BEFORE 2020, very few members of the public knew the meaning of the term “disease enhancement”. After 2020, it has become widely understood that coronavirus vaccines have, in the past, caused worse health outcomes upon viral infection.
The rush toward vaccinations against SARS-CoV-2 had skipped early animal studies.
Therefore, I sent the following message to ACIP, the committee that chooses whether any vaccine and which vaccines are recommended for children, and more recently, for adults.
The animal studies conducted in the past on MERS and SARS vaccines show unequivocally that vaccines against members of this clade of coronaviruses caused DISEASE ENHANCEMENT, mostly in the older animals, meaning more severe COVID upon exposure to the virus following vaccines. The two studies conducted by Moderna and Pfizer on the leading vaccines failed to measure for enhanced immunopathology in any organ site other than the lung – and they failed to measure a key indicator of disease enhancement (IL-5). Pfizer removed an outlier from their small study, which is not accepted practice in the statistical analysis of studies such as these.
My own research shows that all immunogenic epitopes in the SARS-CoV-2 virus except one have high potential for pathogenic priming due to homology to human proteins in a wide variety of human tissues (Lyons-Weiler, 2020). Since no animal studies were conducted on older animals, we have no idea of the COVID19 vaccines being considered will cause pathogenic priming leading to disease enhancement in the liver, pancreas, spleen, brain, intestines, and central nervous system. Unqualified recommendations of COVID19 vaccines could lead to a public health crisis due to disease enhancement that makes 2020 look like a walk in the park.
The vaccine should be sent back to the drawing board for proper translational studies. Unsafe epitopes should be removed. I have peer reviewed three COVID19 vaccine studies and the authors of those studies all agreed to remove the unsafe epitope found easily by computational search.
I urge with every ounce of my scientific background that you specifically exclude the elderly from recommendation until autoimmune and immune reactogenicity is fully studied in older animals. Further, given the head-spinning pace at which the vaccine studies have been conducted, especially given the combination of Phase2/3, the lack of screening for prior exposure, the dubious interpretations of efficacy published in press-releases without rigorous peer-review, I strongly recommend that you caveat any recommendation of COVID19 vaccines for any population “without mandate” and similarly for any future and past ACIP-recommended vaccine. This at the very least would help stop any insurrection or rioting that will occur if millions of people experience more serious COVID19 symptoms or mass deaths following infection following vaccination.
I attach my NIH Biosketch so that you might consider some of my peer-reviewed research studies in your deliberations.
I also provide references to the studies cited below.
Some contextual comments: I and millions of our fellow Americans have grave concerns regarding testing false positive rates (see Lee, SH. Testing for SARS-CoV-2 in cellular components by routine nested RT-PCR followed by DNA sequencing. International Journal of Geriatrics and Rehabilitation 2020, 2(1):69- 96 and Basile K et al., Accuracy amidst ambiguity: false positive SARS-CoV-2 nucleic acid tests when COVID-19 prevalence is low, Pathology, 2020 https://doi.org/10.1016/j.pathol.2020.09.009) as well as grave concerns over the change in the practice of the diagnosis of COVID19 using only qRT-PCR results of which the entire committee should also become aware (e.g., Ealy, H, M McEvoy, D Chong, J Nowicki, M Sava, S Gupta, D White, J Jordan, D Simon and P Anderson. COVID-19 Data Collection, Comorbidity & Federal Law: A Historical Retrospective. Science, Public Health Policy & the Law Oct 2020 2:4-22.).
Since early treatment with any number of published therapeutic protocols can reduce the incidence of serious illness and mortality from COVID19, I urge ACIP to recommend early and prophylatic use of hydroxychloroquine, budesonide. See http://c19study.com/ for a compilation of studies that support early use of hydroxychloroquine.
You and all who serve in public health are just that – public health servants. You are not an elected board, you should not be empowered with the de facto power of rule of law by decree. That type of law-making was rigorously ousted from these United States of America in 1776. I ask on behalf of all who will suffer lifelong chronic illness and death from a COVID19 vaccine mandate – please do your job and provide proper stewardship of all aspects of public health. Respect choice.
James Lyons-Weiler, PhD
Lyons-Weiler J. 2020. Pathogenic Priming Likely Contributes to Serious and Critical Illness and Mortality in COVID-19 via Autoimmunity. J Transl Autoimmun. 2020 Apr 9:100051. doi: 10.1016/j.jtauto.2020.100051.
Immunization with inactivated Middle East Respiratory Syndrome coronavirus vaccine leads to lung immunopathology on challenge with live virus. “Lung mononuclear infiltrates occurred in all groups after virus challenge but with increased infiltrates that contained eosinophils and increases in the eosinophil promoting IL-5 and IL-13 cytokines only in the vaccine groups. Inactivated MERS-CoV vaccine appears to carry a hypersensitive-type lung pathology risk from MERS-CoV infection that is similar to that found with inactivated SARS-CoV vaccines from SARS-CoV infection.” https://www.ncbi.nlm.nih.gov/pubmed/27269431
Vaccine efficacy in senescent mice challenged with recombinant SARS-CoV bearing epidemic and zoonotic spike variants.“VRP-N vaccines not only failed to protect from homologous or heterologous challenge, but resulted in enhanced immunopathology with eosinophilic infiltrates within the lungs of SARS-CoV-challenged mice. VRP-N-induced pathology presented at day 4, peaked around day 7, and persisted through day 14, and was likely mediated by cellular immune responses.” https://www.ncbi.nlm.nih.gov/pubmed/17194199
Immunization with Modified Vaccinia Virus Ankara-Based Recombinant Vaccine against Severe Acute Respiratory Syndrome Is Associated with Enhanced Hepatitis in Ferrets “Immunized ferrets developed a more rapid and vigorous neutralizing antibody response than control animals after challenge with SARS-CoV; however, they also exhibited strong inflammatory responses in liver tissue.”
Animal Models for SARS and MERS coronaviruses. “The concern that is extrapolated from the FIPV vaccine experience to human SARS-CoV vaccines is whether vaccine recipients will develop more severe disease if they are exposed to or infected with SARS-CoV after neutralizing antibody titers decline. The second concern is whether recipients of a SARSCoV vaccine would be at risk of developing pulmonary immunopathology following infection with an unrelated human coronavirus e.g. 229E, OC43, HKU1 or NL63 that usually causes mild, self limited disease. Although findings from preclinical evaluation have revealed these concerns, studies in animal models may not be able to provide data to confirm or allay these concerns.”