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A Bivalent Omicron-Containing Booster Vaccine against Covid-19
Open accessPublished version of a preprint
Abstract
BACKGROUND: The safety and immunogenicity of the bivalent omicron-containing mRNA-1273.214 booster vaccine are not known. METHODS: In this ongoing, phase 2-3 study, we compared the 50-μg bivalent vaccine mRNA-1273.214 (25 μg each of ancestral Wuhan-Hu-1 and omicron B.1.1.529 [BA.1] spike messenger RNAs) with the previously authorized 50-μg mRNA-1273 booster. We administered mRNA-1273.214 or mRNA-1273 as a second booster in adults who had previously received a two-dose (100-μg) primary series and first booster (50-μg) dose of mRNA-1273 (≥3 months earlier). The primary objectives were to assess the safety, reactogenicity, and immunogenicity of mRNA-1273.214 at 28 days after the booster dose. RESULTS: Interim results are presented. Sequential groups of participants received 50 μg of mRNA-1273.214 (437 participants) or mRNA-1273 (377 participants) as a second booster dose. The median time between the first and second boosters was similar for mRNA-1273.214 (136 days) and mRNA-1273 (134 days). In participants with no previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, the geometric mean titers of neutralizing antibodies against the omicron BA.1 variant were 2372.4 (95% confidence interval [CI], 2070.6 to 2718.2) after receipt of the mRNA-1273.214 booster and 1473.5 (95% CI, 1270.8 to 1708.4) after receipt of the mRNA-1273 booster. In addition, 50-μg mRNA-1273.214 and 50-μg mRNA-1273 elicited geometric mean titers of 727.4 (95% CI, 632.8 to 836.1) and 492.1 (95% CI, 431.1 to 561.9), respectively, against omicron BA.4 and BA.5 (BA.4/5), and the mRNA-1273.214 booster also elicited higher binding antibody responses against multiple other variants (alpha, beta, gamma, and delta) than the mRNA-1273 booster. Safety and reactogenicity were similar with the two booster vaccines. Vaccine effectiveness was not assessed in this study; in an exploratory analysis, SARS-CoV-2 infection occurred in 11 participants after the mRNA-1273.214 booster and in 9 participants after the mRNA-1273 booster. CONCLUSIONS: The bivalent omicron-containing vaccine mRNA-1273.214 elicited neutralizing antibody responses against omicron that were superior to those with mRNA-1273, without evident safety concerns. (Funded by Moderna; ClinicalTrials.gov number, NCT04927065.).
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“In addition, modified bivalent mRNA SARS-CoV-2 vaccines elicited significantly higher nAb responses against recent SARS-CoV-2 variants and non-inferior titres against ancestral virus compared with monovalent vaccines in humans and preclinical animal models9,24.”
From Efficacy of an unmodified bivalent mRNA vaccine against SARS-CoV-2 variants in female small animal models (2023) · cites this paper as [24]
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“These results are similar to the neutralizing antibody titer ratios observed with the other approved BA.1-adapted mRNA vaccines when compared with their prototype vaccines.”
From An Omicron-specific, self-amplifying mRNA booster vaccine for COVID-19: a phase 2/3 randomized trial (2024) · cites this paper as [20]
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“Neutralizing antibody response is considered to be a surrogate for efficacy against severe disease24 and has been used in immunobridging studies, especially for variant-updated COVID-19 vaccines20.”
From An Omicron-specific, self-amplifying mRNA booster vaccine for COVID-19: a phase 2/3 randomized trial (2024) · cites this paper as [20]
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Metadata
- Authors
- Chalkias, S., Harper, C., Vrbicky, K., Walsh, S. R., Essink, B., Brosz, A., McGhee, N., Tomassini, J. E., Chen, X., Chang, Y., Sutherland, A., Montefiori, D. C., Girard, B., Edwards, D. K., Feng, J., Zhou, H., Baden, L. R., Miller, J. M., & Das, R.
- Affiliations
- Brigham and Women's Hospital (US)
- Corresponding author
- Chalkias, Spyros
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2022-10-06
- Volume
- 387
- Issue
- 14
- Pages
- 1279-1291
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC9511634
- OpenAlex
- W4296026861
- Cited by
- 627
- References
- 24
- Citations by year
- 2026: 29 · 2025: 74 · 2024: 163 · 2023: 276 · 2022: 83
- FWCI
- 72.71
- Type
- journal article
- Language
- en
- Open access
- green
- doi.org
- Licence
- Locations
- New England Journal of Medicine (publishedVersion)
- medRxiv (acceptedVersion, cc-by-nc)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Moderna
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
- Social Sciences › Health › Vaccine Coverage and Hesitancy
- Keywords
- Omicron variant, BA.1, neutralizing antibodies, vaccine immunogenicity, vaccine safety, reactogenicity, SARS-CoV-2 infection history
- MeSH terms
- Immunogenicity, Vaccine, COVID-19, SARS-CoV-2, COVID-19 Vaccines, mRNA Vaccines, 2019-nCoV Vaccine mRNA-1273, Adult, Antibodies, Viral, Humans, Immunization, Secondary, Vaccines, Combined, Antibodies, Neutralizing
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