Tuberculosis

Tuberculosis Cases in Children Increased 10%

Karen McClorey Hackett — Tue, 25 Mar 2025 08:49:24 +0000

Reviewer:

Over the past five years, healthcare resources have been concentrated on a novel disease. Meanwhile, the leading historical cause of respiratory disease has spread significantly worldwide, affecting millions of unvaccinated children, including those in the United States.

The 2025 “Tuberculosis Surveillance and Monitoring in Europe” report, released on March 24, 2025, by the European Centre for Disease Prevention and Control (ECDC) and WHO/Europe, shows that children under 15 years of age accounted for 4.3% of those with new and relapsed tuberculosis (TB) cases in the WHO European Region.

This data represents a worrying 10% surge in pediatric TB cases for 2023.

These findings of increased TB among children show that transmission of TB in the European Region is still ongoing, and immediate public health measures are needed, wrote the ECDC.

Furthermore, a significant concern is that for about 20% of children with TB in the EU/EEA, it is unknown whether their treatment has been completed, which indicates they may be spreading this disease.

“Ending TB is not a dream. It’s a choice. Sadly, the current TB burden and the worrying rise in children with TB serve as a reminder that progress against this preventable and curable disease remains fragile,” commented Dr Hans Henri P. Kluge, WHO Regional Director for Europe, in a media release.

Previously, the U.S. CDC reported similar unfortunate data regarding TB outbreaks.

After decades of consistent decline in TB cases, rates began increasing in 2021.

In 2024, 10,347 TB cases were provisionally reported by thirty-four states and the District of Columbia.

The percentages of TB case counts (8%) and rates (6%) increased from 2023 to 2024.

According to the ECDC, WHO, and the CDC, tuberculosis is a vaccine-preventable disease.

Access to TB vaccines should not be an issue, with about 15 versions of the 100-year-old Bacille Calmette-Guérin (BCG) vaccine available globally. Over 4 billion BCG vaccinations have been completed worldwide since 1921.

While BCG has demonstrated significant effectiveness (50%), protection against all TB forms in all age groups has not been consistent.

As of March 2025, no universal BCG vaccination policy has been published by the WHO.

In the United States, the U.S. FDA authorizes two BCG vaccines for specific health conditions.

As of March 13, 2025, the Serum Institute of India and ImmunityBio’s recombinant BCG vaccine became available in the U.S. for bladder cancer therapies.

However, these TB vaccines are not commercially available at pharmacies in the U.S.

Sub Title:

Tuberculosis is prevented with the BCG vaccine

References:

Childhood tuberculosis cases rise by 10%: a disturbing wake-up call for European Region

Provisional 2024 Tuberculosis Data, United States

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US CDC March 2025

Can Vaccinations Resolve Tuberculosis Disruptions

Karen McClorey Hackett — Sat, 22 Mar 2025 10:27:06 +0000

Reviewer:

Robert Carlson, MD

With the theme "Yes! We Can End TB: Commit, Invest, Deliver," World Tuberculosis Day 2025 highlights a rallying cry for urgency, accountability, and hope.

Scheduled for March 24, 2025, World Tuberculosis Day 2025 activities amplify the urgency of ending tuberculosis outbreaks, the world's deadliest infectious disease, responsible for over 1 million people annually, devastatingly impacting families and communities.

The WHO says global efforts to combat tuberculosis (TB) have saved an estimated 79 million lives since 2000. However, reductions in global health funding are threatening to reverse these gains.

Dr Tedros Adhanom Ghebreyesus, WHO Director-General, stated in a press release, "But we cannot give up on the concrete commitments that world leaders made at the UN General Assembly just 18 months ago to accelerate work to end TB. WHO is committed to working with all donors, partners, and affected countries to mitigate the impact of funding cuts and find innovative solutions."

The WHO Global Tuberculosis Report 2024 says TB is a vaccine-preventable disease.

The WHO has stated that increasing access to TB vaccines could save up to 1.9 billion antibiotic doses annually, helping reduce antimicrobial resistance.

While versions of the Bacille Calmette-Guérin (BCG) vaccine have been used for about 100 years and over 4 billion completed vaccinations, it has demonstrated only 50% effectiveness.

Unfortunately, the WHO has not issued a universal BCG vaccination policy.

To fill this void, about 15 different TB vaccines are currently used in various countries, with localized vaccination guidelines.

For example, access to the BCG vaccines has been minimal in the United States.

An article published by IJID Regions (Volume 14) on March 2, 2025, underscores that achieving TB elimination requires vaccines to prevent TB infection reactivation and transmission of drug-resistant strains.

For certain cancer patients, U.S. policy recently changed.

As of March 13, 2025, the Serum Institute of India and ImmunityBio's recombinant Bacillus Calmette-Guérin (rBCG) became available in the U.S. for bladder cancer therapies.

The rBCG vaccine has two gene modifications to improve its immunogenicity and safety. Compared to earlier BCG vaccine formulations, it has demonstrated potent immunogenicity with CD8+ and CD4+ T-cell stimulation.

