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Comparative Effectiveness of BNT162b2 and mRNA-1273 Vaccines in U.S. Veterans.
N Engl J Med. 2022 01 13; 386(2):105-115.NEJM

Abstract

BACKGROUND

The messenger RNA (mRNA)-based vaccines BNT162b2 and mRNA-1273 are more than 90% effective against coronavirus disease 2019 (Covid-19). However, their comparative effectiveness for a range of outcomes across diverse populations is unknown.

METHODS

We emulated a target trial using the electronic health records of U.S. veterans who received a first dose of the BNT162b2 or mRNA-1273 vaccine between January 4 and May 14, 2021, during a period marked by predominance of the SARS-CoV-2 B.1.1.7 (alpha) variant. We matched recipients of each vaccine in a 1:1 ratio according to their risk factors. Outcomes included documented severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, symptomatic Covid-19, hospitalization for Covid-19, admission to an intensive care unit (ICU) for Covid-19, and death from Covid-19. We estimated risks using the Kaplan-Meier estimator. To assess the influence of the B.1.617.2 (delta) variant, we emulated a second target trial that involved veterans vaccinated between July 1 and September 20, 2021.

RESULTS

Each vaccine group included 219,842 persons. Over 24 weeks of follow-up in a period marked by alpha-variant predominance, the estimated risk of documented infection was 5.75 events per 1000 persons (95% confidence interval [CI], 5.39 to 6.23) in the BNT162b2 group and 4.52 events per 1000 persons (95% CI, 4.17 to 4.84) in the mRNA-1273 group. The excess number of events per 1000 persons for BNT162b2 as compared with mRNA-1273 was 1.23 (95% CI, 0.72 to 1.81) for documented infection, 0.44 (95% CI, 0.25 to 0.70) for symptomatic Covid-19, 0.55 (95% CI, 0.36 to 0.83) for hospitalization for Covid-19, 0.10 (95% CI, 0.00 to 0.26) for ICU admission for Covid-19, and 0.02 (95% CI, -0.06 to 0.12) for death from Covid-19. The corresponding excess risk (BNT162b2 vs. mRNA-1273) of documented infection over 12 weeks of follow-up in a period marked by delta-variant predominance was 6.54 events per 1000 persons (95% CI, -2.58 to 11.82).

CONCLUSIONS

The 24-week risk of Covid-19 outcomes was low after vaccination with mRNA-1273 or BNT162b2, although risks were lower with mRNA-1273 than with BNT162b2. This pattern was consistent across periods marked by alpha- and delta-variant predominance. (Funded by the Department of Veterans Affairs and others.).

