Formulation technology to protect vaccines from freeze damage


All vaccines that contain aluminum hydroxide or aluminum phosphate as an adjuvant (by far the most common adjuvants in the world) are susceptible to damage if accidentally frozen. Exposure to freezing temperatures occurs frequently in vaccine distribution systems due to poorly controlled refrigerators, use of frozen ice packs, and exposure to freezing ambient conditions. The technology that has been developed involves the use of formulation excipients that can protect vaccines from loss of potency due to freezing. These excipients are inexpensive, commonly used in pharmaceutical products, and included on the FDA list of excipients that are "Generally Regarded As Safe" (GRAS).

Chagas disease
Research areas
Condition of use

Any vaccines to these or other NTDs that contain aluminum adjuvants would be candidates for use of the freeze protection technology.

IP information

Patent applications were filed on the technology in 2005 in the US and in 2006 internationally PCT/US2006/013188 . The patents were abandoned after the publication in Vaccine in the interest of making the technology broadly available to all companies.
Reference: Vaccine 27 2009 72-79.