Bacille Calmette-Guerin (BCG) Vaccine

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

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

BCG Vaccine Shortage Ends in the United States

Karen McClorey Hackett — Wed, 19 Feb 2025 15:08:09 +0000

Reviewer:

Robert Carlson, MD

Following years of inadequate supply, a recently approved recombinant Bacillus Calmette-Guérin (rBCG) is now available in the United States to treat non-muscle invasive bladder cancer (NMIBC) patients.

Access to this vaccine may end the multi-year shortage of the TICE® BCG vaccine.

ImmunityBio, Inc. announced today that the U.S. Food and Drug Administration (FDA) has authorized an expanded access program that will bring an alternative source of BCG, a standard-of-care medicine in bladder cancer, to patients in the United States.

As of February 19, 2025, ImmunityBio says shipments of the Serum Institute of India (SII) TUBERVAC-rBCG vaccine will begin immediately in the U.S.

TUBERVAC-rBCG was approved in India in 2023 as a single-dose tuberculosis (TB) prevention vaccine. In European bladder cancer phase 2 clinical trials, the rBCG vaccine has demonstrated potent immunogenicity with CD8+ and CD4+ T cell stimulation and improved safety compared to earlier BCG strains and formulations.

"With the increasing threat of supply shortages of essential medicines, the biopharmaceutical industry must innovate and secure new means of ensuring uninterrupted access to vital therapeutics," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio, in a press release.

"Our collaboration with the FDA and SII to ensure a reliable supply of this vital drug for bladder cancer patients underscores ImmunityBio's commitment to addressing critical access issues that affect so many patients."

BCG is a benign bacterium that was developed over 100 years ago as a live vaccine against TB. It has been administered to more than 4 billion individuals worldwide. In 2002, Neonatal BCG vaccination was practiced in 157 countries and territories.

SII is the world's largest manufacturer of BCG vaccines, while Merck & Co. is currently the only manufacturer of the U.S. FDA-approved TICE® BCG vaccine.

The WHO's Civil Society Taskforce on TB confirmed that 16 TB vaccines were available globally. Two gene modifications have been implemented in rBCG to improve its immunogenicity and safety compared to earlier strains and formulations of BCG.

ImmunityBio's FDA-approved ANKTIVA® is a cytokine interleukin-15 that plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells, NK and CD8+ killer T cells, that kill cancer cells. ANKTIVA's protocol integrates rBCG vaccinations.

Sub Title:

BCG vaccine is FDA approved to bladder cancer and tuberculosis prevention

Reference:

FDA Authorizes ImmunityBio to Provide Recombinant BCG (rBCG) to Urologists to Address TICE® BCG Shortage

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from Pixabay 2025

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

Innovative Cancer Treatment Through Targeted Bacterial Vaccines

Donald Hackett — Sun, 01 Sep 2024 19:36:00 +0000

Reviewer:

Robert Carlson, MD

Bacterial vaccines offer a promising solution by targeting specific pathogens without harming the broader microbiome. However, researchers wrote on August 30, 2024, that developing effective bacterial vaccines is challenging due to the weak immunogenicity of major bacterial antigens.

This emerging antibacterial nanovaccine delivers enhanced chemotherapy by selectively eliminating tumor-colonizing bacteria.

In Science Bulletin, Volume 69, Issue 16, these researchers commented that although adjuvants can enhance the humoral response, effective vaccines require robust activation of the antigen-specific cellular response to eliminate intracellular pathogens.

Hence, there is a strong desire for an antibacterial vaccine capable of eliciting robust immune responses to eradicate F. nucleatum while selectively preserving other microbiota.

To address these challenges, a research team led by Professor Qian Chen from Soochow University (Institute of Functional Nano & Soft Materials, FUNSOM) proposed a novel bacterial vaccine (LipoFM-CPG) by inserting cholesterol-modified agonist CpG into F.nucleatum derived membranes.

Compared with traditional emulsions with inactivated bacteria and Alum adjuvant, LipoFM-CPG co-delivers antigens and adjuvants, significantly enhancing dendritic cell maturation and antigen presentation.

This stimulation leads to robust antibacterial cellular and humoral immune responses.