As of March 22, 2025, this rBCG vaccine is available for bladder cancer therapies.

Previously, Merck's TICE® BCG was the only TB vaccine available in the U.S., primarily offered at public health departments to prevent TB in children.

With the increasing number of TB cases in the U.S. and changes in healthcare policy, TB vaccinations may become a tool in reducing this infectious disease.

Sub Title:

Tuberculosis vaccines available in most countries in 2025

References:

World TB Day

WHO TB news March 20, 2025

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Recombinant BCG Vaccine Becomes Available in the U.S.

Donald Hackett — Thu, 13 Mar 2025 20:48:14 +0000

Reviewer:

Robert Carlson, MD

The Bacillus Calmette-Guérin (BCG) is one of the most widely used vaccines worldwide, with about 4 billion doses administered over the past 100 years.

However, BCG is a biologic drug that uses benign bacteria, which makes it more complicated to manufacture than other drugs. This production limitation has led to decades-long vaccine shortages.

It has also been found to offer limited protection against diseases such as tuberculosis, an expanding health risk.

To resolve these shortcomings, ImmunityBio, Inc., today announced that U.S. Urology Partners, one of the nation's largest independent providers of urology and related specialty services, is one of the first providers to participate in ImmunityBio's Expanded Access Program (EAP) for the recombinant Bacillus Calmette-Guérin (rBCG) vaccine.

Serum Institute of India (SII), the largest manufacturer of BCG vaccines globally, has partnered with ImmunityBio to make this vaccine. Also, two gene modifications have been implemented in rBCG to improve its immunogenicity and safety compared to earlier strains and formulations of BCG.

Previously, Merck's TICE® BCG was the only vaccine available in the U.S., primarily used to prevent TB in children. Healthcare providers unable to source TICE BCG can access rBCG through the ImmunityBio EAP.

"It is gratifying to see the rapid uptake and interest in the rBCG EAP, which was authorized recently by the FDA," commented Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific Medical Officer of ImmunityBio, in a press release on March 13, 2025.

"Participation by a major national provider like U.S. Urology Partners is a testament to the critical importance of rBCG and the need for an alternative supply of this essential medicine."

Supply shortages of TICE BCG become a significant impediment to the treatment of bladder cancer patients. In a recent survey of 100 U.S. urologists, 57% indicated they could not treat patients in the last 12 months due to a lack of access to TICE BCG.

The SII is the world's largest vaccine manufacturer by volume. In European bladder cancer clinical trials, the rBCG vaccine (TUBERVAC-rBCG ) demonstrated potent immunogenicity with CD8+ and CD4+ T cell stimulation and improved safety compared to earlier BCG strains and formulations. It was approved in Europe in 2023.

rBCG vaccination induces an immune response in the bladder near the cancer cells, leading to cancer clearance in many patients.

Other countries, such as Brazil, are evaluating rBCG vaccines for use with children.

ImmunityBio has been awarded multiple patents covering the composition and methods of use for the combination of BCG plus ANKTIVA® in bladder cancer, which the U.S. FDA has approved.

In a 2024 study, ANKTIVA, in combination with BCG, achieved a 71% complete response rate in bladder cancer therapy.

Sub Title:

ImmunityBio rBCG vaccine plus ANKTIVA approved to treat certain bladder cancer patients

Reference:

ImmunityBio Announces First Dosing of Recombinant BCG

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Protective Genes Enable Tuberculosis Airborne Transmission

Donald Hackett — Wed, 12 Mar 2025 10:38:11 +0000

Reviewer:

Robert Carlson, MD

For over 100 years, a vaccine has been deployed 4 billion times to prevent tuberculosis (TB) outbreaks. Unfortunately, versions of the Bacille Calmette-Guérin (BCG) vaccine have only been about 50% protective at reducing severe disease.

To understand this shortcoming and why TB treatments often fail, researchers recently identified genes that the tuberculous bacteria rely on to survive and spread. These genes could help stop the spread of the world's leading infectious disease killer.

They present an introductory study in a series of efforts of increasing technical difficulty to identify the transmission survival genome of Mtb. The identified genes were previously considered unimportant since they appear not to play a role in disease progression when a person is infected.

Instead, the new study suggests that these genes are essential for successful transmission from person to person.

Until this study, very little was known about how tuberculous bacteria survived temperature changes, oxygen levels, humidity, and other environmental factors from one person's lungs to another's.

On March 7, 2025, PNAS published a Reach Article by researchers at Weill Cornell Medicine and the Massachusetts Institute of Technology. The article stated that Mycobacterium tuberculosis (Mtb) travels from the lungs of one person through the air to the lungs of another and survives multiple stresses en route, including changes in temperature and concentrations of oxygen, carbon dioxide, hydrogen ions, salts, and organic solutes.

This research presents a genetically tractable transmission model to begin identifying the transmission survival genome of Mtb.

