tetano
Editor, Senior Moderator
BMC Med
. 2022 Oct 25;20(1):409.
doi: 10.1186/s12916-022-02600-0.
Immunogenicity, efficacy, and safety of SARS-CoV-2 vaccine dose fractionation: a systematic review and meta-analysis
Bingyi Yang[SUP] 1 [/SUP], Xiaotong Huang[SUP] 2 [/SUP], Huizhi Gao[SUP] 2 [/SUP], Nancy H Leung[SUP] 2 [/SUP], Tim K Tsang[SUP] 2 3 [/SUP], Benjamin J Cowling[SUP] 4 5 [/SUP]
Affiliations
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: COVID-19; Dose fractionation; Systematic review; Vaccine.
. 2022 Oct 25;20(1):409.
doi: 10.1186/s12916-022-02600-0.
Immunogenicity, efficacy, and safety of SARS-CoV-2 vaccine dose fractionation: a systematic review and meta-analysis
Bingyi Yang[SUP] 1 [/SUP], Xiaotong Huang[SUP] 2 [/SUP], Huizhi Gao[SUP] 2 [/SUP], Nancy H Leung[SUP] 2 [/SUP], Tim K Tsang[SUP] 2 3 [/SUP], Benjamin J Cowling[SUP] 4 5 [/SUP]
Affiliations
- PMID: 36284331
- DOI: 10.1186/s12916-022-02600-0
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: COVID-19; Dose fractionation; Systematic review; Vaccine.