What developing vaccines at “warp speed” really means

Vaccine development can ordinarily take as long as 15-20 years, including a lengthy period of animal testing to make sure that the vaccine is safe and effective. The initial development process requires iterative tests in animal models where adjustments are made along the way¹. Many vaccines never even make it to the Phase III trials.

For the Covid-19 vaccine, however,

They are moving new technologies from the computer into the clinic at an unprecedented rate, and normally distinct phases of a drug program—preclinical animal models, clinical testing, and manufacturing —are happening all at once.
“It is like building an airplane while you are flying …” ².

Human guinea pigs

That isn’t how vaccine testing normally happens. Regulators require that a manufacturer show a product is safe before it goes into people, and while it isn’t enshrined in law, researchers almost always check that a new concoction is effective in lab animals before putting human volunteers at potential risk ³.

Animal testing is important; previous coronavirus vaccine development was halted when it was discovered that the vaccines created a paradoxical immune enhancement response in animals where vaccinated animals challenged with the virus became sicker than they would have without the vaccine and died. ⁴. In the absence of animal testing, they are planning on doing these challenge studies on people⁵.

Telescoping testing timelines and approvals may expose all of us to unnecessary dangers related to the vaccine. While preclinical trials to evaluate the potential safety and efficacy of vaccine candidates are likely to include tens of thousands of patients, it is still unclear whether that number will be large enough and a trial will last long enough to evaluate safety for a drug that would be administered to so many. The US alone plans to vaccinate hundreds of millions of people with the first successful candidate. One serious adverse event per thousand of a vaccine given to 100 million people means harm to 100,000 otherwise healthy people ⁶.

On the dangers of a coronavirus vaccine

A 2012 paper,  Immunization with SARS Coronavirus Vaccines Leads to Pulmonary Immunopathology on Challenge with the SARS Virus⁷ concluded:

Conclusions: These SARS-CoV vaccines all induced antibody and protection against infection with SARS-CoV. However, challenge of mice given any of the vaccines led to occurrence of Th2-type immunopathology suggesting hypersensitivity to SARS-CoV components was induced. Caution in proceeding to application of a SARS-CoV vaccine in humans is indicated.

Dr, Anthony Fauci, the head of President Trump’s Coronavirus Task Force had this to say:

‘I must warn that there’s also the possibility of negative consequences, where certain vaccines can actually enhance the negative effect of the infection.’ Dr Fauci later explained that in rare cases people vaccinated against a condition could end up contracting the virus they thought they’d been protected against, and falling more seriously-ill with that disease as a result⁸.

Well known vaccinologists, Dr. Peter Hotez and Dr. Paul Offit on the dangers of a coronavirus vaccine:

Regarding the mRNA vaccine, Professor Eric Caumes, head of the infectious and tropical disease department at a major Paris hospital said:

‘I have never seen such a high frequency’ of side effects from an injection, the head of the infectious and tropical disease department at a Paris hospital observed. Apart from minor injection reactions such as local redness and pain, other side effects occur at relatively high rates, especially in young people and after the second dose.

“Take the example of fever. It can occur transiently after an injection; it is classic. But here, 15.8 percent of 18- to 55-year-olds had a fever of 38 degrees Celsius or higher within seven days after the second injection. And 45 percent had to take medication for fever or pain. Another 55 percent had headaches and 62 percent were tired. No, really, that’s much too much, perhaps there’s a problem … ”

Caumes is also concerned that there is a lace of scientific data available regarding the vaccine trial results. He said that “he would never blindly trust the vaccine industry merely on their press releases”.

Professor Caumes is willing to be vaccinated against Covid-19, but not with an mRNA vaccine⁹.

Genetic vaccines never before approved for use in humans

No mRNA vaccine has ever been approved for use in humans before and they have never been tested in a large-scale clinical trial for an infectious disease. “The COVID crisis is a great opportunity for those technologies to be pushed”¹⁰.

mRNA vaccines, like those of Moderna (which has never yet had a product approved for market¹¹) and Pfizer (that set a record for the largest health care fraud settlement and the largest criminal fine of any kind with $2.3 billion in 2009¹²) work by providing the blueprint for the Covid-19 spike protein for the individual’s cells to reproduce. The body is then expected to create antibodies against the spike protein so that should the person come in contact with Covid-19, they will automatically have antibodies ready to combat it¹³.

 It is a bit like wadding up plans for a Cessna, throwing them through the ventilation shaft of a Ford factory, and hoping that someone inside finds them, and that the factory starts rolling airplanes out its doors instead of pickups¹⁴.

Even more troubling is Moderna’ CEO’s own description of their products.

Moderna’s chief medical officer has described the company’s products as “hacking the software of life” and permanently altering a person’s genetic code”¹⁵.

Emergency Use Authorization

Both Moderna and Pfizer are applying for Emergency Use Authorization (EUA) for their vaccines. EUA is given for  investigational drugs or biological products [like vaccines] for a human subject in a life-threatening situation for which no standard acceptable treatment is available and for which there is not sufficient time to obtain IRB [independent revue board] approval¹⁶.

In this case, the Covid-19 virus is said to present a life threatening situation for which there is no treatment. However, September CDC statistics show that 99.9% – 99.5% of the people infected with Covid-19 under 70 years and 94.6% of people over 70 years recuperate¹⁷. Furthermore, proven therapies like hydroxychloroquine have been delegitimized and no longer approved for Covid-19 patients¹⁸’¹⁹.

No plant inspections

COVID-19 vaccine developers seeking FDA emergency use authorizations won’t have to undergo pre-approval site inspections, agency official Jerry Weir said at the FDA’s open meeting last week … The FDA conducts thousands of facility inspections per year, and some find flaws that drug or vaccine companies must remedy before launching new products.

