Are New Tuberculosis Vaccines Really Needed

Karen McClorey Hackett — Thu, 21 Mar 2024 16:36:00 +0000

Reviewer:

Due to the unexpected three-year increase in tuberculosis (TB) cases in the United States, there is a lot of attention focused on developing new preventive vaccines.

In the United States, the USAID Annual Tuberculosis Report to Congress, FY 2023, indicates about 8,300 individuals were diagnosed with TB in 2022, a 5% increase in the U.S. from the previous year, and global case notifications increased over the last year by 70%.

According to the World Health Organization (WHO), it is estimated that TB outbreaks caused 10.6 million people to contract TB in 2022, and 1.3 million died from the disease, many in India.

While 16 versions of the Bacille Calmette-Guérin (BCG) vaccine are currently in use, this century-old vaccine only provides around 50% protection against bacterial infection.

BCG vaccination does protect children against severe forms of TB, but it offers inadequate protection for adolescents and adults against the pulmonary form of the disease, which is primarily responsible for transmitting the TB bacterium, says the WHO.

Moreover, harmful TB bacteria can also impact the kidneys, spine, and brain.

Making effective TB vaccines accessible and affordable in areas of high disease burden is a long-term priority for the WHO.

To address this health need, the Bill & Melinda Gates Medical Research Institute (Gates MRI), a nonprofit organization and subsidiary of the Bill & Melinda Gates Foundation, is sponsoring a TB vaccine candidate study supported by the Gates Foundation and Wellcome funding.

The M72/AS01E vaccine candidate has been in development since the early 2000s.

In 2020, GSK plc partnered with the Gates MRI to further develop M72/AS01E.

If proven effective, the M72/AS01E vaccine candidate could be the first licensed TB vaccine in decades.

GSK continues to provide technical assistance to the Gates MRI, supplies the adjuvant component of the vaccine for the Phase 3 trial, and will provide the adjuvant post-licensure should the trial be successful.

The Gates MRI has worked with various stakeholders, including communities around clinical trial sites, to guide the TB candidate vaccine to Phase 3.

At total capacity, this clinical trial (NCT06062238), which started on March 5, 2024, may include up to 20,000 participants, including people living with HIV, at up to 60 trial sites in seven countries.

To this end, the Gates MRI, GSK, Wellcome, and the Gates Foundation are working together to understand the potential demand for the vaccine and build an end-to-end plan to ensure long-term sustainable access if the trial is successful.

“The launch of this pivotal Phase 3 trial demonstrates our commitment to harnessing the power of medical innovation to fight diseases like TB that are particularly devastating for low- and middle-income countries,” said Emilio A. Emini, Ph.D., CEO of the Gates MRI, in a press release on March 19, 2024.

“Clinical study of the vaccine will still require years, but our incredible partners in South Africa and elsewhere who have come together for the Phase 3 study share our hope in the vaccine’s potential.”

This study is anticipated to take up to five years (April 2028) to complete, which leads to regulatory approvals,

As such, worldwide collaboration and strong partnerships are a core component of planning for future access to the candidate vaccine, wrote Gates MRI.

“After dedicating over 20 years to developing this essential candidate vaccine, we at GSK are delighted that the Phase 3 trial is underway. Developing and ensuring access to global health products is complex. Still, our collaboration with the Gates MRI, Wellcome, and the Gates Foundation exemplifies the transformative power of leveraging diverse partners’ expertise to change the trajectory of challenging diseases, like TB, which place a huge burden on communities around the world,” commented Deborah Waterhouse, CEO, ViiV Healthcare and President, Global Health, GSK.

The WHO estimated that over 25 years, at 50% protection, this new vaccine could save 8.5 million lives, prevent 76 million new TB cases, and save $41.5 billion for TB-affected households.

As of late March 2024, other TB vaccine candidates are conducting clinical research.

Sub Title:

M72/AS01E vaccine candidate has been in development since the early 2000

References:

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

Annual Tuberculosis Report to Congress, FY 2023

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Friday, March 22, 2024 - 06:00

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University of Montana 2024

$39 to $1 ROI Realized When Deploying Tuberculosis Screening and Prevention

Donald Hackett — Mon, 18 Mar 2024 18:00:09 +0000

Reviewer:

Robert Carlson, MD

As World Tuberculosis Day approaches on March 24, 2024, the World Health Organization (WHO) released an investment case for tuberculosis (TB) screening and preventive treatment.

This year's World Tuberculosis Day is commemorated under the theme 'Yes! We can end TB', conveying a message of hope.

In 2023, the WHO's Director-General announced plans to establish a new TB Vaccine Accelerator Council to encourage proactive strategies.

A new investment case published on March 15, 2024, aims to aid countries in advocating for and allocating additional resources to expand TB screening and preventive treatment to achieve targets set by Heads of State at the 2023 UN High-Level Meeting on TB.

The economic risk-benefit evaluation results indicate that even small investments can produce substantial health and financial advantages, yielding up to $39 for every dollar invested.

The modeling showed that should the status quo be maintained, between 2024 and 2050, over 10 million people will develop TB, and more than 1.3 million people will die from TB in the four countries studied.

This analysis shows that an additional investment of between $0.28 and $1.11 per capita per year could reduce the burden of TB.

"The next five years will be critical for ensuring that the political momentum we have now is translated into concrete actions towards reaching global TB targets," said Dr. Tereza Kasaeva, Director of WHO's Global Tuberculosis Programme, in a press release on March 18, 2024.

"WHO will continue to provide global leadership for the TB response, working with all stakeholders until we reach and save every person, family, and community impacted by this deadly disease."

The global targets approved at the 2023 UN High-Level Meeting on TB include, but are not limited to, the following:

reaching 90% of people in need of TB prevention and care services;
using a WHO-recommended rapid test as the first method of diagnosing TB;
providing a health and social benefits package to all people with TB;
ensuring the availability of at least one new TB vaccine that is safe and effective; and
closing funding gaps for TB implementation and research by 2027.

While the Bacille Calmette-Guerin (BCG) vaccine has shown effectiveness against TB over the past 100 years, no universal BCG vaccination policy exists.

However, newer TB vaccine candidates have produced significant results in clinical trials.

For example, the M72/AS01E (M72) subunit vaccine candidate showed approximately 50% efficacy in reducing pulmonary TB in adults with latent TB infection in the Phase IIb trial. In 2020, the Bill & Melinda Gates Foundation out-licensed M72/AS01E to the Gates Medical Research Institute to focus on phase 3 clinical studies.

The WHO estimated 10.6 million people fell sick with TB in 2022, and 1.3 million people died in 192 countries and areas.

As of November 15, 2023, the U.S. CDC reported that TB cases increased by 5% nationally, provisionally reporting 8,331 TB cases. About 13 million people in the U.S. are living with latent TB infection.

Sub Title:

World Tuberculosis Day 2024 includes positive investment case for expanding TB screening and preventive treatments

References:

Funding a tuberculosis-free future: an investment case for screening and preventive treatment

WHO urges investments for the scale up of tuberculosis screening and preventive treatment