Novel non-aqueous rotavirus vaccine: Formulated for thermostability and easy administration.

Rotavirus vaccination has greatly reduced the number of deaths caused by the virus, lowering childhood mortality by an estimated 37% globally. Although low- and middle-income countries (LMIC) demonstrate reduced efficacy than high-income countries, the vaccines still make a significant impact in these areas and continued efforts to support vaccination are needed. Liquid rotavirus vaccines are desirable for their ease of administration and reduced packing footprint; however, current ready-to-use rotavirus vaccines require refrigerated transport and storage. Here, we describe production methods and stability data for a ready-to use non-aqueous formulation that is suitable for ambient shipping and is shelf-stable. In-line sonication and filtration methods were employed during viral vaccine production to increase viral yields and streamline viral harvest steps. Lyophilized vaccine was formulated with medium-chain triglyceride (MCT) oil and excipients to form a suspension. Stability studies were performed for up to 36 months, and predictive regression analysis was carried out to estimate shelf-life. These results suggest a ready-to-use vaccine candidate with comparable thermostability to lyophilized commercially available products, formulated to a low dosage volume, amenable to ambient shipping with a reduced storage footprint.