The Wistar Institute and Batavia Biosciences have launched a strategic collaboration aimed to streamline the clinical grade manufacture and global distribution of Wistar’s rubella vaccine seed stock commonly known as RA 27/3. In December 2019, Wistar was awarded a $1 million grant from the Bill & Melinda Gates Foundation to support this global access-focused international collaboration.
 
Rubella is a contagious viral disease that mainly affects children and young adults, typically manifested with mild clinical symptoms. However, rubella infection during pregnancy, especially during the first trimester, can result in severe complications including miscarriage, fetal death, stillbirth, and congenital malformations, known altogether as congenital rubella syndrome (CRS).
    
The rubella vaccine was developed at Wistar in 1969 in the laboratory of Stanley A. Plotkin, M.D. The vaccine is safe and effective at providing long-lasting protection. The number of countries using rubella vaccines in their national immunization programs is steadily increasing, and global rubella vaccine coverage in 2018 was estimated at 69% by the World Health Organization. Despite this progress, rubella control is lagging behind, and several countries have neither introduced the vaccine nor set elimination or control targets.
 
“Combining the established know-how and experience at The Wistar Institute with our technology to manufacture vaccines at low cost and the support of the Bill & Melinda Gates Foundation provides us with an exciting opportunity to increase the distribution of a critical vaccine,” said Chris Yallop, Ph.D., Batavia’s CSO and COO.
 
One major issue is supply shortage, mainly due to insufficient production capability. The number of companies that produce rubella vaccines has been steadily decreasing, causing global shortages of the vaccine.
 
Batavia shares with Wistar a focus on rapidly accelerating the development of vaccines and other biopharmaceutical product candidates from discovery to market to improve global health. This collaboration with the Netherlands-based company bolsters the developing relationship between geographies as Wistar also recently announced the establishment of the Wistar-Schoemaker International Postdoctoral Fellowship with the Leiden University Medical Center in the Netherlands (LUMC), which will bring recent Ph.D. graduates trained at LUMC to Wistar to advance their research education under the mentorship of cutting-edge biomedical research leaders. 
 
Thanks to support from the Bill & Melinda Gates foundation, Wistar will be able to archive the existing supplies of research-grade rubella virus seed stock and transfer the necessary supplies to Batavia, to enable the development of readily accessible good manufacturing practice (GMP)-grade rubella drug substances and drug product formulations, with the intent to distribute these critical materials to vaccine manufacturers around the world through a universal license agreement construct.