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GC Biopharma announced today that the World Health Organization (WHO) granted prequalification for BARYCELA, a varicella vaccine.

BARYCELA is a live attenuated varicella virus vaccine containing MAV/06 strain, a virus exclusively attenuated by GC Biopharma.

While containing a higher amount of virus, this new vaccine, compared to its previous product (Suduvax), shows higher product stability.

BARYCELA has also proved non-inferior in immunogenicity with an equivalent level of safety to Merck's Varivax®, an existing prequalified vaccine in the market.

In addition, BARYCELA is being produced in a state-of-the-art aseptic condition from cell culture and virus infection to purification to make it the world's single-only varicella vaccine produced without antibiotics.

WHO prequalification decision has made BARYCELA eligible for procurement by the United Nations agencies for national immunization programs. 

With the WHO's prequalification decision, MAV/06 strain has moved closer to being registered in the WHO Technical Report Series and the previously listed OKA strain.

According to the U.S. CDC, Varicella, known as chickenpox, is an acute infectious disease.

It is caused by the varicella-zoster virus (VZV), which is a DNA virus that is a member of the herpesvirus group. Primary infection with VZV causes varicella.

After the primary infection, VZV stays in the body as a latent infection.

Reactivating latent infection causes herpes zoster (shingles), and approved vaccines are available.

"We hope BARYCELA will continue our contribution to reducing the world's social and economic cost incurred by varicella outbreaks," said EC Huh, Ph. D., President of GC Biopharma, in a press release on February 19, 2023.

Developed in 1993, GC Biopharma's Suduvax was Korea's first and the world's second varicella vaccine.

Over 28 million doses of the vaccine have been sold worldwide.

GC Biopharma's strategy is to utilize the global supply network for Suduvax to distribute BARYCELA.

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The Florida Health Department recently reported 18 additional travel-associated dengue case were reported in week #6. 

At this pace, Florida may exceed its case reports for 2022, when 903 travel-associated dengue cases have been reported.

Florida is not alone in reporting dengue cases in 2023.

The Pan American Health Organization reported on February 19, 2023, that Brazil confirmed the highest number of dengue cases in the Region in 2022, with 2,363,490 cases (84%), followed by Nicaragua, Peru, Colombia, and Mexico.

 And the U.S. territory of Puerto Rico continues to report severe dengue cases in 2023.

While the U.S. Centers for Disease Control and Prevention issued a Watch - Level 1, Practice Usual Precautions travel notice regarding dengue outbreaks in 2022, it did not include Florida or Puerto Rico. 

Dengue is a disease caused by a virus spread through mosquito bites.

Furthermore, a recent study published by the Royal Society indicates the mosquitoes that carry dengue are expanding their range.

Using a regression approach, these researchers estimated that specific mosquitoes gained an average of 6.5 m of elevation per year, and the southern limits of their ranges are moving polewards 4.7 km per year. 

The good news is dengue is a vaccine-preventable disease.

As of February 19, 2023, two authorized dengue vaccines (Qdenga and Dengvaxia) are available in certain countries.

Dengue vaccination is not required to visit Florida or the Caribbean during 2023.

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Chemicals in rivers
Vaccines for chemical exposure are unavailable

Tuberculosis Outbreaks

Tuberculosis Outbreaks 2025

The World Health Organization (WHO) predicts that tuberculosis outbreaks will continue to pose a global health risk in 2025. The WHO issued an updated Global Tuberculosis (TB) Report 2025 in November. Between 2023 and 2024, the global rate of people falling ill with TB declined by nearly 2%, while deaths from TB fell by 3%. The WHO states that most people who develop TB reside in the Regions of Southeast Asia, Africa (specifically South Africa), Europe, and the Western Pacific. India, Indonesia, China, the Philippines, and Pakistan together accounted for over 50% of the global TB burden. As of March 2025, UK Health Security Agency (UKHSA) data showed a 13% increase in reported TB cases in 2024 (5,480) compared to 2023, resulting in more than 600 additional diagnoses in 2024 (in London and the Midlands) compared to 2023. 

Tuberculosis in Children 2025

The 2025 Tuberculosis Surveillance and Monitoring Report, released by the European Centre for Disease Prevention and Control (ECDC) and the WHO Regional Office for Europe on March 24, 2025, shows that children under 15 years of age accounted for 4.3% of those with new and relapsed TB in the WHO European Region, representing a 10% surge in pediatric TB for 2023, compared to 2022. The WHO estimates that 200,000 children die from TB annually.

