Rushed Vaccine Trials Revealing Safety Concerns
There are more than seventy (70) vaccine candidates in trials around the world.
Usually, trials happen quietly, without much public knowledge and little media attention, and safety issues with clinical trial design and data are not revealed until after the release of the product to the public when adverse reactions begin to occur and drive individuals to deeply research and demand answers, which takes years of legal wrangling to resolve, if ever.
The COVID-19 Pandemic is putting vaccine development into the spotlight, providing everyone with a rare view into the science, the politics, and the competitive business of vaccines. The race to be the first licensed has led the government and the industry to take shortcuts in what was already a system without adequate safety checks.
Entire categories of vaccines (such as Hep B and pertussis) recommended by the CDC for inclusion in the Pediatric Schedule fall under the 1986 National Vaccine Injury Act, which protects manufacturers and those who administer them from liability for injuries or deaths, in both children and adults. Vaccines designed for pandemics are different.
SHIELDED FROM LIABILITY
Vaccines licensed for COVID-19 are granted liability protection under the the Public Readiness and Emergency Preparedness Act (PREP Act). According to the Secretary of Health and Human Services:
Covered Countermeasures are any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom, or any device used in the administration of any such product, and all components and constituent materials of any such product . . .
Covered Countermeasures must be qualified pandemic or epidemic products, or security countermeasures or drugs, biological products [includes vaccines], or devices authorized for investigational or emergency use, as those terms are defined in the PREP Act, the FD&C Act, and the Public Health Service Act . . .
Section 319F-4 of the PHS Act, 42 U.S.C. 247d-6e, authorizes the Countermeasures Injury Compensation Program (CICP) to provide benefits to eligible individuals who sustain a serious physical injury or die as a direct result of the administration or use of a Covered Countermeasure. Compensation under the CICP for an injury directly caused by a Covered Countermeasure is based on the requirements set forth in this Declaration, the administrative rules for the Program, and the statute. To show direct causation between a Covered Countermeasure and a serious physical injury, the statute requires “compelling, reliable, valid, medical and scientific evidence.” The administrative rules for the Program further explain the necessary requirements for eligibility under the CICP. Please note that, by statute, requirements for compensation under the CICP may not align with the requirements for liability immunity provided under the PREP Act. Section XIV of the Declaration, “Countermeasures Injury Compensation Program,” explains the types of injury and standard of evidence needed to be considered for compensation under the CICP.
RUSHING VACCINES IS DANGEROUS AND UNNECESSARY
The Centre for Evidence-Based Medicine at the University of Oxford is monitoring and continually updating COVID-19 data. They say that data indicates, at this time and subject to change, that at the population level, the Infection Fatality Rate (IFR) is likely around .1 to .4% — meaning the Infection Survival Rate is around 99.6 to 99.9%. The subpopulations of those who are experiencing much higher Case Fatality Rates (CFR) and IFRs are known and should, of course, take precautions, be protected by those caring for them or working with them, and be afforded the best possible treatments. While the FDA and CDC have not announced an official treatment, many effective treatments exist and are saving lives. And as more data comes in from front line doctors, and those working in relative media-isolation, like the many thousands of naturopaths and chiropractors who are successfully providing treatment protocols that are keeping their patients out of the hospital, the more patients will be saved, and the fatality rates among those subpopulations will also drop.
Rushed vaccines thrust upon a public made fearful by public health and the media could cause far more harm than good.
Below is information about Moderna’s vaccine candidate. We will attempt to keep readers informed as news comes in about clinical trial results of this and other candidates. Please check back often, and please do your due diligence in researching any preventative or treatment offered you. Remember, it is your right to be afforded the opportunity for fully informed consent or fully informed dissent. Stay well and safe.
MODERNA’S mRNA-1273 VACCINE CANDIDATE
Moderna: “mRNA-1273 was generally safe and well tolerated, with a safety profile consistent with that seen in prior Moderna infectious disease vaccine clinical studies.”
ICWA: What does that mean? What adverse reactions were seen in prior clinical trials? Did these trials include inert placebo groups? Why is Moderna not doing any inert saline placebo trials now since no licensed vaccine for SARS-Cov-2 currently exists? It is accepted that gold-standard safety testing for any new product for which there is no safe and effective existing comparator must use inert placebos in clinical trials. Other vaccines designed to protect against other infections cannot be used as comparators, neither can any other product that itself has not been through an inert placebo controlled study.
Moderna: “The sole incidence of a grade 3 adverse event in the 25 µg and 100 µg dose cohorts was a single participant at 100 µg who experienced grade 3 erythema (redness) around the injection site. To date, the most notable adverse events were seen at the 250 µg dose level, comprising three participants with grade 3 systemic symptoms, only following the second dose. All adverse events have been transient and self-resolving. No grade 4 adverse events or serious adverse events have been reported.”
One of the volunteers who experienced grade 3 systemic reactions, explained the fever, the nausea, and the hospital visit. Read the article.
ICWA: There were just 15 participants in the 250 µg dose level arm, and they were all screened — only healthy adults were accepted. The FDA describes Grade 3 systemic symptoms as: “Severe but not life threatening; hospitalization required; limitation of patient’s ability to care for him/herself.” And 3 out of 15 healthy adults experienced these sort of reactions in this group after the second dose? That is very concerning. Moderna says they will only proceed with the lower dosages in Phase II and III trials — but it must be remembered that individuals in the general population range from under-responders (who can tolerate very large doses) to over-responders (those for whom a 25 µg hits them like a 250 µg dose). And since the reactions only occurred AFTER the second dose, does this indicate “disease enhancement” also known as “pathogenic priming“?
Moderna: “Preclinical results from a viral challenge study in mice conducted in collaboration with NIAID and its academic partners are also available. In this study, vaccination with mRNA-1273 prevented viral replication in the lungs of animals challenged with SARS-CoV-2.”
ICWA: Where is that mice challenge study? Moderna did not provide or link to it. Why did Moderna only report that viral replication in the lungs was prevented? Does this mean viral replication was not prevented in the nose and throat and upper respiratory tract? That the vaccinated mice, after challenge, could become infected and spread that infection, much like those vaccinated with the acellular pertussis vaccines? Why didn’t Moderna or the NIAID report any safety findings in this animal-model challenge? The world knows pathogenic priming is expected with vaccination for this particular virus because it has always happened with vaccines attempted in the past for its cousins, SARS and MERS. If there were no safety concerns in the mouse-model-challenge, why not publish the good news?
Moderna: “Phase 3 trial initiation in July, subject to finalization of the clinical trial protocol.”
ICWA: What were Phase I trial participants told about the past failures of vaccines in this family? About the likelihood of disease enhancement? About the mRNA novel platform that has never yet been used in a licensed human vaccine before? What will the Phase II and III volunteers be told? Will they be informed of the safety results of that animal challenge? Are the Federal Rules guiding Clinical Trials being followed?
A sampling of responses in the news:
- Moderna Shares Slump As Coronavirus Vaccine Questions Mount
- Scientists Raise Questions About Moderna Vaccine In Market-Shaking Report
- Coronavirus vaccine czar to divest some holdings amid conflict concerns