The nanovaccine has demonstrated the ability to selectively and efficiently eradicate F. nucleatum, enhancing chemotherapy efficacy and reducing cancer metastasis in F. nucleatum-infected CRC.

Notably, compared to systemic or oral antibiotics, the nanovaccine has a negligible impact on the intratumoral and gut microbiota.

This nanovaccine, with a simple manufacturing process, strong immunogenicity, and desired biocompatibility, should be a promising technology for selectively eliminating intratumoral bacteria and improving the therapeutic effect in bacteria-infected cancer.

Overall, this work represents the rational application of bacterial nanovaccine and provides a blueprint for future development in enhancing the antitumor effect against bacterial-infected cancer.

The study's authors declare that they have no conflict of interest. The National Research Programs of China partially supported this article.

Sub Title:

Novel bacterial nanovaccine LipoFM-CPG inserts cholesterol-modified agonist CpG into F.nucleatum derived membranes.

Reference:

An emerging antibacterial nanovaccine for enhanced chemotherapy by selectively eliminating tumor-colonizing bacteria

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Science China Press 2024

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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KARINA TOLEDO

100 Year Old Vaccine Protects People From Infectious Diseases

Donald Hackett — Fri, 14 Jun 2024 02:26:31 +0000

Reviewer:

Robert Carlson, MD

New research published by investigators at Massachusetts General Hospital (MGH) shows that the 100-year-old Bacillus Calmette-Guérin (BCG) vaccine, originally developed to prevent tuberculosis, protects individuals with type 1 diabetes from infectious diseases.

Two back-to-back randomized double-blinded placebo-controlled trials found that the BCG vaccine provided continuous protection for nearly the entire pandemic in the U.S., regardless of the SARS-CoV-2 variant.

The MGH Phase II and Phase III clinical trials testing BCG differed from other BCG trials in important ways.

Instead of receiving one dose of BCG, participants received five or six doses of a particularly potent strain of BCG vaccine.

“Individuals with type 1 diabetes are highly susceptible to infectious diseases and had worse outcomes when they were infected with the SARS-CoV-2 virus,” said senior author Denise Faustman, MD, PhD, director of the Immunobiology Laboratory at MGH and an Associate Professor of Medicine at Harvard Medical School, in a press release.

“....we’ve shown that BCG can protect type 1 diabetics from COVID-19 and other infectious diseases.”

The 18-month Phase III trial, published in iScience, was conducted when the highly transmissible Omicron variant was circulating.

A 15-month Phase II trial was conducted early in the pandemic; the results of that trial were published in Cell Reports Medicine.

During the COVID-19 pandemic, several international trials tested whether BCG, given as a single shot or booster to previously BCG-vaccinated adults, protected them from infection and COVID-19.

However, results from these COVID-19 booster trials were mixed in people previously vaccinated with BCG. Five randomized trials showed efficacy, and seven trials showed no benefit.

“Our study showed that the BCG vaccine neither increased the efficacy of the COVID-19 vaccine nor was it harmful to those who received the COVID-19 vaccine,” said Faustman.

The U.S. participants were followed for 36 months instead of weeks or months.

“We know that in people who are naïve to BCG vaccine, the off-target effects can take at least two years to achieve full protection,” said Faustman. “Giving multiple doses of the vaccine may speed up that process.”

The MGH trials enrolled 141 participants with type 1 diabetes; 93 people in the treatment group received five or six doses of BCG vaccine, and the 48 individuals in the placebo group received sham vaccine and were followed for 36 months to capture diverse COVID-19 genetic variants and many infectious disease exposures.

During the earlier Phase II trial (January 2020 to April 2021), when the virus was more lethal but less transmissible, the BCG vaccine’s efficacy was 92%, comparable to the efficacy of COVID-19 vaccines in healthy adults.

Over 34 months of the pandemic, the BCG vaccine had a significant efficacy of 54.3%.

The investigators also found that the BCG-treated participants had lower viral, bacterial, and fungal infection rates.

This research expanded the extensive global clinical trial database, showing that BCG administered to newborns works as a platform for all infectious diseases, maybe for decades.

In the U.S., BCG vaccinations have been an effective treatment for bladder cancer for several years.