They devised a fluid that mimics TB lesions, found that it protects Mtb from transmission-related stresses, associated this with the structure of the droplets as they dry and their ability to retain water, and used it to query the potential contribution of each of Mtb's genes to Mtb's survival in models of three sequential stages of transmission.

In summary, these studies of MAF as a model for TB lesional fluid are consistent with evidence that Mtb induces the host to provide it with a medium that confers tolerance to some antibiotics. They also reveal that such a fluid can promote the formation of aerosols in a size range consistent with substantial time in the air and access to pulmonary alveoli in new hosts while partially protecting Mtb from death in rapidly shifting environmental conditions before and during its airborne journey.

To the extent that our study of sessile droplets is relevant to aerosol transit, Mtb may depend not only on the host fluid in which it is carried but also on hundreds of its genes.

"The idea of waiting to identify someone with tuberculosis, then treating and curing them, is a inefficient way to stop the pandemic," Carl Nathan, chair of the Department of Microbiology and Immunology and R.A. Rees Pritchett Professor of Microbiology at Weill Cornell Medicine, said in a MIT News article on March 10, 2025.

"Most people who exhale tuberculosis bacteria do not yet have a diagnosis. So, we have to interrupt its transmission. And how do you do that if you don't know anything about the process itself? We have some ideas now."

"Now we have a sense, through these genes, of the tools tuberculosis uses to protect itself."

The World Health Organization says most people who developed TB live in the Regions of Southeast Asia, Africa, Europe, and the Western Pacific. Countries such as India (26%), Indonesia (10%), China (6.8%), the Philippines (6.8%), and Pakistan (6.3%) together accounted for 56% of the global TB burden.

In the United States, TB cases have been increasing for three years, led by California and Texas.

Most of these countries offer various BCG vaccines to children. However, access to the BCG vaccine remains restricted in most states.

Hopefully, with several late-stage clinical trials nearing completion, access to innovative TB vaccines will increase.

Sub Title:

New drug targets identified for stopping tuberculosis spread

Reference:

Candidate transmission survival genome of Mycobacterium tuberculosis

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Proceedings of the National Academy of Sciences, 122(10), e2425981122

100 Year Old Tuberculosis Vaccine Getting an Upgrade

Donald Hackett — Wed, 26 Feb 2025 19:31:27 +0000

Reviewer:

Robert Carlson, MD

After 100 years of use and billions of vaccinations, the world's deadliest infectious disease vaccine may soon be enhanced to meet the needs in 2025.

In a press release published on February 26, 2025, IAVI and Biofabri, a subsidiary of Zendal, announced that the first doses of tuberculosis MTBVAC vaccine candidate had been administered in the IMAGINE phase 2 clinical trial in Paarl, South Africa.

The IMAGINE trial will assess the safety and efficacy of a single-dose MTBVAC in preventing active tuberculosis (TB) lung disease in adolescents and adults, an underserved age group. Study participants will be followed for two to three years to assess the vaccine candidate's efficacy.

If MTBVAC is shown to be efficacious, Biofabri, IAVI, and other partners will collaborate to ensure a sufficient, affordable supply for low—and middle-income countries.

TB disease caused 1.25 million deaths in 2023, with cases reported in most countries, including an increasing number in the United States in 2024.

The only U.S. FDA-approved TB vaccine, Merck's Bacillus Calmette-Guérin (BCG) vaccine, offers partial protection (about 50%) to children but limited TB disease prevention in adolescents or adults.

IAVI wrote, 'A TB vaccine effective in children, adolescents, and adults would save millions of lives otherwise lost to TB over time.'

"We are working towards the same common goal: the end of the devastating impacts of TB disease. We are honored to be part of this coalition to ensure an accelerated R&D push for a new TB vaccine and its equitable, affordable global distribution once authorized," said Ana Céspedes, Pharm.D., MBA, and COO of IAVI, in the press release.

As of February 2025, about 15 versions of the BCG vaccine are in use globally, including in the U.S., which offers limited commercial access to the general public.

Recently, the FDA authorized importing the Serum Institute of India's TUBERVAC BCG vaccine to treat non-muscle-invasive bladder cancer patients.

Sub Title:

BCG vaccine approved for tuberculosis and bladder cancer

Reference:

IAVI and Biofabri/Zendal announce first vaccinations in the IMAGINE clinical trial

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Can Tuberculosis Cases Decrease in 2025

Karen McClorey Hackett — Mon, 09 Dec 2024 21:47:25 +0000

Reviewer:

Robert Carlson, MD

The World Health Organization (WHO) recently published an updated report on tuberculosis (TB), placing this infectious disease as the leading killer in 2023 and a substantial public health threat in the years to come.

The 2024 WHO Global TB Report highlights the return of tuberculosis, caused by Mycobacterium tuberculosis, after three years dominated by SARS-CoV-2 as the leading cause of death from infectious disease, TB causing an estimated 1.25 million related fatalities.

The disease disproportionately affects people in a few high-burden countries: India (26%), Indonesia (10%), China (6.8%), the Philippines (6.8%), and Pakistan (6.3%).

