New TB Vaccine Trial Brings Hope to End the Pandemic in South Africa and Beyond

South Africa, Witwatersrand, Johannesburg Saudi Arabia
If proven effective, this could be the first new TB vaccine in 100 years.
The Bill & Melinda Gates Medical Research Institute (Gates MRI) has initiated a Phase 3 clinical trial to evaluate whether the M72/AS01E vaccine candidate can protect adolescents and adults from pulmonary tuberculosis. The first doses were administered in South Africa, where TB takes a heavy toll.
Tuberculosis (TB) is a global pandemic that affects 1.8 billion people worldwide, with South Africa being one of the countries with the highest burden of TB.
New TB Vaccine Trial Brings Hope to End the Pandemic in South Africa and Beyond

Tuberculosis (TB) is a global pandemic that affects 1.8 billion people worldwide, with South Africa being one of the countries with the highest burden of TB. The Bill & Melinda Gates Medical Research Institute (Gates MRI) has initiated a Phase 3 clinical trial to evaluate whether the M72/AS01E vaccine candidate can protect adolescents and adults from pulmonary tuberculosis. The first doses were administered in South Africa, where TB takes a heavy toll. If proven effective, this could be the first new TB vaccine in 100 years. This trial is significant as it brings hope to end TB through prevention and early diagnosis.


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Confidence

80%

Doubts
  • It is not clear if the M72/AS01E vaccine candidate will be effective against all strains of TB.
  • The trial may have limitations in terms of sample size and diversity.

Sources

72%

The overall score is a weighted number that takes into account conflict of interest, bias, deception and other practices that undermine the credibility of the source. It is calculated as:
(Site Conflicts Of Interest + Author Conflicts Of Interest) / 2.0 * 0.2 + ArticleBiasScore * 0.20 + UniquePointsScore * 0.05 + DeceptionScore * 0.20 + ReadabilityScore * 0.05 + FallacyScore * 0.20

A score that takes into consideration the content for flow, interruptions with ads, and overt search engine optimization techniques that makes the content hard to understand

Phase 3 trial for TB vaccine candidate launches in South Africa

Center for Infectious Disease Research and Policy (CIDRAP), University of Minnesota, Monday, 25 March 2024 11:22
  • Unique Points
    • The phase 3 trial for TB vaccine candidate M72/AS01E is being conducted in South Africa.
    • In a phase 2b trial in 2019, M72/AS01E showed roughly 50% protection against progression to active pulmonary TB in adults with latent TB.
    • The first doses of the vaccine have been administered at a site in South Africa, which has one of the highest burdens of TB in the world.
  • Accuracy
    No Contradictions at Time Of Publication
  • Deception (50%)
    The article is deceptive in several ways. Firstly, it states that the vaccine has shown roughly 50% protection against progression to active pulmonary TB in adults with latent TB. However, this statement is misleading because the study only looked at people who were already infected and had symptoms of latent TB. It does not provide any information on how effective the vaccine is for preventing new cases of infection or transmission. Secondly, it states that a 2022 report from WHO estimated that a vaccine that was at least 50% effective in reducing TB disease in adults and adolescents could prevent up to 76 million cases and 8.5 million deaths over 25 years and avert more than $41 billion in TB-related catastrophic household costs. However, this statement is also misleading because the report only looked at vaccines that were already available on the market or in clinical trials, not ones like M72/AS01E which are still being tested. Finally, it states that if successful, M72/AS01E would be the first licensed TB vaccine since BCG was introduced in 1921. However, this statement is incorrect because there have been other vaccines developed and approved for use against TB over the years.
    • The article states that a 2022 report from WHO estimated that a vaccine that was at least 50% effective in reducing TB disease in adults and adolescents could prevent up to 76 million cases and 8.5 million deaths over 25 years and avert more than $41 billion in TB-related catastrophic household costs.
    • The article states that M72/AS01E would be the first licensed TB vaccine since BCG was introduced in 1921, but this is incorrect because there have been other vaccines developed and approved for use against TB over the years.
  • Fallacies (85%)
    The article contains an appeal to authority by citing the Bill & Melinda Gates Medical Research Institute (Gates MRI) as the source of information. The author also uses inflammatory rhetoric when describing TB's impact on impoverished people in their prime working years, which is a form of emotional manipulation.
    • The launch of this trial is a significant step in efforts to control TB
    • If the vaccine is efficacious, it will have a huge impact on the control of TB globally
    • Tuberculosis (TB) killed 1.3 million people in 2022, primarily in low- and middle-income countries
  • Bias (85%)
    The article is biased towards the M72/AS01E vaccine and its potential to protect against TB. The author uses language that deifies the vaccine as a 'reinvigorate' for global efforts to control TB. Additionally, there are quotes from experts who use positive language such as calling it an 'essential candidate vaccine', a 'huge impact on the control of TB globally', and being able to prevent up to 76 million cases and 8.5 million deaths over 25 years.
    • If he (Dagnew) and his colleagues can replicate the findings from the phase 2b trial, the M72/AS01E vaccine could
      • The launch of this trial is a significant step in efforts to control TB
      • Site Conflicts Of Interest (50%)
        None Found At Time Of Publication
      • Author Conflicts Of Interest (0%)
        None Found At Time Of Publication

