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Bacille Calmette-Guérin (BCG) Vaccine Clinical Trials, Dosage, Efficacy, Indications, Side Effects

In 1921, French scientists Albert Calmette and Camille Guérin developed the initial Mycobacterium bovis Bacillus Calmette-Guérin (BCG) vaccine. The BCG vaccine was designed to protect cattle from bovine tuberculosis and was administered to a newborn baby in Paris. BCG-induced whole-blood cytokine levels differ by age, vaccine formulation, and concentration. In addition, BCG-induced cytokine production correlated with CFU, suggesting that mycobacterial viability may contribute to BCG-induced immune responses. Mycobacterium tuberculosis (Mtb) is the etiological agent of tuberculosis (TB).

Since 1921, BCG vaccines have been administered approximately 4 billion times worldwide. BCG vaccines initially targeted against TB, tuberculosis meningitis, and non-specific protective effects against other respiratory tract infections and certain cancers. In naive adult populations, the BCG vaccine, administered as an intradermal injection, takes at least two years to achieve complete protection due to several off-target effects. A study published in September 2023 characterized the mechanisms of BCG revaccination-induced trained immunity (TI). Data highlights a balanced immune response comprising pro- and anti-inflammatory mediators, a feature of BCG revaccination-induced immunity. These immune responses have been used to prevent and treat various diseases, including bladder cancer, herpes, human papillomavirus, leprosy, and Buruli ulcers.

BCG immunization or MTB infection of the human body induces an increase in gene rearrangement and metabolism in intrinsic immune cells, such as macrophages, NK cells, and monocytes, leading to the increased secretion of cytokines, including TNF-α, IL-1β, and IL-6. During reinfection with other pathogens, such as HSV-1, these trained innate immune cells rapidly secrete TNF-α, IL-1β, IL-6, and other cytokines to eliminate invading pathogens.

A study reported in July 2024 found that the immune response to M. tuberculosis (Mtb) is associated with the activation of type 1 T helper (Th1) responses and the production of a range of cytokines, including tumor necrosis factor-alpha (TNF-α) and interferon-gamma (IFN-γ). Genetic defects, such as mutations in cytokine receptors like interleukin-12 (IL-12) or IFN-γ, enhance the cell differentiation, leading to increased susceptibility to progressive mycobacterial disease. In addition, the neutralization of TNF-α by monoclonal antibodies (such as those used in treating rheumatoid arthritis) can prevent LTBI reactivation. 

On January 19, 2021, Dr. Camille Locht, research director at Inserm's Institut Pasteur de Lille, stated, "The BCG can train the cells of the innate immune system to make them more fit and active to fight against other diseases." The U.S. National Institutes of Health (NIH) says the BCG vaccine is safe. The BCG vaccine is used in many countries (Mexico, the U.K., Canada) for emerging therapeutic off-target benefits, such as treating bladder cancer. As of February 2023, the biological interaction between M. tuberculosis (Mtb) and the human host is complex and only partially understood, according to the World Health Organization (WHO). The WHO 2022 Report says BCG vaccination should continue for all infants soon after birth, except for those living with HIV in high tuberculosis-prevalence settings. The WHO adopted requirements for the BCG vaccine in 1965, and these were updated in 1978 to reflect the increased knowledge of vaccinations and the change to freeze-dried preparations. These were modified in 1985 to amend requirements concerning the expiry date. In its thirteenth report, the WHO Expert Committee on Biological Standardization considered formulating international requirements for manufacturing and controlling the BCG vaccine. On September 30, 2022, the WHO published consolidated guidelines on TB, Module 3. The WHO recommends BCG vaccination at birth in countries where tuberculosis is endemic. In 2024, the U.K.'s NHS states that the BCG vaccine will be particularly beneficial in protecting babies and young children against more severe forms of TB.

On August 5, 2022, new research (MIS BAIR) led by the Murdoch Children's Research Institute in Australia and published in the peer-reviewed Science Advances journal showed how BCG vaccination produces 'trained immunity responses' lasting more than 14 months after administration. On August 15, 2022, research findings published by the Cell Reports Medicine journal suggested that the BCG platform protects against infectious diseases and that vaccine efficacy takes 1-2 years to manifest, but the protection may last decades. The Rockefeller Foundation announced on September 20, 2022, that it would commit US$15 million to the Global Fund to Fight AIDS, TB, and Malaria.

