New Vaccine Strategy to Advance Solutions for Tuberculosis

Against a backdrop of growing concern about the impact of tuberculosis on children, top scientific experts of the TB vaccine community have come up with a global plan of action for developing safe and effective TB vaccines that are critical to eliminating the disease. A strategic blueprint titled ‘Tuberculosis Vaccines: A Strategic Blueprint for the Next Decade’ was published today (20th March, 2012) in a special issue of the journal, Tuberculosis. It emphasizes that effective vaccines will remain out of reach unless the world scales up efforts to solve the scientific puzzles now hindering their development. Authors have called for researchers, scientists, clinicians, advocates in endemic communities, vaccine manufacturers, and governments around the world to work together on creative new approaches from initial research in the laboratory to clinical trials in the field to global introduction.

Tuberculosis kills 1.4 million people every year, and one out of every three people globally is thought to be infected by the airborne TB organism, although only a portion will go on to develop the disease.

An estimated one million children below 14 years of age will need treatment for tuberculosis this year, which is about 15% of the total cases estimated by the WHO Global TB Control Report 2011.

Also, more than 10 million children have been orphaned by the disease. As of now, worldwide there are well over half a million cases of multidrug resistant TB, which is a great global threat and adds urgency to the Blueprint’s call to action. Besides, the disease causes significant financial and economic damage, with the WHO estimating the global economic burden of TB at nearly $12 billion a year, with India and China together accounting for more than half the global economic toll. London is said to have the highest TB rate of any capital city in Western Europe, and an estimated 18 percent of the global burden of drug resistant TB is in the European region. In the United States, just one case of extremely drug-resistant TB is estimated to cost a quarter-million dollars to treat.

To address these challenges posed by TB, it is of paramount importance to develop more effective and safe vaccines.  Ideal vaccine regimens must protect babies at birth from childhood TB, and prevent infection with the organism in older children and adults. The only currently existing  BCG vaccine  protects children from severe forms of TB in the first years of life, but it does not prevent pulmonary TB, which affects the largest group of people infected with the disease—adolescents and adults. A vaccine also is needed to protect people with latent TB who have not yet developed signs of disease.

But effective solutions will remain out of reach unless the world scales up efforts to solve the scientific puzzles now hindering development of vaccines against the airborne pathogen. It is a task that no one country or organisation can do alone. Dr. Lucica Ditiu, Executive Secretary of the Stop TB Partnership, rightly says that, “To develop a new TB vaccine that will be fully effective, researchers, donors and other partners will need to collaborate and coordinate their efforts as they address tough research questions. We cannot allow ourselves to be overwhelmed by either the costs or the obstacles. It is time to be bold and dare to do more in TB, especially in supporting the development of a new vaccine."

True to the spirit of this ambitious plan, the Bill & Melinda Gates Foundation has recently given a grant of up to US $220 million over five years to Aeras, which is one of the world’s largest not-for –profit product development organization dedicated to the development of effective TB vaccines and biologics to prevent TB across all age groups. Globally, the TB vaccine field estimates it will need in excess of US$1 billion over the next five years to support worldwide efforts against a disease so complex it is expected to require more than one vaccine to address geographic variations in the strains, different stages of disease, and a variety of target populations. Aeras estimates that US $400-500 million will be needed over the next five years if the organization is to accomplish critical TB vaccine development goals set jointly with global research and development partners. 

This grant provides approximately half of the estimated cost of meeting 2012-2016 milestone targets, and  will help advance several vaccine candidates into pivotal large-scale efficacy trials, build a robust and diverse pipeline of innovative, next-generation candidates, and develop and utilize key scientific approaches including challenge models, systems biology, and innovative vaccine designs to strengthen and accelerate TB vaccine development. TB vaccine research over the past decade has made great advances, with the number of TB vaccines in clinical trials growing from a measly zero to a hopeful more than dozen, between 2000 and 2010. Six of these have been developed by Aeras or with support from Aeras and its partners, and two of them are currently the most clinically-advanced TB vaccine candidates in the world.

“We began 10 years ago with an empty clinical pipeline, and we have made astounding progress,” said Dr. Michael J. Brennan, senior advisor for scientific and global affairs at Aeras, and co-editor of the Blueprint. “But we have to persevere. Given the trends we are seeing globally, failure to develop effective new vaccines for this disease puts everyone at risk.”

Still there is much work to be done and now, more than ever, there is a need for intensified global collaboration, leadership, partnership and commitment. According to Dr. Jelle Thole, Director of the TuBerculosis Vaccine Initiative (TBVI) and co-editor of the Blueprint, “The new Blueprint represents the best thinking of the field,” said “It makes clear that the next 10 years will be vital in moving forward the global search for a dramatically improved vaccine against tuberculosis.”

Jim Connolly, President and Chief Executive Officer of Aeras said, “This infusion of funding must be seen as a global call to action in response to one of the world’s deadliest diseases. It will allow Aeras to expand upon existing partnerships around the world, and to build new partnerships that will accelerate the development of safe and effective vaccines. Aeras is now at the centre of the most promising research with the potential to deliver a vaccine by the end of this decade.  But the scientific challenges are immense, and no single organization—including Aeras—can do this alone. Without support for this search for new vaccines from every quarter, we will never eliminate TB as a global health threat. We are in this together, and to succeed we will need to work with everyone—more investors, researchers, manufacturers, regulatory agencies, and national leaders.”

In the words of Dr. Aaron Motsoaledi, the Minister of Health of South Africa, “The TB Vaccine Blueprint provides an enormous opportunity to coordinate efforts to halt the spread of this devastating disease. Governments have an important role to play, and guided by this common strategy we will do our part to make a vaccine a reality.”