A Different Perspective of COVID-19 Pandemic: Efficacy and Safety of mRNA Vaccines in Immunocompetent and Immunocompromised Individuals (Part 3).

ABSTRACT

Shortly after the declaration of the pandemic, several anti-SARS-CoV-2 vaccines entered phase 3 clinical trials. One year later, Pfizer-BioNTech and Moderna published their initial trial results, encompassing a 2-month follow-up. The studies were only designed to test whether the vaccines were effective and safe on the short-term.The vaccine's efficacy in the 2 trials was defined as relative risk reduction instead of absolute risk reduction, a more accurate determinant of vaccine effectiveness in the real world. These studies were not designed to assess viraltransmission, disease severity, and death as primary outcomes.Vulnerable subgroups of individuals were excluded from the studies. No correlate of immunity against the SARS-CoV2 was identified.Vaccine-induced immunity declined shortly after vaccination and was not protective against new variants. Vaccination and boosting effectiveness were suboptimal in immunocompromised patients. In contrast, in recovered COVID-19 patients, natural immunity was shown to be protective, lasting longer and being more effective against new variants. Findings from subsequent scientific reports questioned the effectiveness of these vaccines in providing protective immunity despite boosting in infection-naïve and infection-experienced individuals. Reports also raised concerns on their safety in relation to cardiovascular pathology, sudden death, and acquired autoimmunity mainly in the low-risk young population. With the doubtful accuracy of the polymerase chain reaction testing in relation to case definition and diagnosis, the inability of the vaccines to stop viral transmission, the uncertain effectiveness of these vaccines, and serious adverse events of these vaccines lead us to question the validity ofthe vaccine mandate in public and private domains.