People’s Response to COVID-19 Vaccine Efficacy and Safety (PROVES)
Seeking participation from both unvaccinated and vaccinated individuals worldwide with or without COVID and/or adverse events for a study approved by institutional review board.
COVID-19 pandemic caused by SARS-CoV-2 has touched all of us in some way or the other. There are 3 different categories of vaccines being used- (i) Inactivated whole virus or traditional vaccine; (ii) mRNA (Moderna and Pfizer), and (iii) recombinant AAV-DNA (AstraZeneca J&J and others). The numbers of breakthrough infections in fully vaccinated people are on the rise. New emerging variants may evade vaccine-induced immunity, but whether the naturally immune are protected, remains unclear. Recent data from Israel and other countries suggests that natural immunity is superior and provides protection against other emerging variants. The mental trauma from this pandemic is different for the vaccinated versus the unvaccinated and remains to be evaluated. The misinformation about the vaccines, adverse events, and efficacy is rampant. FDA recently cautioned against use of J&J due to blood clot events. Many European countries do not recommend use of Moderna for children. Despite citing efficacy in clinical trials for children, Pfizer announced that 2 doses are not sufficient in children. Full datasets for clinical trials conducted by the Pharma will not be released for several decades. Thus, it is imperative to obtain this information by independent investigators to validate findings.
Using questionnaire-based measures, we expect to gain valuable information on severity of COVID illness, health outcomes, course of recovery, vaccine efficacy, safety, and mortality in vaccinated and unvaccinated people of all ages, worldwide. VAERS and other adverse event reporting systems only collect data from a subset of people. Data from unvaccinated individuals and their health outcomes is severely lacking. Data from vaccinated individuals without any serious side effects is also not collected by VAERS or other such agencies. This study will allow us to independently answers questions about COVID-19 vaccine safety and efficacy in a properly controlled manner. Independent studies are essential for scientific process especially given that data from original clinical trials will not be released for decades. In this study, we will survey both vaccinated and unvaccinated people about their mental health, stress, anxiety, COVID symptoms, and vaccine-induced events, if any. The objective is to ascertain…