By Sunday Isuwa
The groundbreaking progress in the development of a new tuberculosis (TB) vaccine, M72/AS01E (M72), as Wellcome and the Bill & Melinda Gates Foundation provide substantial funding for a Phase III clinical trial.
We explore the potential impact of the vaccine on combating the global TB crisis, emphasizing the urgent need for new tools to save lives and reduce the burden of this devastating disease.
Tuberculosis (TB) remains one of the most lethal diseases globally, claiming the lives of approximately 4,300 individuals daily, predominantly those in impoverished conditions. In a significant stride towards combating this deadly infectious disease, Wellcome and the Bill & Melinda Gates Foundation have announced substantial funding to propel the progress of a promising TB vaccine candidate called M72/AS01E (M72) through a Phase III clinical trial. If successful, M72 has the potential to become the first new vaccine in over a century that can effectively prevent pulmonary TB, a severe form of active TB. This article delves into the groundbreaking advancements in TB vaccine research, shedding light on the urgent need for innovative solutions to tackle this global health crisis.
The Global Impact of Tuberculosis
TB poses a grave threat to global public health, with an estimated 10.6 million people falling ill and 1.6 million succumbing to the disease in 2021 alone. This deadly infectious disease disproportionately affects individuals in low- and middle-income countries, particularly those enduring impoverished living and working conditions, malnutrition, and inadequate healthcare access. Alarmingly, nearly a quarter of the world’s population is estimated to have latent TB, a condition where individuals carry the TB bacterium without displaying symptoms but are at risk of developing active TB.
M72 Vaccine: A Beacon Of Hope
The introduction of the M72 vaccine represents a significant breakthrough in the fight against TB. To facilitate the Phase III clinical trial for M72, which requires an estimated US$550 million, Wellcome has pledged up to US$150 million in funding, with the remaining US$400 million covered by the Gates Foundation. By investing in this potential game-changing vaccine, these philanthropic organizations aim to mitigate the escalating threat of infectious diseases, protecting the most vulnerable populations. Eliminating TB as a public health menace necessitates global collaboration, financial support, and political will. Working alongside affected communities and researchers in high TB burden regions, we can move closer to achieving a TB-free future.
Challenges And Limitations Of Current TB Vaccine
The sole TB vaccine currently in use, bacille Calmette-Guérin (BCG), has been administered since 1921. While BCG provides protection against severe systemic forms of TB in infants and young children, its efficacy against pulmonary TB in adolescents and adults is limited. With the rise in TB cases and deaths, there is an urgent need for innovative tools to combat this disease effectively.
The Urgency For New Tools
Bill Gates, co-chair of the Bill & Melinda Gates Foundation, stresses the pressing need for new tools in addressing the surging TB crisis. Investing in safe and effective TB vaccines, alongside innovative diagnostics and treatments, has the potential to revolutionize TB care, saving countless lives and significantly reducing the burden of this costly disease. Over a span of 25 years, a vaccine with just 50% efficacy could prevent up to 76 million new cases of TB, saving 8.5 million lives and obviating the need for 42 million antibiotic treatments. Moreover, it could avert approximately US$41.5 billion in TB-related catastrophic household costs, primarily benefiting the world’s most impoverished and vulnerable communities, as highlighted by the World Health Organization (WHO).
Unprecedented Progress Of The M72 Vaccine Candidate
The M72 vaccine candidate, among the 17 TB vaccines currently under development, has shown immense promise since its inception in the early 2000s. GSK, in collaboration with Aeras and the International AIDS Vaccine Initiative (IAVI), spearheaded the development of M72 up to the proof-of-concept phase (Phase IIb). Notably, the Gates Foundation played a crucial role in providing financial support for this groundbreaking research. During the Phase IIb trial, M72 exhibited an unprecedented 50% efficacy in reducing pulmonary TB among adults with latent TB infection, marking a significant breakthrough in decades of TB vaccine research.
