Immunogenicity, efficacy, and safety of SARS-CoV-2 vaccine dose fractionation: a systematic review and meta-analysis

Yang, Bingyi; Huang, Xiaotong; Gao, Huizhi; Leung, Nancy; Tsang, Tim K.; Cowling, Benjamin J.

doi:10.1186/s12916-022-02600-0

Cited by 9 publications

(7 citation statements)

References 73 publications

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“…Among 14 study results, [19][20][21][22][23][24][25][26][27][28][29][30][31][32] there was acceptable for immunogenicity, a key response for the development of a vaccinationinduced immunogenicity both humoral and cellular immunity 2 or 3 doses of vaccination) 19 and acceptable safety in 11 studies (78.57 %). Acceptable potent immunogenicity was found in patients aged more than 40 years with chronic diseases, particularly, chronic respiratory diseases and coronary artery diseases.…”

Section: Discussionmentioning

confidence: 99%

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Patients under medical conditions, immunogenicity and safety of covid-19 vaccines: a systematic review and meta-analysis

Cheepsattayakorn¹

2023

JLPRR

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A comprehensive search was carried out in mainstream bibliographic databases or Medical Subject Headings, including ScienDirect, PubMed, Scopus, and ISI Web of Science. The search was applied to the articles that were published between January 2020 and early 2023 with strict literature search and screening processes, it yielded 14 articles from 373 articles of initial literature database. Among 14 study results, there was acceptable for immunogenicity (both humoral and cellular immune responses (a key response for the development of a vaccination-induced immunogenicity and safety in 11 studies (78.57 %), whereas acceptable potent immunogenicity was found in patients aged more than 40 years with chronic diseases, particularly, chronic respiratory diseases and coronary artery diseases. Only potent T-cell response was identified in one study. No significant difference in vaccine safety compared with healthy subjects and effective neutralizing antibodies (two doses completion) against SARS-CoV-2 (COVID-19) in patients older than 60 years with diabetes and/or hypertension were demonstrated after completion of COVID-19 vaccination. Immunogenicity (both humoral and cellular) and safety in aged people and individuals living with various chronic diseases (both infectious and non-infectious) is highlighted in this study. In conclusion, specified local and systemic AEs and unsolicited AEs, AESI, and SAEs after each vaccination and after the second dose should be monitored. Recording the adverse events of special interest (AESI) and serious adverse events (SAEs) throughout the patients’ vaccination course should be performed and can decrease COVID-19 vaccination hesitancy in these persons.

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Section: Discussionmentioning

confidence: 99%

“…against ancestral SARS-CoV-2 strains and up to Omicron variant with dose fractionation of mRNA and protein subunit vaccines, whereas safety profiles were non-inferior to the standard fractional dose. 25 2022…”

Section: Published Yearmentioning

confidence: 99%

Patients under medical conditions, immunogenicity and safety of covid-19 vaccines: a systematic review and meta-analysis

Cheepsattayakorn¹

2023

JLPRR

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“…The immunogenicity, efficacy, and safety of fractional doses have been reviewed as of December 2021, indicating that they would be safe and effective comparable to the standard dose [20]. We further investigate the relationship among NAb titers and the vaccine efficacies against infection for standard doses and derive vaccine efficacies for fractional doses, informed by available data from published studies of vaccination efficacy for both standard and fractional doses.…”

Section: Discussionmentioning

confidence: 99%

Predictive efficacies of vaccine dose fractionation using neutralizing antibody levels

