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. 2024 Sep 27;12(10):1107.
doi: 10.3390/vaccines12101107.

Comparative Effectiveness of the Bivalent (Original/Omicron BA.4/BA.5) mRNA COVID-19 Vaccines mRNA-1273.222 and BNT162b2 Bivalent in Adults with Underlying Medical Conditions in the United States

Affiliations

Comparative Effectiveness of the Bivalent (Original/Omicron BA.4/BA.5) mRNA COVID-19 Vaccines mRNA-1273.222 and BNT162b2 Bivalent in Adults with Underlying Medical Conditions in the United States

Hagit Kopel et al. Vaccines (Basel). .

Abstract

Background/objectives: This retrospective cohort study evaluated the relative vaccine effectiveness (rVE) of two bivalent (original/Omicron BA.4/BA.5) vaccines mRNA-1273.222 versus the BNT162b2 Bivalent in preventing COVID-19-related outcomes in adults with underlying medical conditions associated with increased risk for severe COVID-19.

Methods: In a linked electronic health record/claims dataset, US adults (≥18 years) with ≥1 underlying medical condition of interest who received either the bivalent vaccine between 31 August 2022 and 28 February 2023 were identified. The inverse probability of treatment weighting was used to adjust for cohort differences. Cohorts were followed up for COVID-19-related hospitalizations and outpatient encounters until 31 May 2023. Hazard ratios and rVEs were estimated using Cox regression. Subgroup analyses were performed on individuals with pre-specified comorbid conditions.

Results: 757,572 mRNA-1273.222 and 1,204,975 BNT162b2 Bivalent recipients were identified. The adjusted rVE over a median follow-up of 198 days was 10.9% (6.2%-15.2%) against COVID-19-related hospitalization and 3.2% (1.7%-4.7%) against COVID-19-related outpatient encounters. rVE estimates for COVID-19 hospitalizations among subgroups with comorbid conditions were as follows: diabetes 15.1% (8.7%-21.0%), cerebro- and cardiovascular disease 14.7% (9.0%-20.1%), chronic lung disease 11.9% (5.1%-18.2%), immunocompromised 15.0% (7.2%-22.2%), chronic kidney disease 8.4% (0.5%-15.7%).

Conclusions: Overall, among adults with underlying medical conditions, mRNA-1273.222 was more effective than BNT162b2 Bivalent, especially in preventing COVID-19-related hospitalizations.

Keywords: BNT162b2; COVID-19; comorbidities; high risk; mRNA-1273; rVE; vaccine.

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Conflict of interest statement

H.K., D.B.E., M.B.-J., E.B. and J.A.M. are employees of and shareholders in Moderna Inc. A.B., J.P.W.-J., N.Z., I.W. and M.B. are employees of Veradigm, which was contracted by Moderna and received fees for data management and statistical analyses. V.H.N., C.B. and T.D. are employees of VHN Consulting, which was contracted by Moderna to help conduct this analysis.

Figures

Figure 1
Figure 1
Study design. CED, cohort entry date. a The index date is the vaccination date. b Begins 365 days before vaccination with a bivalent vaccine.
Figure 2
Figure 2
Selection of participants for inclusion in the study. CED, cohort entry date.
Figure 3
Figure 3
Adjusted relative vaccine effectiveness (rVE) estimates of mRNA-1273.222 vs. BNT162b2 Bivalent for adults with ≥1 underlying medical condition. CI, confidence interval.
Figure 4
Figure 4
Adjusted relative vaccine effectiveness (rVE) estimates of mRNA-1273.222 versus BNT162b2 Bivalent among subgroups with specific underlying medical conditions. CI, confidence interval.

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