In addition to Phillip M. Altman BPharm(Hons) MSc PhD, coauthors on this piece include Wayne Rowe BPharm, MSc, PhD FRSN, Wendy Hoy AO FAA FRACP, Gerry Brady MBBS, Astrid Lefringhausen, PhD, Robyn Cosford MBBS(Hons) FACNEM FASLM, and Bruce Wauchope MBBS – DTM& H, Dip OBS RACOG, FRACGP.
The US Department associated with Defense (US DoD) has already established a dominant role in the response to the SARS-CoV-2 malware and in the development, plus distribution of the Covid nineteen vaccines, a fact hidden in the general public. In those procedures many standard steps and procedures, otherwise required for pharmaceutic products, were omitted or even circumvented.
Definition of these types of vaccines as “ countermeasures” rather than therapeutic agents provides permitted their expedited progression to emergency use authorisation and widespread rollouts. A lot of adverse consequences have been the outcome of this secret military reaction to a public health issue. Why are governments around the world, which includes Australia, planning to make further significant investments in this rushed vaccine technology driven by the US military?
Operation Warp Speed
With the US Food and Drug Administration’s Emergency Use Authorisation of the COVID-19 vaccines (FDA, 2020) and the Provisional Approval of the first COVID-19 vaccine in Australia (TGA, 2021), these agents were hailed as innovative life-saving reactions by the pharmaceutical industry to some deadly global pandemic.
The development, testing and drug regulating approval of these novel COVID-19 gene-based vaccines using messenger ribonucleic acid (mRNA) technology was said to have been required for less than one year, whereas growth and approval of regular vaccines normally takes about 10 years. (Seneff and Nigh, 2021). The public was told that this was assisted by economic support of vaccine companies by the US government below Operation Warp Speed.
The public has been told that these COVID-19 gene-based vaccines were “ safe and effective” (CDC a , 2022): they would prevent infection plus chances of serious illness plus death from the virus, and would prevent transmission of the virus. We now know they cannot prevent infection nor transmitting and have not prevented a relentless high incidence of COVID-19. Furthermore they are connected with an unprecedented incidence of serious adverse events plus deaths compared to any other medicines in the history of the pharmaceutical industry. (Turni and Lefringhausen 2022; Altman, 2022; CMN, 2022; Blaylock, 2022).
Based on the US CDC Vaccine Adverse Event Reporting System (VAERS), there have been 1, 476, 227 undesirable event reports associated with these types of “ vaccines” (CDC b , 2022). through December 2, 2022, which include 32, 621 reported deaths and 185, 412 hospitalizations. Furthermore, a rise within unexplained deaths has been documented around the world coincident with their launch. In Australia, up to August 2022 there were 18, 671 excess deaths (17 percent) greater than average, with most of these fatalities not due to COVID-19 (ABS, 2022). We are possibly facing the worst health disaster in history.
How did the pharmaceutical industry, our governments and our drug regulators get it so wrong? The plausible answer to this issue has emerged within the last few weeks.
A National Security Operation
Contrary to popular belief that pharmaceutical companies drove the COVID vaccine development programs, the united states FDA’s website (FDA, 2020) reveals that the United States Division of Defence (DoD) has been around full control of the Covid Vaccine development program since its beginning. The DoD has been responsible for development, manufacturing, clinical trials, quality peace of mind, distribution and administration, since that time (FDA, 2020; Rees and Latypova, 2022; KEI, 2022; Medical Defense Consortium, 2022; Rees, 2022). The main pharmaceutical companies have been included as “ Project Coordination Teams” effectively performing since subcontractors to the DoD. The Chief Operating Officer for that Warp Speed vaccine program is the US Department of Defence, and the Chief Science Advisor is the US Division of Health and Human Solutions (HHS).
The Nature of Gene-based Vaccines
The true character of the COVID-19 ‘ vaccines’ has been largely misrepresented by mainstream media, big pharmaceutical companies and governments and it is poorly understood by the population at large. Referring to these items as “ vaccines” led most people to consider them because relatively safe and well-researched and readily accept their own widespread use. However , they are not really vaccines – these are serious gene-based interventions that have never been deployed widely in any population, especially never to healthy individuals including kids, infants and pregnant women. In this sense they should be considered experimental.
COVID-19 ‘ vaccines’ get into a special class of therapeutic agents under the US FOOD AND DRUG ADMINISTRATION Office of Cellular, Cells and Gene Therapies’ thought as “ gene therapy products, ” which involve “ introducing a new or customized gene into the body to assist treat a disease” (FDA, 2018). Heretofore, use of gene therapy products has been restricted to the treatment of usually rare, serious and debilitating disease or genetic conditions. They have potential to cause permanent intergenerational genetic damage, cancer and interfere with reproductive capacity.
The FDA and other drug regulatory companies have specific rules plus guidelines to direct manufacturers in development and screening of such products, meant for both preclinical (FDA, 2013) and clinical (FDA, 2015) research. However , the particular FDA did not evaluate these types of COVID-19 “ vaccines” according to these gene therapy guidelines.
Instead, there was a concerted effort to avoid referring to them as gene therapy items, based, in part, on the argument that the genetic material in the COVID-19 vaccines was not designed to be incorporated into an individual’s DNA, nor to modify gene expression. There was no previous short-term safety information and no long-term data on which to predict future effects. No similar therapeutic products have been previously approved anywhere in the world. Their widespread administration internationally with no historical safety experience was an unprecedented risk in human health.