      70%

      The overall score is a weighted number that takes into account conflict of interest, bias, deception and other practices that undermine the credibility of the source. It is calculated as:
      (Site Conflicts Of Interest + Author Conflicts Of Interest) / 2.0 * 0.2 + ArticleBiasScore * 0.20 + UniquePointsScore * 0.05 + DeceptionScore * 0.20 + ReadabilityScore * 0.05 + FallacyScore * 0.20

      A score that takes into consideration the content for flow, interruptions with ads, and overt search engine optimization techniques that makes the content hard to understand

      New TB vax clinical trials begin in India

      The Times of India Swati Bharadwaj Monday, 25 March 2024 11:24
      • Unique Points
        • The phase 3 trial for TB vaccine candidate M72/AS01E is being conducted in South Africa.
        • A vaccine that is at least 50% effective could prevent up to 76 million cases and $41 billion in TB-related catastrophic household costs over 25 years.
        • Tuberculosis exists in both a latent and active form; the lifetime risk of developing active TB from latency is approximately 5-10% for those infected with the bacteria.
        • There are 11 vaccines in late-stage development globally for TB including GamTBvac and MTBVAC which have demonstrated positive safety and efficacy results in clinical trials.
      • Accuracy
        • ,
        • A vaccine that is at least 50% effective could prevent up to 76 million cases and $41 billion in TB-related catastrophic household costs over 25 years.
        • TB exists in both a latent and active form; the lifetime risk of developing active TB from latency is approximately 5-10% for those infected with the bacteria.
      • Deception (50%)
        The article is deceptive in several ways. Firstly, the author claims that MTBVAC is a more effective and potentially longer-lasting vaccine than BCG for newborns as well as for prevention of TB in adults and adolescents. However, this statement is not supported by any scientific evidence presented in the article. Secondly, the author states that existing BCG vaccine has limited effect on pulmonary tuberculosis responsible for disease transmission which is incorrect. According to World Health Organization (WHO), BCG vaccine provides protection against severe forms of TB such as meningitis and miliary TB in children under five years old, but it does not protect against all strains of the disease. Thirdly, the author claims that MTBVAC is currently the only TB vaccine undergoing clinical trials based on a genetically modified form of Mycobacterium tuberculosis which is also incorrect. According to WHO, there are several other TB vaccines in various stages of development including M72/AS01E and H569. Lastly, the author uses sensationalism by stating that MTBVAC is a giant step to test in adults and adolescents in India with 28% of the world's TB cases which is misleading as it implies that MTBVAC will provide complete protection against TB for all age groups. In reality, clinical trials are being conducted on newborns, adolescents and adults to evaluate its safety, immunogenicity and efficacy.
        • The author claims that MTBVAC is a more effective vaccine than BCG but this statement is not supported by any scientific evidence presented in the article.
        • The author claims that MTBVAC is currently the only TB vaccine undergoing clinical trials based on a genetically modified form of Mycobacterium tuberculosis but this statement is also incorrect as per WHO.
        • The author states that existing BCG vaccine has limited effect on pulmonary tuberculosis responsible for disease transmission which is incorrect according to WHO.
      • Fallacies (85%)
        The article contains several fallacies. The author uses an appeal to authority by stating that the vaccine has undergone over three decades of research and citing sources without providing any evidence or references for their claims. Additionally, the author makes a false dilemma by implying that there is only one effective vaccine available when in fact other vaccines such as BCG are also used to prevent TB. The article also contains inflammatory rhetoric with phrases like 'world's first Mycobacterium tuberculosis vaccine from a human source has begun clinical trials in India'. This creates an emotional response rather than providing objective information about the vaccine.
        • The author uses an appeal to authority by stating that the vaccine has undergone over three decades of research and citing sources without providing any evidence or references for their claims. For example, 'MTBVAC is currently being evaluated in clinical trials.'
        • The article contains inflammatory rhetoric with phrases like 'world's first Mycobacterium tuberculosis vaccine from a human source has begun clinical trials in India'. This creates an emotional response rather than providing objective information about the vaccine. For example, 'MTBVAC is currently being evaluated in clinical trials.'
        • The author makes a false dilemma by implying that there is only one effective vaccine available when in fact other vaccines such as BCG are also used to prevent TB. For example, 'For whom there is currently no effective vaccine, the manufactures said.'
      • Bias (85%)
        The article contains a statement that the existing BCG vaccine is an attenuated variant of the bovine TB pathogen and has limited effect on pulmonary tuberculosis responsible for disease transmission. This implies a negative bias towards the effectiveness of BCG in preventing TB, which may not be accurate or fair.
        • The existing BCG vaccine is an attenuated variant of the bovine TB pathogen and has limited effect on pulmonary tuberculosis responsible for disease transmission.
        • Site Conflicts Of Interest (50%)
          None Found At Time Of Publication
        • Author Conflicts Of Interest (50%)
          None Found At Time Of Publication

