A seasonality‐adjusted sequential test for vaccine safety surveillance

Rex Shen, Keran Moll, Ying Lu and Lu Tian

Biometrics, 2023, vol. 79, issue 4, 3533-3548

Abstract: Post‐market active safety monitoring is important for the timely capture of safety signals associated with exposure to a new vaccine or drug. The group sequential analysis is a common method employed in safety surveillance. Specifically, it compares the post‐vaccination incidence of adverse event (AE) in a vaccinated population with a pre‐specified reference level by sequentially conducting hypothesis testing during the surveillance. When the number of AEs is “too high”, a safety signal is identified. If the null hypothesis is never rejected, the vaccine is considered safe. Such an approach does not account for either the variation in determining the reference risk from a control population or the seasonality effect. Furthermore, not rejecting the null could be due to a lack of power and cannot always be interpreted as proof of safety. In this paper, we proposed a new group sequential test procedure fully accounting for both seasonality and variation from the historical controls. More importantly, we proposed to construct a confidence interval for the relative AE risk between the exposed and control groups at the end of the study, which can be used to quantify the safety of the vaccine. The proposed method is illustrated via real‐data examples on anaphylaxis and examined by extensive simulation studies.

Date: 2023
References: View references in EconPapers View complete reference list from CitEc
Citations:

Downloads: (external link)
https://doi.org/10.1111/biom.13829

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:bla:biomet:v:79:y:2023:i:4:p:3533-3548

Ordering information: This journal article can be ordered from
http://www.blackwell ... bs.asp?ref=0006-341X

Access Statistics for this article

More articles in Biometrics from The International Biometric Society
Bibliographic data for series maintained by Wiley Content Delivery ().