Randomized controlled trials (RCTs) are considered the “gold standard” in clinical medicine. Perhaps for this reason, health authorities all over the world have assumed the universal validity of RCTs and have not recognized that RCT results may not be valid everywhere or for the epidemiology of infectious diseases. Using the Pfizer-BioNTech vaccine trial as a case study, we illustrate the limitations of the RCT and show that the results may be inappropriate for COVID-19 epidemiology. This critique explains why health authorities have not recognized that the vaccines have failed to stem the growth of the COVID-19 pandemic. This insight has also broader implications for the global pharmaceutical industry. Continue reading
The vaccine efficacy measure relevant for COVID-19 epidemiology, should be based on real-world data, not on clinical data which have data selection biases indicated in this paper. Recent United Kingdom data suggest that age-dependent asymptomatic breakthrough cases and natural immunity of the unvaccinated, may have led to negative vaccine efficacy where vaccinated infectivity is higher than unvaccinated infectivity among major age groups. The phenomenon of relative risk enhancement of vaccines among certain cohorts suggests diminishing effectiveness of the vaccination strategy for the COVID-19 pandemic.
The epidemiological impact of increased vaccination on COVID-19 pandemic is investigated by a study of the long-term cross-sectional correlation of 98 countries using the database of Our World in Data. Higher percentages of fully vaccinated population are found in 94 countries to be associated with higher increases in infections in 2021 relative to 2020.