Efficacy of the wild-type/Omicron BA.1 bivalent vaccine as the second booster dose against Omicron BA.2 and BA.5

Abstract

Introduction In addition to the original monovalent vaccines available for SARS-CoV-2, bivalent vaccines covering wild-type (WT) and Omicron BA.1 are also available. However, there is a lack of real-world data on the effectiveness of bivalent vaccines as second boosters on the dominant Omicron sublineages, including BA.2 and BA.5. Methods This prospective longitudinal cohort study was conducted at Toyama University Hospital, a tertiary medical center in Japan. Participants (n = 565) who received the first booster vaccination were followed up until 2 weeks after the second booster dose of the monovalent mRNA-1273 (WT group, n = 168) and bivalent BNT162b2 (WT+BA.1 group, n = 23) vaccines. Participants with previous SARS-CoV-2 infections were excluded from the study. Anti-receptor-binding domain (RBD) antibody levels and neutralizing activity were measured. Vaccine-related symptoms were also assessed using a questionnaire after the second booster dose. Results The anti-RBD antibody levels after the second booster dose in the WT and WT+BA.1 group were similar (median [inter quartile], 26262.0 [16951.0-38137.0] U/mL vs. 24840.0 [14828.0-41460.0] U/mL, respectively). Although the neutralization activity of the pooled sera of the WT+BA.1 group was the lowest against BA.5, the activities against BA.2 and BA.5 were higher than those of the WT group in both pseudotyped and live virus assays. Vaccine-related symptoms, including systemic and local symptoms, were strongly correlated with anti-RBD antibody levels and neutralizing titers with significant differences. Conclusion The second booster dose of the bivalent (WT/Omicron BA.1) vaccine induced higher neutralizing activity against BA.2 and BA.5 than that of the original monovalent vaccine.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

This study was supported by the Research Program on Emerging and Re-emerging Infectious Diseases from the AMED (grant number JP20he0622035) (YM, HT, and YY) and (grant number JP21fk0108588) (YM and HT), a research funding grant from the president of the University of Toyama (YM, NH, and YY), Toyama Pharmaceutical Valley Development Consortium (YM, NH, and YY), Morinomiyako Medical Research Foundation (HK), Kurozumi Medical Foundation (HK), The Hokuriku Bank grant-in-aid for Young Scientists (HK), and Japan Society for the Promotion of Science (JSPS) KAKENHI grant number JP22K20768 (HK). The funding bodies played no role in the design of the study, collection, analysis, or interpretation of data, nor in writing the manuscript.

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I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

This study was performed in accordance with the Declaration of Helsinki and approved by the ethical review board of the University of Toyama (approval No.: R2019167).

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Data Availability

The authors confirm that data supporting the findings of this study are available within the article.

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