FDA authorized mRNA COVID 19 vaccines are effective per real world evidence synthesized across a multi state health system
Background Two FDA authorized mRNA COVID 19 vaccines, BNT162b2 (Pfizer/BioNTech) and mRNA 1273 (Moderna) have demonstrated high efficacies in large Phase 3 randomized clinical trials. It is important to assess their effectiveness in a real world setting. Methods This is a retrospective analysis of 136,532 individuals in the Mayo Clinic health system (Arizona, Florida, Iowa, Minnesota, Wisconsin) with PCR testing data between December 1, 2020 and April 20, 2021. We compared clinical outcomes for a vaccinated cohort of 68,266 individuals who received at least one dose of either vaccine (nBNT162b2 51,795; nmRNA 1273 16,471) and an unvaccinated control cohort of 68,266 individuals propensity matched based on relevant demographic, clinical, and geographic features. We estimated real world vaccine effectiveness by comparing incidence rates of positive SARS CoV 2 PCR testing and COVID 19 associated hospitalization and ICU admission starting 7 days after the second vaccine dose. Findings The real world vaccine effectiveness in preventing SARS CoV 2 infection was 86.1% (95% CI: 82.4 89.1% for BNT162b2 and 93.3% (95% CI: 85.7 97.4% for mRNA 1273. BNT162b2 and mRNA 1273 were 88.8% (95% CI: 75.5 95.7% and 86.0% (95% CI: 71.6 93.9% effective in preventing COVID 19 associated hospitalization. Both vaccines were 100% effective (95% CIBNT162b2: 51.4 100% 95% CImRNA 1273: 43.3 100% in preventing COVID 19 associated ICU admission. Conclusions BNT162b2 and mRNA 1273 are both effective in a real world setting and are associated with reduced rates of SARS CoV 2 infection and decreased burden of COVID 19 on the healthcare system.
Med