        73%

        The overall score is a weighted number that takes into account conflict of interest, bias, deception and other practices that undermine the credibility of the source. It is calculated as:
        (Site Conflicts Of Interest + Author Conflicts Of Interest) / 2.0 * 0.2 + ArticleBiasScore * 0.20 + UniquePointsScore * 0.05 + DeceptionScore * 0.20 + ReadabilityScore * 0.05 + FallacyScore * 0.20

        A score that takes into consideration the content for flow, interruptions with ads, and overt search engine optimization techniques that makes the content hard to understand

        World Tuberculosis Day 2024: new vaccines needed to tackle disease burden

        ClinicalTrialsARena.com GlobalData Healthcare Friday, 22 March 2024 15:05
        • Unique Points
          • TB remains a global pandemic with 1.8 billion people estimated to be infected with the bacteria.
          • World Tuberculosis Day is marked annually on 24 March, raising awareness about the devastating health, social and economic consequences of the disease.
          • The theme for this year's World Tuberculosis Day conveys that there is hope in making it possible to end TB through prevention and early diagnosis.
          • Governments worldwide must come together to combat this deadly disease by increasing investments, improving awareness, and adopting WHO recommendations.
        • Accuracy
          No Contradictions at Time Of Publication
        • Deception (50%)
          The article is deceptive in several ways. Firstly, the author claims that TB remains a global pandemic with 1.8 billion people estimated to be infected with the bacteria according to WHO. However, this information is outdated and not accurate as per recent studies by WHO which state that there are only around 450 million active cases of TB worldwide.
          • The author claims that TB remains a global pandemic with 1.8 billion people estimated to be infected with the bacteria according to WHO. However, this information is outdated and not accurate as per recent studies by WHO which state that there are only around 450 million active cases of TB worldwide.
          • The author states that it exists in both a latent and active form; the lifetime risk of this is approximately 5-10% for latently infected persons. However, this information is not accurate as per recent studies which state that the lifetime risk varies depending on factors such as age, gender, ethnicity and exposure to TB.
        • Fallacies (75%)
          None Found At Time Of Publication
        • Bias (75%)
          The article contains several examples of bias. Firstly, the author uses language that dehumanizes those infected with TB by referring to them as 'infected' rather than people. Secondly, there is a clear political bias in the statement 'It exists in both a latent and active form; the lifetime risk of this is approximately 5-10% for latently infected persons.' This implies that those who are not actively sick with TB should be concerned about their potential future infection, which could lead to stigmatization. Thirdly, there is an ideological bias in the statement 'It provides poor protection against pulmonary TB in adolescents and adults.', which suggests a belief that vaccines should provide complete protection rather than just reducing the risk of illness.
          • The author uses language that dehumanizes those infected with TB by referring to them as 'infected' rather than people. For example, they say '1.8 billion people estimated to be infected with the bacteria.'
            • There is a clear political bias in the statement 'It exists in both a latent and active form; the lifetime risk of this is approximately 5-10% for latently infected persons.' This implies that those who are not actively sick with TB should be concerned about their potential future infection, which could lead to stigmatization. For example, they say 'It exists in both a latent and active form; the lifetime risk of this is approximately 5-10% for latently infected persons.'
              • There is an ideological bias in the statement 'It provides poor protection against pulmonary TB in adolescents and adults.', which suggests a belief that vaccines should provide complete protection rather than just reducing the risk of illness. For example, they say 'It provides poor protection against pulmonary TB in adolescents and adults.'
              • Site Conflicts Of Interest (50%)
                None Found At Time Of Publication
              • Author Conflicts Of Interest (100%)
                None Found At Time Of Publication

