The Health and Human Services' Operation Warp Speed pledges to deliver 300 million doses of a COVID-19 vaccine by 2021.1 However, developing a safe and effective vaccine normally takes years and begins with animal studies. Given the urgency of the COVID-19 pandemic, vaccine makers are rushing into human clinical tests and circumventing lengthy animal trials.
Such fast-tracked vaccines pose unknown risks to humans, which are magnified because governments are granting COVID-19 vaccine makers immunity from liability for all vaccine injuries and deaths that occur after the vaccines are recommended (or mandated) by public health officials.2
In August, AstraZeneca announced that most countries it expects to supply with COVID-19 vaccine will grant the pharmaceutical company liability protection when people are harmed by the new vaccine.
In the U.S., vaccine makers already have something of a "free pass" when it comes to vaccine injury liability and lawsuits through the National Childhood Vaccine Injury Act of 19863 and the Public Readiness and Emergency Preparedness (PREP) Act, passed in 2005 (more on those later.)4
The main concern is that the combination of COVID-19 vaccines being fast-tracked to market at "warp speed" with minimal testing, together with blanket liability protection for Pharma for injuries their products cause, is a public health nightmare waiting to happen.
Vaccine Makers Already Enjoy Protection in the US
When the National Childhood Vaccine Injury Act became law in 1986, it gave vaccine manufacturers partial liability protection from lawsuits and did not protect doctors or other vaccine providers for vaccine injury malpractice claims.
The 1986 Act established a federal no-fault vaccine injury compensation program (VICP) as an administrative alternative to a lawsuit for injuries caused by vaccines recommended by the CDC for children.
Contested vaccine injury claims are adjudicated by U.S. Court of Federal Claims in Washington, D.C., and there is a Trust Fund out of which claims are paid, sparing insurance companies representing vaccine makers and vaccine providers from costly payouts for vaccine injuries and deaths.5
According to Legal Talk Network, the purpose for the 1986 Act was to induce vaccine makers wary of costly vaccine injury lawsuits to stay in the vaccine manufacturing business and create and market vaccines with impunity and no fear of being sued.6
Unfortunately, the bottom line is that, today, if you receive an FDA-licensed and state-mandated vaccine that injures or kills you or your child, the vaccine maker and the health care practitioner who administered the vaccine are protected from being sued in civil court. But the story behind it goes far deeper.
The Act Admits That Vaccines Can and Do Cause Injury, Death
Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, worked closely with Congress7 for years before the 1986 Act became law. In the historic federal legislation that was characterized by the pharmaceutical and medical care industries as badly needed "tort reform," the U.S. government acknowledged for the first time that:8
1. Federally licensed and recommended vaccines mandated by states for children to attend school can and do cause injury and death
2. Vaccine safety should be a priority for health agencies, vaccine manufacturers, doctors and other vaccine administrators
3. Individuals injured by government recommended and mandated childhood vaccines should have access to a federal vaccine injury compensation program administrative alternative to filing a vaccine injury lawsuit in civil court. Furthermore, they should have access to the civil court system in cases where:
• Federal compensation is denied or is inadequate
• There is evidence a pediatrician or other vaccine administrator negligently administered a vaccine
• A vaccine manufacturer engaged in criminal fraud or negligence
• A vaccine manufacturer could have made a vaccine less harmful (design defect)
New Laws and Rulings Chip Away at the Act
According to NVIC, the safety and compensation provisions in the 1986 law have been chipped away to the point that the law has been fatally compromised. At the time the Act was passed:9
"Although vaccine product liability for manufacturers was restricted, it was not completely eliminated, and manufacturers continued to be liable for design defect.
In 1987, medical trade organizations successfully lobbied for inclusion of a one-sentence amendment in an Omnibus funding bill that broadened liability protection for pediatricians and other vaccine administrators, but did not broaden liability protection for vaccine manufacturers when there was evidence the company could have made a vaccine less harmful."10,11
The erosion of the law continued in 2011 when, in a split decision, the U.S. Supreme Court:
"… blocked the legal right of vaccine injured persons to hold drug companies liable for design defect and failing to improve an FDA licensed vaccine to make it less harmful.12 This means that, today, even if a drug company could have improved a government licensed and mandated vaccine to make it less reactive, a vaccine injured person cannot sue the company in a civil court in front of a jury of peers."
According to NVIC:13
"Neglect and lack of congressional oversight on the Act for more than 30 years has enabled DHHS and the Department of Justice to turn what was supposed to be a non-adversarial, expedited, less expensive, fairer and more predictable federal vaccine injury compensation program, which Congress promised parents in 1986, into a highly adversarial, lengthy, traumatic and unpredictable imitation of a lawsuit in front of a one-person jury."
With No Liability Vaccine Makers Race to Make Vaccines
With the threat of vaccine injury lawsuits removed, more pharmaceutical companies have entered the lucrative vaccine business. For the past three decades, the global vaccine industry has been busy creating hundreds of new experimental vaccines, pushing for some of them to be fast-tracked, even before the recent push for a COVID-19 vaccine.
