Interim estimates in null models of COVID-19 vaccine effectiveness.
Int J Infect Dis
; 106: 169-170, 2021 May.
Article
in English
| MEDLINE | ID: covidwho-1144721
ABSTRACT
Recently released interim numbers from advanced vaccine candidate clinical trials suggest that a COVID-19 vaccine effectiveness (VE) of >90% is achievable. However, SARS-CoV-2 transmission dynamics are highly heterogeneous and exhibit localized bursts of transmission, which may lead to sharp localized peaks in the number of new cases, often followed by longer periods of low incidence. Here we show that, for interim estimates of VE, these characteristic bursts in SARS-CoV-2 infection may introduce a strong positive bias in VE. Specifically, we generate null models of vaccine effectiveness, i.e., random models with bursts that over longer periods converge to zero VE but that for interim periods frequently produce apparent VE near 100%. As an example, by following the relevant clinical trial protocol, we can reproduce recently reported interim outcomes from an ongoing phase 3 clinical trial of an RNA-based vaccine candidate. Thus, to avoid potential random biases in VE, it is suggested that interim estimates on COVID-19 VE should control for the intrinsic inhomogeneity in both SARS-CoV-2 infection dynamics and reported cases.
Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Clinical Trials, Phase III as Topic
/
COVID-19 Vaccines
/
SARS-CoV-2
/
COVID-19
Type of study:
Experimental Studies
/
Observational study
/
Prognostic study
/
Randomized controlled trials
/
Systematic review/Meta Analysis
Topics:
Vaccines
Limits:
Humans
Language:
English
Journal:
Int J Infect Dis
Journal subject:
Communicable Diseases
Year:
2021
Document Type:
Article
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