Almost two-thirds of TB cases in children worldwide were either not reported or went undiagnosed and untreated. Of the children who developed TB in 2023, the diagnosis was confirmed in only 36%. Estimates show that about 67 million children with latent TB infection are at risk of developing active TB. In a prospective South African birth cohort study published by The Lancet in November 2024, M tuberculosis transmission was found to be consistently high throughout the first decade of life, leading to approximately 10% of children developing TB disease. 

Tuberculosis Outbreaks in the United States

After nearly three decades of consistent decline in TB in the United States, the infection rate began increasing in 2021. In 2024, 10,347 TB cases were provisionally reported by the U.S. CDC. The percentage increase in case counts (8%) and rates (6%) from 2023 to 2024. Thirty-four states and the District of Columbia reported increases in TB case counts. The CDC Morbidity and Mortality Weekly Report, published in June 2024, examined the most recent five years of data from the National TB Indicators Project. This data indicated that up to 13 million people in the U.S. (60 jurisdictions) live with latent TB infection. The CDC reports that four U.S. states combined accounted for half of all U.S. TB cases in 2022: California, Texas, New York (including New York City), and Florida.

On January 23, 2024, USAID published its Annual TB Report to Congress, which indicated that global TB case notifications increased by 70% in 2022 compared to 2021.

A study published in September 2024 showed that tuberculosis infection (TBI) disproportionately affects non-US-born persons. Among persons born in countries with high rates, 9.9% had TBI. In an April 2024 analysis of TB incidence rates for racial/ethnic populations, incidence rate ratios were 14.2 times higher among younger American Indian or Alaska Native females. In January 2024, the CDC Tuberculosis Yellow Book 2024 reported that immigrants from countries with a high TB burden and long-term residents of high-burden countries have a 10× greater incidence of TB than the U.S. national average.

Texas reported 1,235 TB cases in 2023, up from 1,100 in 2022. Data from 2023 indicates TB rates are accelerating in certain cities (DallasFort WorthHidalgo CountyHouston, and San Antonio) in 2024. In 2022, 7,415 Texans were exposed to TB. Public health departments treated over 2,900 people for TB infection in 2022, and 50 Texans died of TB, the second most in any state. Harris County Public Health was recognized by the CDC for its Tuberculosis Elimination Program in 2025. Harris County (Houston) reported the most TB cases (269) in 2022. In 2021, 998 TB patients were reported throughout Texas, representing a 12.5% increase from the previous year. In 2019, Texas's 32 border counties had an average TB incidence nearly triple the national rate. About 69% of people diagnosed with TB in Texas were non-U.S.-born.

Tuberculosis Vaccines

As of 2025, various TB vaccines have been authorized worldwide.

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Type 1 Diabetes Vaccines April 2023

Type 1 Diabetes Vaccines April 2023

According to the U.S. Centers for Disease Control and Prevention (CDC), Type 1 Diabetes (T1D) is caused when a person's pancreas doesn't produce enough insulin, which helps blood sugar enter human cells. Without insulin, blood sugar can't get into cells and builds up in the bloodstream. Studies aimed at blocking the immune attack on β cells in people at risk or individuals with very early onset type 1 diabetes show promise in preserving endogenous insulin production.

As of April 2023, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) had not approved a Type 1 diabetes vaccine. The search for vaccine therapies to improve blood sugar control continues in various countries.

Type 1 Diabetes Vaccine Candidates

Vaccination with BCGΔBCG1419c increased memory CD8+T cell-associated immunogenicity and mitigated pulmonary inflammation compared with BCG.

Preclinical study results indicate that red beet plants are suitable for producing a candidate oral vaccine based on GAD65 for the future preclinical and clinical testing of T1D immunotherapy approaches.

A research group at the University of Tampere has identified a prototype vaccine to prevent the viruses that may cause T1D.

Type 1 Diabetes and BCG Vaccination

Massachusetts General Hospital (MGH) published results from a study led by Denise Faustman in the peer-review journal Cell Reports on August 15, 2022, that found people with T1D vaccinated with 3-doses of bacille Calmette-Guerin (BCG) displayed fewer infectious disease symptoms, lesser severity, and fewer infectious disease events per patient. In addition, on June 25, 2021, researchers from MGH announced positive updates that BCG vaccination was associated with significantly lower blood sugars. On January 20, 2023, NYU Langone Health withdrew from this phase 2 clinical study. Last Update Posted: February 9, 2023.

The results from a study published on November 16, 2022 - BCG vaccinations drive epigenetic changes to the human T cell receptor: Restored expression in type 1 diabetes. In randomized controlled trials, BCG vaccinations were to improve autoimmune conditions, such as type 1 diabetes. 

