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

Le résumé fourni par la source

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.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.