Authors+Show Affiliations

From CAUSALab (B.A.D., A.L.M., M.A.H.) and the Departments of Epidemiology (B.A.D., A.L.M., M.A.H.) and Biostatistics (M.A.H.), Harvard T.H. Chan School of Public Health, Massachusetts Veterans Epidemiology Research and Information Center, Veterans Affairs Boston Healthcare System (H.G., K.E.K., B.R.F., M.J.F.M., D.R.G., J.M.G., K.C., J.P.C.), the Department of Surgery (A.L.M.) and Division of Aging (J.M.G., K.C., J.P.C.), Brigham and Women's Hospital, Harvard Medical School, and the Department of Biostatistics (M.J.F.M., D.R.G.), Boston University School of Public Health - all in Boston.From CAUSALab (B.A.D., A.L.M., M.A.H.) and the Departments of Epidemiology (B.A.D., A.L.M., M.A.H.) and Biostatistics (M.A.H.), Harvard T.H. Chan School of Public Health, Massachusetts Veterans Epidemiology Research and Information Center, Veterans Affairs Boston Healthcare System (H.G., K.E.K., B.R.F., M.J.F.M., D.R.G., J.M.G., K.C., J.P.C.), the Department of Surgery (A.L.M.) and Division of Aging (J.M.G., K.C., J.P.C.), Brigham and Women's Hospital, Harvard Medical School, and the Department of Biostatistics (M.J.F.M., D.R.G.), Boston University School of Public Health - all in Boston.From CAUSALab (B.A.D., A.L.M., M.A.H.) and the Departments of Epidemiology (B.A.D., A.L.M., M.A.H.) and Biostatistics (M.A.H.), Harvard T.H. Chan School of Public Health, Massachusetts Veterans Epidemiology Research and Information Center, Veterans Affairs Boston Healthcare System (H.G., K.E.K., B.R.F., M.J.F.M., D.R.G., J.M.G., K.C., J.P.C.), the Department of Surgery (A.L.M.) and Division of Aging (J.M.G., K.C., J.P.C.), Brigham and Women's Hospital, Harvard Medical School, and the Department of Biostatistics (M.J.F.M., D.R.G.), Boston University School of Public Health - all in Boston.From CAUSALab (B.A.D., A.L.M., M.A.H.) and the Departments of Epidemiology (B.A.D., A.L.M., M.A.H.) and Biostatistics (M.A.H.), Harvard T.H. Chan School of Public Health, Massachusetts Veterans Epidemiology Research and Information Center, Veterans Affairs Boston Healthcare System (H.G., K.E.K., B.R.F., M.J.F.M., D.R.G., J.M.G., K.C., J.P.C.), the Department of Surgery (A.L.M.) and Division of Aging (J.M.G., K.C., J.P.C.), Brigham and Women's Hospital, Harvard Medical School, and the Department of Biostatistics (M.J.F.M., D.R.G.), Boston University School of Public Health - all in Boston.From CAUSALab (B.A.D., A.L.M., M.A.H.) and the Departments of Epidemiology (B.A.D., A.L.M., M.A.H.) and Biostatistics (M.A.H.), Harvard T.H. Chan School of Public Health, Massachusetts Veterans Epidemiology Research and Information Center, Veterans Affairs Boston Healthcare System (H.G., K.E.K., B.R.F., M.J.F.M., D.R.G., J.M.G., K.C., J.P.C.), the Department of Surgery (A.L.M.) and Division of Aging (J.M.G., K.C., J.P.C.), Brigham and Women's Hospital, Harvard Medical School, and the Department of Biostatistics (M.J.F.M., D.R.G.), Boston University School of Public Health - all in Boston.From CAUSALab (B.A.D., A.L.M., M.A.H.) and the Departments of Epidemiology (B.A.D., A.L.M., M.A.H.) and Biostatistics (M.A.H.), Harvard T.H. Chan School of Public Health, Massachusetts Veterans Epidemiology Research and Information Center, Veterans Affairs Boston Healthcare System (H.G., K.E.K., B.R.F., M.J.F.M., D.R.G., J.M.G., K.C., J.P.C.), the Department of Surgery (A.L.M.) and Division of Aging (J.M.G., K.C., J.P.C.), Brigham and Women's Hospital, Harvard Medical School, and the Department of Biostatistics (M.J.F.M., D.R.G.), Boston University School of Public Health - all in Boston.From CAUSALab (B.A.D., A.L.M., M.A.H.) and the Departments of Epidemiology (B.A.D., A.L.M., M.A.H.) and Biostatistics (M.A.H.), Harvard T.H. Chan School of Public Health, Massachusetts Veterans Epidemiology Research and Information Center, Veterans Affairs Boston Healthcare System (H.G., K.E.K., B.R.F., M.J.F.M., D.R.G., J.M.G., K.C., J.P.C.), the Department of Surgery (A.L.M.) and Division of Aging (J.M.G., K.C., J.P.C.), Brigham and Women's Hospital, Harvard Medical School, and the Department of Biostatistics (M.J.F.M., D.R.G.), Boston University School of Public Health - all in Boston.From CAUSALab (B.A.D., A.L.M., M.A.H.) and the Departments of Epidemiology (B.A.D., A.L.M., M.A.H.) and Biostatistics (M.A.H.), Harvard T.H. Chan School of Public Health, Massachusetts Veterans Epidemiology Research and Information Center, Veterans Affairs Boston Healthcare System (H.G., K.E.K., B.R.F., M.J.F.M., D.R.G., J.M.G., K.C., J.P.C.), the Department of Surgery (A.L.M.) and Division of Aging (J.M.G., K.C., J.P.C.), Brigham and Women's Hospital, Harvard Medical School, and the Department of Biostatistics (M.J.F.M., D.R.G.), Boston University School of Public Health - all in Boston.From CAUSALab (B.A.D., A.L.M., M.A.H.) and the Departments of Epidemiology (B.A.D., A.L.M., M.A.H.) and Biostatistics (M.A.H.), Harvard T.H. Chan School of Public Health, Massachusetts Veterans Epidemiology Research and Information Center, Veterans Affairs Boston Healthcare System (H.G., K.E.K., B.R.F., M.J.F.M., D.R.G., J.M.G., K.C., J.P.C.), the Department of Surgery (A.L.M.) and Division of Aging (J.M.G., K.C., J.P.C.), Brigham and Women's Hospital, Harvard Medical School, and the Department of Biostatistics (M.J.F.M., D.R.G.), Boston University School of Public Health - all in Boston.From CAUSALab (B.A.D., A.L.M., M.A.H.) and the Departments of Epidemiology (B.A.D., A.L.M., M.A.H.) and Biostatistics (M.A.H.), Harvard T.H. Chan School of Public Health, Massachusetts Veterans Epidemiology Research and Information Center, Veterans Affairs Boston Healthcare System (H.G., K.E.K., B.R.F., M.J.F.M., D.R.G., J.M.G., K.C., J.P.C.), the Department of Surgery (A.L.M.) and Division of Aging (J.M.G., K.C., J.P.C.), Brigham and Women's Hospital, Harvard Medical School, and the Department of Biostatistics (M.J.F.M., D.R.G.), Boston University School of Public Health - all in Boston.From CAUSALab (B.A.D., A.L.M., M.A.H.) and the Departments of Epidemiology (B.A.D., A.L.M., M.A.H.) and Biostatistics (M.A.H.), Harvard T.H. Chan School of Public Health, Massachusetts Veterans Epidemiology Research and Information Center, Veterans Affairs Boston Healthcare System (H.G., K.E.K., B.R.F., M.J.F.M., D.R.G., J.M.G., K.C., J.P.C.), the Department of Surgery (A.L.M.) and Division of Aging (J.M.G., K.C., J.P.C.), Brigham and Women's Hospital, Harvard Medical School, and the Department of Biostatistics (M.J.F.M., D.R.G.), Boston University School of Public Health - all in Boston.

