Analysis of Vaccine Studies and Causal Inference

Authored by: M. Elizabeth Halloran

Handbook of Infectious Disease Data Analysis

Print publication date:  November  2019
Online publication date:  November  2019

Print ISBN: 9781138626713
eBook ISBN: 9781315222912
Adobe ISBN:

10.1201/9781315222912-8

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Abstract

The analysis of vaccine studies enjoys a long history. In 1915, Greenwood and Yule (1915) published an 85-page treatise on “The Statistics of Anti-typhoid and Anti-cholera Inoculations, and the Interpretation of such Statistics in general.” In the days before randomization, they stated three conditions for valid inference when estimating protective effects of vaccination (inoculation). “1. The persons must be, in all material respects, alike. 2. The effective exposure to the disease must be identical in the case of inoculated and uninoculated persons. 3. The criteria of the fact of inoculation and of the fact of the disease having occurred must be independent.” Since the advent of randomized trials, randomization is supposed to ensure the validity of the comparison groups. Greenwood and Yule also discussed heterogeneity in susceptibility and protection and the role of a possible immune threshold level for protection, issues that are still discussed today.

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