TY - JOUR
T1 - FDA-authorized mRNA COVID-19 vaccines are effective per real-world evidence synthesized across a multi-state health system
AU - Pawlowski, Colin
AU - Lenehan, Patrick
AU - Puranik, Arjun
AU - Agarwal, Vineet
AU - Venkatakrishnan, A. J.
AU - Niesen, Michiel J.M.
AU - O'Horo, John C.
AU - Virk, Abinash
AU - Swift, Melanie D.
AU - Badley, Andrew D.
AU - Halamka, John
AU - Soundararajan, Venky
N1 - Publisher Copyright:
© 2021 Elsevier Inc.
PY - 2021/8/13
Y1 - 2021/8/13
N2 - Background: Two US Food and Drug Administration (FDA)-authorized coronavirus disease 2019 (COVID-19) mRNA vaccines, BNT162b2 (Pfizer/BioNTech) and mRNA-1273 (Moderna), have demonstrated high efficacy 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, and 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 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) PCR testing and COVID-19-associated hospitalization and intensive care unit (ICU) admission starting 7 days after the second vaccine dose. Findings: The real-world vaccine effectiveness of preventing SARS-CoV-2 infection was 86.1% (95% confidence interval [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 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. Funding: This study was funded by nference.
AB - Background: Two US Food and Drug Administration (FDA)-authorized coronavirus disease 2019 (COVID-19) mRNA vaccines, BNT162b2 (Pfizer/BioNTech) and mRNA-1273 (Moderna), have demonstrated high efficacy 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, and 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 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) PCR testing and COVID-19-associated hospitalization and intensive care unit (ICU) admission starting 7 days after the second vaccine dose. Findings: The real-world vaccine effectiveness of preventing SARS-CoV-2 infection was 86.1% (95% confidence interval [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 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. Funding: This study was funded by nference.
KW - COVID-19
KW - COVID-19 vaccines
KW - Translation to population health
KW - propensity score matching
KW - real world evidence
UR - http://www.scopus.com/inward/record.url?scp=85110291573&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85110291573&partnerID=8YFLogxK
U2 - 10.1016/j.medj.2021.06.007
DO - 10.1016/j.medj.2021.06.007
M3 - Article
C2 - 34223401
AN - SCOPUS:85110291573
SN - 2666-6359
VL - 2
SP - 979-992.e8
JO - Med
JF - Med
IS - 8
ER -