We are now in the new reality, the new normal reality of identifying, coding and the invention of vaccines that are inserting foreign and manipulated messenger RNA (mRNA) into the human genome and producing vast numbers of transhumanist vaccines for that new normal. And, at a tremendous speed.
Normally vaccine research could and usually took 10 to 15 years. Especially a new type of vaccine that was for a new and recently discovered unique and novel virus. This process can take up a lot of time — so much research. So much protocol and red tape and “I’s” to dot and “t’s” to cross. The paperwork alone is enormous. A mountain of legal, so many stages to go through before the vaccine is deemed safe. And it has to be because there is a lot at stake. Enormous amounts of money — oceans of money and time and research in state of the art and hugely expensive research facilities.
The general stages of the development cycle of a vaccine are:
- Exploratory stage
- Pre-clinical stage
- Clinical development
- Regulatory review and approval
- Quality control
– CDC Website
And then, the vaccine product approval process…
The sponsor of a new vaccine product follows a multi-step approval process, which typically includes
- An Investigational New Drug application
- Pre-licensure vaccine clinical trials
- A Biologics License Application (BLA)
- Inspection of the manufacturing facility
- Presentation of findings to FDA’s Vaccines and Related Biological Products Advisory CommitteeExternal (VRBPAC)
- Usability testing of product labeling
– CDC Website
“Until a vaccine is given to the general population, all potential adverse events cannot be anticipated. Thus, many vaccines undergo Phase 4 studies-formal studies on a vaccine once it is on the market. Also, the government relies on the Vaccine Adverse Event Reporting System (VAERS) to identify problems after marketing begins. The VAERS system and how it works is discussed further on this website.”
But again, this is, a new normal so, we are at Warp Speed…
President Donald Trump introduced “Operation Warp Speed” (OWS) on April 2020…
“The idea for Operation Warp Speed was introduced in early April 2020. Operation Warp Speed will promote mass production of multiple vaccines based on [preliminary evidence] allowing for faster distribution if clinical trials confirm one of the vaccines is safe and effective. The plan anticipates that some of these vaccines will not prove safe or effective, making the program more costly than typical vaccine development, but potentially leading to the availability of a viable vaccine several months earlier than typical timelines.”
…using the United States Department of Health & Human Services (HHS) and the NIH (National Institutes of Health) partnerships of the NIH ACTIV (Accelerating COVID-19 Therapeutic Interventions and Vaccines) and the NIH RADx (Rapid Acceleration of Diagnostics) along with BARDA (Biomedical Advanced Research and Development Authority) to gain vaccines efficiently and quickly as the name implies.
The FDA has stated publicly that the vaccine/s would have to be 50% effective to gain their approval in diminishing the severity of COVID-19.
Fifty-percent effective? If we can understand that it takes about 100 doses of regular old flu vaccine to avert one single case of the flu? What can we expect from a vaccine that is 50% effective?
Moncef Slaoui was named the chief advisor of this ‘Operation’. A veteran of the big Pharma cluster, he was Chairman of the Global R&D of GlaxoSmithKline where he led the development of 5 new novel vaccines. Of course, there would be no conflict of interest since Slaoui was a shareholder and a member of the board of the leading contender, MODERNA.
“To avoid a conflict of interest, Slaoui resigned from the board of the Massachusetts-based biotech firm Moderna, which had been developing a vaccine for the coronavirus.” – Wikipedia
Slaoui had about $10 million in Moderna stock at that time of his resignation. He supposedly sold them as of the end of May 2020. And donated the recent gains to cancer research. He found the time period of 12-18 months, very aggressive. He had to also resign from being a top advisor to Brii Biosciences.
President Trump gave Operation Warp Speed $10 Billion, with additional monies to be gained from BARDA.
Sidebar: Seems there was some infighting in Barda and with President Trump and the director of BARDA…
“On April 20, 2020, during the COVID-19 pandemic in the United States, in an action that led to the filing of a US whistleblower complaint  and testimony before the US House of Representatives , Dr. Rick Bright was asked to step down as Director of BARDA. Bright claimed he had been removed from his post because he had insisted that “the billions of dollars allocated by Congress to address the COVID-19 pandemic” be invested “into safe and scientifically vetted solutions, and not in drugs, vaccines and other technologies that lack scientific merit.” Bright was reassigned to the National Institutes of Health (NIH). The ASPR at the time, who was implicated in the complaint, was Robert Kadlec MD.”
“On May 5, 2020 Bright filed a whistleblower complaint, including accompanying exhibits only some of which have entered the public domain, alleging that his early warnings about the coronavirus were ignored. In his complaint, delivered through videoconference, Bright asked to be reinstated as director at BARDA, accusing the Trump Administration of firing him in retaliation for his warnings about the virus and his opposition to off-label use of the antimalarial drug hydroxychloroquine, which increased mortality in subjects. He also suggested that the administration was prioritizing “cronyism over science”.”
“On May 5, 2020, Kadlec was implicated in an official whistleblower complaint, of participating in multiple schemes to funnel contracts to politically connected companies, even while subject matter experts at the agency determined such contracts were not meritorious, then retaliating against Rick Bright, his Director of BARDA.“
Yes and so…to continue.
Seven companies are in the running with Moderna and AstraZeneca-University of Oxford in the lead. Moderna got an initial $483 million and AstraZeneca gained $1.2 Billion.
