HQ Team
June 30, 2023: Two philanthropic health majors, Wellcome and the Bill & Melinda Gates Foundation, have come together to invest around $550 million for Phase III trials for what could be the first new vaccine against tuberculosis (TB) in more than 100 years.
TB, a bacterial disease (caused by Mycobacterium tuberculosis), is the world’s deadliest infectious disease. It mostly affects the lungs and kills one person every 20 seconds and 10 million people catch it annually. The disease is both preventable and treatable.
M72, the new TB vaccine
Bill Gates’ organization will provide the bulk of the financing for the new trial: around $400 million. But the organization is also looking for commercial partners to deliver the vaccine at scale if the trial is successful.
“We need a vaccine manufacturer. That’s what we are in discussions around. We have a couple of partners that are interested,” said Trevor Mundel, president of global health at the Gates Foundation.
The phases 111 trial will involve 26,000 people over a period of 4-6 years, across Africa and Southeast Asia. The vaccine, M72, is a “sub-unit” vaccine and contains two proteins found on the bug’s surface. The vaccine was earlier acquired in 2005 by GSK, a big pharmaceutical firm, from Corixa, an American company. Early trials, showed that it was about 50% effective in preventing TB in the lungs of those with a latent infection—a group in which no other vaccine has worked. Butt he research was not taken further as it was found to be not commercially viable.
The existing TB vaccine – Bacille Calmette-Guérin (BCG) – was first introduced in 1921. It offers limited protection against the common form of the disease that invades the lungs of adolescents and adults.
That efficacy of around 50% is on the low side for vaccines, but over 25 years, it could save 8.5 million lives, according to the World Health Organization. It could also avert 42m courses of antibiotic treatment, which might slow the rate at which TB is evolving resistance to such drugs.
Marketing and distribution limbo
Beyond the trail phase the vaccine will need marketing and distribution partners. Despite their financial firepower, “there is no way Wellcome and the Gates Foundation can…become a vaccine company,” says Mr Mundel. Other vaccines, such as one for Lassa fever being developed by the non-profit group iavi, remain in commercial limbo for such reasons.
The two partners are hoping to find manufacturers in India, as firms here are more open to investing in developing medicines. The economics of production are also favourable due to low cost of production.