It doesn't matter how sloppy their work is or whether there is a lack of safety testing because, with no liability, there is no reason for safety testing, Robert Kennedy Jr., founder and chairman of the board of directors of the Children's Health Defense, says in a video.14
Their biggest cost, "paying liability at the back end," is not there, Kennedy says. "There's no reason to make [vaccines] safe because nobody can sue [them] … there's no consequence of giving you a really dangerous vaccine … it's a goldmine. If you can get a vaccine on the CDC schedule, it's worth a billion dollars a year typically to your company."
Moreover, the public has no redress against potential harm from the vaccine companies. "You cannot sue them for redress," says Kennedy. "There's no discovery; there's no depositions; there's no medical malpractice; there's no class actions."
The PREP Act Also Protects Vaccine Makers
In 2005, the Public Readiness and Emergency Preparedness Act (PREP Act) was passed as part of Bioshield legislation addressing potential bioterrorism threats after 9/11. The PREP Act shields vaccine makers from lawsuits for injuries caused by vaccines created and used during a declared public health emergency (such as the COVID-19 pandemic).
According to the Department of Health and Human Services, the PREP Act provides immunity from "claims of loss caused" by countermeasures or treatment of:15
"… diseases, threats and conditions determined by the Secretary to constitute a present, or credible risk of a future public health emergency to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures.
A PREP Act declaration is specifically for the purpose of providing immunity from liability, and is different from, and not dependent on, other emergency declarations."
Like the National Childhood Vaccine Injury Act, the Public Readiness and Emergency Preparedness Act of 2005, or Prep Act, facilitates the administration of potentially inadequately tested, risky vaccines and drugs by releasing drug manufacturers from all liability for covered "countermeasures."
Moreover, it gives the Secretary of HHS the power to detain, examine and quarantine indefinitely any individual thought to be infected with a communicable disease.
When the Act was passed in 2005, it paved the way for then HHS Sec. Kathleen Sebelius to impose quarantines and mandatory vaccinations if deemed necessary for the swine flu pandemic occurring at the time. Today, of course, the PREP Act allows those same scenarios as they relate to the COVID-19 pandemic.
AstraZeneca: Fast-Tracked Vaccines Need Liability Shield
Marketing of a COVID-19 vaccine is developing rapidly, especially in the U.K., where the government has signed vaccine supply pacts with AstraZeneca and Oxford, Pfizer, BioNTech, Valneva, Sanofi and GlaxoSmithKline.16 Yet, a recent article in Stat News asked "would vaccine manufacturers be willing to roll out vaccines on such a slight evidence base" without a liability shield? It's a good question that the article really didn't answer.17
Experts admit that "fast-tracking" to licensure an experimental vaccine like COVID-19 at "warp-speed" has never been done and is problematical for public safety. In an interview with Harvard Business School, Ken Frazier, chairman and CEO of Merck & Co., said:18
"I think when people tell the public that there's going to be a vaccine by the end of 2020, they do a grave disservice to the public … first of all, it takes a lot of time. I think the record for the fastest vaccine ever brought to market was Merck in the mumps vaccine. It took about four years. Our most recent vaccine for Ebola took five and a half years …
And here we [don't] even understand the virus itself or how the virus affects the immune system. We're starting there. We're starting with a spike protein as the antigen … we're hoping … to create a vaccine that we can study quickly that can be both safe and effective and … durable … if you're going to use a vaccine in billions of people, you better know what that vaccine does."
Officials at AstraZeneca, the U.K.'s second-largest drug maker, acknowledge that the risks of a hastily-marketed and tested vaccine necessitate a shield from risk which they have sought.
"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 senior AstraZeneca member, told Reuters.19 "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.
A Grave Risk Barely Acknowledged by Big Vax
The history of vaccines against coronaviruses has not been encouraging — a paradoxical effect has been seen. Rather than fighting the infection, they can actually trigger what's known as paradoxical immune enhancement.
What this means is that, despite a robust antibody response when you're exposed to the actual virus, rather than protecting you, the vaccine actually enhances the virus' ability to make you sick or even kill you.
This paradoxical effect means that "the most hazardous hurdle for the inoculation is … challenging participants with wild COVID infection," says Kennedy.20 "Past attempts at developing COVID vaccines have always faltered at this stage as both humans and animals achieved robust antibody response, then sickened and died when exposed to the wild virus." He gives a chilling example:
"They tested it [a coronavirus vaccine] on about 35 children, and … the children developed a champion antibody response, robust, durable. It looked perfect, and then the children were exposed to the wild virus and they all became sick. Two of them died. They abandoned the vaccine. It was a big embarrassment to FDA and NIH."
