A rapid cycle analytics framework for vaccine safety surveillance within a real-world data network: Experience with enhanced surveillance of the Janssen COVID-19 vaccine
This work demonstrates the value and feasibility of conducting rapid cycle analysis across numerous outcomes in multiple databases employing complementary methodologies over successive time points while maintaining scientific integrity. The scalability of the approach is facilitated by the a priori specification of analytic diagnostics and corresponding thresholds, which excludes analyses likely to yield unreliable results, thereby minimizing subjective interpretation and post-hoc rationalization of failed diagnostic tests.
Authors
- Nicolas Praet (ORCID: https://orcid.org/0000-0002-6680-9588)
- Kevin Haynes (ORCID: https://orcid.org/0000-0002-7087-9159)
- Clair Blacketer (ORCID: https://orcid.org/0000-0003-2570-2124)
- Rupa Makadia (ORCID: https://orcid.org/0000-0002-3767-969X)
- E. Claire Newbern (ORCID: https://orcid.org/0000-0002-8486-6471)
- Frank DeFalco (ORCID: https://orcid.org/0000-0002-5810-8298)
- Yimei Xu (ORCID: https://orcid.org/0000-0003-0013-4044)
- Luis Felipe Clemente Velarde
- Gowtham Rao (ORCID: https://orcid.org/0000-0002-4949-7236)
- Azza Shoaibi (ORCID: https://orcid.org/0000-0002-6976-2594)
- Patrick B. Ryan (ORCID: https://orcid.org/0000-0002-9727-2138)
- Corinne Willame (ORCID: https://orcid.org/0000-0002-6310-6019)
- Martijn J. Schuemie (ORCID: https://orcid.org/0000-0002-0817-5361)
- Kourtney J. Davis
Institutions
- Janssen (Belgium) (BE)
- Janssen (United States) (US)
Publication Details
- Journal
- Vaccine
- Published
- 2025-03-31
- DOI
- https://doi.org/10.1016/j.vaccine.2025.127044
- Citations
- 3
- Primary Topic
- Pharmacovigilance and Adverse Drug Reactions
- Type
- article
- Field-Weighted Citation Impact
- 3.92