A Bethesda foundation developing vaccines for tuberculosis plans to announce a deal today with a large drug company to move forward with human tests of a promising new injection it hopes will prove useful in poor countries.
If all goes well, the arrangement would allow the Aeras Global TB Vaccine Foundation to produce an effective tuberculosis vaccine within a decade. The partnership is also a test of whether public health experts can help solve some of the pervasive business problems that have plagued research on vaccines for poor countries.
Development of a tuberculosis vaccine has long been seen as a crucial step in combating health problems in those countries, where tuberculosis -- brought under control in most rich countries by the 1950s -- is still killing 1.8 million people every year. The lung ailment was recently declared a public health emergency in southern Africa, where AIDS and tuberculosis have fed on each other with particular ferocity.
Despite the urgency of the problem, no new tuberculosis vaccine has been developed since the 1920s, and the one created then, though used in many countries, is considered inadequate since it appears to provide limited immunity to the disease in childhood. The disease can be cured, but only with an arduous drug regimen that is out of reach in many poor countries.
With more than $100 million from the Bill & Melinda Gates Foundation, of Seattle, Aeras has set out to change the situation. Under an arrangement to be announced today, Aeras will spend as much as $13 million over the next two years to accelerate work on a tuberculosis vaccine by GlaxoSmithKline PLC, of London.
Scientists at GlaxoSmithKline's biologicals division in Rixensart, Belgium, have progressed further than any group in the world at developing a vaccine that may provide strong protection from tuberculosis. Executives at the company said they would be committed to the vaccine even without the Gates money but can afford to speed the work significantly under the new arrangement.
"There will be a huge need for a TB vaccine in the developing world," said Deborah Myers, a Glaxo executive who oversees deals such as the Aeras plan. "We are looking for partnerships in terms of helping us develop the vaccine, helping in advocacy, working on funding to purchase vaccine for countries."
If the Glaxo vaccine continues to show promise, "much larger sums" will eventually be required to conduct large-scale tests in as many as 20,000 people to prove the effectiveness of the vaccine, according to Jerald C. Sadoff, president and chief executive of Aeras. Even bigger sums would be needed to procure a newly licensed vaccine for the poorest countries.
"The importance of doing this work can't be overstated," said Helene Gayle, a senior officer at the Gates Foundation who oversees tuberculosis programs. "The fact that we're still using a vaccine developed in the early 1920s for a disease as serious as TB is a real shortcoming."
The Glaxo vaccine, created using modern genetic methods, has already gone through two small human tests, showing an ability to induce immune responses that may protect people from tuberculosis. But scientists must conduct far larger studies to determine exactly how well the vaccine works and how best to use it, so it is unlikely to reach the market before 2012 or 2013, Sadoff said. It might be used in combination with the old vaccine.
Though Aeras is a charitable foundation, Sadoff, a former vaccine executive at Merck & Co., has structured it much like a biotechnology company, with a portfolio of potential vaccines. The foundation is moving forward with three others, none as far along as the Glaxo product.
Gayle called tuberculosis "a forgotten disease" despite its toll. That wasn't always so. The suffering of people with "consumption" was a staple of Victorian literature, and the disease is a fact of life all over the world. But as drug treatment and sanitation brought it under control at mid-century, concern faded in the rich countries.
In recent years the National Institutes of Health in Bethesda have funded scientific work on the ailment. But few drug companies have been willing to follow up with the expensive development and testing needed to turn that basic research into products.
With few cases of tuberculosis in developed countries, a vaccine would be used almost entirely in poor countries, limiting how much companies could charge. Many companies have felt they could not recoup the hundreds of millions of dollars it might take to develop a vaccine.
Lately, public health advocates have been analyzing such business problems and looking for creative ways to solve them. They have been encouraged by a flood of money and ideas from the Gates Foundation, which is devoting most of its efforts to improving global heath. (Melinda Gates is a board member of The Washington Post Co.)
One idea, largely untested, is to create incentives for drug companies by guaranteeing that governments and other donors buy a fixed amount of a new, badly needed product if the companies develop it.
Another is to change the profit calculations of drug companies by subsidizing their research, as Aeras has decided to do. GlaxoSmithKline has established a track record recently of being willing to invest in products that might primarily benefit poor countries, but people at the company said they can move faster on projects that get foundation subsidies.
Glaxo is also pursuing vaccines for malaria and AIDS under arrangements similar to the one Aeras is planning to announce today.