BCG Vaccine United States

Merck TICE® BCG vaccine is an attenuated, strain tice live antigen preparation of Mycobacterium bovis. The TICE strain was developed at the University of Illinois from a strain originating at the Pasteur Institute. Since 2012, Merck & Co. has been the supplier of the TICE BCG vaccine in the U.S. Merck confirmed it was experiencing a global shortage due to the growing demand for BCG vaccines. In October 2020, Merck announced plans to construct a manufacturing facility in Durham, North Carolina, to expand production of the TICE BCG vaccine.

The U.S. Centers for Disease Control and Prevention (CDC) states that the BCG vaccine is not generally recommended for use in the U.S. due to the minimal risk of infection with Mycobacterium tuberculosis. The CDC recommends BCG vaccination only for children who have a negative tuberculin skin test and are at ongoing risk of exposure to tuberculosis. BCG vaccination may be recommended for older children who have an increased risk of developing TB, such as children who have recently arrived from countries with high levels of TB, including those in Africa, the Indian subcontinent, parts of southeast Asia, parts of South and Central America, and parts of the Middle East, and children who have come into close contact with somebody infected with respiratory TB. Many foreign-born persons have been BCG-vaccinated. BCG is used in many countries with a high prevalence of TB to prevent childhood tuberculous meningitis.

BCG Vaccines 2025

As of 2025, various BCG vaccines are available globally, including TUBERVAC-rBCG, BCG vaccine AJV (A.J. Vaccines), VERITY-BCG™, France BCG vaccine (Pasteur 1173P2), Brazil strain (BCG oral Mearou RJ), Bulgarian substrain (Sofia SL222), Japan 172 strain (Tokyo 172-1), and BCG-Denmark 133.

BCG Vaccination Benefits For Infants

A study published by the BMJ in September 2025 concluded that in newborn babies weighing <2000 g in intensive care, BCG-OPV administered at a median age of 0.9 days reduced all-cause neonatal mortality, owing to a decrease in deaths from infections other than tuberculosis.

BCG Vaccine Alzheimer's Disease Dementia

On August 24, 2023, a systematic review and meta-analysis of BCG administration on the risk of dementia in bladder cancer patients found the pooled HR was 0.55 (0.42–0.73), indicating that BCG exposure or treatment reduced the risk of incident dementia by 45%. The JAMA Network published an Original Investigation on May 19, 2023, led by investigators at Massachusetts General Hospital and Brigham and Women's Hospital. The investigation concluded that the BCG vaccine was associated with a significantly lower rate and risk of Alzheimer's disease and related dementia in a cohort of patients with bladder cancer when accounting for death as a competing event. This phase 2 clinical trial is ongoing.

A mini-review published on June 27, 2022, highlights how immune cells can mediate the relationship between BCG vaccination and AD, thereby supporting the health of the central nervous system. On February 22, 2022, MDPI published "BCG Vaccination and Plasma Amyloid: A Prospective, Pilot Study with Implications for Alzheimer's Disease," in which participants tended to have higher values of the Aβ42/Aβ40 ratio after receiving the BCG vaccine. On November 7, 2019, researchers at the Hadassah-Hebrew University Medical Centre collected the data of 1,371 people who had or had not received BCG as part of their treatment for bladder cancer. They found that just 2.4% of the patients treated with BCG developed Alzheimer's over the following eight years, compared with 8.9% of those not given the vaccine.

BCG Vaccine Bladder Cancer

The study of BCG anti-tumor activity began in 1929. Since 1977, BCG vaccination has been the standard therapy for treating high-risk nonmuscle-invasive bladder cancer (NMIBC) patients to avoid the recurrence and progression of the disease. BCG is the most common intravesical immunotherapy for treating early-stage bladder cancer, according to Cancer.org. BCG vaccination induces the recruitment and polarization of macrophages towards a pro-inflammatory phenotype, accompanied by the induction of the inflammatory cytokines TNF-α, IL-1β, and IL-6 in the tumor microenvironment. Macrophages directly induced apoptosis of human cancer cells through zebrafish TNF signaling.

Serum Institute of India's BCG vaccine is exported to Canada for immunotherapy to treat bladder cancer. In Australia, intravesical immunotherapy with BCG is approved. On April 22, 2024, the U.S. FDA approved the multi-dose ANKTIVA for BCG-unresponsive non-muscle Invasive Bladder Cancer. The End Drug Shortages Alliance confirmed in 2023 that about 20% of the organizations were not providing complete BCG vaccination routines to eligible cancer patients. When comparing BCG strains, the Tice stain showed a relatively high probability of recurrence compared with the Connaught (RR, 1.29; 95% CI 1.01–1.64) and RIVM (RR, 2.04; 95% CI 1.28–3.25) strains.

