Effectiveness of vaccination against SARS-CoV-2 Omicron variant infection, symptomatic disease, and hospitalization: a systematic review and meta-analysis
Open accessPublished version of a preprint
Abstract
Abstract Background The rapid rise of Sars-Cov2 B.1.1.529 variant (named Omicron) in the late November 2021 prompted the health authorities to estimate the potential impact on the existing countermeasures, including vaccines. This meta-analysis aims to assess the effectiveness of the current Sars-Cov2 vaccine regimens against laboratory-confirmed Omicron infection. A secondary endpoint aims to investigate the waning effectiveness of primary vaccination against symptomatic Omicron infection and related hospitalization. Methods The systematic review started on December 1, 2021 and was concluded on March 1, 2022. Random-effects (RE) frequentist meta-analyses are performed to estimate the primary vaccination course and the booster dose effectiveness against Omicron. Multiple meta-regressions are performed under mixed-effects model. This study is registered with PROSPERO, CRD42021240143. Findings In total, 15 out of 502 records are included in the quantitative synthesis. The meta-analysis on B.1.1.529 infection risk produces an OR=0·69 (95%CI: 0·57 to 0·83; τ2=0·225; I2=99·49%) after primary vaccination and an OR=0·30 (95%CI: 0·23 to 0·39; τ2=0·469; I2=99·33%) after one additional booster dose. According to the multiple meta-regression models, one booster dose significantly decreases by 69% the risk of symptomatic Omicron infection (OR=0·31; 95%CI: 0·23 to 0·40) and by 88% the risk of hospitalization (OR=0·12; 95%CI: 0·08 to 0·19) with respect to unvaccinated. Six months after primary vaccination, the average risk reduction declines to 22% (OR=0·78; 95%CI: 0·69 to 0·88) against symptomatic infection and to 55% against hospitalization (OR=0·45; 95%CI: 0·30 to 0·68). Interpretation Despite the high heterogeneity, this study confirms that primary vaccination does not provide sufficient protection against symptomatic Omicron infection. Although the effectiveness of the primary vaccination against hospitalization due to Omicron remains significantly above 50% after 3 months, it dramatically fades after 6 months. Therefore, the administration of one additional booster dose is recommended within 6 months and provides a 76% decrease in the odds of symptomatic Omicron after five months. Funding There was no funding source for this study. ARTICLE HIGHLIGHTS the primary vaccination decreases the risk of Omicron infection by 31%, while one additional booster dose decreases the risk by 70% the primary vaccination course reduces the risk of symptomatic Omicron infection by 24% and the risk of hospitalization by 50% one additional booster dose decreases by 69% the risk of symptomatic Omicron infection and the risk of hospitalization by 88% the effectiveness of the primary vaccination against hospitalization dramatically wanes after 3 months from vaccination, reaching a minimum of 45% in risk reduction after more than 6 months PANEL: research in context Evidence before this study Omicron variant’s higher transmissibility combined with an increased risk of infection among individuals vaccinated with primary vaccination have prompted health authorities to introduce a booster vaccination. The systematic review including “vaccine effectiveness”, “Covid-19”, “SARS-CoV-2”, and “Omicron” search terms, is performed over three web engines and one early stage research platform (i.e., WHO COVID-19 DATABASE, PubMed, medRxiv + bioRxiv) Additionally, all relevant web sources reporting living data on vaccine effectiveness (i.e., https://view-hub.org/covid-19/ and https://covid-nma.com/ ), electronic databases and grey literature are considered. The last search update was on March 1, 2022. No country, language, study design restrictions are applied. Added value of this study Primary vaccination provides relatively low protection against the Omicron VOC, while one additional booster dose decreased substantially the risk of symptomatic Omicron infection and of hospitalization. Implications of all the available evidence The booster dose should be recommended after three months and no later than six months after the primary course vaccination, in order to avoid severe consequences, in particular among the elderly population.
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Prior evidence has reported robust protection of up to 86% against severe disease caused by the Omicron subvariant after a single dose of mRNA booster, for up to 6 months.
“Similar to our findings, prior evidence has reported robust protection of up to 86% against severe disease caused by the Omicron subvariant after a single dose of mRNA booster, for up to 6 months.18 19 81”
From Protection of the third-dose and fourth-dose mRNA vaccines against SARS-CoV-2 Omicron subvariant: a systematic review and meta-analysis (2023) · cites this paper as [81]
The stratified forest plot (p. 13) reports an 86% reduction in Omicron-related hospitalization after a booster dose, supporting the protection figure. But the Discussion (p. 18) gives a maximum booster follow-up of five months and says longer-term evidence is limited; it does not establish protection for six months. (LLM, conf=0.89)
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- Authors
- Meggiolaro, A., Sane Schepisi, M., Farina, S., Castagna, C., Mammone, A., Siddu, A., Stefanelli, P., Boccia, S., & Rezza, G.
- Affiliations
- Ministero della Salute (IT)
- General Directorate for Health Prevention, Italian Ministry of Health, Viale Ribotta 5, 00144 Rome, Italy
- Università Cattolica del Sacro Cuore (IT)
- Istituto Superiore di Sanità (IT)
- Corresponding author
- Meggiolaro, Angela
- ORCID
- Venue
- Expert Review of Vaccines
- Publisher
- Informa UK Limited
- Published
- 2022-10-14
- Volume
- 21
- Issue
- 12
- Pages
- 1831-1841
- ISSN
- 1476-0584 (ISSN-L)
- 1744-8395
- OpenAlex
- W4306316643
- Cited by
- 17
- References
- 44
- Citations by year
- 2025: 3 · 2024: 5 · 2023: 7 · 2022: 2
- FWCI
- 0.65
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Expert Review of Vaccines (publishedVersion, cc-by-nc-nd)
- medRxiv (acceptedVersion)
- PubMed (publishedVersion)
- Archivio Istituzionale della Ricerca - Università Vita-Salute San Raffaele (submittedVersion, cc-by-nc-nd)
- Figshare (submittedVersion, cc-by)
- PubliCatt (Università Cattolica del Sacro Cuore) (submittedVersion, cc-by-nc-nd)
- Figshare (cc-by)
- Funders
- This paper was not funded
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Physical Sciences › Mathematics › Modeling and Simulation › COVID-19 epidemiological studies
- Social Sciences › Health › Vaccine Coverage and Hesitancy
- Keywords
- Omicron variant, COVID-19 vaccines, vaccine effectiveness, booster vaccination, waning immunity, symptomatic infection, hospitalization
- MeSH terms
- COVID-19, SARS-CoV-2, Hospitalization, Humans, RNA, Viral, Vaccination
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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