The Journal of International Infectious Disease recently published an Editorial (Volume 150107325, January 2025) that asks, 'How far are we from the End TB goals of reduction of TB incidence by 80%, deaths by 90%, and elimination of catastrophic costs for TB-affected households by 2030?

These authors stated, 'The findings from the 2024 WHO report underscore the critical need for accelerating global action. The report clarifies that global milestones for reducing TB incidence are off-track."

"Immediate and sustained actions, increased financial investment, and collaborative efforts across sectors are essential to address these challenges, echoing UN sustainable development goals (SDG)."

"We call for strategic actions that align with the SDG to achieve the WHO End TB goals. Immediate and coordinated measures are critical to mitigate gaps in TB diagnosis, treatment, and prevention while addressing the socio-economic factors that exacerbate the spread of TB."

In the United States, TB cases have been increasing.

As of December 2024, the U.S. CDC reported 7,152 TB cases this year, led by California and New York (NYC).

The U.S. CDC Morbidity and Mortality Weekly Report, published in June 2024, examined the most recent five years of National TB Indicators Project data, which indicates that up to 13 million people in 60 U.S. jurisdictions live with latent TB infection.

While TB is a vaccine-preventable disease, the access has been constrained.

The Global Coalition of TB Advocates confirmed that 16 TB vaccines are available in 2024. As of December 2024, GlobalData reported that 11 TB vaccine candidates are in late-stage development globally.

The complete, unedited article is posted at this link.

Sub Title:

Tuberculosis is a vaccine preventable infectious disease

References:

Insights from the 2024 WHO Global Tuberculosis Report – More Comprehensive Action, Innovation, and Investments required for achi

WHO’s Global Tuberculosis Report 2024

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Strategic actions for accelerating progress to achieve the End TB goals.

New Investments in Vaccine Development Needed

Donald Hackett — Sun, 01 Dec 2024 12:51:03 +0000

Reviewer:

Robert Carlson, MD

A recent report by the World Health Organization (WHO) finds that vaccines against 23 pathogens could reduce the number of antibiotics needed by 22% annually, supporting worldwide efforts to address antimicrobial resistance (AMR).

The misuse and overuse of antimicrobials primarily drive AMR.

While some vaccines are already available but underused, the WHO says others need to be developed and brought to the market as soon as possible.

The new report expands on Original Research published in BMJ Global Health on October 18, 2023. It estimates that vaccines already in use against pneumococcus pneumonia, Haemophilus influenzae type B (Hib, a bacteria causing pneumonia and meningitis), and typhoid could avert up to 106,000 deaths associated with AMR yearly.

An additional 543,000 deaths associated with AMR could be averted annually when new vaccines for tuberculosis (TB) and Klebsiella pneumoniae are developed and rolled out globally. While several new TB vaccines are in clinical trials, one against Klebsiella pneumoniae is in the early stage of development.

“Addressing antimicrobial resistance starts with preventing infections, and vaccines are among the most powerful tools for doing that,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General, in a WHO press release.

“Prevention is better than cure, and increasing access to existing vaccines and developing new ones for critical diseases, like tuberculosis, is critical to saving lives and turning the tide on AMR.”

Sub Title:

Vaccines against 23 pathogens could reduce the number of antibiotics needed by 22%

References:

More investment in vaccines could avert deaths due to antimicrobial resistance

Global and regional burden of attributable and associated bacterial antimicrobial resistance avertable by vaccination

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Can Children Access Tuberculosis Vaccines

Karen McClorey Hackett — Mon, 11 Nov 2024 22:02:17 +0000

Reviewer:

Robert Carlson, MD

A recent study published by The Lancet Children & Adolescent Health revealed about 10% of children in High-Burden Tuberculosis (TB) settings may develop the disease by age ten.

Published on November 5, 2024, this study also indicates that children who live in settings with a high burden of TB have a consistent annual risk of developing TB, a severe lung infection caused by bacteria.

Despite being both preventable and curable, TB remains one of the world's leading infectious disease killers. TB outbreaks cause an estimated 1.2 million children to be infected, and 200,000 children die from TB worldwide each year.

This study, led by the Boston University School of Public Health (BUSPH), the University of São Paulo, and the University of Cape Town, sheds new light on this substantial health risk. It is the first birth cohort study to assess TB infection and active TB disease during children's first decade of life in high-burden settings.

By eight years old, the research team estimated that children's cumulative risk of developing TB infection reached 36%.

This observational study builds upon a previous analysis, which also found high rates of TB infection and disease in children up to five years old.

"These results are striking and show that children in these communities in South Africa are at extraordinarily high risk," says study co-senior author Dr. Leonardo Martinez, assistant professor of epidemiology at BUSPH, in a press release.

"Perhaps 1,000 to 2,000 South African children are at greater risk of TB than their young counterparts in the United States. It's an urgent health problem with short- and long-term impacts on these children and their families."

As part of its Sustainable Development Goals, the World Health Organization (WHO) has pledged to reduce the incidence of TB by 80% by 2030.

