Methodological Analysis: Randomized Controlled Trials for Pfizer and Moderna COVID-19 Vaccines.

ABSTRACT

Critical appraisal of randomized controlled trials (RCTs) determines rigor, quality, and whether the findings are applicable to the populations served in clinical practices. The authors conducted a rigorous analysis using the RCT Critical Appraisal Skills Programme (CASP) Checklist for the two RCTs Pfizer (New York, NY) and Moderna (Cambridge, MA) conducted and the reporting of these RCTs using the Consolidated Standards of Reporting Trials checklist. The goals for this analysis were twofold (1) enable health care providers to understand the methods and outcomes of these RCTs, and (2) enable health care providers and community leaders to become champions for the vaccines to reduce vaccine hesitancy among all populations. The analysis is presented using each of the 11 questions on the CASP tool while comparing the methodology and results for each vaccine. Most CASP tool items were positive or yes for both the Pfizer and Moderna RCTs. Items that were not scored as yes are discussed. The analysis outcomes revealed that both RCTs were rigorously conducted and provide an assurance to all health care providers and the public of the safety and efficacy of both vaccines to impact the astounding morbidity and mortality of COVID-19 disease. The authors believed that the analysis was an essential component of the distribution process to develop plans and communication strategies to reduce potential vaccine hesitancy and resistance.