By Jennifer Rigby
LONDON (Reuters) – Two major players in global health philanthropy are joining forces to fund the final stage of trials for what could be the first new vaccine against tuberculosis (TB) in more than 100 years.
Wellcome and the Bill & Melinda Gates Foundation will invest around $550 million in total for the Phase III trials of the M72 vaccine.
TB, a bacterial disease that mostly affects the lungs, is preventable and treatable, but 10 million people still catch it annually, and 1.6 million people died from TB in 2021, almost entirely in low and middle-income countries.
It has long been the world’s deadliest infectious disease, although it was briefly overtaken by COVID-19.
Earlier this year, Bill Gates lambasted the world for failing to fund new TB tools. His 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,” Trevor Mundel, president of global health at the Gates Foundation, told Reuters.
The trial is set to take 4-6 years, he said, among 26,000 people at more than 50 sites across Africa and Southeast Asia. The vaccine will be tested to see how well it prevents latent TB, which may infect up to a quarter of people worldwide, from becoming active TB and causing illness. The trial will include people with HIV.
The existing TB vaccine – Bacille Calmette-Guérin (BCG) – was first given in 1921. It helps to protect babies and young children against severe TB, but it wears off and only offers limited protection against the common form of the disease that invades the lungs of adolescents and adults.
M72 was first developed in the early 2000s by the Gates-backed non-profit Aeras and GSK, which continues to provide the adjuvant, or immune-boosting portion, of the vaccine. Now led by the Bill and Melinda Gates Medical Research Institute, the shot prevented TB from developing in around half of the people who received it in Phase II trials, data from 2018 shows.
That efficacy of around 50% is on the low side for vaccines, but could still make a big difference: over 25 years, it could save 8.5 million lives, the World Health Organization said.
(Reporting by Jennifer Rigby; Editing by Mark Potter)
