Novartis Vaccines Institute for Global Health (NVGH)
Developing vaccines for a developing world
Infectious diseases impose the major health burden in the developing world. There is a desperate need for effective, affordable and accessible vaccines to combat these neglected infectious diseases that affect over two billion(1) people in the developing world. Novartis is committed to improving global health and the Novartis Vaccines Institute for Global Health (NVGH) is an important part of that strategy as they discover and develop vaccines specifically addressing the needs of developing countries.
A major bottleneck in the path to new vaccines is the expertise and facilities needed to turn a laboratory concept into high quality vaccines that are both clinically effective and economically viable for manufacture. Our role is to bridge that gap by applying our expertise to the translational research required to move a laboratory concept through development to the proof of concept in the clinic and then transferring this knowledge to the eventual manufacturer. Together with our funding partners, we reduce development risks and the investment required for the manufacturer to viably produce and distribute NVGH vaccines to the public health sector of the developing world. Our focus on developing robust and inexpensive processes combined with our location on the campus of the Novartis Vaccines and Diagnostics campus in Siena, Italy gives us a unique combination of industrial comparative advantage and economic prudence to achieve our mission.
To do this successfully, we bring together a network of partners who cooperate globally to combine the knowledge of academia, the efforts of charities, the reach of governments and the capabilities of business to deliver vaccines, training and infrastructure that will improve global health by preventing disease.
(1) Lack of access to sanitation facilities is used as an indicator for poor communities most affected by neglected diseases. It is estimated that 2.4 billion are without access to any type of improved sanitation facility. (http://www.who.int/water_sanitation_health/hygiene/en/)
Novartis Vaccines Institute for Global Health
Via Fiorentina 1
53100 Siena ITALY
Developing Vaccines for a Developing World
Exploring potential new projects
New pre-development projects that have the potential to address the unmet needs of impoverished populations can arise from within Novartis or externally from collaborators. The decision to accept a new project into the NVGH portfolio is based on:
- The technical feasibility of producing the vaccine,
- The likelihood that the vaccine will induce a protective immune response,
- The likelihood that a successful vaccine would make a significant impact on health
- The synergies of the project with NVGH portfolio, competencies, and technologies.
When the vaccine “design” is selected and initial processes for candidate antigens are successfully demonstrated in our laboratories (or of collaborators), the NVGH pre-development project is eligible to transition to the Development phase.
Development Phase – realizing the research into clinical trials
During the Development Phase, the process for making and testing the vaccine at a scale and quality suitable for clinical trials is developed by NVGH scientists. This involves scaling-up processes, including fermentation of bacteria, purification of antigens, chemical reactions and analytics, so that they are robust and utilize inexpensive raw materials and equipment. The vaccine is then transferred to a GMP (contract) manufacturer to produce vaccine suitable for early clinical trials. Our clinical development and regulatory experts are responsible for the clinical trial design, clinical site selection and preparation, and regulatory filing and approvals of the early clinical trials. We characterize (in Phase 2 clinical trials) our vaccine’s clinical potential in the endemic countries where the vaccines will eventually be used. The entire Development Phase, including project planning and other pre-clinical activities, including toxicology and stability studies, are led by our project leaders.
Transferring the vaccine to the manufacturer
The efforts during the Development Phase generate a complete package of robust processes and early clinical trial data for a vaccine manufacturer, with a good strategic fit and capabilities, to build a viable business case to deliver our vaccines in a sustainable, affordable, and accessible manner to the public health sector of the developing world. We seek only manufacturers who can and will obtain WHO prequalification for our vaccines so that the vaccines can be purchased and distributed by supranational organizations, such as UNICEF and GAVI, sharing the same vision as NVGH.
Many of the endemic countries where our vaccines will have the most impact have a need for more trained scientists and clinicians to help build the capacity to conduct local research and carry out clinical trials, both of which are critical to improving public health of those countries. NVGH actively contributes to the training of developing country scientists in the laboratory through scientific collaborations and European Union grant initiatives; and the training of medical professionals in the joint Masters Program in Vaccinology and Pharmaceutical Clinical Development, a joint program together with Novartis Vaccines & Diagnostics and University of Siena.