Pub Type(s)

Comparative Study
Journal Article
Observational Study
Research Support, N.I.H., Extramural
Research Support, U.S. Gov't, Non-P.H.S.

Language

eng

PubMed ID

34942066

Citation

Dickerman, Barbra A., et al. "Comparative Effectiveness of BNT162b2 and mRNA-1273 Vaccines in U.S. Veterans." The New England Journal of Medicine, vol. 386, no. 2, 2022, pp. 105-115.
Dickerman BA, Gerlovin H, Madenci AL, et al. Comparative Effectiveness of BNT162b2 and mRNA-1273 Vaccines in U.S. Veterans. N Engl J Med. 2022;386(2):105-115.
Dickerman, B. A., Gerlovin, H., Madenci, A. L., Kurgansky, K. E., Ferolito, B. R., Figueroa Muñiz, M. J., Gagnon, D. R., Gaziano, J. M., Cho, K., Casas, J. P., & Hernán, M. A. (2022). Comparative Effectiveness of BNT162b2 and mRNA-1273 Vaccines in U.S. Veterans. The New England Journal of Medicine, 386(2), 105-115. https://doi.org/10.1056/NEJMoa2115463
Dickerman BA, et al. Comparative Effectiveness of BNT162b2 and mRNA-1273 Vaccines in U.S. Veterans. N Engl J Med. 2022 01 13;386(2):105-115. PubMed PMID: 34942066.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparative Effectiveness of BNT162b2 and mRNA-1273 Vaccines in U.S. Veterans. AU - Dickerman,Barbra A, AU - Gerlovin,Hanna, AU - Madenci,Arin L, AU - Kurgansky,Katherine E, AU - Ferolito,Brian R, AU - Figueroa Muñiz,Michael J, AU - Gagnon,David R, AU - Gaziano,J Michael, AU - Cho,Kelly, AU - Casas,Juan P, AU - Hernán,Miguel A, Y1 - 2021/12/01/ PY - 2021/12/24/pubmed PY - 2021/12/24/medline PY - 2021/12/23/entrez SP - 105 EP - 115 JF - The New England journal of medicine JO - N Engl J Med VL - 386 IS - 2 N2 - BACKGROUND: The messenger RNA (mRNA)-based vaccines BNT162b2 and mRNA-1273 are more than 90% effective against coronavirus disease 2019 (Covid-19). However, their comparative effectiveness for a range of outcomes across diverse populations is unknown. METHODS: We emulated a target trial using the electronic health records of U.S. veterans who received a first dose of the BNT162b2 or mRNA-1273 vaccine between January 4 and May 14, 2021, during a period marked by predominance of the SARS-CoV-2 B.1.1.7 (alpha) variant. We matched recipients of each vaccine in a 1:1 ratio according to their risk factors. Outcomes included documented severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, symptomatic Covid-19, hospitalization for Covid-19, admission to an intensive care unit (ICU) for Covid-19, and death from Covid-19. We estimated risks using the Kaplan-Meier estimator. To assess the influence of the B.1.617.2 (delta) variant, we emulated a second target trial that involved veterans vaccinated between July 1 and September 20, 2021. RESULTS: Each vaccine group included 219,842 persons. Over 24 weeks of follow-up in a period marked by alpha-variant predominance, the estimated risk of documented infection was 5.75 events per 1000 persons (95% confidence interval [CI], 5.39 to 6.23) in the BNT162b2 group and 4.52 events per 1000 persons (95% CI, 4.17 to 4.84) in the mRNA-1273 group. The excess number of events per 1000 persons for BNT162b2 as compared with mRNA-1273 was 1.23 (95% CI, 0.72 to 1.81) for documented infection, 0.44 (95% CI, 0.25 to 0.70) for symptomatic Covid-19, 0.55 (95% CI, 0.36 to 0.83) for hospitalization for Covid-19, 0.10 (95% CI, 0.00 to 0.26) for ICU admission for Covid-19, and 0.02 (95% CI, -0.06 to 0.12) for death from Covid-19. The corresponding excess risk (BNT162b2 vs. mRNA-1273) of documented infection over 12 weeks of follow-up in a period marked by delta-variant predominance was 6.54 events per 1000 persons (95% CI, -2.58 to 11.82). CONCLUSIONS: The 24-week risk of Covid-19 outcomes was low after vaccination with mRNA-1273 or BNT162b2, although risks were lower with mRNA-1273 than with BNT162b2. This pattern was consistent across periods marked by alpha- and delta-variant predominance. (Funded by the Department of Veterans Affairs and others.). SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/34942066/full_citation L2 - https://www.nejm.org/doi/10.1056/NEJMoa2115463?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -