Agent de santé s'apprêtant à vacciner un jeune homme avec un vaccin.Crédit : nicolamiodrag ignjatovics_/ E+/ Getty Images

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A Phase 3 trial is underway for what could be the first vaccine to help prevent pulmonary TB in adolescents and adults, the most common form of the disease, and the first new TB vaccine in more than a century.

Initiated across six provinces in South Africa, the trial of candidate M72/AS01E aims to combat the progression to active pulmonary TB in adults infected with the TB-causing bacteria.

Results from a Phase 2b clinical trial conducted in Kenya, South Africa, and Zambia, showed that administering two doses of M72/AS01E was successful in reducing the development of active TB disease with about 50% efficacy. This was regarded as a major milestone in the last few decades of TB vaccine research. Such a level of efficacy, if sustained over 25 years, could potentially avert 8.5 million deaths, prevent 76 million new TB cases, and alleviate a financial burden of $41.5 billion on households affected by TB, according to WHO estimations.

Kate O’Brien, director of the department of immunization, vaccines, and biologicals at WHO, said the Strategic Advisory Group of Experts on Immunization would be watching the trial carefully.

Since its development a century ago, the BCG vaccine remains the sole licensed TB vaccine, its efficacy remains limited, preventing only about 20% of infections in children and offering partial protection against disease development. TB kills more than 1.3 million lives annually, with South Africa alone recording 280,000 new TB cases each year.