Safety signal identification for COVID-19 bivalent booster vaccination using tree-based scan statistics in the Vaccine Safety Datalink

CONCLUSIONS: For Pfizer-BioNTech only, we detected clusters of: (1) unspecified adverse effects, as have been observed in other vaccine studies using this method, and (2) respiratory disease toward the end of follow-up. The respiratory clusters were likely due to overlap of follow-up with the spread of respiratory syncytial virus, influenza, and COVID-19, i.e., confounding by seasonality. The untargeted nature of the method and its inherent adjustment for the many diagnoses and risk intervals evaluated are unique advantages. Limitations include susceptibility to time-varying confounding, lower statistical power for assessing risks of specific outcomes than in traditional studies targeting fewer outcomes, and the possibility of missing adverse events not strongly clustered in time or within the "tree."PMID:37479610 | DOI:10.1016/j.vaccine.2023.07.010

Source: Vaccine - July 21, 2023 Category: Allergy & Immunology Authors: W Katherine Yih Matthew F Daley Jonathan Duffy Bruce Fireman David L McClure Jennifer C Nelson Lei Qian Ning Smith Gabriela Vazquez-Benitez Eric Weintraub Joshua T B Williams Stanley Xu Judith C Maro Source Type: research