Research published in the Journal of Translational Autoimmunity confirms that treatment with a vaccine may increase the risks associated with a wild type virus rather than protect against it. The researchers call the process pathogenic priming.21
"The problem, highlighted in two studies, became obvious following post-vaccination challenge with the SARS virus. [They] found that recombinant SARS spike-protein-based vaccines not only failed to provide protection from SARS-CoV infection [COVID-19], but also that the mice experienced increased immunopathology with eosinophilic infiltrates in their lungs.
Similarly [research] found that ferrets previously vaccinated against SARS-CoV also developed a strong inflammatory response in liver tissue (hepatitis). Both studies suspected a 'cellular immune response.'"
The pathogenic priming is consistent with other autoimmunity actions including the release of proinflammatory cytokines creating a storm, states the research. It has been seen in coronaviruses similar to COVID-19:22
"Similar to the SARS-CoV animal studies found that mice vaccinated against MERS-CoV (Middle East Respiratory Syndrome) develop[ed] exaggerated pulmonary immunopathology when challenged with the MERS virus following vaccination.
They reported that lung mononuclear infiltrates were observed in all groups after virus challenge, and that increased infiltrates that contained eosinophils and the eosinophil promoting IL-5 and IL-13 cytokines were observed only in the vaccinated animals."
Why would the recombinant vaccines create a greater risk for wild type viruses rather than protect against them? Because, according to the research, immunogenic peptides in viruses have "high local homologous matching"23 to human proteins, meaning they closely resemble each other allowing opportunistic invasion. The immunogenic peptides have:24
" … a large number of opportunities for expected disturbances in the immune system itself, targeting elements of MHC Class I and Class II antigen presentation, PD-1 signaling, cross-presentation of soluble exogenous antigens and the ER-Phagosome pathway."
The research concludes that such similarity between viruses and human proteins, called homology, likely explains the previous failure of SARS and MERS vaccines in the past and dooms a COVID-19 vaccine as well.
New COVID-19 Vaccine Technology Has Not Been Used Before
There is another risk with at least one of the new COVID-19 vaccine candidates, which uses a type of technology never before used in human vaccines, called mRNA.
According to Dr. Andrew Kaufman, a forensic psychiatrist who formerly served as clinical assistant professor of psychiatry at SUNY Upstate Medical University,25 RNA vaccines actually change the genetic makeup of our own cells in a form of gene therapy.26
While news outlets claim to have debunked27 Kaufman's evaluation, the fact remains that this is a type of vaccine that has never been licensed for use in humans before — so how do the debunkers know for certain that it doesn't change your DNA?
Conventional vaccines train your body to recognize and respond to the proteins of a particular virus by injecting a small amount of the actual viral protein into your body, thereby triggering an immune response and the development of antibodies. But, mRNA vaccines are designed to co-opt your body to force it to produce its own viral protein, which, theoretically your immune system should then attack.
As I said, the danger is that no previous vaccines have had your own cells produce the viral proteins responsible for producing immunity and no one can predict what will happen, especially for individuals genetically and epigenetically predisposed to developing autoimmune disorders.
What might go wrong when you turn your body into a viral protein factory making antibodies on a continual basis? Again, no one knows since no mRNA vaccines are on the market and their first users will be guinea pigs. But, according to researchers at the University of Pennsylvania and Duke University.28
"Potential safety concerns that are likely to be evaluated in future preclinical and clinical studies include local and systemic inflammation, the biodistribution and persistence of expressed immunogen, stimulation of auto-reactive antibodies and potential toxic effects of any non-native nucleotides and delivery system components."
When looking at other research the scientists also worried about blood clots and edema, and some of these effects, such as systemic inflammation and blood clots, resemble severe symptoms of COVID-19 itself. Since the changes work at the genetic level, could this vaccine technology create long-term or even generational effects in the human genome?
Brave New Vaccine Technology
To repeat, mRNA technology has never been approved for use in human vaccines that will function very differently from traditional vaccines. The mRNA technology is not like other viruses where a vaccine is inactivated or simply weakened. In a video Kaufman says:29
"They have to use a special technology. It is not like a regular vaccine where there's just a syringe with one needle and a liquid containing whatever is in the vaccine. This has three needles so the needle in the middle is the typical type that the material would flow through but the other two needles on either side are actually electrodes."
The electrodes generate an electric current inside of our cells called electroporation:
"… the electricity causes the cell membranes to create little holes called pores and then the genetic material can enter the cell through those pores whereas normally the cell membrane would be a barrier."
The bottom line is, Kaufman says, not only is the source of the genetic material found in the vaccine undetermined, but the brave new vaccines could be used for "all sorts of purposes that we may not know about."30
Extending protection from liability to vaccine-makers allows the irresponsible sale and marketing of vaccines that have been poorly tested and formulated because the manufacturers have "nothing to lose." If the mRNA vaccine technology found in many COVID-19 vaccines harms us and permanently alters our genes, unaccountable vaccine manufacturers will be totally off the hook.