A Shot at Success: A Vax-Zine on New Tuberculosis Vaccines

TAGTBDAY2026

LOT/MFG

A Shot at Success

A Vax-Zine on New Tuberculosis Vaccines

For reading use to understand TB vaccines including new candidates. For use by everyone.

After reading, share with people in your life and get excited about the promise of new TB vaccines in the pipeline.

Tuberculosis Vaccines Can Save Lives TB is preventable, diagnosable, treatable, and curable.

Yet every year more than 1.3 million people die from TB globally due to challenges in accessing medicines and diagnostics.

Luckily, new TB vaccines are in development with the potential to overcome some of those barriers and save upwards of 8.5 million lives and prevent 76 million new TB cases over 25 years.

EXISTING TB PREVENTION TOOLS TB Prevention Treatment regimens exist, but they require one to three months of pills. Access gaps and adherence concerns mean that preventive treatment, while effective, is not enough to eliminate TB. New, safe, effective, and widely available vaccines are required if we hope to end of TB.

Immunity is a shared space—a garden we tend together.

— Eula Biss

THE TB VACCINE OF YESTERYEAR Over 100 years ago, scientists developed the Bacille Calmette-Guérin (BCG) vaccine, currently the only TB vaccine approved for use and given to infants.

SUCCESSES BCG given in infancy has proven to be highly effective at preventing severe forms of TB for infants & young children.

It is estimated that BCG has saved an estimated 10.9 million lives between 1974 and 2024 alone.

LIMITATIONS Despite its importance, the BCG vaccine doesn’t work for the majority of folks at risk of TB: adolescents, adults, or people already infected.

The Need for New Vaccines A TB-free world requires preventive vaccines for adults and adolescents. This is because TB in these older age groups is responsible for most disease transmission.

New TB vaccines won’t replace existing tools like BCG or preventive treatment, but when used together will give governments a powerful set of tools for protecting people, families, and communities against TB. This is not only an investment in health. By protecting those most affected, new TB vaccines will allow people to pursue their dreams and thrive.

For the first time since BCG entered use, new TB vaccines are coming down the pipeline, with several candidates in advanced development. The first new TB vaccine could be approved as early as 2028. This begs the question....

WHAT ARE WE LOOKING FOR FROM NEW VACCINES? Protection against TB disease.

The broadest possible coverage for groups at risk.

Examples: Adults and adolescents, including those who are living with HIV, pregnant, immunocompromised, diabetic, and already infected with TB (but not yet sick from the disease).

Safe and effective (efficacy of 50% or greater).

Affordable, acceptable and accessible to communities impacted by TB. We may need multiple new vaccines to Fulfill all of these desired qualities and expand vaccination Coverage and choice for communities around the world.

NEW OPTIONS ON THE HORIZON Over 15 new vaccines are currently being tested, with several currently in Phase 3 clinical trials *This means they’re in the final stage of testing before they can be considered for market.

M72/AS0E1 works like this!

Many of these candidate vaccines make use of existing technologies in already approved and licensed vaccines — like adjuvants, mRNA, and viral vectored platforms.

Two phase III vaccine candidates — M72/AS0E1 and MTBVAC — are particularly exciting.

MEET (SOME) CANDIDATES M72/AS01E protein and adjuvant subunit vaccine Protein subunit vaccines use specific proteins from the disease-causing pathogen (here, M. tuberculosis) to trigger protective immunity against it in the body. The proteins function like a WANTED poster for TB so the body can quickly mobilize after infection.

The proteins in these vaccines are paired with adjuvants: something that helps the body develop an immune response to the proteins in the vaccine.

M. tuberculosis

First Protein/Adjuvant Vaccine Introduced: Anthrax (1970)

M72/AS01E is currently completing a Phase III Subunit Vaccines are currently trial where the vaccine is administered in two used for Hepatitis B, Shingles, COVID19 (Novavax), and HPV doses, one month apart.

Participants: 20,000 aged 15 – 44 years old Study Sites in: Indonesia, Kenya, Malawi, South Africa, and Zambia Developers: Gates Medical Research Institute, GSK Results are expected around 2028!

In an earlier clinical trial, M72 showed ~50% efficacy* in preventing pulmonary TB disease in adults with TB infection over a three-year period.