Learn more about our programs:
Collaborate with us
NVGH relies on global partnerships to achieve its mission to accelerate the development and use of vaccines for neglected infectious diseases in developing countries. We look to collaborators to help select the most promising antigens, conduct in vitro and in vivo testing for “validation,” and establish preliminary feasibility data for manufacturability. During the subsequent phase of technical development and early clinical development, where NVGH is most active, we seek partners for subsequent clinical trials and Good Manufacturing Practice (GMP) contract manufacturing, as well as final manufacturers.
For all of its projects throughout the entire product life cycle, NVGH endeavors to work with partners to build upon existing efforts in public health research and advocacy to ensure timely uptake of its vaccine projects. We seek scientific collaborations and partnerships with clinicians, researchers and regulatory agencies who are interested to evaluate the baseline conditions of neglected diseases of the developing countries and the cost-effectiveness of potential vaccination programs.
Interested in working with us? Contact firstname.lastname@example.org
Koeberling O, Ispasanie E, Hauser J, Rossi O, Pluschke G, Caugant DA, Saul A, Maclennan CA. A broadly-protective vaccine against meningococcal disease in sub-Saharan Africa based on Generalized Modules for Membrane Antigens (GMMA).Vaccine. 2014 May 13;32(23):2688-95. doi: 10.1016/j.vaccine.2014.03.068. Epub 2014 Apr 3. PubMed PMID: 24704334.
Micoli F, Ravenscroft N, Cescutti P, Stefanetti G, Londero S, Rondini S,Maclennan CA. Structural analysis of O-polysaccharide chains extracted from different Salmonella Typhimurium strains. Carbohydr Res. 2014 Feb 19;385:1-8.doi: 10.1016/j.carres 2013.12.003. Epub 2013 Dec 11. PubMed PMID: 24384528.
Bhutta ZA, Capeding MR, Bavdekar A, Marchetti E, Ariff S, Soofi SB, Anemona A, Habib MA, Alberto E, Juvekar S, Khan RM, Marhaba R, Ali N, Malubay N, Kawade A, Saul A, Martin LB, Podda A. Immunogenicity and safety of the Vi-CRM197 conjugate vaccine against typhoid fever in adults, children, and infants in south and southeast Asia: results from two randomised, observer-blind, age de-escalation,phase 2 trials. Lancet Infect Dis. 2014 Feb;14(2):119-29. doi: 10.1016/S1473-3099(13)70241-X. Epub 2013 Nov 28. PubMed PMID: 24290843.
Micoli F, Romano MR, Tontini M, Cappelletti E, Gavini M, Proietti D, Rondini S, Swennen E, Santini L, Filippini S, Balocchi C, Adamo R, Pluschke G, Norheim G, Pollard A, Saul A, Rappuoli R, MacLennan CA, Berti F, Costantino P. Development of a glycoconjugate vaccine to prevent meningitis in Africa caused by meningococcal serogroup X. Proc Natl Acad Sci U S A. 2013 Nov 19;110(47):19077-82. doi: 10.1073/pnas.1314476110. Epub 2013 Nov 4. PubMed PMID: 24191022; PubMed Central PMCID: PMC3839747.
Saul A, Smith T, Maire N. Stochastic simulation of endemic Salmonella enterica serovar Typhi: the importance of long lasting immunity and the carrier state. PLoS One. 2013 Sep 10;8(9):e74097. doi: 10.1371/journal.pone.0074097. eCollection 2013. PubMed PMID: 24040177; PubMed Central PMCID: PMC3769365.
Micoli F, Rondini S, Gavini M, Lanzilao L, Medaglini D, Saul A, Martin LB. O:2-CRM(197) conjugates against Salmonella Paratyphi A. PLoS One. 2012;7(11):e47039. doi: 10.1371/journal.pone.0047039. Epub 2012 Nov 7. PubMed PMID: 23144798; PubMed Central PMCID: PMC3492368.
Berlanda Scorza F, Colucci AM, Maggiore L, Sanzone S, Rossi O, Ferlenghi I, Pesce I, Caboni M, Norais N, Di Cioccio V, Saul A, Gerke C. High yield production process for Shigella outer membrane particles. PLoS One. 2012;7(6):e35616. doi: 10.1371/journal.pone.0035616. Epub 2012 Jun 6. PubMed PMID: 22701551; PubMed Central PMCID: PMC3368891.