Moderna with its Gates-funded mRNA-1273 vaccine which of late has been causing adverse reactions in the people in the trials being tested.
It may also explain why Fauci publicly announced he was “encouraged” by Moderna’s catastrophic Phase 1 clinical trials despite the fact that 20% of the high dose and 6% of the low dose groups of super healthy volunteers had Grade 3 “severe or medically significant” reactions following vaccination.
– Robert F. Kennedy, Jr., Chairman, Children’s Health Defense
“In January 2016, we entered a global health project framework agreement with the Bill & Melinda Gates Foundation to advance mRNA-based development projects for various infectious diseases. The Bill & Melinda Gates Foundation has committed up to $20.0 million in grant funding to support our initial project related to the evaluation of antibody combinations in a preclinical setting as well as the conduct of a first-in-human Phase 1 clinical trial of a potential mRNA medicine to help prevent human immunodeficiency virus, or HIV, infections. Follow-on projects which could bring total potential funding under the framework agreement up to $100.0 million (including the HIV antibody project) to support the development of additional mRNA-based projects for various infectious diseases can be proposed and approved until the sixth anniversary of the framework agreement, subject to the terms of the framework agreement, including our obligation to grant to the Bill &Melinda Gates Foundation certain non-exclusive licenses.”
AstraZeneca is trying their vaccine ChAdOx1 nCoV-19 on some 5000 Brazilian citizens. They have used children as young as 5 years old within their phase ll study, and here you thought the Nazi’s lost the war.
Moderna on their website reported that Catalent Inc was given the contract to ‘Fill-Finish’ manufacturing of Moderna’s COVID-19 vaccine candidate. Catalent will produce 100 million doses of mRNA-1273 initially; vial filling and packaging for the US market to use, starting in the third quarter of 2020.
Catalent is state of the art and has facilities in Brussels, Belgium and Anagni, Italy.
Moderna’s vaccine is designed to direct, through messenger RNA the host’s cells to manufacture secreted proteins. Turning your cells into protein factories.
Catalent, it seems was more heavily invested in recently by The Blackstone Group a multinational private equity alternative investment management and financial services firm based in Manhatten. Catalent was formed in April 2007…“Catalent was formed in April 2007 when affiliates of the Blackstone Group L.P. acquired the core of the pharmaceutical technologies and services (PTS) segment of Cardinal Health, Inc”.
“In 2007, the pharmaceutical technologies and services segment of Cardinal Health was purchased by Blackstone Group and re-branded as Catalent Pharma Solutions.”
Catalent has acquired…
- In June 2019, Catalent acquired Bristol-Myers’ European launch pad to expand its global CDMO.
- In January 2020, Catalent purchased a manufacturing facility located in Anagni, Italy, from Bristol-Myers Squibb, to manufacture and package biologic and oral solid dose products for multiple companies. In February 2020, Catalent agreed to acquire MaSTherCell, a Belgian gene and cell therapy manufacturer, for $315 million. The acquisition allows Catalent to expand into cell therapy development.
- In 2020, Catalent partnered with multiple drugmakers, including Pfizer, Johnson & Johnson, AstraZeneca, and Moderna to provide manufacturing, vial filling and packaging capabilities for COVID-19 vaccine candidates.
So Catalent has the contract to fill and package for the two top runners in the vaccine warp speed race. As well as Pfizer and Johnson & Johnson?
In March of 2020 Blackstone bought a major stake in HealthEdge, a healthcare software company that helps insurers lessen their costs and maximize their profits.
Blackstone was able to pick up for pennies on the dollar, during the buyout boom of 2005-2007 some of the most lucrative investments one could gain. Blackstone is vulture capitalism.
Stephen Allen Schwarzman CEO of the Blackstone Group has had a long-running relationship with President Donald Trump. Schwarzman ranked 100th in the billionaire’s list of who’s who served as Chairman of the President’s Strategic and Policy Forum. He personally donated $850,000 to Trump’s inauguration and political action committees. He previously donated some $5.5 million to the Republicans.
That’s quite a sizable return on an investment of $850,000 in the filling and packaging of the vaccines for Moderna and AstraZeneca. That’s potentially hundreds and hundreds of millions of doses of vaccine in the operation called ‘Operation Warp Speed’.
“In June 2019, the University of Oxford announced that Schwarzman had donated £150 million to establish the Schwarzman Centre for the Humanities.“
Aw isn’t that nice. A $150 million. That’s right, that’s right the same University of Oxford that…
“In June 2020, further to making 100 million doses available to the UK’s NHS, AstraZeneca and Emergent BioSolutions signed [an] $87 million deal to manufacture doses of the Oxford University‘s adenovirus-based COVID-19 vaccine specifically for the U.S. market. The deal 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. Catalent will be responsible for the finishing and packaging process.”
“On 13 June 2020, AstraZeneca signed a contract with Europe’s Inclusive Vaccines Alliance, a group formed by France, Germany, Italy and the Netherlands, to supply up to 400 million doses of its experimental COVID-19 vaccine to all European Union member states.”
With Bill Gates wishing to vaccinate the whole planet and talks of producing some 7 billion doses of mRNA. Catalent aims to be a monster of an investment.
This COVID swamp keeps getting wider and wider, and deeper and stinkier with more reptiles every day…