Massachusetts General Hospital, founded in 1811, is the original and largest teaching hospital of Harvard Medical School. This research was supported by The Iacocca Foundation, Boston, MASS. No conflicts of interest were disclosed.

Sub Title:

Multi-dose BCG vaccine protects against tuberculosis, infectious diseases and bladder cancer

Reference:

BCG vaccines protect against COVID-19 and infectious diseases

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iScience May 2024

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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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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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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Friday, March 29, 2024 - 12:45

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US CDC Tuberculosis deaths in the United States 2024

Disease X Explained in Five

Donald Hackett — Sun, 17 Mar 2024 18:00:41 +0000

Reviewer:

Robert Carlson, MD

Numerous scientists are currently working to prevent the next pandemic in 2024. To prepare for it, countries need to take certain measures says the World Health Organization (WHO).

In February 2018, the WHO included the term "Disease X" in its Blueprint list of diseases for the first time.

According to the WHO, this concept represents the knowledge that a pathogen currently unknown to cause human disease could cause a serious international epidemic.

In a recent episode (#114) of the WHO series "Science in Five," Ana Maria Henao-Restrepo, Co-Lead R&D Blueprint for Epidemics, outlined the research and development needs that the world must invest in to prevent and prepare for the next pandemic.

Published on March 15, 2024, the unedited transcript is inserted below:

VGS We are talking about Disease X today and the priority list of pathogens. How does a bacteria or virus get on this list? And what do countries need to do to keep you safe from these pathogens? Here to talk about it is Dr. Ana Maria Henao-Restrepo. Welcome, Ana Maria. Let's talk Disease X. Is that a real disease that's circulating right now?

AHR Well, I think the first thing I want to clarify today is that there is no virus or bacteria circulating right now that is called Disease X and is causing disease. We are preparing for the future. So we are talking about a hypothetical disease and to give a name the scientists call it Disease X to prepare for the hypothetical virus or bacteria that in the future can cause large outbreaks or epidemics or pandemics.

There are many viruses and bacteria that can infect animals, including humans. For a few we already have vaccines, diagnostics and therapeutics. We know what are the viruses that we need to be alert to, we know what are the bacteria we need to be alert to, but there are many thousands of them. So we need to have a simplified way to refer to them without knowing which one will cause the next pandemic. And we call it Pathogen X.

VGS So, Ana Maria, talk to us about the WHO Priority List for Pathogens. Why do we need such a list and how does a pathogen get on that list?

AHR There are many viruses and bacteria that can infect humans and animals in general. So how do you go about preparing for them? You cannot investigate each of them in clear detail, so you have to have a strategy to deal with it. This is why WHO has invited hundreds of scientists to work with us to try to identify which ones have the pandemic potential.

Which ones we know now with the information we have today can cause severe disease and outbreaks. We also have a list of the ones that are not causing severe disease and outbreaks now, but that may change in the future. So we have to keep an eye on them.

So how do we prepare? So we do four things. First of all, we keep an eye. It means we have systems to monitor how they circulate among humans and animals, If they change, if they improve their ability to infect us and cause disease.

Second, we have to conduct research to understand how they infect us, how our immune system protects when they infect us. That's critical because it leads to the third step that is developing in advance vaccines, diagnostics and therapeutics that can potentially help us reduce the risk of being sick, reduce the risk of having severe disease, and reduce the risk of transmission if they cause an outbreak.

Also, we work very much on how to produce these vaccines and these diagnostics, and these therapeutics when we develop them, how we ensure that we produce enough of them, use technology to produce large amounts. How do we evaluate them to ensure they are safe? And they are indeed effective against the disease and the severe outcomes that we want to protect people from?

And finally, having this list also helps us to focus our collective efforts To see that with shared information, scientists talk to each other, we identify what we know and what is missing. And that way we maximize the capacity we have today to conduct research. In the end, what everybody wants to do and what the scientists want to do is to help governments to be prepared.

So if there is a new pathogen like we have with COVID emerging, that we are better prepared, that there are less people who get sick, less suffering, less economic damage, less problems for society.

The entire discussion is available at this WHO link.

Separately, the U.S. National Institutes of Allergies and Infectious Diseases developed a Pandemic Preparedness Plan to prepare for future public health emergencies caused by infectious diseases.