According to research published in The Lancet Diabetes and Endocrinology on May 5, 2020, a novel vaccine candidate that uses a person’s own immune cells and vitamin D3 to treat type 1 diabetes is both safe and feasible. β-cell function and overall diabetic control remained stable during the 6 months of extensive monitoring.

In May 2022, the National Institute of Scientific Research in Quebec researchers published a study that found that early-life BCG vaccination did not reduce the risk of diabetes in adolescence. Still, when those children were older than 30, their risk of T1D was 35% lower.

Recent studies (Mar. 2020) concluded there is no robust evidence to support using the Bacillus Calmette-Guerin (BCG) vaccine to treat T1D, although the HbA1c levels tended to improve by augmenting aerobic glycolysis.

On February 27, 2020, the Journal of Internal Medicine published a meta-analysis study that concluded, 'New findings of immune and metabolic defects in T1D that can be corrected with repeat BCG vaccination.'

On May 22, 2020, Science Direct published a study: BCG Vaccinations Upregulate Myc, a Central Switch for Improved Glucose Metabolism in Diabetes. This is the first documentation of BCG induction of Myc and its association with systemic blood sugar control in a chronic disease like diabetes.

On June 21, 2018, the journal Nature published a study: Long-term reduction in hyperglycemia in advanced T1D. After year 3, BCG lowered hemoglobin A1c to near-normal levels for the next five years.

Type 1 Diabetes Injectable Drugs

November 17, 2022, the U.S. Food and Drug Administration approved Tzield (teplizumab-mzwv) injection to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients eight years and older who currently have stage 2 type 1 diabetes. 

Type 2 Diabetes

On May 13, 2022, the U.S. Food and Drug Administration approved Eli Lilly's Mounjaro injection to improve blood sugar control in adults with type 2 diabetes as an addition to diet and exercise. Mounjaro is a treatment and is not indicated for use in patients with type 1 diabetes and is not a vaccine.

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Chlamydia Vaccines

Chlamydia Vaccines 2025

Researchers are progressing with Chlamydia vaccine candidates in clinical trials in March 2025. However, the U.S. Food and Drug Administration (FDA), the United Kingdom, and the European Medicines Agency (EMA) have not approved a vaccine to prevent chlamydia infections, a common bacterial sexually transmitted pathogen. The Annals of Family Medicine journal published a study (23 (2) 136-144) on March 24, 2025, concluding that many women do not receive guideline-adherent treatment in primary care settings. For example, the time to treat chlamydia was longer for patients aged 50-59 years (time ratio relative to those aged 20-29 years = 1.61; 95% CI, 1.12-2.30).

Chlamydia Vaccine Candidates

The U.S. FDA has granted fast-track designation to Sanofi's mRNA vaccine candidate for preventing chlamydia infection. The decision announced on March 26, 2025, was based on the potential of the vaccine candidate to address a serious condition and an unmet public health need. Sanofi's multi-antigen chlamydia vaccine candidate proceeded to Phase 1/2 in 2024.

Statens Serum Institut's adjuvanted vaccine candidate (CTH522) has completed clinical Phase Ia and Ib testing in The Lancet Infectious Diseases and Research Square. The vaccine antigen CTH522 is a recombinant, engineered version of the C. trachomatis major outer membrane protein, comprising heterologous immunorepeats from four genital C. trachomatis serovars (D, E, F, and G). In April 2024, CTH522, with CAF01 or CAF09b, was found safe and immunogenic in the EU Horizon Program TRACVAC-funded phase 1 clinical trial. 85 μg CTH522-CAF01 induced robust serum IgG binding titers. Intradermal vaccination conferred systemic IgG neutralization breadth, and topical ocular administration increased ocular IgA formation. 

LinKinVax, linked to the Vaccine Research Institute, is conducting pre-clinical research on the Anti.CD40.chlamydia vaccine candidate.

The UNC Chlamydia Vaccine Initiative is funded by the National Institute of Allergy and Infectious Diseases to accelerate the development of a novel vaccine that prevents CT ascension in the female genital tract, eliminating CT-associated PID and infertility.

A safe and effective multi-epitope vaccine was designed using an immunoinformatics approach to prevent C. pneumoniae infection. As of September 12, 2023, the study's results provided novel strategies for developing C. pneumoniae vaccines; however, future experimental validation of this vaccine candidate is needed to determine its efficacy, effectiveness, and safety.