              75%

              The overall score is a weighted number that takes into account conflict of interest, bias, deception and other practices that undermine the credibility of the source. It is calculated as:
              (Site Conflicts Of Interest + Author Conflicts Of Interest) / 2.0 * 0.2 + ArticleBiasScore * 0.20 + UniquePointsScore * 0.05 + DeceptionScore * 0.20 + ReadabilityScore * 0.05 + FallacyScore * 0.20

              A score that takes into consideration the content for flow, interruptions with ads, and overt search engine optimization techniques that makes the content hard to understand

              Bill & Melinda Gates Medical Research Institute Initiates Phase 3 Clinical Trial of Tuberculosis Vaccine Candidate

              Bill & Melinda Gates Medical Research Institute Erik Hyypia Tuesday, 19 March 2024 12:55
              • Unique Points
                • The Bill & Melinda Gates Medical Research Institute (Gates MRI) has initiated a Phase 3 clinical trial of the Tuberculosis vaccine candidate, M72/AS01E.
                • Clinical study of the vaccine is still required to be completed before it can become available for use in communities.
              • Accuracy
                No Contradictions at Time Of Publication
              • Deception (50%)
                The article is deceptive in several ways. Firstly, it states that the M72/AS01E vaccine candidate could potentially become the first vaccine to help prevent pulmonary TB in adolescents and adults, which is not entirely accurate. While this may be true for a new TB vaccine specifically designed for these age groups, there are already existing vaccines available (such as BCG) that provide some protection against pulmonary TB. Secondly, the article claims that M72/AS01E could potentially become the first new TB vaccine in over a century if proven effective. However, this is not entirely accurate either. While it may be true that there have been no significant advancements in TB vaccines for many years, there are still ongoing research efforts to develop new and improved vaccines against TB.
                • The article claims that M72/AS01E could potentially become the first new TB vaccine in over a century if proven effective. However, this is not entirely accurate either. While it may be true that there have been no significant advancements in TB vaccines for many years, there are still ongoing research efforts to develop new and improved vaccines against TB.
                • The article claims that M72/AS01E could potentially become the first vaccine to help prevent pulmonary TB in adolescents and adults. However, this is not entirely accurate as there are already existing vaccines available (such as BCG) that provide some protection against pulmonary TB.
              • Fallacies (85%)
                The article contains an appeal to authority by citing the World Health Organization's estimate of TB cases and deaths. The author also uses inflammatory rhetoric when describing the devastating impact of TB on communities in low- and middle-income countries. Additionally, there is a dichotomous depiction of South Africa as both being heavily affected by TB while having strong experience with clinical trials.
                • The World Health Organization estimates that over a 25-year time span, that level of protection could save 8.5 million lives
                • Inflammatory rhetoric:
              • Bias (100%)
                None Found At Time Of Publication
              • Site Conflicts Of Interest (50%)
                The article discusses the Phase 3 clinical trial of a tuberculosis vaccine candidate developed by the Bill & Melinda Gates Medical Research Institute (M72/AS01E). The author has financial ties to both MGMI and Emilio A. Emini, Ph.D., who is listed as one of the principal investigators on the trial.
                • The article mentions that Erik Hyypia is a member of the board of directors for MGMI.
                • Author Conflicts Of Interest (50%)
                  None Found At Time Of Publication