Optimizing the Route to Regulatory Approval for a Novel Vaccine

The rapid delivery of safe and effective vaccines is critical, clearly demonstrated by COVID-19 pandemic. Streamlining vaccine development through novel trial design is essential for expediting the process. This paper presents key insights on optimizing the path to regulatory approval, with a focus on:

• Early phase studies: To optimize the development of new vaccines, it is crucial to leverage multidisciplinary expertise and include multiple exploratory endpoints. Human challenge studies can be valuable when dealing with mild or treatable infections. Case examples from the literature illustrate the application of these strategies.
• Immune correlates and immuno-bridging: The concepts of immune correlates and immuno-bridging are discussed with example of circumstances when these might be applied in lieu of clinical effectiveness studies.
• Considerations for later phase studies: The challenges associated with clinical effectiveness trials are discussed as well as approaches to accelerate vaccine development such as adaptive trial designs together with examples.
• Generating safety data: The regulatory expectations  for safety data are discussed along with examples of known and potential risks to be addressed both pre- and post-approval, including the potential for vaccines to exacerbate subsequent infections 
• Population diversity: Addressing population diversity in vaccine development is critical. Factors such as ethnicity, socioeconomic status, nutrition, and gut biota can influence vaccine effectiveness and safety.

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