Considerations for the stability of vaccines as liquid-, frozen-, or lyophilized presentations

An important aspect of vaccine process development is that the final product maintains its stability specifications throughout its intended shelf life. Storage of vaccine products at temperatures of -20°C and lower may be readily available in High- and Upper Middle-Income Countries (HIC) but such storage- and distribution conditions may not be widely available in Low- and Middle-Income Countries (LMICs), which may hinder their usability for addressing the needs of such regions. Thus, enabling equitable access to vaccines in LMICs may be best achieved by ensuring long-term stability of vaccine drug products at more readily available cold chain temperatures of 2–8°C or above. This in turn necessitates an assessment early in vaccine development of the appropriate steps to ensure that the desired stability is achieved. This document is intended as a potential guide to vaccine developers when considering storage conditions appropriate for their intended use.

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