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 - Funding Information:
We thank Murali Aravamudan for his mentorship and insightful discussions regarding study design. We thank the peer reviewers for their thoughtful reviews and feedback, which greatly improved the quality of the final manuscript. In addition, we thank the commentators on medRxiv who provided feedback on the initial preprint for this study. Finally, we thank the healthcare workers at Mayo Clinic Health Systems and around the United States who have administered COVID-19 vaccines to millions of people, which has made this real-world effectiveness analysis possible. This study was funded by nference. C.P. and A.P. performed the statistical analysis and had unrestricted access to all data. C.P. P.L. A.P. M.J.M.N. A.V. and V.S. prepared the first draft of the manuscript, which was reviewed and edited by all authors. All authors agreed to submit the manuscript, read and approved the final draft, and take full responsibility of its content, including the accuracy of the data and statistical analysis. C.P. P.L. A.P. V.A. A.V. M.J.M.N. and V.S. are employees of nference and have financial interests in the company and in the successful application of this research. J.C.O. receives personal fees from Elsevier and Bates College and small grants from nference, Inc. outside of the submitted work. A.D.B. is a consultant for Abbvie, is on scientific advisory boards for nference and Zentalis, and is founder and President of Splissen Therapeutics. J.H. J.C.O. M.D.S. A.V. and A.D.B. are employees of the Mayo Clinic. The Mayo Clinic may stand to gain financially from the successful outcome of the research. nference collaborates with Janssen and other bio-pharmaceutical companies on data science initiatives unrelated to this study. These collaborations had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. This research has been reviewed by the Mayo Clinic Conflict of Interest Review Board and is being conducted in compliance with Mayo Clinic Conflict of Interest policies.
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
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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 -