Messenger RNA platform technologies has been researched by DARPA (Defense Advanced Projects Study Agency) since at least this year (McCullough, 2022). At the begining of 2020, in the panic to build up the COVID-19 vaccines, specific critical research and development procedures had been omitted, bypassed, curtailed, or not done in a logical sequential manner, or to established laboratory or manufacturing standards. Although the surge protein is the active medication and is directly responsible for the particular immune response, its pharmacology and toxicology have not been studied in animals or even in humans as might normally have been required.
Other significant deficiencies include lack of essential research on carcinogenicity, mutagenicity, genotoxicity and reproductive toxicology in appropriate animal species. In particular, the potential for invert transcription of mRNA genetic material into an individual’s GENETICS was not investigated. Furthermore, scale-up manufacturing was premature plus lacked adequate quality manage to ensure that product made in large batches is the same as made in smaller batches.
Without such research, the particular potency, mRNA integrity, existence of contaminants and stability of the “ vaccines” can not be guaranteed. Such oversights are usually directly responsible for the failure to predict the serious adverse drug reactions plus mortality which have now already been reported in association with these vaccines .
To mitigate danger, the plan in vaccine development was to use multiple systems, multiple facilities and redundancy. Leverage of existing facilities would also take place. In the interest of expediency, the plan was to avoid using traditional pathways from early advancement to large-scale production. Avoidance of quality specifications and guidelines such as Good Manufacturing Practice and Great Laboratory Practice guidelines has been necessary to speed development, plus conventional New Drug Program (NDA) and Biologics Permit Application (BLA) approvals had been bypassed.
Instead, the process moved quickly using compressed timelines plus overlapping stages of development towards Emergency Use Authorization (EUA). Scale-up and large volume manufacturing had been planned in parallel along with, instead of before, clinical tests which, again, may have contravened accepted codes of Good Manufacturing Practices. These strategies were probably a recipe for potential disaster. (Latypova, 2022; Watt and Latypova, 2022).
The Legal Framework
Key legislative elements allow the US government to authorise, account, contract and control several DoD research programs, the following:
- the Emergency Use Authorisation regulations (1997) allow, in cases of emergency, a new medication to be made available with less supportive safety and efficacy data than normally required for full approval.
- the Other Transaction Authority regulations (2015) permit contractual transactions that are not required in order to comply with Federal laws and regulations, and
- the Public Readiness and Emergency Preparedness Take action (PREP Act 2020) establishes limited liability for the companies involved in the contract arrangements using the DoD.
Two US DoD firms, the Defense Advanced Research Projects Agency (DARPA) and the Biomedical Advanced Research and Development Authority (BARDA), possess considerable resources for research, development and authorization for various products. They also contract with a large number of companies for such functions.
The products of those programs, including the COVID-19 vaccines, are sometimes classified as “ countermeasures, ” “ prototypes, ” or “ demonstrations” rather than pharmaceutical products. Those labels permit a product to avoid lengthy conventional regulatory, commercial development and testing paths normally required for pharmaceutical items (ICH, 2022) and to proceed to Emergency Use Authorization.
The Rush to Considerable Manufacture
The rush to make available the Covid vaccines has reportedly resulted in batch-to-batch variability, with some batches associated with a high incidence of adverse vaccine reactions and mortality (Gutschi, 2022). Additionally , at least 26 researchers/research teams in 16 countries, using various microscopic methods of analysis, have reported the presence of undeclared microscopic geometric and tube-like structures in both the Covid vaccine vials, and in the blood of people in widely vaccinated populations, for which there is no satisfactory explanation at this time. Furthermore, various spectroscopic methods of analysis have detected the existence of undeclared and unexpected metals(German Working Group, 2022; Hughes, 2022).
Under normal circumstances, a tiny fraction of the reported quality, efficacy or safety problems associated with the Covid vaccines could have led to their immediate withdrawal, but this has not occurred. Pharmaceutical regulators internationally seem to be wilfully blind towards the problems. Governments and the mainstream media appear to show simply no interest in uncovering the truth or conducting a public debate on these critical matters. Why?
The answer appears to be that, within the interest of national safety, the US DoD took charge of the Covid vaccine funding, development and testing through the very start of the perceived threat in early 2020. In the early panic, normal wise quality, safety and efficacy considerations were compromised. Drug regulators played, plus continue to play, an acquiescent role in approving and endorsing these vaccines. We have now see this was a mistake. Many are now of the viewpoint that the Covid vaccines seem to have done more harm than good (Dopp and Seneff, 2022). Uncovering the truth has been a slow and difficult process, which has been exacerbated by intense and unprecedented censorship of doctors and researchers, which continues to this day.
Many questions have got arisen about the COVID vaccines concerning the lack of adequate production practices, quality control, basic pharmacological and toxicological studies and the lack of appropriate clinical safety and efficacy research. Drug regulatory regulators seem reluctant to acknowledge the unprecedented level of reported serious adverse drug responses and deaths associated with these items. There is also serious concern regarding the increases in excess deaths through all causes in many countries suspiciously with their use. Our overall health authorities steadfastly refuse to think about that the vaccines themselves may be to blame.
The general public was told these COVID vaccines were “ safe and effective” without certification even though they were not fully approved. Why was the public not advised the normal standards of quality, safety and efficacy were not applied to the development plus testing of these vaccines? Why was this kept secret? Why are governments all over the world, including Australia, planning to make further significant investments with this unsafe vaccine technology? Will certainly these national security preparations still be in place for upcoming vaccines and other pharmaceutical items?
The fate of humanity and all long term generations is literally at a crucial tipping point and few global power brokers plus political decision-makers appear to understand the gravity of the situation.
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