The power and potential of study tokenisation for vaccine research and post-commercialisation

As of February 2025, the US FDA has approved 110 vaccines, ranging from smallpox, flu and COVID to the more recent approval of Chikungunya. A median of seven clinical trials supports each vaccine approval, including two pivotal efficacy trials.

This comes at a significant cost of about $886.8m to bring a novel vaccine to market and can take almost ten years: to gain approval, the typical safety follow-up period is between six and twelve months after the last vaccination.

After approval, post-marketing surveillance may be required to assess the long-term safety and benefit–risk profile.

Longer and more extensive post-marketing follow-up may be required for paediatric vaccines or trials involving elderly or immunocompromised subjects.

Clinical trial tokenisation (CTT) offers vaccine developers a way to seamlessly and passively capture long-term patient data.

Post-marketing regulatory requirements pose challenges for both vaccine developers and participating patients, including:

• Privacy and compliance: managing sensitive health data for extended periods raises concerns under regulations like HIPAA and GDPR
• Data fragmentation: participants may access care from multiple providers, leading to siloed data that is difficult to integrate
• Resource intensiveness: primary long-term follow-up data collection requires significant additional time, staffing and financial resources
• Participant attrition: maintaining participant engagement becomes challenging over time, increasing the risk to data completeness

Clinical trial tokenisation enables vaccine developers to track large volumes of real-world patient data for cohorts of study participants without the risk of identification.

Tokenisation is the process of substituting personally identifiable information (PII) with a unique token or deidentifier: this token becomes a reference point in the health data universe so that real-world healthcare data can be linked and analysed to understand trends in disease, indication and post-exposure safety/effectiveness patterns without compromising patient privacy.

Patient data is captured discreetly and non-intrusively to facilitate valuable insights.

• Provides data visibility over an extended period: using CTT gives sponsors a retrospective view of the study population. The standard lookback period is one year, but up to fifteen years of historical patient data may be accessible, depending on the indication
• Reduces patient and site burden: CTT can passively collect longitudinal follow-up after the study with no additional burden for patients, caregivers or sites. Follow-up continues even when a patient changes care providers or relocates
• Ensures a scientifically significant study population: CTT can be used to evaluate the study population for representativeness compared with the general population with the disease
• Enhanced real-world evidence generation: a more efficient means of generating evidence, which can be leveraged to support regulatory submissions (for example, the 21st Century Cures Act)
• Real-world data source analysis: enables sponsors to optimise research protocol and study design
• Statistical comparison between study participants and the general population: providing better understanding and insights into research cohorts.

Pharma companies have begun to recognise the value that CTT offers, and we believe it will be more widely adopted in the next generation of vaccine trials.
The benefits for sponsors are clear: valuable patient insights and seamless long-term data collection without increasing the burden on patients or sites.

Having real-world evidence drawn from both study participants and the general population addresses regulatory requirements and informs decisions on vaccine efficacy and safety.

From a patient perspective, this makes study participation less onerous and may mean that vaccines come to market sooner.