Rédaction Africa Links 24 with Mariam Ileyemi
Published on 2024-03-20 08:04:48
The Bill & Melinda Gates Medical Research Institute (Gates MRI) has initiated the third phase clinical trial for the M72/AS01E tuberculosis (TB) vaccine candidate. The vaccine is being tested in South Africa, where TB is prevalent, and if successful, it could be the first vaccine to prevent pulmonary TB in adolescents and adults.
This trial is significant because it could lead to the development of the first new TB vaccine in over a century, specifically targeting the most common and contagious form of the disease, pulmonary TB. The Gates MRI estimates that the trial will take up to five years to complete, followed by data analysis and submission to regulatory authorities.
According to the World Health Organization, 10.6 million people worldwide were diagnosed with TB in 2022, resulting in 1.3 million deaths. In South Africa alone, approximately 280,000 people are diagnosed with TB annually. The current TB vaccine, Bacilli Calmette-Guerin (BCG), which dates back to 1921, only provides protection to babies and young children against severe forms of TB, leaving adolescents and adults vulnerable to pulmonary TB.
Nigeria has the highest TB burden in Africa and ranks sixth globally, with BCG being the only available vaccine against TB in the country. The M72/AS01E vaccine trial will involve up to 20,000 participants across seven countries, including people living with HIV. The participants will receive either the vaccine or a placebo in a double-blind trial to assess safety and efficacy.
The Gates MRI, which is a subsidiary of the Bill & Melinda Gates Foundation, is sponsoring the trial with support from the Gates Foundation and Wellcome. The M72/AS01E vaccine candidate has been in development since the early 2000s, with promising results from previous trials showing approximately 50% protection against pulmonary TB in Mycobacterium tuberculosis-infected HIV-negative adults.
If successful, the M72/AS01E vaccine could save 8.5 million lives and prevent 76 million new TB cases over 25 years, according to WHO estimates. The CEO of Gates MRI, Emilio Emini, highlighted the importance of medical innovation in combating diseases like TB, especially in low- and middle-income countries. Alemnew Dagnew, leading the development of the vaccine, emphasized the impact of TB on individuals and families, noting the socioeconomic challenges associated with the disease.
The launch of this Phase 3 trial represents a significant step in the fight against TB, particularly amidst the challenges posed by the COVID-19 pandemic. The success of the M72/AS01E vaccine could revitalize global efforts to combat TB and reduce the social and economic burden caused by the disease. It is a crucial development in the field of TB research and could potentially transform the landscape of TB prevention and treatment.
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