…

Moderna, one of the leading vaccine developers, has never had a facility inspected by the FDA … ²⁰.

Worrying signs

Netanyahu, who has spent billions of taxpayer dollars since June²⁴’²⁵ on not yet developed and approved vaccines, calling them a light at the end of the tunnel, said: “… I suppose we don’t know the long-term effect of an RNA vaccine on human beings …” ²⁶

According to the FDA: “… currently there is not enough research to guarantee the vaccine’s safety for immunocompromised groups, pregnant women and children²⁷.”

The FDA Vaccines and Related Biological Products Advisory Committee October 22, 2020, Meeting Presentation has put out a draft list of possible adverse effects of Covid-19 vaccines.

“FDA Safety Surveillance of COVID-19 Vaccines – DRAFT – Working list of possible adverse event outcomes; ***Subject to change***”:

• Guillain-Barré syndrome,
• Acute disseminated encephalomyelitis,
• Transverse myelitis,
• Encephalitis/myelitis/encephalomyelitis/meningoencephalitis/meningitis/encephalopathy,
• Convulsions/seizures,
• Stroke,
• Narcolepsy and cataplexy,
• Anaphylaxis,
• Acute myocardial infarction,
• Myocarditis/pericarditis,
• Autoimmune disease,
• Deaths,
• Pregnancy and birth outcomes,
• Other acute demyelinating diseases,
• Non-anaphylactic allergic reactions,
• Thrombocytopenia,
• Disseminated intravascular coagulation,
• Venous thromboembolism,
• Arthritis and arthralgia/joint pain,
• Kawasaki disease,
• Multisystem Inflammatory Syndrome in Children, and
• Vaccine enhanced disease.²⁸.

The U.K. government is concerned that there will be an unusually high volume of adverse events caused by the Covid-19 vaccines. In October their  Medicines & Healthcare products Regulatory Agency (MHRA), posted a bid for an AI software tool to help them “process the expected high volume of Covid-19 vaccine Adverse Drug Reaction (ADRs).” The bid explains that “it is not possible to retrofit the MHRA’s legacy systems to handle the volume of ADRs that will be generated by a Covid-19 vaccine,” and that this “represents a direct threat to patient life and public health²⁹.

Vaccines and sterilization

Section 13 of all vaccine package inserts say that the vaccines haven’t been tested for carcinogenicity, genetic mutations, or impairment of fertility (some of tested fertility in mice, but never humans).

In June 2010, Bill Gates, in a TedTalk, discussed reducing the world population by 10-15%.

The world today has 6.8 billion people, heading up to 9 Billion. Now if we do a really great job on NEW vaccines, healthcare and reproductive health services [abortion], we can lower that [world population] by 10%-15%” [=1 billion people]³⁰.

By “new vaccines” Gates was referring to contraceptive vaccines. A study, “Vaccines for Immunologic Control of Fertility”, was published shortly before his TedTalk³¹.

In 2014, a contraceptive vaccine was used on Kenyan, Philippine, Nicaraguan, and Mexican women and girls of childbearing age under the guise of a tetanus vaccine campaign (funded by WHO and UNICEF; both are heavily funded by the Gates Foundation³²’³³’³⁴.

(This will “… put the Gates Foundation “in a position to potentially reap considerable financial gains from the COVID-19 pandemic …” ³⁵)

Serious warnings about the Covid-19 vaccines causing infertility

Drs. Yeadon and Wodarg have petitioned the EUMA to stop the coronavirus vaccine studies immediately. Among their several concerns, is that one of the proteins, syncytin-homologous proteins, important to the development of the placenta, can possibly lead to infertility. “It must be absolutely ruled out that a vaccine against SARS-CoV-2 could trigger an immune reaction against syncytin-1, as otherwise infertility of indefinite duration could result in vaccinated women”³⁶.

The UK sent a 10 page informational document to healthcare workers regarding the Pfizer Covid-19 mRNA BNT162b2 Vaccine.
They had this to say about pregnancy, lactation, and fertility (emphasis added):

4.6 Fertility, pregnancy and lactation

Pregnancy
There are no or limited amount of data from the use of COVID-19 mRNA Vaccine BNT162b2.
Animal reproductive toxicity studies have not been completed. COVID-19 mRNA Vaccine
BNT162b2 is not recommended during pregnancy.
For women of childbearing age, pregnancy should be excluded before vaccination. In addition, women
of childbearing age should be advised to avoid pregnancy for at least 2 months after their second dose.

Breast-feeding
It is unknown whether COVID-19 mRNA Vaccine BNT162b2 is excreted in human milk. A risk to
the newborns/infants cannot be excluded. COVID-19 mRNA Vaccine BNT162b2 should not be used
during breast-feeding.

Fertility
It is unknown whether COVID-19 mRNA Vaccine BNT162b2 has an impact on fertility³⁷.

• The Covid-19 vaccines are being developed at unprecedented speed by cutting corners for a disease that nearly everyone recovers from and for which there are treatments.
• Coronavirus vaccines come with inherent risk of making the disease worse.
• The vaccines are not expected to stop transmission and have not been tested to see if they even decreases hospitalizations or death.
• The FDA doesn’t have information to say that it is safe for immunocompromised people – the very ones who would be expected to benefit from a Covid-19 vaccine.
• There are serious concerns about it’s safety that will not be answered until millions of people receive it.

The only people poised to benefit from Covid vaccines seem to be the manufacturers and investors in these companies.

Is a Covid-19 vaccine worth risking your health or life for?