BCG Vaccine Diabetes

Various studies are investigating whether BCG vaccine therapy can enhance blood sugar control in Type 1 Diabetes by altering metabolism. In January 2023, PLOS ONE published the results of two observational studies. The epidemiological evidence analyzed here suggests that BCG may play a role in the prevention of type 1 diabetes (T1D) but does not support its role in preventing type 2 diabetes (T2D), most likely due to the interference of metformin. Our ecological analysis of global data suggests a potential role for neonatal BCG in preventing type 1 diabetes (T1D) and, to a lesser extent, type 2 diabetes (T2D). Researchers from Massachusetts General Hospital (MGH) presented positive updates in 2021 on their trials of the BCG vaccine, which aim to safely and significantly lower blood sugar levels. Over the course of three years, BCG restores the gene expression pattern of Tregs in type 1 diabetics to a pattern consistent with that of non-type one control subjects. In June 2018, an MGH research team published in npj Vaccines that three years after receiving two administrations of the BCG vaccine, four weeks apart, all members of a group of adults with longstanding type 1 diabetes showed an improvement in HbA1c to near-normal levels. This improvement persisted for the following five years.

BCG Vaccine Eczema

The Murdoch Children's Research Institute's initial study findings, published in the journal Allergy on August 24, 2021, showed that the BCG vaccine had a modest beneficial effect in preventing eczema in high-risk infants. However, a single dose of BCG-Denmark soon after birth could reduce the incidence of eczema in infants with two atopic parents.

BCG Vaccination Endometriosis

A mini-review published in 2021 addresses the possible use of BCG as a therapeutic for endometriosis, a syndrome of chronic pelvic pain due to ectopic growth of endometrial-type tissue outside of the uterine lining. The immune response to endometriosis reveals a complex balance between systemic pro-inflammatory immune activation and local anti-inflammatory characteristics that permit tumor growth. Lesions of endometriosis have an immune-cell-rich stroma with aberrant expression of pro- and anti-inflammatory cytokines, including IL-16, IL-18, and IL-1. BCG vaccination has been shown to alter the secretion of pro-inflammatory cytokines.

BCG Vaccine Herpes

The Lancet's eClinicalMedicine published results from a phase 3 clinical trial conducted across multiple countries on October 16, 2023, assessing the impact of BCG vaccination on recurrent herpes labialis. The study's results suggest that BCG-induced non-specific immune responses can enhance the body's immune response, particularly in males with a history of frequent recurrences. 

A systematic review of Medline, EMBASE, and PubMed in June 2020 identified 16 articles that were deemed relevant, comprising eight animal and eight human studies (301 patients). In nonrandomized human studies (that failed to control for a placebo effect), BCG vaccination appeared beneficial in 78% of adults with recurrent herpes genitalis or labialis, with 37% being recurrence-free for an extended period, 41% experiencing less frequent or severe episodes, and only 22% reporting no change. In the two studies on recurrent herpes labialis, 94% appeared to benefit from BCG. The one randomized controlled trial used an intervention in the control group with immunomodulatory effects, which limited its interpretation. In conclusion, the BCG vaccine is a readily available vaccine candidate that can help decrease diseases associated with HSV infection.

BCG Vaccine HIV

Coinfection with Mtb and HIV is a lethal combination, says the WHO. In sub-Saharan Africa, where HIV is most prevalent, the annual incidence of TB has risen to more than 300 cases per 100,000 inhabitants. In some of these places, nearly 50% of the HIV-infected population is coinfected with TB, and more than two-thirds of TB patients are infected with HIV. The lifetime risk of developing TB is as high as 30-50% for HIV-infected persons. In some parts of Southeast Asia, an estimated 20-25% of TB cases will be directly attributable to HIV, according to the WHO.

For neonates born to mothers with an unknown HIV status and neonates with an unknown HIV status born to HIV-infected mothers (regardless of their ART status), the WHO recommends BCG vaccination, as the benefits outweigh the risks. For a neonate confirmed by virologic testing to be positive for HIV, it is recommended that BCG vaccination be delayed until ART has been started.

Experts at Fred Hutchinson Cancer Center suggested in a study published in The Lancet HIV on October 11, 2022, that future TB vaccine development clinical trials should ensure people living with HIV have access to safe and effective TB vaccines.

