Solutions / Vaccines
Vaccine vigilance for safer immunisation
Adverse events following immunisation, batch traceability, surge-ready case processing, observed-versus-expected analysis and reporting, for vaccine manufacturers and marketing authorisation holders.
What is vaccines?
Vaccine vigilance, also called vaccine pharmacovigilance, is the detection, assessment, understanding and communication of adverse events following immunisation (AEFI) and other vaccine-related issues. The WHO defines an AEFI as any untoward medical occurrence that follows immunisation and does not necessarily have a causal relationship with the vaccine.
Vaccines differ from other medicines in ways that shape safety work. They are given to large numbers of healthy people, often infants, pregnant women and older adults; they are frequently given together; and they are biological products where batch-level traceability matters. Public confidence depends on fast, transparent and well-evidenced safety decisions.
The main requirements
| Region | Regulation | Key obligations |
|---|---|---|
| European Union | Directive 2001/83/EC, GVP modules and GVP Product- or Population-Specific Considerations I: Vaccines | ICSRs with product name and batch number, PSURs, signal management, RMPs |
| United States | 21 CFR 600.80 and the Vaccine Adverse Event Reporting System (VAERS), co-managed by CDC and FDA | 15-day reports for serious, unexpected events; periodic reports |
| International | WHO AEFI surveillance and causality assessment guidance; ICH E2 series | Harmonised definitions, causality assessment and reporting |
| Other markets | National AEFI surveillance and immunisation programmes | Local reporting rules, often linked to national programmes |
A summary for orientation, not legal advice. Always check the current regulations and guidance for each market.
What makes vaccines hard
Report surges
Mass immunisation campaigns can multiply case volumes within weeks.
Batch traceability
Every report needs the batch or lot number, and batch-level patterns must be watched.
Healthy and special populations
Infants, pregnant women and older adults, with low tolerance for risk.
Background rates
Signals must be judged against how often events occur anyway.
Co-administration
Several vaccines given at the same visit complicate assessment.
Public scrutiny
Decisions must be fast, transparent and well evidenced.
One platform for vaccines
The same modules, intelligence and controls used across every vigilance domain, configured for this one.
Why teams choose vGenix Ai
Surge-ready intake
Immunisation campaigns can multiply report volumes within weeks. Intake, extraction and coding scale with the volume, and eligible non-serious cases can be processed zero-touch, so experts stay focused on serious cases.
- Every channel in one queue, at any volume
- Eligible non-serious AEFIs processed zero-touch
- Serious cases prioritised to the top of the queue
- Workload views show where pressure is building
Example view. [Confirm surge capacity.]
Batch and lot traceability
For biological products, the batch matters. Batch and lot numbers are captured on every report, checked against your batch records, and used to spot batch-level patterns.
- Batch and lot number captured on every case
- Checked against your batch release records
- Missing batch numbers requested in follow-up
- Batch-level views for quality and safety teams
| Batch | Doses released | Reports | Status |
|---|---|---|---|
| [Lot A1] | [__] | 12 | Normal |
| [Lot A2] | [__] | 31 | Review |
| [Lot A3] | [__] | 9 | Normal |
Example values.
Observed-versus-expected analysis
Many events after vaccination would have happened anyway. Comparing observed cases with the number expected from background rates shows whether there is a real signal.
- Observed counts by event, age group and time window
- Expected counts from background rates you provide
- Ratios flagged against your thresholds
- Evidence ready for signal assessment
| Event | Window | Observed | Expected | O/E |
|---|---|---|---|---|
| [Event A] | 0–7 days | 18 | 6 | 3.0 |
| [Event B] | 0–42 days | 11 | 10 | 1.1 |
Example values. Background rates and thresholds are configured with you.
Special populations and co-administration
Vaccines are given to infants, pregnant women and older adults, often several at the same visit. These details are captured as structured data so assessments account for them.
- Age, pregnancy status and gestational age captured
- Every vaccine given at the same visit recorded
- Dose number in the schedule recorded
- Special-population cases flagged for review
Standard case definitions
Brighton Collaboration case definitions help classify AEFIs consistently by level of diagnostic certainty, so cases from different sources can be compared and assessed.
- Case definitions applied as structured criteria
- Level of diagnostic certainty recorded
- Missing criteria identified for follow-up
- Consistent classification across sources and markets
[Confirm Brighton case definition support.]
Transparent, defensible decisions
Vaccine safety decisions are watched closely by regulators, health professionals and the public. Every decision is traceable to its evidence, so it can be explained clearly and quickly.
- Every case and signal decision linked to its evidence
- Complete audit trail
- Rapid summaries for regulators and safety committees
- Consistent answers across markets
[Confirm which domain-specific terminologies, forms and gateways are live for vaccines before publishing.]
One platform for every vigilance domain
Run all your vigilance domains on the same data model, rules engine and audit trail.
Intelligent safety should be one connected operation
Automate the work. Keep the decisions with your experts. Keep the evidence traceable. See it on your own data in six weeks.
6-week pilot on literature monitoring
- Baselines agreed up front
- Configured to your SOPs
- Measured on your own data
- Validation evidence from day one