SARS-CoV-2 Peptide Vaccine, Gen 11 (Published September 16, 2021: Version 4-1-3)
Latest versions always hosted on https://radvac.org/white-paper
TERMS OF USE/INFORMED CONSENT (updated 2021-04-30)
This document describes the rationale, design, formulation, and self-administration of a vaccine for SARS-CoV-2. By using this information you agree to the following: 1) you are a consenting adult (in the USA, at least 18 years of age); and 2) you take full responsibility for your use of RaDVaC information and vaccine or material--including redistribution, modification, vaccine formulation, production and administration.
A foundational principle of the vaccine development and deployment strategy of RaDVaC is rapid iteration and testing of vaccine designs, based on newly published information from the forefront of biomedical research. This agile approach has the potential to produce better vaccines much more quickly than traditional approaches. However, such rapid design improvements currently are not compatible with established clinical trial requirements of fixed vaccine design, nor with review and approval by ethics committees (due to shifting vaccine design and continually updating self-experimentation and testing protocols). Therefore, the information presented within has not been approved by an institutional review board or any other type of ethics committee, and you understand and agree that any implementation of this information constitutes self-experimentation.
The purpose of this open-source vaccine effort is to reduce risk of harm from SARS-CoV-2. In addition to providing the results of our own research and experimentation, we hope to motivate others to build on our work, and to pursue diverse evidence-based approaches. Given the immense complexity and variability of individual human biology, it is not possible to predict all potential physiological responses to any vaccine. But as is true for most or all vaccines used on a large scale, there is a tradeoff between a larger known risk from the disease the vaccine is designed to prevent or mitigate, and the smaller risk introduced by the vaccine itself. Any vaccine poses risks, and, if used in enough people, will cause some degree of harm. Furthermore, certain harm, such as allergic and possibly anaphylactic response, will be readily seen and measured, whereas benefit is more difficult and takes longer to assess. This vaccine is no different; and because quality of delivery is highly dependent on the meticulousness of individual end users, it might pose unique risks not posed by typical commercial vaccines.
Does Not Constitute or Substitute for Medical Advice
Information presented here is ongoing research, and is not intended as a substitute for medical advice. RaDVaC is not responsible for the decision to administer, or to receive administration of, any vaccine.
No Promises or Guarantees of Efficacy
Vaccines are often received with the false hope of efficacy, without testing to determine the degree of individual immune response. For example, influenza killed about 100,000 people in the U.S. between late 2016 and early 2018. Yet, the influenza vaccines available in that period were substantially less than 50% effective against H3N2, the flu strain mainly responsible for the death toll. Many who died were vaccinated but not protected from the virus, and testing for vaccine-induced immunity was essentially non-existent. Vaccine-induced immunity can be more challenging to assess than immunity due to viral infection, and such is probably the case for the nasal vaccine described here. Because this work is a research undertaking, no expectation is given regarding any degree of efficacy in granting protection against SARS-CoV-2. On the contrary, see possible risks and uncertain benefits below.
Preventive, Not Therapeutic
Even if this vaccine works as intended, it will not help someone who has been infected. It will only work as a preventive measure taken weeks in advance of virus exposure.
Not a Clinical Trial
Any use of the information in this document, or provided in correspondence with us does not constitute ‘partnership’ or ‘recruitment’ for an organized trial in any way. The supported conjecture here is given as a starting point for additional individual or organized, sponsored research. As of public release of this information, no organized clinical trials have been performed to test this vaccine.
Not Approved or Reviewed by the FDA
The information, procedures, and conclusions presented here have not been approved, or reviewed by the FDA, or any other regulatory body.
Possible Risks and Uncertain Benefits
- Immediate allergic or other serious reaction
- Unforeseen long-term effects
- Instillation/administration of the vaccine in an inappropriate way or in an infected area might increase the risk of infection by enhancing viral entry into the body
- Benefits are uncertain. There are extensive published histories of the materials and procedures described in this document, but every novel vaccine should be considered experimental, with the possibility there will be no benefit.
- Even if there are signs of immune response there is no guarantee this response is indicative of protection from SARS-CoV-2 infection, or if protection is achieved, how long it will last.
- Even if the vaccine confers protection from the virus, certain methods for assessing protection--such as measuring antibodies due to previous infection--might not capture vaccine-induced immunity. In such cases, infection, and thus a positive test result, are unlikely to occur. Immunity passports and other privileges given to convalescents might be difficult to obtain for those with vaccine-induced immunity.
- Use of this vaccine may change the efficacy of any future vaccines you may take or that are administered to you, in unknown ways
No Offer of Service and No Access to Materials
All information in this document or via correspondence is made available as open science. We do not sell equipment or services, e.g. we will not prepare this formulation or any other on behalf of a requestor. All vaccine materials at our disposal are kept in a secured laboratory. We cannot and will not keep materials outside the lab for easy access or distribution. We will not provide laboratory or equipment access for vaccine production.
Probability and Coincidence
Vaccines have become associated with negative outcomes that do not result from the vaccine, but that occur soon after administration. Increasing use of any vaccine will increase the probability of recipients experiencing an unconnected negative outcome. By using the information presented here, you acknowledge the increasing likelihood of such coincidences, and assume full responsibility for any use of the information herein and for real or perceived negative outcomes, irrespective of the cause.
Self-Experimentation
By utilizing the information and scientific opinions in this document, and in any correspondence with us, you acknowledge and agree that any use to develop and self-administer a substance is an act of self-experimentation. Laws and regulations on such actions may differ in your national or state jurisdiction, and it is your responsibility to be informed about them.
Additionally, the type of work described in this document requires certain equipment and level of skill with laboratory techniques. You agree to assume full responsibility for acquiring proper equipment, knowledge, and training, and for attempting to formulate or administer vaccine.
Licenses
All contents of the RaDVaC website and white papers are covered by a Creative Commons Attribution 4.0 License (CC BY 4.0), and by an Open COVID License – Patent 1.1 (OCL-P v1.1). You are free to Share (copy and redistribute the material in any medium or format), and Adapt (fork, alter, and build upon) the material for any purpose. The only requirement is Attribution.