M72/AS01E Tuberculosis Vaccine Candidate: A New Hope After 100 Years

Inavimed News – For the first time in over a century, the world may soon have a new vaccine to prevent tuberculosis (TB), one of the deadliest infectious diseases globally. The M72/AS01E vaccine candidate has shown promising results in earlier trials and is now advancing into large-scale phase 3 clinical testing. This breakthrough brings renewed optimism, particularly for high-burden countries like Indonesia, which is playing a key role in the global study.

What is M72/AS01E?

M72/AS01E is a subunit vaccine candidate designed to prevent the progression of latent TB infection to active TB disease. Originally developed by GlaxoSmithKline (GSK), the vaccine’s development is now spearheaded by the Gates Medical Research Institute (Gates MRI) in collaboration with the Wellcome Trust.The vaccine combines two antigens (Mtb32A and Mtb39A) from Mycobacterium tuberculosis with AS01E, a proven adjuvant system also used in vaccines for malaria and shingles.

Promising Results from Phase 2b

In a landmark phase 2b clinical trial published in The New England Journal of Medicine in 2019, M72/AS01E demonstrated 49.7% efficacy in preventing the development of active TB among adults with latent TB infection. The trial included more than 3,500 participants across South Africa, Zambia, and Kenya, with the vaccine showing a good safety profile and mild-to-moderate side effects.

Government Response and Commitment

The Indonesian Ministry of Health has shown strong support for the vaccine trial, recognizing its strategic value in accelerating TB elimination. During national TB meetings and media briefings, government officials—including the Directorate General of Disease Prevention and Control (P2P)—have emphasized Indonesia’s commitment to contributing to global TB innovation while also ensuring equitable future access for its population. Indonesia has also integrated the trial within its National TB Elimination Roadmap, targeting a TB-free Indonesia by 2030, and is advocating for inclusion of the M72 vaccine in Gavi’s pipeline of supported vaccines, pending successful results.

Why M72/AS01E Matters

TB remains a major public health crisis, causing 1.3 million deaths and over 10 million new cases annually, according to the WHO Global TB Report 2023. The existing BCG vaccine, introduced in 1921, provides only limited protection—mainly for young children—and is ineffective in preventing adult pulmonary TB. If successful, M72/AS01E would be the first new TB vaccine approved for adults and adolescents in over 100 years, offering a powerful tool to stop transmission, reduce deaths, and end the TB epidemic.

The M72/AS01E vaccine candidate is a major step forward in global health and infectious disease prevention. With Indonesia actively contributing to the pivotal phase 3 trial, the country is not only a research site, but a key global health player in the fight against TB.