As of November 2, 2024, the U.S. CDC reported 6,646 TB cases this year, led by California and New York.

The CDC reported 7,793 TB cases last year, representing an annual increase of 16% compared with 2022. For children, TB incidence in 2023 (68 cases) corresponds to a 42% increase.

In 2023, among persons for whom birth origin was known, 76% of TB cases occurred among non-U.S.–born persons, an 18% increase compared with 2022.

To help achieve its goal, the WHO recommends using the decades-old Bacillus Calmette-Guérin (BCG) vaccine in settings with a high incidence of TB. Over four billion BCG doses have been given since it was approved in 1921.

The U.S. CDC says BCG vaccination protects children from severe forms of active TB disease, such as TB meningitis and miliary TB.

However, the BCG vaccine is not included in the CDC's approved children's vaccination schedule. BCG is only considered for people who meet specific criteria and consult with a TB expert and public health officials.

For example, tuberculosis continues to be a health problem in Houston, Texas. Harris Country (Houston) reported the most TB cases (267) in Texas in 2022. The local public health department informed Precision Vaccination News on March 11, 2024, that the BCG vaccine is only available to qualified children living with an infectious adult.

In 2022, the journal MDPI published an analysis titled 'BCG Vaccine—The Road Not Taken.' These researchers wrote that the BCG vaccine has been used for many years to protect people against the most lethal infectious agent in human history, tuberculosis.

According to a chart from Wikipedia, various Central and South American countries offer universal BCG immunizations.

As of November 2024, over ten versions of the BCG vaccines are in use worldwide, and several vaccine candidates are conducting late-stage clinical trials.

Sub Title:

Tuberculosis vaccination approved for children in various countries

References:

BCG Vaccine—The Road Not Taken

Mycobacterium tuberculosis infection and tuberculosis disease in the first decade of life: a South African birth cohort study

US CDC TB vaccination

WHO TB case report

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US CDC - Tuberculosis — United States, 2022 | MMWR

Tuberculosis Killed 1.25 Million People Globally

Karen McClorey Hackett — Wed, 30 Oct 2024 09:52:23 +0000

Reviewer:

Robert Carlson, MD

Tuberculosis (TB) is an ancient yet typically treatable infectious disease. Unfortunately, approximately a quarter of the global population has been infected, and over 1 million people died from TB last year.

According to the World Health Organization (WHO), as of October 29, 2024, TB has once again become the world's leading cause of death from a single infectious agent, resulting in nearly twice as many deaths as HIV/AIDS.

The newly published WHO's Global Tuberculosis Report 2024 highlights that while TB-related deaths decreased from 1.32 million in 2022 to 1.25 million in 2023, the total number of people falling ill with TB rose slightly to an estimated 10.8 million in 2023.

The WHO says urgent action is required to end the global TB epidemic by 2030, a goal adopted by all Member States of the United Nations and the WHO.

Dr. Tereza Kasaeva, Director of the WHO Global Tuberculosis Programme, commented in the report, "WHO's Global Tuberculosis Report for 2024 reveals a sobering reality: TB has probably returned to being the world's leading infectious disease killer."

"It is imperative that we unite across all sectors and stakeholders to confront these pressing issues and ramp up our efforts, transforming our promises into tangible resources and unwavering resolve."

"Only through our collective determination can we make significant strides in our battle to end TB once and for all."

As of late 2024, TB infections continue impacting public health in the United States.

The U.S. CDC recently reported that up to 13 million people in 60 jurisdictions live with latent TB infection in the U.S. As of October 30, 2024, the CDC reported 6,159 TB cases this year, led by outbreaks in California and New York (NYC).

TB is caused by the bacillus Mycobacterium tuberculosis, which is spread when people who are sick with TB expel bacteria into the air. Following infection, the risk of developing TB disease is highest in the first 2 years. The disease typically affects the lungs.

Without treatment, the death rate from TB disease is close to 50%. With treatments currently recommended by WHO (a course of anti-TB drugs for 4–6 months), about 85% of people with TB can be cured.

One of the oldest vaccines is the Bacillus Calmette-Guérin (BCG) vaccine. Although it has a modest effectiveness rate and may cause false-positive test results, it has been administered over 4 billion times worldwide.

In the U.S., the CDC says the inexpensive Merck's TICE® BCG vaccine has limited availability.

And in the UK, the Health Security Agency says BCG vaccination is not recommended for travelers to countries with low annual TB incidence.

However, BCG vaccination is recommended for immunocompetent travelers from the U.K. who will spend more than three months in a country where the presumed or average annual incidence of TB is high and/or where the risk of Multi-Drug-Resistant TB is high.

Recently, the U.K. updated country-specific TB vaccine recommendations for India, Armenia, Bosnia and Herzegovina, Colombia, Honduras, Latvia, Maldives, Qatar, and Syria. For example, tuberculosis in India is a significant health problem, causing about 220,000 deaths every year.

As of October 2024, over ten versions of the BCG vaccine are currently in use globally, and various next-generation vaccine candidates are conducting late-stage research.

