De-risking vaccine development: lessons, challenges, and prospects

Area of Science:

• Vaccinology
• Public Health
• Pharmaceutical Development

Background:

• Vaccine development is a lengthy and resource-intensive process.
• Numerous technical, clinical, regulatory, and manufacturing risks impede progress, particularly for less commercially viable vaccine targets.
• These challenges have significant public health consequences, limiting the availability of essential vaccines.

Purpose of the Study:

• To propose strategies for early de-risking in vaccine development.
• To address the vaccine productivity gap and promote sustainable vaccine access.
• To enhance the success rates of vaccine development programs through efficient decision-making.

Main Methods:

• Review of existing challenges in vaccine development.
• Identification of key risk factors throughout the development lifecycle.
• Proposal of early-stage decision-making frameworks and strategies.
• Illustration with practical examples of successful de-risking initiatives.

Main Results:

• Early and efficient decision-making can mitigate technical, clinical, regulatory, and manufacturing risks.
• De-risking strategies can improve the economic viability of developing vaccines for challenging targets.
• Successful implementation of these strategies can lead to increased vaccine program success rates.

Conclusions:

• Implementing early de-risking strategies is crucial for overcoming hurdles in vaccine development.
• These strategies can help close the vaccine productivity gap, ensuring broader access to immunizations.
• Proactive risk management enhances the likelihood of successful vaccine programs and strengthens global public health