On June 27, 2022, The Lancet Infectious Diseases published the results from a phase 2 study on HIV-infected children in South Africa. The researchers' Interpretation: The VPM1002 vaccine candidate was less reactive than BCG and was not associated with serious safety concerns. Both vaccines were immunogenic, with higher responses to the BCG vaccine.

In October 2020, the journal Nature published a BCG vaccine review that stated 'the potential TB vaccine candidates that can be exploited for use as a dual vaccine against TB/HIV copandemic (ii) progress made in the realm of TB/HIV dual vaccine candidates in a small animal model, NHP model, and human clinical trials the failures and promising targets for a successful vaccine strategy while delineating the correlates of vaccine-induced protection.'

BCG Vaccine Leprosy

Repeat BCG vaccination is standard practice in many countries to prevent Hansen's disease (leprosy). In 2018, the WHO included leprosy in its recommendation for single-dose BCG vaccination.

BCG Vaccine Liver Cancer Tumors

A study published in Advanced Science by UC Davis Health in February 2024 found that a dose of the BCG vaccine reduced liver tumor burden and extended the survival of mice with liver cancer. The study is the first to show BCG vaccinations as a potential treatment for hepatocellular carcinoma, a condition often associated with unfavorable treatment outcomes. Vaccination was characterized by a favorable safety profile and efficacy in inhibiting fibrosis, improving metabolism, and engaging trained immunity and T cells in therapeutic mechanisms.

BCG Vaccine Tuberculosis

Tuberculosis (TB) is a vaccine-preventable disease, says the WHO. A study titled "Efficacy of BCG Vaccine in the Prevention of Tuberculosis: Meta-analysis of the Published Literature" was published in 1994. On January 24, 2023, PLOS Medicine published a research article titled "The Cost and Cost-Effectiveness of Novel Tuberculosis Vaccines in Low- and Middle-Income Countries: A Modeling Study." Our analysis projected that an effective new TB vaccine could offer significant health and economic benefits from 2028 to 2050. The Lancet published an early-release survey on August 10, 2022 - Infant BCG vaccination and risk of pulmonary and extrapulmonary TB throughout the life course: a systematic review and individual participant data meta-analysis. Interpretation: Our results suggest that BCG vaccination at birth prevents tuberculosis in young children but is ineffective in adolescents and adults. Immunoprotection, therefore, needs to be boosted in older populations.

The WHO's Global Tuberculosis Report 2024 highlights mixed progress in the global fight against TB. While the number of 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.

BCG Vaccine Yellow Fever

The study demonstrated the effects of BCG vaccination on genome-wide histone modifications induced in trained monocytes. These modifications are associated with reduced yellow fever virus viremia levels due to increased IL-1β production and release.

BCG Vaccine for Children

BCG vaccination at birth or in infancy significantly reduces the risk of TB. The potential implications for child health are substantial, according to a study published in October 2020. For example, if BCG vaccination were given to children at birth, if higher measles vaccination coverage could be obtained, if diphtheria, tetanus, and pertussis-containing vaccines were not provided with or after the measles vaccine, or if the BCG strain with the best non-specific effects could be used consistently, then child mortality could be considerably lower. In 2005, all EU countries, including Andorra, Bulgaria, Norway, Romania, and Switzerland, participated in a survey on BCG vaccination in children. 

BCG Vaccine Pregnancy

BCG vaccination should not be given during pregnancy. However, no harmful effects on the fetus have been observed, and further studies are needed to prove its safety.

BCG Vaccine Dosage

In its thirteenth report, the WHO Expert Committee first considered establishing international requirements for the manufacture and control of the BCG vaccine in the context of Biological Standardization. Approved dose: BCG vaccine can be given either cutaneously or intradermally. Research is currently being conducted on respiratory administration, as humans' natural infection and sensitization to Mycobacterium tuberculosis typically occur in the respiratory system. The timing and dose of BCG vaccination were assessed by the 1995 Tuberculin Vaccination Survey (US FDA), Medline.gov, the U.K., 2020, and WHO. The intact vials of BCG VACCINE should be stored refrigerated at 2–8°C (36–46°F). This agent contains live bacteria and should be protected from direct exposure to the environment. When used to protect against TB, BCG is injected into the skin. Keep the vaccination area dry for 24 hours after receiving the vaccination, and keep it clean until the vaccination area is indistinguishable from the surrounding skin.

BCG Vaccine Side Effects

If you experience any unusual or severe symptoms after receiving this vaccine, tell your healthcare provider promptly or report them to the Vaccine Adverse Event Reporting System at www.vaers.hhs.gov.