Sub Title:

Tuberculosis is a vaccine preventable disease in 2024

References:

WHO TB Report 2024

CDC BCG vaccine

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US CDC tuberculosis case map

Brazil Considers Recombinant BCG Vaccine for Infants

Donald Hackett — Wed, 10 Jul 2024 21:24:48 +0000

Reviewer:

Robert Carlson, MD

While most infants in Brazil's five regions are vaccinated against tuberculosis, the search for a more effective Bacillus Calmette-Guérin (BCG) vaccine accelerated in 2024.

Researchers from the Butantan Institute and collaborators confirmed on July 3, 2024, that they are developing a more potent version of the 100-year-old BCG vaccine.

While the conventional BCG vaccine reduces infection by 90% in experiments with mice, the so-called recombinant BCG (rBCG) increased the protection rate to 99%.

In addition, the rBCG formulation protected animals for a significantly more extended period of time (15-20 years).

“BCG is the first vaccine we receive at birth, effectively protecting children. However, immunity against the disease tends to wane in adulthood, and as bacteria become resistant to antibiotics, no one is safe. There’s been a global effort to improve the prevention of pulmonary tuberculosis in adults. Today, there are about 10 million new cases and 1.5 million deaths per year in the world,” commented Agência FAPESP Luciana Cezar de Cerqueira Leite, a researcher at Butantan Institute’s Vaccine Development Laboratory, in a press release.

To understand why rBCG leads to a more robust and longer-lasting immune response, the Butantan group and collaborators have adopted an approach known as systems biology – observing in an animal model the behavior of thousands of genes in different tissues throughout the assembly of the immune response.

This systems biology involves sequencing hundreds of samples, followed by intensive bioinformatics and data mining.

Cerqueira Leite addressed this topic on June 29, 2024.

“We sequenced all the RNA that was expressed and present in samples taken at different times: before the animal was immunized, seven and 90 days after immunization – when the challenge is performed [the bacteria are inoculated into the rodents’ noses] – and seven and 90 days after the challenge,” explains Cerqueira Leite.

“As early as seven days after immunization, a very big change could be seen in the group that received the recombinant version: about 200 genes were already being activated, while almost nothing happened in the conventional BCG group."

"After 90 days, the response to the conventional BCG began to decline, while it remained the same in the recombinant group. But the big news is that the two vaccines work through very different metabolic pathways, and we’ve been able to map them. The data will be published soon,” revealed the researcher.

Through genetic engineering, the rBCG version gained the ability to produce a fragment of a toxin originally secreted by Escherichia coli, a species commonly found in the human gut.

“Some E. coli bacteria produce heat-labile toxins, known by the acronym LT, which are highly immunogenic, i.e., they induce a strong response from the immune system. In the rBCG vaccine, we use a detoxified fragment of the LT toxin [called LTAK63]. It isn’t capable of causing disease, but it maintains immunogenicity, so it acts as an adjuvant to the rBCG vaccine.”

The researcher explained that the first studies using the recombinant BCG strategy were aimed at developing a neonatal pertussis vaccine.

In experiments with an animal model of tuberculosis, rBCG vaccination was found to reduce the amount of bacteria in the lungs a hundredfold and reduce inflammation in the organ.

“In trying to kill the bacteria, the defense cells end up attacking everything nearby and causing tissue damage. However, the lungs of the animals immunized with recombinant BCG are white and less inflamed. By detailing the mechanism of action of the two vaccines, we now understand why this happens.”

According to Cerqueira Leite, the production of the immunizer’s experimental rBCG batches is expected to begin in 2025 following one more round of tests in cattle, and human clinical trials could start in 2026.

The Global Coalition of TB Advocates recently confirmed that there are 16 TB vaccines in use in 2024. As of March 2024, 11 TB vaccine candidates were in late-stage development globally.

In the United States, Merck's TICE® BCG vaccine is U.S. FDA-approved, but has limited distribution.

Note: All RNA sequencing was performed in Shenzhen, China, by the company BGI, which provides genomics services to laboratories worldwide. Researchers from the Shenzhen Institute of Advanced Technology, the University of São Paulo, the Albert Einstein Israelite College of Health Sciences, Fiocruz Bahia, Novartis/GSK, the Institut Pasteur, and the Federal University of Goiânia, among others, collaborated in the studies.

Sub Title:

Recombinant BCG vaccine may increase disease protection over more years

References:

New tuberculosis vaccine results presented at FAPESP Week

Tuberculosis in Brazil: one country, multiple realities

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Tuberculosis Outbreak Confirmed in Long Beach California

Donald Hackett — Fri, 03 May 2024 14:39:18 +0000

Reviewer:

Robert Carlson, MD

The City of Long Beach recently issued an official statement regarding a Tuberculosis (TB) outbreak.

On May 2, 2024, City Health Officer Dr. Anissa Davis declared a local public health emergency to strengthen the City's preparedness and ability to respond to a localized TB outbreak.

Several individuals associated with a single-room occupancy (SRO) hotel in Long Beach have recently been identified with TB disease.

