LAWRENCE – In the global health community, they call it “the last mile.”
A vaccine’s journey from manufacturer to a child in the developing world takes it through a complex, refrigerated “cold chain” designed to preserve its medicinal value during shipment and storage. To then reach remote villages, vaccines might have to travel through dense jungles, over hot deserts and across large bodies of water. This final leg of the journey, referred to as the “last mile,” can expose vaccines to harsh conditions that compromise their potency and efficacy.
These harrowing voyages pay off. Vaccines save an estimated 2.5 million lives each year, according to the World Health Organization. But there is more work to be done. One in five children worldwide is still missing routine vaccinations for preventable diseases, resulting in about 1.5 million deaths each year.
Researchers at the University of Kansas hope to change that as part of a global coalition collaborating to increase access to existing and new vaccines.
A KU team led by School of Pharmacy Distinguished Professor David Volkin is working hard to develop the next generation of these life-saving medicines aimed at protecting 100% of the world’s children. On the strength of three new research grants and a service contract totaling approximately $10 million from the Bill & Melinda Gates Foundation, Volkin and co-investigator Sangeeta Joshi recently launched the Vaccine Analytics & Formulation Center (VAFC).
Volkin and Joshi, director of the VAFC, are leading an experienced team now turning its attention toward advancing vaccine candidates for the developing world. VAFC scientific staff, postdoctoral fellows and graduate students are working on dozens of collaborative projects supported primarily by the Gates Foundation and its global partners, including nonprofit organizations, academics, biotech companies as well as developing countries vaccine manufacturers.
“We work collaboratively with researchers worldwide who are developing new vaccine candidates to ensure they remain stable and potent throughout the vaccine cold chain, as well as to enable their manufacture at low-cost to provide improved global access,” Volkin said.
The awarded service agreement allows KU to work collaboratively with vaccine development partners to address analytical and formulation challenges encountered with their new candidates as they move from the laboratory into clinical trials. The three most recent Gates Foundation grants provide directed funding to KU to evaluate:
- New, multi-dose formulations of HPV vaccines that remain potent during long-term storage, while allowing for low-cost administration using antimicrobial preservatives so that a single vial of vaccine can provide protection to many children. The study will also provide a roadmap for developing multi-dose formulations of other vaccines in the future.
- Various combination formulations of a vaccine candidate to prevent rotavirus, by addition to inactivated polio vaccine or to the currently used pentavalent vaccine (to protect against diphtheria, tetanus, pertussis, haemophilus influenzae and hepatitis B) – again providing a framework and expertise to generate other low-cost combination vaccines tailored for the developing world.
- Stable, low-cost formulations of antibodies that can potentially be delivered orally to protect against infectious diseases, a strategy known as passive immunization.
The life-saving benefits of KU’s work for the Gates Foundation will be compounded by the organization’s open access policy.
“I really like their commitment to publishing research results,” Joshi said. “The hope is that once our work is shared with the scientific community, other researchers and developing country vaccine manufacturers can build on our results to produce vaccines that meet the needs of specific countries and regions.”
The VAFC is also preparing the next generation of scientists with specialized expertise to help improve the lives of people who have the most urgent needs and the fewest champions.
“Training of students and postdoctoral scientists is a key role for us,” Volkin said. “We’re working in a highly specialized field. You don’t get a college degree in how to make vaccines. You first must have a really good science background, and then you must learn how to apply it to this field.”
The KU center’s growing relationship with the Gates Foundation includes a $17.6 million Grand Challenge Grant awarded in 2017 for a collaboration with University College London and the Massachusetts Institute of Technology. Through this ongoing project, Ultra-low Cost Transferable Automated (ULTRA) Platform for Vaccine Manufacture, the academic researchers are attempting to standardize the development of new recombinant protein vaccines and producing them for less than 15 cents a dose.
After that, it could still be a decade or more before a new vaccine travels “the last mile” to children in the developing world – and for good reason.
“Vaccines can take up to 20 years to develop before they are ready for widespread use,” Volkin said. “Vaccines are very difficult to produce at a large manufacturing scale, and vaccine clinical trials require very extensive, multi-phased testing to ensure their safety and efficacy.”
For Volkin and Joshi, who have made this type of vaccine development the top priority of their professional careers, every milestone achieved is exciting.
“We’re advancing new vaccine candidates at the VAFC,” Joshi said. “Hopefully one of these projects will lead to a new vaccine for use in the developing world. That would be a dream come true for me.”
“One thing I’ve learned is the importance of finding purpose and meaning in your work,” Volkin said. “After spending 20 years as an R&D scientist in the vaccine and biopharmaceutical industry, I came to KU 10 years ago to develop a research program for something I really feel passionate about, and I have found it with our new mission here at the VAFC.”
Top photos: KU Vaccine Analytics & Formulation Center staff members, clockwise from left, John Hickey, scientific assistant director; Ozan Kumru, scientific assistant director; Kaushal Jerajani, graduate research assistant; Oluwadara Ogun, assistant researcher; and Ying Wan, associate researcher, work in the lab to formulate and analyze vaccine candidates. Credit: Dan Storey, KU Alumni Association
Right photos: David Volkin and Sangeeta Joshi. Credit: Lisa Pickel