Chlamydia Tests

The U.S. FDA granted marketing authorization to LetsGetChecked for the Simple 2 Test on November 15, 2023. This is the first diagnostic test for Chlamydia and gonorrhea with at-home sample collection to be granted marketing authorization. A new WHO report on the Diagnostics Landscape for Sexually Transmitted (July 2023) Infections highlights diagnostics available to support scale-up of screening for STIs, including Chlamydia.

Chlamydia Overview

On April 21, 2023, the U.S. Centers for Disease Control and Prevention (CDC) announced Chlamydia was the most common sexually transmitted disease (STD) in the U.S. in 2021, with 1,644,416 cases, a 3.9% increase compared with 2020, with 58% of all chlamydia cases occurring among people aged 15 to 24 years. If undetected or left untreated, the STD Chlamydia represents a significant cause of pelvic inflammatory disease and infertility in women. In the United Kingdom, chlamydia diagnoses (all ages) increased by 24.3% to 199,233 in 2022.

Chlamydia Vaccine News

April 11, 2024 - The Lancet published an Editorial - Immunological responses in a Chlamydia trachomatis vaccine trial.

May 8, 2023 - Australian scientists have begun vaccinating wild koalas against Chlamydia in an ambitious field trial in New South Wales. A Chlamydia vaccine for koalas has shown promise for replacing antibiotic treatment in mild ocular Chlamydia disease. 

April 12, 2023—Blue Water Vaccines Inc. announced the signing of a Sponsored Research Agreement with the University of Texas Health Science Center at San Antonio to fund a non-human primate study to evaluate the efficacy of BWV-401, a live attenuated, orally delivered Chlamydia vaccine. In this new effort, BWV will fund an NHP study to evaluate the effectiveness of BWV-401 further and provide additional support for development towards human clinical trials.

April 6, 2023—The NEJM journal published the findings from Original Research, which disclosed that the incidence of Chlamydia disease was two-thirds lower following treatment with doxycycline compared to standard care.

March 20, 2023 - Kathryn Frietze, Ph.D., an assistant professor in The University of New Mexico's Department of Molecular Genetics & Microbiology, received a five-year grant from the U.S. NIH for $250,000 per year to support efforts to develop a vaccine for Chlamydia.

February 20, 2023 - Researchers from the University of Washington, Kenya Medical Research Institute, and Hennepin Healthcare Research Institute announced results from a clinical trial demonstrating that doxycycline taken after sex does not prevent bacterial sexually transmitted infections (Chlamydia or gonorrhea) among women. 

May 30, 2022 - The journal Vaccines published: Epitope-Based Vaccines against the Chlamydia trachomatis Major Outer Membrane Protein Variable Domain 4 Elicit Protection in Mice. Immunization with these MS2 VLPs protected from vaginal Chlamydia infection in a murine challenge model. These data suggest that short peptide epitopes targeting the MOMP-VD4 could be appropriate for Ct vaccine design when displayed on an immunogenic bacteriophage VLP vaccine platform.

January 12, 2022 - The journal Vaccines published: Immunogenicity and Protective Capacity of a Virus-like Particle Vaccine against Chlamydia trachomatis Type 3 Secretion System Tip Protein, CT584. These data demonstrate the potential for antibodies against the T3SS to contribute to protection against C. trachomatis and the value of VLPs as a novel platform for C. trachomatis vaccines.

April 28, 2021 - Chlamydia trachomatis vaccines for genital infections: where are we, and how far is there to go? The first Phase, one clinical trial of a C. trachomatis vaccine to protect against genital infections, was completed.

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Chlamydia is a common STD among women. The U.S. FDA has not approved a vaccine to prevent chlamydia infection.
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RSV Monoclonal Antibody

Respiratory Syncytial Virus (RSV) Monoclonal Antibody Therapy 2025

According to the U.S. Centers for Disease Control and Prevention (CDC), respiratory syncytial virus (RSV) is a leading cause of respiratory disease in infants and young children. The European Medicines Agency (EMA) and the CDC say RSV monoclonal antibody (mAb) therapy prevents serious lower respiratory tract disease (LRTD) caused by RSV in newborns and young children during their first RSV season. In 2024, the World Health Organization (WHO) published its preferred product characteristics for mAb therapy that delivers passive immunization against RSV disease.

A CDC report released on May 8, 2025, demonstrated that in 2024–25, RSV hospitalization rates were 45-52% lower in infants younger than 3 months old and 28-43% lower in infants younger than 8 months old compared to the 2018-2020 seasons before product introduction. In the United States, among mothers with an infant younger than eight months, 41.3% reported that their infant received nirsevimab as of March 2024.