As of April 29, 2024, 14 cases of TB disease have been associated with this outbreak; nine people have been hospitalized during their illness, and one person has died.

People staying at the SRO hotel during this outbreak or who could have otherwise been exposed to this respiratory disease have been or will be contacted by the Health Department.

The population at risk in this TB outbreak has significant barriers to care, including homelessness and housing insecurity, mental illness, substance use, and serious medical comorbidities.

In an April 2024 analysis of TB incidence rates for racial/ethnic populations in the U.S., the disease incidence rate ratios were 14.2 higher among younger American Indian or Alaska Native females.

According to the City's press release, the risk to the general public is low.

Long Beach has a population of about 450,000 and is located 24 miles south of Los Angeles, CA.

Approximately 20% of all TB cases in the United States are reported in California. The California Department of Health reported a 9% increase in TB cases in 2023 (2,113).

The U.S. Centers for Disease Control and Prevention (CDC) recently reported 9,615 TB cases were provisionally reported by 50 states and the District of Columbia in 2023, representing an increase of 16% compared with 2022.

The Long Beach Health Department's TB Control Program treats everyone with TB disease affected by this outbreak and provides temporary housing, food, and transportation as necessary.

As of 2023, the CDC recommended testing persons at increased risk for TB infection as part of routine health care using TB blood tests, when possible, and prescribing a short-course treatment regimen if a diagnosis is made.

Treatment for TB disease requires months of multiple medications, and medicine is given under direct observation by TB Control staff.

TB is a vaccine-preventable disease with the Bacille Calmette-Guerin (BCG) vaccine, but vaccinations are generally not offered in California. The CDC recommends speaking with a local healthcare provider about TB vaccination options.

Sub Title:

Long Beach tuberculosis outbreak includes 14 people and 1 death

References:

Long Beach Statement Regarding Public Health Emergency in Response to Local Tuberculosis Outbreak

City of Long Beach TB Control Program

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TB, vaccinations

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by Lisa Larsen

Adult Vaccinations Produce 19 to 1 ROI

Karen McClorey Hackett — Sun, 21 Apr 2024 14:43:12 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

In recent times, the pandemic highlighted contagious diseases that affect older individuals, leading to an increased burden of costly hospitalization.

One proven tactic to prevent disease is vaccination.

A recent study across 10 countries revealed that adult immunization programs can generate a return of up to 19 times their initial investment when considering the full range of benefits.

This study calculated the equivalent of billions of dollars in net monetary benefits to society or, more concretely, up to $4,637 for one individual's entire vaccination course.

Published on April 17, 2024, the report concludes that vaccination programs deliver substantial returns on government investment through cost savings within healthcare systems and more comprehensive socio-economic benefits.

Furthermore, governments are recommended to adopt a prevention-first mindset to help ease increasing pressures on health systems and society, with adult immunization playing a crucial role in enabling us to live longer, healthier, and more productive lives.

Professor Lotte Steuten, Deputy CEO of the Office of Health Economics and co-author of the report, commented in a press release, "Our report sets out a compelling case for adult immunization programs playing a key role in the shift to prevention."

"Our findings show that costs are offset multiple times over by benefits to society when governments invest in adult immunization programs."

"These returns are realized through benefits to individuals, families, and communities, providing a clear call to action to countries not already implementing or expanding robust vaccination schedules."

Furthermore, these economic findings are likely to underestimate the total value that adult vaccines bring to society.

A recent U.S. CDC MMWR revealed the fourth consecutive year of TB case increases. In 2023, there was a 16% increase in TB cases across various demographics, including seniors in the U.S.

According to USAID, treating one TB case in the U.S. costs about $20,000, and a drug-resistant tuberculosis case can cost over $150,000.

From a prevention perspective, a significant number of TB cases can be prevented with a US FDA-approved vaccine (BCG) for less than $500.

This first-of-its-kind financial analysis of adult immunization programs focusing on vaccines that protect against influenza, pneumococcal disease, respiratory syncytial virus, and herpes zoster was commissioned by the Office of Health Economics and commissioned by IFPMA.

Sub Title:

Immunization programs return measurable value

Reference:

Socio-Economic Value of Adult Immunisation Programmes

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Seniors

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health, vaccines, vaccinations

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by Steve Buissinne

Tuberculosis Cases Increased 16% Last Year

Donald Hackett — Fri, 29 Mar 2024 10:42:56 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

Despite being both preventable and curable, tuberculosis (TB) remains a global health risk. Last year, TB continued to be a leading cause of death worldwide.

Traditionally, the United States had one of the lowest TB rates globally.

Unfortunately, TB cases in the U.S. have now increased for four consecutive years amidst the worldwide resurgence of this contagious disease, which usually affects the lungs, as reported by the U.S. Centers for Disease Control and Prevention (CDC).

Published on March 28, 2024, the CDC's most recent MMWR indicates a 16% increase in overall TB cases across various demographics and 50 states in 2023. These TB cases were concentrated in about eight states, including Washington, D.C.

