AFRICA—The German government has committed to contribute US$10.3 million to the International AIDS Vaccine Initiative (IAVI) to support the late-stage development of promising tuberculosis (TB) vaccine candidate, MTBVAC currently in clinical trials in Africa.
The German Federal Ministry of Education and Research (BMBF) through the KfW Development Bank will contribute this financial support for the MTBVAC vaccine development process for the next five years.
The grant is especially geared to assist in the completion of the ongoing European and Developing Countries Clinical Trials Partnership (EDCTP)-supported Phase III clinical trial of MTBVAC in infants that launched in South Africa, Madagascar, and Senegal in late 2022.
Moreover, the award will assist IAVI and its partners in their efforts to initiate an efficacy trial in adults and adolescents.
IAVI noted that by supporting an integrated product development plan, this grant will also help reduce the time to market approval by at least one to two years if the vaccine is found to be safe and effective.
MTBVAC has been developed by an innovative public-private collaboration between IAVI and partners, the Spanish biopharmaceutical company Biofabri, and the Netherlands-based Tuberculosis Vaccine Initiative (TBVI).
Dr. Mark Feinberg, President, and CEO of IAVI said, “The world urgently needs a new, effective vaccine that can prevent TB disease in adults, adolescents, and infants to make the goal of ending TB achievable.”
Dr. Feinberg expressed his gratitude by stating that IAVI was honored to receive the new award from the German government to support the development of one of the most promising TB vaccine candidates.
“This award provides critical support to help prepare and conduct late-stage testing of the vaccine candidate in efficacy trials in infants, as well as adolescents and adults,” the CEO stated.
Christoph Tiskens, director at KfW Development Bank said that KfW was committed to fighting poverty-related and neglected infections that hamper the achievement of the sustainable development goals.
Tisken also remarked, “Thanks to sizable and reliable support by BMBF, we have already managed to support PDPs that develop new and improved diagnostics and therapies for over a decade. Their efforts directly improve the lives and livelihoods of people in need in developing countries.”
The Journey to Develop MTBVAC
MTBVAC is currently being developed as a more effective and potentially longer-lasting TB vaccine for newborns and for the prevention of TB disease in adults and adolescents.
IAVI conveyed that the candidate was designed by the Spanish researcher Dr. Carlos Martin, University of Zaragoza, and Dr. Brigitte Gicquel, Institut Pasteur.
The only licensed TB vaccine, the Bacille Calmette-Guérin (BCG) vaccine, was developed more than 100 years ago.
BCG is largely ineffective in adolescents and adults who are most at risk of developing and transmitting the disease.
Additionally, MTBVAC is the only live, attenuated Mycobacterium tuberculosis vaccine in the pipeline.
Especially, given the vaccines derivation from the human, rather than bovine, TB organism, MTBVAC has the potential to maximize the breadth of immune response in vaccinated individuals.
IAVI notes that, if shown to be effective, MTBVAC could have a transformative impact in high TB burden countries, significantly reducing TB-related illness and death, and breaking the cycle of TB transmission.
Support from BMBF for MTBVAC development, jointly with support from EDCTP, will serve as an important lever to bring additional resources from other funders to this program, and to TB vaccine R&D overall.
This announcement comes amidst renewed calls from the global TB community for greatly increased investment in TB vaccine development, in line with the ambitions and targets outlined in the Global Plan to End TB 2023-2030.
IAVI urges funders, especially from the public sector, to commit additional resources for TB vaccine R&D and join the German government in supporting the late-stage testing of other promising TB vaccine candidates in the pipeline.
Moreover, if MTBVAC is shown to be safe and effective, IAVI, in partnership with Biofabri, will ensure that MTBVAC is manufactured and supplied in sufficient quantities to neonates, infants, adolescents, and adults and is accessible at affordable prices in low- and middle-income countries.
The TB surge and the MDR TB threat
The World Health Organisation notes that since the COVID-19 emergency has ended, TB is on track once again to be the deadliest infectious disease in the world, killing an estimated 1.6 million people in 2021, about 14% of whom were children.
Additionally, around 10.6 million people fell ill with tuberculosis in 2021, and the disease is one of the 10 leading causes of death worldwide.
Essentially, Drug-resistant/multi-drug resistant TB (DR/MDR TB) is becoming an increasing threat, with about 450,000 cases in 2021.
DR/MDR TB treatment is arduous, expensive, and not always successful, and hence a vaccine that prevents TB disease would have a major impact on the DR/MDR TB problem.
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