FDA-authorized mRNA COVID-19 vaccines are effective per real-world evidence synthesized across a multi-state health system

Abstract

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 (n BNT162b2 = 51,795; n mRNA-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% CI BNT162b2 : 51.4-100%; 95% CI mRNA-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.

Real-time analysis of a mass vaccination effort confirms the safety of FDA-authorized mRNA COVID-19 vaccines

“…The cohorts of vaccinated and unvaccinated individuals considered for this study are identical to the cohorts considered in a previous analysis: ''FDA-authorized COVID-19 vaccines are effective per real-world evidence synthesized across a multi-state health system.'' 21 , 2020 and the date of their first vaccine dose were excluded, as were individuals with zero follow-up days after vaccination (i.e., those who received the first vaccine dose on the last date of data collection). Individuals who had received their second vaccine dose four or more days earlier than recommended (17 or fewer days after the first dose for BNT162b2; 24 or fewer days after the first dose for mRNA-1273) were also excluded, leaving 85,676 eligible individuals for the final vaccinated cohort.…”

“…We thus employed a one-to-one propensity matching procedure to derive a cohort of unvaccinated individuals who are balanced for demographic factors, residential location, history of SARS-CoV-2 and influenza testing, and current residence at long-term care facilities (see STAR Methods), and we curated their clinical notes over specified time periods to quantify the frequency of the defined symptoms of interest. 21 This propensity-matched group serves a purpose similar to that of the placebo arm in clinical trial safety assessments, allowing us to contextualize and better interpret the absolute rates of adverse effects documented in the notes of vaccinated individuals. The results of this study support the safety and tolerability of both BNT162b2 and mRNA-1273 in clinical practice, further strengthening the case for the rapid and broad distribution of these vaccines to the public.…”

“…Taken together with our recent study highlighting the real-world effectiveness of these vaccines, these data reinforce that individuals, providers, and public health officials should proceed rapidly with vaccination efforts with high confidence in their safety. 21…”

SARS‐CoV‐2 vaccination in patients with inflammatory bowel disease

“…An associated decrease in 14-day hospitalisation rate in those who were vaccinated and subsequently diagnosed with COVID-19 was also appreciable when compared to propensity-matched unvaccinated COVID-19-infected individuals at 3.7% compared to 9.2% respectively, with a relative risk of 0.4; P = 0.007. 47 In 53 However, the clinical implications of this are unknown.…”

Beyond the new normal: Assessing the feasibility of vaccine-based suppression of SARS-CoV-2

“…On the other hand, a CDC study suggests a 90% reduction in risk of infection among working-age adults recently vaccinated with Pfizer or Moderna vaccines [25], while the UK SIREN study similarly reports an 86% reduction in risk of infection among fully vaccinated participants (who largely received the Pfizer vaccine) [26]. Many studies of this nature [27,28] are limited by the inclusion of voluntary or symptom-gated SARS-CoV-2 test results, which may exaggerate vaccine efficacy against infection if vaccinees are less likely to present with classic COVID-19 symptoms or less likely to seek testing.…”