BCG Vaccine United Kingdom

In the U.K. and various countries, BCG vaccination is administered to newborn infants at risk of TB. The WHO suggests that BCG programs for different age groups are equally effective against TB during puberty. BCG vaccines have effectively protected children against the rarer, severe forms of TB, such as TB meningitis. The Lancet Global Health published a study in September 2022 that found that BCG vaccination at birth protects against TB among children under five.

Public Health England (PHE) announced on July 27, 2021, that eligible babies should be offered the BCG vaccine at 28 days of age or soon after. BCG vaccination is recommended for babies up to 1 year old, and BCG vaccination may also be recommended for older children who have an increased risk of developing TB. On September 15, 2021, the U.K.'s PHE updated its fact sheet, which had previously been published in The Lancet on September 7, 2021, and in Cancer Immunology on June 24, 2022. Epidemiologist   Christine Stabell Benn and colleagues found (Mar. 2012) that BCG administered to children with low birth weight reduced all-cause mortality in these children by about 40% in the first year of life.

BCG Vaccine Price

UNICEF data show that the price awarded for the BCG vaccine per dose is nominal. The U.S. CDC Vaccine Price List was last updated in December 2022; many pharmacies in the U.S. charge over $100.00 for a single vial of BCG vaccines. According to various reports, the global TB Vaccine revenue is expected to increase by over 3% annually by 2027. Additional information on the BCG vaccine discount is posted at InstantRx™.

BCG Vaccine Clinical Trials

BCG is currently involved in active clinical trials covering various conditions. Click here to review the various ongoing clinical trials. 

NanoVax Herpes Simplex Virus Vaccine Description 2022

NanoVax is an adjuvant platform used in the development of a vaccine candidate that will provide protection against the two viruses that can cause genital herpes. The subunit vaccine composition comprises isolated surface glycoproteins from herpes simplex viruses, fusion proteins, or fragments mixed in varied combinations with a nanoemulsion, which is a potent immune enhancer.

NanoVax Indication

This vaccine candidate will provide protection against HSV1 and HSV2, two viruses that cause genital herpes.

NanoVax Dosage

NanoVax is administered intranasally.  

Intranasal NanoVax platform elicits both mucosal and systemic immunity through its novel oil-in-water nanoemulsion (NE) adjuvant, offering a unique advantage to combat sexually transmitted infections (STIs) including genital herpes.

The mucosal immunity elicited by intranasal NE vaccines provides critical protection against infections at the port of entry by which a pathogen enters the body.

The intranasal NanoVax HSV vaccine has demonstrated safety and efficacy in both prophylactic and therapeutic animal models for genital herpes.

In a prophylactic guinea pig study, the intranasal vaccine prevented genital herpes infection in 92 percent of animals vaccinated.

Therapeutic study animals previously infected with genital herpes who received the BlueWillow NanoVax vaccine reduced recurrent lesions and viral shedding by more than 50 percent compared to animals who received no treatment.

NanoVax News 2018 - 2022

September 21, 2021 - Announced the formation of the Company’s Scientific Advisory Board (SAB) with three leading viral infectious disease experts. The SAB will provide strategic and scientific counsel to BlueWillow’s clinical programs. Robin Isaacs, M.D., Akiko Iwasaki, Ph.D. and Steve Projan, Ph.D. are newly named members of the SAB.

July 23, 2019 - Announced the issuance of U.S. patent number 10,206,996 to BlueWillow for the development of an intranasal NanoVax® herpes simplex virus (HSV) vaccine. The patent protects the use of BlueWillow’s unique NanoVax adjuvant platform in the development of a vaccine that provides protection against HSV-1 and HSV-2, the two viruses that can cause genital herpes.

May 7, 2018 - NanoBio Corporation, a clinical-stage biopharmaceutical company, announced that it has changed its corporate name to BlueWillow Biologics® in conjunction with the closing of a $10 million Series A financing. The Series A financing round was led by North Coast Technology Investors, Line Moon Ventures and the University of Michigan through its MINTS initiative.

Recent research conducted by the University of Cincinnati in conjunction with BlueWillow has demonstrated that an intranasal NE vaccine elicits protection in both the prophylactic & therapeutic guinea pig models for HSV-2.

SKYZoster™ Shingles Vaccine 2023

SK bioscience SkyZoster (NBP608) is a live-attenuated zoster vaccine developed in South Korea. The vaccine was approved in South Korea by the Ministry of Food and Drug Safety (KMFDS) in September 2017 based on the results of clinical trials conducted in domestic and global institutions.

