Four things scale changes
The population is healthy, not sick
The risk-tolerance bar for reactogenicity and adverse events is fundamentally different when the recipient wasn't already a patient.
Rare signals only surface at volume
A signal that appears in 1 in 100,000 recipients is invisible in a typical trial and only becomes detectable at population-scale surveillance.
Reactogenicity needs its own framework
Expected, solicited local and systemic reactions have to be tracked separately from unsolicited adverse events — conflating the two obscures both.
Public trust is part of the safety system
How a signal is communicated shapes uptake at population scale — safety governance and public communication can't be designed separately.
Four recurring failure points
Solicited-reactogenicity diary design borrowed from a therapeutic program instead of built for a healthy, population-scale recipient base.
Signal-detection thresholds set for trial-scale volume, leaving the program unprepared for the surveillance demands of post-authorization scale.
Post-authorization safety surveillance commitments (e.g. registries, active surveillance) scoped too late to be operationally ready at launch.
A pharmacovigilance system sized for a therapeutic pipeline, not for the case volume a successful vaccine launch actually generates.
Where the judgment sits, stage by stage
Reactogenicity-diary design and solicited-event definitions, set for a healthy-population trial.
Site readiness review sized for the enrollment volume a vaccine trial typically requires.
Named physician adjudicates reactogenicity and safety signals against solicited-event criteria set at study start.
Population-scale surveillance design — the discipline that catches a rare signal after authorization, not before.
Named, credentialed, and on the record
Dr. Ashok Srivastava, MD, Ph.D., MBA
President & Chief Medical Officer
Recognized as one of the inventors of the Japanese encephalitis vaccine IXIARO®, brought to global markets. Built global drug safety and pharmacovigilance organizations in the USA and India from the ground up — the population-scale surveillance discipline a vaccine program depends on.
Educate · Evaluate · Execute for vaccines
Vaccine safety briefing
Reactogenicity frameworks, population-scale signal detection, and post-authorization surveillance design — for your board and clinical team.
IHASG Readiness Assessment
A graded review of your safety governance against a vaccine-specific standard, with a roadmap to Level 4.
Continuous Medical Oversight
A named physician reviewer on the Workbench, adjudicating reactogenicity and safety signals at the volume a vaccine program generates.
Questions vaccine programs ask us
Why does vaccine safety need a different approach than a typical therapeutic program?
Scale. A vaccine is given to healthy people at population volume, so rare signals only become visible at a scale most program-level pharmacovigilance systems aren't sized to detect — and the tolerance for reactogenicity is different than in a sick population.
Do you help design reactogenicity monitoring, not just adverse-event reporting?
Yes — expected reactogenicity (injection-site reactions, transient systemic symptoms) needs its own solicited-event framework, separate from and in addition to unsolicited adverse-event surveillance.
Has your named reviewer actually brought a vaccine to market?
Yes — Dr. Srivastava is recognized as one of the inventors of the Japanese encephalitis vaccine IXIARO, brought to global markets, and has built drug safety and pharmacovigilance organizations from the ground up.
Talk to a vaccine safety expert.
Bring us the reactogenicity framework, the surveillance design, or the safety review you're building.
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