This MMWR presented these highlights:

As in 2022, California reported the highest number of cases in 2023 (2,113), followed by Texas (1,235), and Alaska reported the highest rate (10.6).

In 2023, 7,259 (76%) TB cases occurred among non-U.S.–born persons, an 18% increase compared to 2022.

In the U.S., TB incidence increased in every age group in 2023 compared with 2022. The most significant relative increase was among children, corresponding to a 42% increase in case count.

Among persons with TB in 2023 for whom HIV status was known, 5% were coinfected with TB and HIV.

The MMWR offered some good news.

Approximately 85% of TB cases in the U.S. were attributed to the reactivation of latent TB infection (LTBI) rather than recent transmission. This finding indicates that sustained transmission of TB leading to outbreaks is uncommon.

Furthermore, TB elimination activities should include increased testing among populations at risk and treating persons with LTBI or TB disease.

To prevent transmission and reduce morbidity, TB disease must be detected quickly, effective treatment must be initiated promptly, and all exposed persons must be identified, evaluated, and treated if infected, says the CDC.

This approach has proven successful. It led to a 66% reduction in TB cases in the first 25 years of implementation.

One aspect of TB prevention has not improved in 2024.

Access to the U.S. FDA-approved TB-prevention vaccine (BCG) remains restricted to public health agencies and unavailable in local clinics or pharmacies.

From a vaccine development perspective, enhanced BCG-type vaccine candidates are conducting late-stage clinical trials in 2024.

Internationally, TB cases have increased in the WHO Regional Office for Europe.

The European Centre for Disease Prevention and Control reported over 170,000 incident TB cases in 2022. Despite the notable progress achieved in the fight against TB, European countries still face various challenges in reaching the goal of ending the TB epidemic in the WHO European Region.

The new Tuberculosis action plan for the WHO European Region 2023–2030 has been published.

Note: This news article was updated on April 3, 2024, to include updated TB case data.

Sub Title:

US FDA approved BCG vaccine prevents tuberculosis in 2024

Reference:

CDC MMWR - Tuberculosis — United States, 2023

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US CDC TB Case trend 2023

Can Vaccines Empower World Tuberculosis Day

Karen McClorey Hackett — Sun, 24 Mar 2024 16:29:35 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

As World Tuberculosis Day is recognized today, health leaders are worried about the increasing number of TB cases in industrialized countries.

While TB outbreaks are typically associated with countries like India, the United States (U.S.) has also experienced an increase in the number of TB cases and deaths over the past three years.

In 2022, the U.S. reported 8,331 TB cases, representing a 5.9% increase compared with 2021.

Specifically, four international gateway states, California, Texas, New York, and Florida, reported about 50% of all TB cases in the U.S.

Furthermore, being born outside of the U.S. remains a key risk factor for TB, with a TB incidence rate 17.1 times higher compared with U.S.-born persons in 2022.

To reverse these negative trends, the global pharmaceutical industry is working hard to develop new, more effective TB vaccines that meet the World Health Organization's (WHO) goal.

The World TB Day 2024 message of hope is... 'Yes! We can end TB!'

On March 22, 2024, Dr. Tereza Kasaeva, Director of the WHO Global TB Program, wrote, "As we come together to commemorate World TB Day, we stand in solidarity with the millions of people who fall ill with TB each year and remember the millions who have lost their lives from this preventable and curable disease."

"This is a pivotal moment for the global fight to end TB."

"We have strong commitments with concrete targets, made by world leaders in the political declaration of the 2023 UN High-Level Meeting on TB, which provide a strong impetus to accelerate the TB response."

"2024 is a year of action to ensure these commitments are met, and millions of people benefit from life-saving TB prevention and care services.

As of March 2024, about 16 versions of the bacille Calmette-Guérin (BCG) vaccine are used to protect people from TB.

The WHO says BCG is one of the most widely used of all current vaccines, reaching about 80% of infants in countries where it is part of childhood immunization programs.

While the BCG vaccine has a documented protective effect against meningitis and disseminated TB in children, it does not prevent primary infection and, more importantly, does not prevent the reactivation of latent pulmonary infection, the principal source of bacillary spread in the community.

Recent advances in mycobacterial immunology and genomics have stimulated research on numerous new experimental TB vaccines. As of March 24, 2024, an expanding group of TB vaccine candidates is conducting clinical research.

Still, it is unlikely that these urgently needed vaccines will be available for routine use within the next few years, says the WHO.

In the meantime, the WHO says that optimal utilization of the BCG vaccine is encouraged.

Sub Title:

Tuberculosis mortality reduced with BCG vaccine in 2024

References:

WHO - World TB Day Message 2024

CDC - Reported Tuberculosis in the United States, 2022

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Age Groups:

Adolescent

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Tuberculosis, vaccinations

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US CDC Tuberculosis deaths in the United States 2024

Are New Tuberculosis Vaccines Really Needed

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

Reviewer:

Robert Carlson, MD

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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Age Groups:

Pre School

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vaccinations

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University of Montana 2024