The v-safe after vaccination health checker: Active vaccine safety monitoring during CDC’s COVID-19 pandemic response
Vaccine·
- DOI
- 10.1016/j.vaccine.2022.12.031
- PMID
- 36697313
- PMCID
- PMC9870038
- OpenAlex
- W4317792006
- Study type
- Journal article
- Publisher
- Elsevier BV
- Article type
- journal-article
- Integrity
- current
Why this research matters now
The system contributed to CDC vaccine safety assessments for FDA-authorized COVID-19 vaccines and may serve as a model for future pandemic response activities and novel vaccine rollouts in non-pandemic contexts.
Structured evidence summary
Research question
The paper describes the development, implementation, and first-year operation of v-safe, an active surveillance system designed to monitor COVID-19 vaccine safety in the United States.
Study design
This is a descriptive report of an active surveillance system using text-message reminders linked to Internet-based health check-in surveys sent at daily, weekly, and monthly intervals after COVID-19 vaccination.
Population and setting
During December 14, 2020 through December 13, 2021, over 9.3 million persons enrolled in v-safe and submitted more than 131 million surveys. Most participants were female (62.3%), non-Hispanic White (61.2%), with a median age of 49 years, and had received an mRNA COVID-19 vaccine as their first dose (95.0%).
Main findings
V-safe enabled near real-time reporting of reactogenicity once community vaccination began, encouraged adverse event reports to VAERS, and facilitated enrollment in a post-vaccination pregnancy registry. The system is described as an integral component of what the authors characterize as the most comprehensive vaccine safety monitoring program in U.S. history.
Public-health relevance
The system contributed to CDC vaccine safety assessments for FDA-authorized COVID-19 vaccines and may serve as a model for future pandemic response activities and novel vaccine rollouts in non-pandemic contexts.
Important limitations
This summary relies on the supplied single-article abstract and metadata. The abstract mentions that the paper describes strengths and limitations of v-safe but does not specify them in the abstract text. A full assessment requires review of the complete published article.
GIDS interpretation
This paper would be discoverable through GIDS queries for COVID-19 vaccine safety surveillance in the United States. It describes the infrastructure and participant characteristics of v-safe but does not report specific adverse event rates or safety signals.
Related GIDS surveillance
Literature context does not validate, explain, or change a surveillance signal. Exact and contextual relationships are shown separately.
Evidence relationships
This article has 12 auditable classifier relationships to diseases, places, topics, and study design.