Designing new rotavirus vaccines to meet country needs

by Darin Zehrung, Jean-Marie Préaud, and Emily Griswold, PATH In an effort to advance the development of promising new rotavirus vaccine candidates, PATH is assisting manufacturers in Brazil, China, and India in the formulation, manufacturing, and clinical development of the vaccine candidates. To ensure that these vaccines will meet the needs of immunization programs in developing countries, PATH is also carefully considering vaccine packaging and delivery technologies. In a recent meeting with emerging-country vaccine manufacturers working on a bovine-human reassortant rotavirus vaccine candidate, PATH presented findings and recommendations on possible oral-delivery devices for rotavirus vaccines. Recommendations on oral-delivery devices emerged after consultations with experts in the field and device developers. Findings show that there are multiple options that a manufacturer can choose from depending on constraints related to presentation (liquid, lyophilized), volume, mono- or multidose presentations, stability requirements, the device’s manufacturing process, cost, and level of investment. Packaging considerations are important as well. Consultation with end users in the field might give manufacturers insight into which parameters are important when considering a delivery device. In addition to these findings, PATH is developing a toolkit that will be made available to bovine human reassortant rotavirus vaccine manufacturers to help them evaluate future packaging and presentation combinations. The toolkit will allow manufacturers to select certain characteristics over others to best fit the unique situation of the vaccine and country. PATH is supporting the manufacturers in actively developing the bovine-human reassortant vaccine through a “shared technology platform,” which provides a kit of technologies, methodologies, and background material designed to meet common needs among these manufacturers and maximize global availability of rotavirus vaccines. New rotavirus vaccines and new suppliers will be essential to meet demand for the vaccine over the years to come. In addition to increasing supply, new vaccines create more competition, which will make rotavirus vaccines affordable. By bringing together vaccine development and delivery expertise, PATH can help industry partners develop new rotavirus vaccines that are affordable and effective. To comment or reply to this article, click “reply.”