UNITED KINGDOM — A breakthrough in the fight against tuberculosis (TB) may be on the horizon as philanthropic institutions pledge over US$500 million (£395 million) for the final trials of a promising vaccine.

The M72/AS01E vaccine, developed by pharmaceutical company GlaxoSmithKline (GSK), demonstrated 50% effectiveness in phase 2b trials in 2018.

However, GSK decided against investing in large-scale trials required for licensure, citing a lack of market potential.

In 2020, GSK transferred the license to the Bill & Melinda Gates Medical Research Institute, a biotech nonprofit linked to the Bill & Melinda Gates Foundation.

The Bill & Melinda Gates Foundation, already invested in the vaccine’s development, will contribute approximately US$400 million towards the phase 3 trials.

Additionally, the Wellcome global charitable organization has committed up to US$150 million. The urgent need for an affordable and accessible TB vaccine, given the disease’s status as one of the world’s deadliest infectious diseases, underscores the significance of this funding.

Unlike the rapid development of COVID-19 vaccines, no new TB vaccines have been introduced since the Bacillus Calmette-Guérin (BCG) in 1921, despite TB causing 1.6 million deaths annually.

While the BCG vaccine is effective in young children for a limited duration, it is no longer considered reliable for broader age groups.

With up to a quarter of the global population infected with TB bacteria, the disease disproportionately affects impoverished communities in Africa and Asia, with pockets of serious issues in Eastern Europe and instances of multi-drug resistant TB worldwide.

Bill Gates, co-chair of the Gates Foundation, emphasized the urgent need for new tools to combat TB and called for increased investment in safe and effective TB vaccines, alongside improved diagnostics and treatments.

The licensing transfer and manufacturing transition from GSK to Gates, as well as site selection in TB-endemic regions, accounted for the five-year interval between the 2018 trial results and the recent funding announcement.

The phase 3 trial, slated to commence early next year and last between four and six years, will monitor the conversion of latent TB to active disease among participants.

If the vaccine performs as well as it did in the smaller trial five years ago, it could prevent half of the expected cases of active TB.

The World Health Organization estimates that a vaccine with 50% efficacy could prevent up to 76 million cases and 8.5 million deaths over 25 years, alleviating financial burdens on affected families.

The Treatment Action Group (TAG) hailed the substantial funding commitment as a historic development.

TAG’s executive director, Mark Harrington, urged all stakeholders to prioritize access to the vaccine should it receive approval.

Governments are urged to support such vital global health initiatives, as TB poses a significant threat beyond national boundaries, with migration and other factors facilitating transmission even in regions with low incidence rates.

The successful development of the M72 vaccine could pave the way for future TB vaccines, further transforming TB care and reducing the impact of this devastating disease.

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