Freeze-Protection of Aluminum-Adjuvanted Vaccines: PATH Formulation Technology
PATH has developed a low-cost and straightforward approach for protecting aluminum-adjuvanted vaccines from irreversible damage that results from freezing. Many current vaccines of importance to global health contain an aluminum-salt adjuvant (such as aluminum hydroxide or aluminum phosphate) and could benefit from this freeze-protection technology. There is no intellectual property barrier for manufacturers wishing to adopt the technology; it has been placed in the public domain. This technical dossier summarizes the rationale for freeze protection, application of the technology to specific vaccines, the data obtained to date, and comments on the likely regulatory pathway for vaccines incorporating the technology. Much of the dossier is focused on studies conducted by PATH and its collaborators using hepatitis B vaccine, though results from studies with other vaccines are also included.
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