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Cited by 138SARS-CoV-2 and COVID-19 ResearchCOVID-19 Clinical Research StudiesCOVID-19 epidemiological studies

Efficacy of SARS-CoV-2 vaccines and the dose–response relationship with three major antibodies: a systematic review and meta-analysis of randomised controlled trials

Open access
Yang, Zhi-Rong, Jiang, Yi-Wen, Li, Fu-Xiao, Liu, Di, Lin, Teng-Fei, Zhao, Zi-Yi, Wei, Chang, Jin, Qian-Yi +7 more·2023·The Lancet Microbe
DOI 10.1016/s2666-5247(22)00390-1PMC PMC9974155
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Abstract

BACKGROUND: The efficacy of SARS-CoV-2 vaccines in preventing severe COVID-19 illness and death is uncertain due to the rarity of data in individual trials. How well the antibody concentrations can predict the efficacy is also uncertain. We aimed to assess the efficacy of these vaccines in preventing SARS-CoV-2 infections of different severities and the dose-response relationship between the antibody concentrations and efficacy. METHODS: We did a systematic review and meta-analysis of randomised controlled trials (RCTs). We searched PubMed, Embase, Scopus, Web of Science, Cochrane Library, WHO, bioRxiv, and medRxiv for papers published between Jan 1, 2020 and Sep 12, 2022. RCTs on the efficacy of SARS-CoV-2 vaccines were eligible. Risk of bias was assessed using the Cochrane tool. A frequentist, random-effects model was used to combine efficacy for common outcomes (ie, symptomatic and asymptomatic infections) and a Bayesian random-effects model was used for rare outcomes (ie, hospital admission, severe infection, and death). Potential sources of heterogeneity were investigated. The dose-response relationships of neutralising, spike-specific IgG and receptor binding domain-specific IgG antibody titres with efficacy in preventing SARS-CoV-2 symptomatic and severe infections were examined by meta-regression. This systematic review is registered with PROSPERO, CRD42021287238. FINDINGS: 28 RCTs (n=286 915 in vaccination groups and n=233 236 in placebo groups; median follow-up 1-6 months after last vaccination) across 32 publications were included in this review. The combined efficacy of full vaccination was 44·5% (95% CI 27·8-57·4) for preventing asymptomatic infections, 76·5% (69·8-81·7) for preventing symptomatic infections, 95·4% (95% credible interval 88·0-98·7) for preventing hospitalisation, 90·8% (85·5-95·1) for preventing severe infection, and 85·8% (68·7-94·6) for preventing death. There was heterogeneity in the efficacy of SARS-CoV-2 vaccines against asymptomatic and symptomatic infections but insufficient evidence to suggest whether the efficacy could differ according to the type of vaccine, age of the vaccinated individual, and between-dose interval (p>0·05 for all). Vaccine efficacy against symptomatic infection waned over time after full vaccination, with an average decrease of 13·6% (95% CI 5·5-22·3; p=0·0007) per month but can be enhanced by a booster. We found a significant non-linear relationship between each type of antibody and efficacy against symptomatic and severe infections (p<0·0001 for all), but there remained considerable heterogeneity in the efficacy, which cannot be explained by antibody concentrations. The risk of bias was low in most studies. INTERPRETATION: The efficacy of SARS-CoV-2 vaccines is higher for preventing severe infection and death than for preventing milder infection. Vaccine efficacy wanes over time but can be enhanced by a booster. Higher antibody titres are associated with higher estimates of efficacy but precise predictions are difficult due to large unexplained heterogeneity. These findings provide an important knowledge base for interpretation and application of future studies on these issues. FUNDING: Shenzhen Science and Technology Programs.

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  1. [41]Palacios R González Patiño E de Oliveira Piorelli R Efficacy and safety of a COVID-19 inactivated vaccine in healthcare professionals in Brazil: the PROFISCOV Study Trials 21 2021 853 PMC7558252 33059771
  2. [54]Andrews N Stowe J Kirsebom F COVID-19 vaccine effectiveness against the omicron (B.1.1.529) variant N Engl J Med 386 2022 1532 1546 35249272 PMC8908811

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Authors
Yang, Z.-R., Jiang, Y.-W., Li, F.-X., Liu, D., Lin, T.-F., Zhao, Z.-Y., Wei, C., Jin, Q.-Y., Li, X.-M., Jia, Y.-X., Zhu, F.-C., Yang, Z.-Y., Sha, F., Feng, Z.-J., & Tang, J.-L.
Affiliations
  • Chinese Academy of Sciences (CN)
  • Sun Yat-sen University (CN)
  • Chinese University of Hong Kong (HK)
Corresponding author
  • Yang, Zu-Yao
  • Sha, Feng
ORCID
Venue
The Lancet Microbe
Publisher
Elsevier BV
Published
2023-04
Volume
4
Issue
4
Pages
e236-e246
ISSN
2666-5247 (ISSN-L)
DOI
10.1016/s2666-5247(22)00390-1
PMC
PMC9974155
OpenAlex
W4322603953
Cited by
138
References
65
Citations by year
2026: 20 · 2025: 36 · 2024: 48 · 2023: 34
FWCI
6.54
Type
journal article
Language
en
Open access
Licence
Locations
  • The Lancet Microbe (publishedVersion, cc-by-nc-nd)
  • PubMed Central (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
  • Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
  • Physical Sciences › Mathematics › Modeling and Simulation › COVID-19 epidemiological studies
Keywords
COVID-19 vaccines, COVID-19 vaccine efficacy, dose-response relationship, neutralizing antibodies, anti-spike IgG, asymptomatic infection, symptomatic infection, hospitalization prevention, vaccine-induced immunity, SARS-CoV-2, COVID-19 mortality, SARS-CoV-2 variants
MeSH terms
COVID-19, SARS-CoV-2, COVID-19 Vaccines, Humans, Immunoglobulin G, Randomized Controlled Trials as Topic, Asymptomatic Infections

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