Liu

Bai

et al. 2022

Preprint

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With the emergence of SARS-CoV-2 variants that eluded immunity from vaccines and prior infections, vaccine shortages and their effectiveness pose unprecedented challenges for governments to expand booster vaccination programs. Fractionation of vaccine doses might be an effective strategy to help society to face these challenges, which may have comparable efficacies in contrast with the standard doses. In this study, we analyzed the relationship between in-vitro neutralization levels and the observed efficacies against asymptomatic and symptomatic infection of ten types of COVID-19 vaccines using data from 13 studies from vaccination and convalescent cohorts. We further projected efficacies for fractional doses based on 51 studies included in our systematic review. By comparing with the convalescent level, vaccine efficacy increases from 8.8% (95% CI: 1.4%, 16.1%) to 71.8% (95% CI: 63.0%, 80.7%) against asymptomatic infection, and from 33.6% (95% CI: 23.6%, 43.6%) to 98.6% (95% CI: 97.6%, 99.7%) against symptomatic infection, respectively, along with the mean neutralization level from 0.1 to 10 folds of convalescent level. And mRNA vaccines provide the strongest protection, and decrease slowly for fractional dosing between 50% and 100% dosage. Our results are consistent with studies for immune protection from COVID-19 infection. Based on our study, we expect that fractional dose vaccination could provide a partial immunity for SARS-CoV-2 virus. Fractional doses of vaccines could be a viable vaccination strategy compared to full-dose vaccination and deserves further exploration.

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“…In some studies, VEs specific to time intervals after vaccination were reported. Therefore, we extracted VE estimates for the first available time interval at least 14 days post-vaccination, because antibodies have been shown to peak by then in naïve persons (28). For studies that reported multiple estimates, such as by age group or type of vaccine, all subgroup-specific estimates were included, but the overall estimates were excluded.…”

Section: Methodsmentioning

confidence: 99%

Prior infections and effectiveness of SARS-CoV-2 vaccine in test-negative study: A systematic review and meta-analysis

Tsang

Sullivan

Huang

et al. 2022

Preprint

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Background: Prior infection with SARS-CoV-2 can provide protection against infection and severe COVID-19. In settings with high pre-existing immunity, vaccine effectiveness (VE) should decrease with higher levels of immunity among unvaccinated individuals. Here, we conducted a systematic review and meta-analysis to understand the influence of prior infection on VE. Methods: We included test-negative design (TND) studies that examined VE against infection or severe disease (hospitalization, ICU admission, or death) for primary vaccination series. To determine the impact of prior infections on VE estimates, we compared studies that excluded or included people with prior COVID-19 infection. We also compared VE estimates by the cumulative incidence of cases before the start of and incidence rates during each study in the study locations, as further measures of prior infections in the community. Findings: We identified 67 studies that met inclusion criteria. Pooled VE among studies that included people with prior COVID-19 infection was lower against infection (pooled VE: 77%; 95% confidence interval (CI): 72%, 81%) and severe disease (pooled VE: 86%; 95% CI: 83%, 89%), compared with studies that excluded people with prior COVID-19 infection (pooled VE against infection: 87%; 95% CI: 85%, 89%; pooled VE against severe disease: 93%; 95% CI: 91%, 95%). There was a negative correlation between the cumulative incidence of cases before the start of the study and VE estimates against infection (spearman correlation (ρ) = -0.32; 95% CI: -0.45, -0.18) and severe disease (ρ = -0.49; 95% CI: -0.64, -0.30). There was also a negative correlation between the incidence rates of cases during the study period and VE estimates against infection (ρ = -0.48; 95% CI: -0.59, -0.34) and severe disease (ρ = -0.42; 95% CI: -0.58, -0.23). Interpretation: Based on a review of published VE estimates we found clear empirical evidence that higher levels of pre-existing immunity in a population were associated with lower VE estimates. Excluding previously infected individuals from VE studies may result in higher VE estimates with limited generalisability to the wider population. Prior infections should be treated as confounder and effect modificatory when the policies were targeted to whole population or stratified by infection history, respectively.

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Immunogenicity, efficacy, and safety of SARS-CoV-2 vaccine dose fractionation: a systematic review and meta-analysis

Cited by 9 publications

References 73 publications

Patients under medical conditions, immunogenicity and safety of covid-19 vaccines: a systematic review and meta-analysis

Patients under medical conditions, immunogenicity and safety of covid-19 vaccines: a systematic review and meta-analysis

Predictive efficacies of vaccine dose fractionation using neutralizing antibody levels

Prior infections and effectiveness of SARS-CoV-2 vaccine in test-negative study: A systematic review and meta-analysis

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