Affordable vaccine maker Serum Institute of India has new results to trumpet from a phase 3 trial of its heat-stable rotavirus vaccine as it preps to deliver millions of doses to a national vaccine program.
International nonprofit PATH partnered on the study and another trial that’s designed to secure WHO prequalification for the shot. Securing that nod would make the inexpensive rotavirus shot eligible for purchase and distribution on a global basis, improving costs and access. Already, though, India’s government has ordered 3.8 million doses of Serum’s oral vaccine that’s administered in three doses at 6, 10 and 14 weeks of age.
Serum Institute says it has manufactured those doses and is awaiting directions for delivery. The Indian vaccine giant is prepping for a launch on the private market later this year. India approved the shot in January after reviewing previous phase 3 data and inspecting the company’s manufacturing operation.
PATH’s Center for Vaccine Access and Innovation director, David Kaslow, said in a statement the new trial results and vaccine licensure are an “encouraging milestone toward the public health goal of improving the supply of affordable rotavirus vaccines, both in India and worldwide.”
India suffered more than 47,000 deaths due to rotavirus in 2013, according to PATH’s release, or more than a fifth of the rotavirus deaths around the world that year.
Based in Seattle, nonprofit PATH recently secured $120 million in grant funding from the Gates Foundation as it works to develop new vaccines for and improve access in low-resource areas around the world.