID-19 disease
among the different age groups is compared with the risk of dying from the severe,
but rare, condition with severe blood clots observed after AstraZeneca vaccination.

"Since there are few people who die from COVID-19 in Norway, the risk of dying after vaccination with the AstraZeneca vaccine would be higher
than the risk of dying from the disease, particularly for younger people," says Bukholm.
fhi.no/en/news/2021/astrazeneca-vaccine-removed-from-coronavirus-immunisation-programme-in-norw/

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Post by Abacus Mon Apr 26, 2021 9:11 pm

(April 26, 2021) EU sues AstraZeneca over delayed deliveries of COVID-19 vaccine
The European Commission said on Monday that it was taking the pharmaceutical company AstraZeneca to court
for breach of contract after a number of delays in supplying COVID-19 vaccines to the bloc.

Germany, France and Hungary were among EU states that were initially reticent to sue the company,
mostly on the grounds that the move might not speed up deliveries, diplomats said, but eventually they supported it.

The announcement comes as commission president Ursula von der Leyen suggested earlier this month to never do business again
with AstraZeneca for its future vaccination campaigns. Former German defense minister von der Leyen said the EU would only buy vaccines using mRNA technology
— such as Pfizer and Moderna — for the next round of jabbing drives.

The vaccine producer on Monday said that there was no legal foundation to the lawsuit against it
and that it regretted the decision by the European Commission.
"AstraZeneca has fully complied with the Advance Purchase Agreement
with the European Commission and will strongly defend itself in court.

dw.com/en/eu-sues-astrazeneca-over-delayed-deliveries-of-covid-19-vaccine/a-57338626

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Post by Abacus Sun Jun 13, 2021 10:50 am

(May 6, 2021) Coronavirus: Germany opens up AstraZeneca COVID vaccines for all adults
AstraZeneca jabs will no longer be limited to people aged 60 and older, German federal and state officials agreed on Thursday.
The move comes as Germany moves to quickly vaccinate its population following a sluggish vaccine rollout that has picked up pace in recent weeks.
On very rare occasions, the AstraZeneca vaccine is believed to trigger serious blood clots in younger people.
Under the scheme, Germany will also aim to offer vaccines to all children aged 12 and over by the end of August,
once the European medical regulator approves a vaccine for younger people.
dw.com/en/coronavirus-germany-opens-up-astrazeneca-covid-vaccines-for-all-adults/a-57453351

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Post by Abacus Sun Jun 13, 2021 10:53 am

(June 11, 2021) Italy halts the use of AstraZeneca’s vaccine in those under 60
Italy will stop administering AstraZeneca’s Covid vaccine to people under the age of 60,
the Italian government announced on Friday, amid a drop in the country’s level of infections
that meant the risks of distributing the vaccine to younger people was judged to outweigh the benefits.
nytimes.com/2021/06/11/world/italy-astrazeneca-covid-vaccine.html

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Post by ShockJock Wed Oct 13, 2021 2:38 pm

How Did Astra-Zeneca Manufacture "COVID-19 Vaccine" in July of 2018 Before the Disease Was Even Discovered or Named?

A whole lot of people have a lot of explaining to do. Boxes of COVID-19 Vaccine from AstraZeneca show a Manufacture Date of July 15, 2018 . . . But "COVID-19" wasn't discovered until 2019 and wasn't NAMED until February 11, 2020.

Here's the smoking gun: A box of COVID-19 Vaccine from AstraZeneca, with the manufacture date of July 15, 2018 computer printed on the box flap:
(image)

https://halturnerradioshow.com/index.php/en/news-page/world/how-did-astra-zeneca-manufacture-covid-19-vaccine-in-july-of-2018-before-the-disease-was-even-discovered-or-named
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