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

Vaccine Insights 2022; 1(5), 241–245

DOI: 10.18609/vac.2022.035

Published: 13 October 2022
Expert Insight
Ramin Sabet Azad, Raafat Fahim

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.