Affiliation:
1. Department of Statistics Federal University of Ouro Preto Ouro Preto Brazil
2. Communicable Disease Control Manitoba Health Manitoba Canada
Abstract
In the postmarket drug and vaccine safety surveillance, when the number of adverse events follows a Poisson distribution, the ratio between the exposed and the unexposed person‐time information is the random variable that governs the decision rule about the safety of the drug or vaccine. The probability distribution function of such a ratio is derived in this paper. Exact point and interval estimators for the relative risk are discussed as well as statistical hypothesis testing. To the best of our knowledge, this is the first paper that provides an unbiased estimator for the relative risk based on the person‐time ratio. The applicability of this new distribution is illustrated through a real data analysis aimed to detect increased risk of occurrence of Myocarditis/Pericarditis following mRNA COVID‐19 vaccination in Manitoba, Canada.
Funder
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Pesquisa do Estado de Minas Gerais
National Institute of General Medical Sciences
Subject
Statistics and Probability,Epidemiology