In February 2024, the U.S. NIH 'All of Us' Research Program confirmed more than 1 billion genetic variants, including about 275 million previously unreported genetic variants.

And the U.S. Project NextGen, a $5 billion initiative, has launched to develop the next generation of vaccines and therapeutics.

Sub Title:

WHO prepares for the next virus or bacteria pandemic

References:

WHO Episode #114 - Disease X - March 15, 2024

US NIH Precision Medicine Data

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WHO website March 15, 2024

Can This Vaccine Conquer Herpes

Karen McClorey Hackett — Sun, 10 Mar 2024 16:24:53 +0000

Reviewer:

Robert Carlson, MD

Despite extensive research and hundreds of millions of infections, no government agency has yet approved an effective vaccine to prevent herpes simplex virus 2 (HSV-2) infection.

While current herpes vaccine development focuses on glycoproteins, recent studies suggest T cell responses against specific HSV-2 antigens are more prevalent in asymptomatic individuals.

Therefore, vaccine development should consider these differences in immune response to create a vaccine that can stimulate T-cell responses against these antigens.

In eClinicalMedicine, part of The Lancet, Laure F Pittet and colleagues published results from their phase 3 clinical trial, which was conducted across multiple countries in late 2023 to assess the impact of the very old tuberculosis Bacillus Calmette-Guérin (BCG) vaccine's implications for recurrent herpes labialis.

The results demonstrated that, over a one-year follow-up period, the BCG group experienced reduced duration, frequency, severity, and impact on quality of life-related to recurrent herpes labialis compared to the control group.

Furthermore, in the BCG-immunised individuals, the time to the first recurrence was extended by 1.55 months compared with the control group (p = 0.02), indicating the potential benefits of BCG vaccination for individuals with herpes labialis (p = 0.003).

A 2020 systematic review also demonstrated the benefits of BCG vaccination for 78% of adult patients with recurrent genital or herpes labialis, with 37% experiencing long-term remission and a reduction in outbreak frequency or severity by 41%.

Although these results differ from a 1985 observational clinical trial by J M Douglas and colleagues, which found that BCG vaccination did not significantly reduce the recurrence rate of genital herpes or prolong the time to the first recurrence, discrepancies may be attributed to variations in sample size, BCG vaccine types, dosage, administration methods, and the immunological status and genetic backgrounds of vaccine recipients.

A cautious interpretation of these clinical trial results is necessary, as the authors acknowledge various study limitations.

Currently, there is no universal BCG vaccination policy.

As of March 10, 2024, about 10 BCG vaccine versions are available worldwide.

In the U.S., the Centers for Disease Control and Prevention recommends the BCG vaccine for TB and bladder cancer patients.

Sub Title:

BCG vaccination presents novel approach to preventing recurrent herpes labialis

Reference:

Exploring BCG vaccination as a novel approach to prevent recurrent herpes labialis

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Google News Keywords:

Herpes, HSV2, vaccinations

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THE LANCET October 2023

Old Vaccine Potentially Treats Liver Cancer

Donald Hackett — Fri, 23 Feb 2024 15:17:37 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

The Bacillus Calmette-Guérin (BCG) vaccine, which has been around for over a century and is known for enhancing the body's immunity against tuberculosis and other diseases, is a potential breakthrough in treating hepatocellular carcinoma (HCC).

HCC is the most common type of liver cancer and the third leading cause of cancer-related deaths globally.

According to the North American Association of Central Cancer Registries, an estimated 41,210 new HCC cases would be diagnosed in the United States in 2023.

A recent study led by UC Davis Health revealed that a single dose of the BCG vaccine significantly reduced liver tumor burden and prolonged the survival of mice with liver cancer.

This groundbreaking study is the first to demonstrate the promising effects of the BCG vaccine in treating liver cancer.

BCG vaccines are derived from the live bacteria Mycobacterium bovis and have been considered safe and widely used worldwide. As of 2024, about 16 versions of the original BCG vaccine are in use.

In the United States, Merck's TICE® BCG vaccine is FDA-approved but is only considered for people who meet specific criteria.

The results of this study, published on February 2, 2024, offer new hope for effective treatment of liver cancer and could potentially save countless lives, wrote these researchers.

