In the vaccine development process, what typically occurs in the “Discovery” phase?

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BlackTom AI · Accepted Answer

The question asks what typically occurs in the Discovery phase of vaccine development. Here is the analysis of each option with reasoning for and against.

Option 1: 'GMP master-seed development' — Good manufacturing practice (GMP) master-seed development is a step associated with later stages of vaccine development, especially manufacturing scale-up and ensuring quality for production lots. It is not a hallmark activity of the initial Discovery phase, which focuses on understanding the biology and establishing vaccine concepts. Therefore this option is not consistent with Discovery.

Option 2: 'Pathogen identification and host-pathogen interactions study' — This option aligns with the core aim of Discovery: identifying the pathogen of interest and studying how it interacts with the host, including identifying antigens, tropism, virulence factors, and initial targets for a vaccine. This foundational research informs subsequent design and development decisions, making it a typical Discovery activity.

Option 3: 'Regulatory approval' — Regulatory approval is a later-stage milestone that follows preclinical and clinical testing, data compilation, and submission to regulatory agencies. It does not occur during the Discovery phase, and thus this option is incorrect for Discovery.

Option 4: 'Field trials' — Field trials are conducted during later phases of clinical evaluation to assess vaccine effectiveness and safety in real-world populations. They are not part of the Discovery phase, so this option does not describe Discovery activities.

In summary, the Discovery phase is about understanding the pathogen and host interactions to identify viable vaccine targets, while the other options reflect activities associated with later stages of development and testing. The option that best matches that Discovery focus is the one describing pathogen identification and host-pathogen interactions study.

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In the vaccine development process, what typically occurs in the “Discovery” phase?

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