The Envisioned Impact And Collaborative Efforts
Dr. Tedros Adhanom Ghebreyesus, the Director-General of WHO, highlights the importance of the Gates Foundation and Wellcome’s support in developing a new TB vaccine, underscoring the opportunity presented by the upcoming UN high-level meeting on TB. These collaborations and commitments demonstrate that concerted political and financial action can turn the tide on the TB crisis. Targeting adults and adolescents, who carry the majority of the TB burden, with an effective vaccine is essential to reduce disease transmission and prevent avoidable deaths. WHO warmly welcomes the dedication of the Bill & Melinda Gates Foundation and Wellcome in advancing the development of this vaccine candidate, while continuing to support broader vaccine development and access through the TB Vaccine Accelerator Council.
The Devastating Impact Of TB And The COVID-19 Pandemic
TB claims more lives annually than any other infectious disease, with the COVID-19 pandemic further exacerbating the crisis. The pandemic has impeded the progress made over the past two decades in expanding access to TB prevention, testing, and treatment. In 2021, TB cases increased by 4.5% compared to the previous year, while fewer individuals received diagnoses or received the necessary treatment. To achieve the United Nations Sustainable Development Goals’ target of an 80% reduction in the TB incidence rate by 2030, the development of new tools to combat this disease is imperative.
TB And Vulnerable Populations
TB poses a particularly grave threat to individuals living with HIV, accounting for one-third of deaths among HIV-positive individuals. Moreover, resource-limited areas and the world’s most vulnerable populations bear the brunt of this disease, with over 80% of TB cases and deaths occurring in low- and middle-income countries.
Investments In TB Research And Development
Over the past two decades, increased investment in research and development (R&D) has strengthened the TB innovation pipeline. Novel diagnostic tests, improved sample collection methods, and shorter drug regimens for both TB and drug-resistant TB are among the innovations in progress. However, to truly eliminate TB as a global health burden, the development and deployment of an effective vaccine for adolescents and adults are paramount.
Accelerating Progress Through Research and Funding
Further investments in effective diagnostics, vaccines, and shorter drug regimens are crucial to expedite progress in combating TB. According to the Global Plan to End TB 2023-2030, an annual investment of over US$26 billion from 2023 to 2030 is required to scale up TB care and prevention services for all individuals in need. Additionally, TB R&D necessitates an extra US$5 billion per year during this period. Achieving these targets requires substantial global support, both in terms of financial backing and political will, to drive innovation, manufacture, and distribute a robust pipeline of TB diagnostics, treatments, and vaccines. This collective effort will save and protect millions of lives from the grip of TB.
Wellcome’s Commitment To Global Health Challenges
Wellcome remains steadfast in its commitment to supporting scientific endeavors that aim to address urgent health challenges on a global scale. With a focus on life, health, and wellbeing, Wellcome actively supports discovery research and takes on three major worldwide health challenges: mental health, infectious diseases, and the intersection of climate and health. By investing in cutting-edge research and fostering collaborations, Wellcome aims to find innovative solutions and drive progress in these critical areas.
The announcement of funding from Wellcome and the Bill & Melinda Gates Foundation to advance the M72/AS01E (M72) TB vaccine candidate marks a significant milestone in the fight against tuberculosis. With the potential to become the first new vaccine to prevent pulmonary TB in over a century, M72 offers hope for a TB-free future. The staggering global burden of TB, with millions of cases and deaths each year, underscores the urgent need for new tools, including effective vaccines, diagnostics, and treatments.
The Phase III clinical trial, sponsored by the Bill & Melinda Gates Medical Research Institute, will assess the efficacy of the M72 vaccine in preventing the progression from latent TB infection to active pulmonary TB. This trial, conducted in collaboration with TB clinical investigators across multiple sites in Africa and Southeast Asia, represents a vital step towards bringing this vaccine to those who need it most.
While progress has been made in TB research and development, sustained investment and global collaboration are crucial to overcome the challenges posed by this devastating disease. With continued support from organizations like the Gates Foundation and Wellcome, along with political commitment and financial resources, we can pave the way for a future free from the burden of TB. Together, we can achieve the ambitious goal of eliminating TB as a public health threat, saving countless lives and creating healthier communities worldwide.