Results indicate positive influences on hepatic fibrosis and metabolism, reducing lipid levels.

Spatial analysis underscores BCG's tumor-specific effects, inducing the enrichment of metabolic pathways and inhibiting various cancer-related pathways.

Furthermore, BCG promotes immune cell infiltration, including CD4+, CD8+ T cells, and M1 macrophages, in both v-akt murine thymoma viral oncogene homolog 1(AKT)/neutoblastoma RAS viral oncogene homolog and β-catenin positive HCC models.

Interestingly, blocking T cells, trained immunity, and Interferon-γ function reverses BCG's anti-HCC effects.

"HCC is very difficult to treat. This cancer is considered a cold tumor, which does not respond well to immunotherapy," said Yu-Jui Yvonne Wan, the study's senior author, and vice chair for research in the UC Davis Department of Pathology and Laboratory Medicine, in a press release on February 20, 2024.

"We had a good reason to believe the BCG vaccine could stimulate an immune response. So, we gave a dose of BCG to mice with liver cancer, and our surprise, it was enough to activate the body's immune system and reduce tumor load."

In conclusion, these researchers added that BCG emerged as a promising treatment option for HCC, characterized by a favorable safety profile and efficacy in inhibiting fibrosis, improving metabolism, and engaging trained immunity and T cells in therapeutic mechanisms.

The current treatment options for liver cancer, including surgery, radiotherapy, chemotherapy, immunotherapy, and liver transplant, have poor outcomes.

Sub Title:

BCG vaccine study focused on treating hepatocellular carcinoma

Reference:

BCG as an Innovative Option for HCC Treatment: Repurposing and Mechanistic Insights

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Association of Cancer Care Centers liver cancer heat map 2020

Is the U.S. CDC Expecting a Tuberculosis Outbreak

Donald Hackett — Thu, 18 Jan 2024 15:39:38 +0000

Reviewer:

Robert Carlson, MD

The U.S. Centers for Disease Control and Prevention (CDC) Division of Global Migration Health published enhanced instructions that define panel physicians' specific responsibilities in testing for and treating infectious tuberculosis (TB) disease among applicants from overseas.

As of January 16, 2024, the new TB screening summary from the CDC is as follows:

Applicants in all countries who are ≥15 years old must have a chest x-ray.
Applicants 2 years of age and older examined in countries with a World Health Organization (WHO)-estimated tuberculosis incidence rate of ≥20 cases per 100,000 population must have an interferon-gamma release assay (IGRA).
Panel physicians may advise applicants for whom testing is clinically indicated about HIV testing.

These instructions are specific to an immigration medical examination.

The molecular testing requirement, IGRA testing for adults, and changes to drug susceptibility testing defined in these instructions go into effect no later than October 1, 2024.

All other instructions components go into effect on January 24, 2024.

While the United States has traditionally reported very few TB outbreaks, this vaccine-preventable disease has impacted 192 countries and areas.

According to the WHO 2023 Global TB Report, an estimated 10.6 million people fell sick with TB in 2022, and 1.3 million people died from TB.

In 2022, most people who developed TB lived in Southeast Asia (46%), Africa (23%), and the Western Pacific (18%).

In the United States, the CDC reported on November 15, 2023, that there were 8,331 TB cases in 2022, an increase of just 5% from 2021.

However, the CDC says about 13 million people living in the U.S. may have a latent TB infection.

Furthermore, 73% of TB cases in persons for whom birth origin was known, cases occurred among non–U.S.-born persons.

TB can often be prevented with a 100-year-old vaccine.

Blessina Kumar, CEO of the Global Coalition of TB Advocates, confirmed that 16 different Bacille Calmette-Guerin (BCG) vaccines are available in 2024.

And various BCG vaccine candidates are under development in response to about 14 BCG sub-strains that have evolved.

In the U.S., Merck's TICE® BCG vaccine is available under specific requirements at most health departments but is not generally available at health clinics or pharmacies.

Sub Title:

Tuberculosis vaccines are globally available in 2024

References:

CDC - Tuberculosis Screening Summary 2024

TB outbreaks 2024

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Tuberculosis, BCG, vaccinations

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US CDC TB cases trends 2023