We introduce an advanced understanding of the genomic expression of immunity in a living human being and an era of personalized vaccines and treatments. A proprietary index of human immunity modulation—Human Immunity Score (HIS)—is proposed as a prognosticator of morbidity and mortality during the pandemic. A measure of 55 and above is postulated to be protective regardless of PPE and vaccines. 26 is a cut-off for patients who while ambulatory are at significantly higher risk. Today's prevalent vaccines may be protective in delaying the manifestations of and reducing the mortality from pneumonic consolidation and primary cardiomyopathy in symptomatic patients. Generic, non-personalized vaccines are more likely to cause side effects in patients with a HIS measure of 26 or lower. We further declare that the new iatrogenic-phase of COVID-19 has now morphed into a different disease in its method of spread, disease manifestations and mortality potential.
- ❯ Pandemics are best managed by early-effective containment. Singularly missing in effective lockdowns—is a key concept of concerted, coordinated and repeated environmental remediation. SHF postulate-estimates that misplaced reliance and its consequent harm by extensive use of multi-layer with N-95 or now N-99 masks is described in a Mask Toxicity Syndrome, that may have been the cause of —violence, intense emotional outbursts and brain-fog— and may be the etiology of clinically—objective worsening of underlying chronic lung disease, metabolic disorders, and reduced humoral immunity. Patients with HIS measure of 42 and lower, who are more likely to want to be cautious, are ironically more likely to get sicker from mask related toxicity, if the use is prolonged and not limited to small periods of time for emergencies only. Masks are definitively protective but overuse in leisure or worse, in physical exertion cause increased side-effects, in SHF analyses.
- The N-phase disease vector was heavier, and larger (2.5 cms in droplets) demonstrated a viable activation life-span of an average of 7-10 days in optimal conditions of ambient temperature, humidity and presence of fomite-hosts.
- By contrast, the I-phase disease vector is smaller (about 1 mm) and can deactivated in about 2.5 hours if no living host is present.
- Similarly, the N-phase had an incubation period of worsened clinical status after an average of 8 days, whereas the I-phase, that manifested during early winter in 2020 with symptom-onset by several weeks. Rapid spread has now caused symptom-onset in just a few days during calendar 2021. Efficient spread in communities especially since early spring has now started manifesting with rapid onset of pneumonic consolidation, respiratory distress in a median of 2-days.
- ❯ Our analyses show that a one-size-fits-all containment and related public policy is crude and has been not well adopted. A nuanced SHF-postulate of the differences between viral-vectors in influenza or COVID-19 and those of poliomyelitis or measles, for example, is important in the role of vaccines in pandemic management. SHF postulates a novel understanding of origin, spread and mechanisms of injury in viral-vectors in COVID-19.
- ❯ It is notable that the number of patients experiencing seasonal cold and flu in several geographical clusters dropped by almost 70% during fall/winter of 2020.
- ❯ The SHF has arrived at empirical-best-fits in possible answers to thousands of questions relating to the pandemic and human disease itself. Empirical HIS score-based analyses have helped us to predict which patients are more at-risk and what protective measures are likely to be more effective.
- ❯ Vaccines and personal protective measures are important but prevailing theories on the extent of efficacy in preventing new-onset infections or further spread of disease-vectors have been largely rejected in the SHF analyses. Spillover of vaccination-related protections have also added to laxity in the careful restraint needed in the vector exposure, especially in closed-spaces such as malls and offices. Continued availability of vector-hosts has manifested in a continued iatrogenic phase of the pandemic, now raging in many countries.
- ❯ Preprint disclosures of SphReI-HxVaccine subset of the Sphenome Heuristics Framework in a series of convertible Public Service Announcements (cPSA) have been released since early 2020.
- ❯ Rigorous observational data analyses—case–controlled and cohort-based—data from over 97 countries have some of SHF-Knowledgebase postulates on the mechanism of how disease vectors cause human disease. In chief, vaccines given to patients with HIS of 26, while being helpful are likely to cause more side-effects.
- ❯ Several predictive analytics-results of our framework, since late 2019, have subsequently been evidenced to be true.
- ❯ The trial-platform is a bold attempt bring a transformational change on how research is conducted with transparency and integrity.
- ❯ The trial-platform's aim is to carefully validate almost every theory and practice prevalent so that humanity can move away from idiosyncracies in pubic policy which necessarily come into play in effecting population-behavior to combat a pandemic, or other public-health issues generally.
- ❯ As we introduce novel concepts and document possible discoveries, we believe that the SphReI-HxVaccine Trial Platform will improve our understanding of the human body and how disease manifests.
- ❯ The trial-platform, together with SHF modeling has the potential to avoid unnecessary animal experiments or human lives, shorten time to conduct clinical trials, develop new classes of personalized therapeutics and pharmaceuticals, and responsibly introduce them into the mainstream of medicine.
- ❯ This trial-platform has the potential to showcase the world's best-in-class technologies and develop best-practices in the access, delivery, and consumption of healthcare services worldwide.