A key ingredient in the AS01E adjuvant used in the M72 vaccine can only be harvested from Quillaja saponaria, a tree native to Chile. Ensuring access to M72 will require investing in sustainable adjuvant supply. *efficacy = how vaccine performs in the ideal conditions of a clincal trial

MEET (SOME) CANDIDATES MTBVAC mycobacterial live-attenuated vaccine to prevent Disease Live attenuated vaccines use a weakened version of the disease-causing pathogen to trigger protective immunity against it without causing disease. The body learns how to fight the weaker version of the pathogen without risking illness.

MTBVAC is currently in a Phase IIb trial where the vaccine is administered in a single dose.

Participants: 5,500 aged 14 – 45 years old Study Sites in: Kenya, South Africa, and Tanzania Developers: Biofabri, Bharat Biotech, IAVI First LiveAttenuated Vaccine introduced in 1798 - Smallpox

MTBVAC is also being studied in a Phase III trial in infants to see if it can replace BCG by improving on BCG safety and efficacy.

Live-attenuated vaccines like MTBVAC are not always suitable for those with weakened or compromised immune systems, so it will be important to carefully study of the safety of MTBVAC in people living with HIV and other immunocompromised groups.

Liv e com -atte n Me mon uate ly d a Ch sles/ used vacc ick i enp Mum for t nes a Po p h li re o s vac o (OP x; & /Rub e cin V ell a( es ) MM R);

FUNDING VACCINES $8 billion the amount needed between 2030 and 2040 to procure the total number of TB vaccines for all countries, according to estimates by the TB Vaccine Accelerator Council. Middle-income countries account for the largest share of procurement funding due to their high TB burdens.

However, there is not yet any money that has been set aside by governments or other donors for procurement.

While 2030 may seem far off, early advocacy campaigns are needed to make sure that governments think ahead and plan for procuring (i.e., buying) enough vaccines for the all communities that will benefit from them.

Maximal Impact = Early Planning + Financing2

Financing2 = domestic spending by governments and catalytic spending by donors

$1.25 billion the amount countries have committed to spend annually for TB vaccine research.

But governments have failed to meet this goal (or even come close!) year after year.

Beyond buying new vaccines when they become available, there is an ongoing need for money for TB vaccine research and development (R&D).

Even once we have a new vaccine, we will need to continue to invest in TB vaccine R&D to close gaps in vaccine science for existing vaccines (e.g., how long do they offer protection?) and develop additional vaccines with complementary characteristics.

Are VACCINES ENOUGH to End TB? The creation of new vaccines is a critical step toward ending the TB epidemic. But new vaccines won’t be enough to End TB alone. For new TB vaccines to reach their full potential, they must be accessible, affordable, and acceptable to those who stand to benefit from them.

Vaccines will be more powerful if matched with other innovations including shorter and better TB treatments, faster and more accurate TB diagnostics, and supportive health system infrastructure.

YES WE CAN, END TB! The following actions must be taken to ensure the success of new vaccines: 1.Expand and strengthen immunization infrastructure: a.Skill building for healthcare workers in support of immunization b.Procurement plans and policies that allow for rapid implementation of new TB vaccines c.Community-led buy in and demand campaigns for TB vaccines d.Infrastructures of trust between governments, health systems, and the people they serve.

2.Address vaccine misinformation and hesitancy by working alongside community partners.

3.Build out access to TB treatment, prevention, and diagnostic tools alongside vaccine implementation.

4.And most importantly, new vaccines MUST meet the needs and preferences of communities who stand to benefit the most.

Our bodies may belong to us, but we, ourselves, belong to a greater body composed of many bodies.

- Eula Biss

WANT TO LEARN MORE? What Could Go Right? Vital Partnerships with Communities and Civil Society for New Tuberculosis Vaccines, TAG taglink.info/WhatCouldGoRight 2024 TB Vaccines Pipeline Report, TAG taglink.info/TBVaxPipeline Catalyzing solutions for equitable global access and sustainable financing for novel tuberculosis vaccines for adults and adolescents, WHO taglink.info/CatalyzingSolutionsforNewTBVax Cheat Sheets for TB Activists - Vaccines in Development, TAG taglink.info/TBVaxDev

Treatment Action Group (TAG) is an independent, activist, and community-based research and policy think tank committed to ending HIV, tuberculosis (TB), and hepatitis C virus (HCV).

We catalyze open collective action by affected communities, scientists, and policymakers to ensure that all people living with or impacted by HIV, TB, or HCV receive life-saving prevention, diagnosis, treatment, care, and information.

Zine Developed by: Frankie Iannuzzi & Erin McConnell