Immunogenicity, efficacy, and safety of SARS-CoV-2 vaccine dose fractionation: a systematic review and meta-analysis.
BMC Med
; 20(1): 409, 2022 10 25.
Article
in English
| MEDLINE | ID: covidwho-2089196
ABSTRACT
BACKGROUND:
Dose fractionation of a coronavirus disease 2019 (COVID-19) vaccine could effectively accelerate global vaccine coverage, while supporting evidence of efficacy, immunogenicity, and safety are unavailable, especially with emerging variants.METHODS:
We systematically reviewed clinical trials that reported dose-finding results and estimated the dose-response relationship of neutralizing antibodies (nAbs) of COVID-19 vaccines using a generalized additive model. We predicted the vaccine efficacy against both ancestral and variants, using previously reported correlates of protection and cross-reactivity. We also reviewed and compared seroconversion to nAbs, T cell responses, and safety profiles between fractional and standard dose groups.RESULTS:
We found that dose fractionation of mRNA and protein subunit vaccines could induce SARS-CoV-2-specific nAbs and T cells that confer a reasonable level of protection (i.e., vaccine efficacy > 50%) against ancestral strains and variants up to Omicron. Safety profiles of fractional doses were non-inferior to the standard dose.CONCLUSIONS:
Dose fractionation of mRNA and protein subunit vaccines may be safe and effective, which would also vary depending on the characteristics of emerging variants and updated vaccine formulations.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
COVID-19 Vaccines
/
COVID-19
Type of study:
Experimental Studies
/
Prognostic study
/
Randomized controlled trials
/
Reviews
/
Systematic review/Meta Analysis
Topics:
Vaccines
/
Variants
Limits:
Humans
Language:
English
Journal:
BMC Med
Journal subject:
Medicine
Year:
2022
Document Type:
Article
Affiliation country:
S12916-022-02600-0
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