RSV Monoclonal Antibody Availability 2025

AstraZeneca and Sanofi co-developed Beyfortus™ (Nirsevimab-alip), a U.S. FDA-approved, single-dose, long-acting mAb designed to protect infants through their first and second RSV seasons. The European Commission granted Beyfortus worldwide approval on November 4, 2022, followed by approvals from the UK, Canada, and the USA. 

Merck's ENFLONSIA™ (Clesrovimab, MK-1654) is an extended half-life monoclonal antibody (mAb) developed as a passive immunization to prevent RSV-associated medically attended lower respiratory infections during the first RSV season. A phase 2/3 clinical trial result published in The New England Journal of Medicine confirmed that clesrovimab mitigates the risk of viral resistance and reduces the risk of viral escape. 

Synagis® (Palivizumab) is a multi-dose injectable RSV antibody that provides one month of protection, requiring five injections to cover a typical RSV season. The U.S. FDA (1998) and Canada, Japan, Israel, the U.K., and India (2023) have approved Synagis to protect at-risk infants against RSV.

Motavizumab is a discontinued investigational RSV mAb. MedImmune filed the original BLA in January 2008.

RSV Monoclonal Antibody Candidates

Shanghai Ark Biopharmaceutical Co., Ltd. announced on November 23, 2023, that it had received IND approval from the National Medical Products Administration in China for its novel antibody, AK0610, which targets RSV. The drug is anticipated to protect infants throughout the entire RSV season. ArkBio licensed the drug's intellectual properties from the Institute of Microbiology, Chinese Academy of Sciences, Beijing Children's Hospital, Capital Medical University, and National Center for Children's Health.

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RSV monoclonal antibody therapies deliver passive immunization.
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During the year since Malawi confirmed its first case of wild poliovirus patient in 30 years, more than 33 million children across five African countries have been vaccinated against the virus.

About 80 million polio vaccine doses have been administered since mid-2022.

A total of nine wild poliovirus cases have been reported, with one in Malawi and eight in neighboring Mozambique, since the declaration of an outbreak in February 2022 in Malawi.

The last confirmed case to date was in August 2022 in Mozambique.

The wild poliovirus in Malawi and Mozambique originated from Pakistan, one of the two last endemic countries.

"Southern Africa countries have made huge efforts to bolster polio detection, curb the spread of the virus and ensure that children live without the risk of infection and lifelong paralysis," said Dr. Matshidiso Moeti, World Health Organization (WHO) Regional Director for Africa, in a press release on February 17, 2023.

"We continue to support the polio control efforts across the region so that every child receives the protection they need."

And at least five more are planned for 2023 in the five countries.

Polio is highly infectious and affects unimmunized or under-immunized children.

There is no cure for polio, and it can only be prevented by immunization.

Children worldwide remain at risk of wild polio type 1 as long as the virus is not eradicated in the remaining areas where it is still circulating.

There are WHO-approved polio vaccines offered throughout Africa.

These African countries were identified in the U.S. CDC's Global Polio Alert - Level 2, Practice Enhanced Precautions alert issued in January 2023.

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The peer-review JAMA Network published an Original Investigation focused on the most appropriate monoclonal antibody (mAb) for preventing respiratory syncytial virus (RSV) in children.

This analysis was essential since RSV is a leading cause of respiratory disease in children and the primary cause of hospitalization for viral respiratory infections.

Published on February 17, 2023, this systematic review and network meta-analysis comparing the efficacy and safety of 4 mAbs for preventing RSV infection in children found associations with the improvement of clinically meaningful outcomes and no significant associations with RSV-related adverse effects and mortality.

These findings suggest that motavizumab, nirsevimab, and palivizumab are associated with reduced rates of RSV infections and hospitalizations.

Similar results were observed in the rate of supplemental oxygen use.

While RSV vaccine candidates are completing late-stage clinical studies, mAbs targeting RSV prevention have been U.S. Food and Drug Administration (FDA) for years.

For example, the U.S. CDC CDCHAN-00479 stated on November 4, 2022, that eligible high-risk children should receive the mAbs palivizumab (Synagis) treatment according to AAP guidelines to prevent RSV-associated hospitalizations. 

Recently, the Biologics License Application for nirsevimab (Beyfortus®) was accepted for review by the FDA on January 5, 2023. The FDA's Prescription Drug User Fee Act date for its decision is in the third quarter of 2023.

If approved, nirsevimab would become available in the U.S. for the 2023/2024 RSV season. 

Nirsevimab (MEDI8897) was developed in partnership between AstraZeneca and Sanofi.

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UK reports 95 Shigella sonnei cases related to travel