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. 2022 Jan 14;3(1):28-41.e8.
doi: 10.1016/j.medj.2021.12.002. Epub 2021 Dec 11.

Comparative effectiveness of mRNA-1273 and BNT162b2 against symptomatic SARS-CoV-2 infection

Arjun Puranik  1 , Patrick J Lenehan  1 , Eli Silvert  1 , Michiel J M Niesen  1 , Juan Corchado-Garcia  1 , John C O'Horo  2   3 , Abinash Virk  2 , Melanie D Swift  4 , Joel E Gordon  5 , Leigh Lewis Speicher  6 , Holly L Geyer  7 , Walter Kremers  8 , John Halamka  9 , Andrew D Badley  2   10 , A J Venkatakrishnan  1 , Venky Soundararajan  1
Affiliations

Comparative effectiveness of mRNA-1273 and BNT162b2 against symptomatic SARS-CoV-2 infection

Arjun Puranik et al. Med. .

Abstract

Background: mRNA coronavirus disease 2019 (COVID-19) vaccines are safe and effective, but increasing reports of breakthrough infections highlight the need to vigilantly monitor and compare the effectiveness of these vaccines.

Methods: We retrospectively compared protection against symptomatic infection conferred by mRNA-1273 and BNT162b2 at Mayo Clinic sites from December 2020 to September 2021. We used a test-negative case-control design to estimate vaccine effectiveness (VE) and to compare the odds of symptomatic infection after full vaccination with mRNA-1273 versus BNT162b2, while adjusting for age, sex, race, ethnicity, geography, comorbidities, and calendar time of vaccination and testing.

Findings: Both vaccines were highly effective over the study duration (VEmRNA-1273: 84.1%, 95% confidence interval [CI]: 81.6%-86.2%; VEBNT162b2: 75.6%, 95% CI: 72.2%-78.7%), but their effectiveness was reduced during July-September (VEmRNA-1273: 75.6%, 95% CI: 70.1%-80%; VEBNT162b2: 63.5%, 95% CI: 55.8%-69.9%) as compared to December-May (VEmRNA-1273: 93.7%, 95% CI: 90.4%-95.9%; VEBNT162b2: 85.7%, 95% CI: 81.4%-88.9%). Adjusted for demographic characteristics, clinical comorbidities, time of vaccination, and time of testing, the odds of experiencing a symptomatic breakthrough infection were lower after full vaccination with mRNA-1273 than with BNT162b2 (odds ratio: 0.60; 95% CI: 0.55-0.67).

Conclusions: Both mRNA-1273 and BNT162b2 strongly protect against symptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. It is imperative to continue monitoring and comparing available vaccines over time and with respect to emerging variants to inform public and global health decisions.

Funding: This study was funded by nference.

Keywords: BNT162b2; COVID-19; SARS-CoV-2; comparative effectiveness; mRNA vaccines; mRNA-1273.

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Conflict of interest statement

A.P., P.J.L., E.S., M.J.M.N., J.C.O., A.J.V., and V.S. are employees of nference and have financial interests in the company. nference is collaborating or has collaborated with Moderna, Pfizer, 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. J.C.O. receives personal fees from Elsevier and Bates College and receives small grants from nference, Inc., outside the submitted work. A.D.B. is supported by grants from NIAID (grants AI110173 and AI120698), Amfar (no. 109593), and Mayo Clinic (HH Shieck Khalifa Bib Zayed Al-Nahyan Named Professorship of Infectious Diseases). A.D.B. is a paid consultant for Abbvie, Gilead, Freedom Tunnel, Pinetree Therapeutics, Primmune, Immunome, and Flambeau Diagnostics; is a paid member of the DSMB for Corvus Pharmaceuticals, Equilium, and Excision Biotherapeutics; has received fees for speaking for Reach MD and Medscape; owns equity for scientific advisory work in Zentalis and nference; and is founder and President of Splissen Therapeutics. M.D.S. received grant funding from Pfizer via Duke University for a vaccine side effect registry. J.C.O., A.V., M.D.S., J.E.G., L.L.S., H.L.G., W.K., J.H., 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. 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.

Figures

None
Graphical abstract
Figure 1
Figure 1
Test-negative case-control analysis to compare the odds of symptomatic infection after vaccination with mRNA-1273 versus BNT162b2 (A) The primary analysis was conducted as a test-negative case-control study, with positive symptomatic SARS-CoV-2 PCR tests considered as cases and negative symptomatic tests considered as controls. We compared the odds of symptomatic infection after full vaccination with mRNA-1273 versus after full vaccination with BNT162b2, while adjusting for clinical and demographic covariates. (B) Odds ratios (ORs) of symptomatic infection obtained in the crude analysis (top) and in the adjusted analysis using conditional logistic regression (CLR) (bottom). In each case, ORs are shown for the entire study duration (December 1, 2020 through September 22, 2021), the early epoch (December 1, 2020 through May 31, 2021), and the late epoch (July 1, 2021 through September 22, 2021). The x axis is log-transformed such that, for example, ORs of 0.5 and 2 are equidistant from the null hypothesis odds ratio of 1. Error bars represent 95% confidence intervals. (C) Estimated effectiveness of mRNA-1273 and BNT162b2 against symptomatic infection in the early epoch and the late epoch. In each time period, effectiveness estimates were derived by comparing the odds of symptomatic infection after full vaccination versus during the 10 days after the first dose. Error bars represent 95% confidence intervals.
Figure 2
Figure 2
Cohort analysis to compare the incidence rates of symptomatic infection after vaccination with mRNA-1273 versus BNT162b2 (A) The secondary analysis was conducted as a retrospective cohort study. After matching on the basis of demographic and clinical features, we compared the incidence rates of symptomatic infection after full vaccination with mRNA-1273 versus after full vaccination with BNT162b2. (B) Incidence rate ratios (IRRs) of symptomatic infection for unmatched (top), matched per protocol (PP) (middle), and matched intention-to-treat (ITT) (bottom) analyses. IRRs are shown for days 1–10 after the first dose (baseline estimate), the entire study duration (December 1, 2020 through September 22, 2021), the early epoch (December 1, 2020 through May 31, 2021), and the late epoch (July 1, 2021 through September 22, 2021). The x axis is log-transformed such that, for example, IRRs of 0.5 and 2 are equidistant from the null hypothesis IRR of 1. Error bars represent 95% confidence intervals.
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