SK bioscience is growing into a domestic and global vaccine developer by continuously making investments and establishing infrastructure for vaccine development. For further information, please visit https://www.skbioscience.co.kr/en/main.

SkyZoster Availability 2023

SkyZoster is authorized in South Korea, Thailand, and Malaysia. SK bioscience plans to submit SKYZoster™ Pre-Qualification to the WHO to further accelerate the vaccine's approval for overseas emerging markets, such as Southeast Asia and developing countries.

SkyZoster Indication

This live attenuated vaccine is indicated for adults over the age of 50 to prevent Shingles (Herpes Zoster). It is contraindicated for individuals with a history of hypersensitivity reactions to gelatin or any other component in SKYZoster.

SkyZoster Dosage

Sky Zoster is administered as a single dose by subcutaneous injection into the outer aspect of the upper arm as one full dose (approximately 0.5 mL) and should not be injected intravascularly or intramuscularly. Keep refrigerated at 2-8°C in an airtight container away from light.

SkyZoster News 2023

February 28, 2023 - SK Bioscience said its shingles vaccine Skyzoster has taken the top market share position in 2022.

January 9, 2023 - SK bioscience announced that the company has received a biologics license application approval of the 'SKYZoster™' from the National Pharmaceutical Regulatory Agency in Malaysia.

May 20, 2019 - The SkyZoster vaccine study's results found ‘no statistically significant difference between the 2 groups in terms of the geometric mean spot numbers determined by IFN-γ and IL-2 ELISPOT assays at 6 weeks post-vaccination.’ 

October 9, 2017 - South Korean drug regulators granted approval to SK Chemicals’ Zoster vaccine.

SkyZoster Clinical Trials

Clinical Trial NCT03120364:  Immunogenicity and Safety of NBP608 Compared to Zostavax in Healthy Adults Aged 50 and Over: This study assesses non-inferiority by comparing GMR(Geometric Mean Ratio) of NBP608 to Zostavax which are evaluated by gpELISA (Glycoprotein Enzyme-Linked Immunosorbent Assay). A total of 824 healthy subjects (412 subjects per treatment arm) aged 50 and over are enrolled, and each subject is administered with a single dose of vaccine which is randomly assigned.

This is a multi-center, randomized, double-blinded, parallel-group study to assess the Immunogenicity and safety of NBP608 compared to Zostavax which are indicated for the prevention of herpes zoster. Total of 824 healthy subjects aged 50 and over are enrolled, and each subject is administered with a single dose of vaccine which is randomly assigned in 1:1 ratio. Stratified randomization for the age group is used to achieve the balance of treatment assignment within age strata.

A total of five visits are scheduled, including two visits via telephone contact. Blood sampling is conducted for immunogenicity assessment before and 6 weeks after vaccination at Visit 2 and Visit 4 respectively. Safety is monitored 1 week, 6 weeks and 26 weeks after vaccination through Visit 3*, Visit 4 and Visit 5* (* telephone contact).

Shingrix® Vaccine Clinical Trials, Dosage, Efficacy, Indication, Side Effects

GlaxoSmithKline plc (GSK) Shingrix® is a non-live, adjuvanted recombinant shingles vaccine (herpes zoster) consisting of the varicella-zoster virus glycoprotein E antigen and the AS01B adjuvant system, a proprietary adjuvant containing QS-21 and MPL with liposomes. Shingrix is up to 90% effective in various clinical trials, says GSK. On October 20, 2017, the US Food and Drug Administration (FDA) authorized Shingrix (STN: 125614). GSK announced on July 26, 2021, that the FDA had approved Shingrix to prevent shingles in adults (18 years and older) at increased risk of shingles due to immunodeficiency or immunosuppression caused by a known disease or therapy.

On January 26, 2018, the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) recommended the use of the Shingrix Herpes Zoster Vaccine. On February 25, 2021, the ACIP Herpes Zoster (HZ) Work Group presented the results of a comprehensive risk-benefit analysis of Shingrix, including a review of post-marketing data. The CDC analysis of clinical trials and observational studies confirms the benefits of Shingrix vaccination in preventing HZ, severe disease, and complications.

The UK Health Security Agency confirmed in September 2021 that seniors with weakened immune systems would be offered the Shingrix vaccine to help protect them against shingles. On August 18, 2021, Public Health England announced that GPs should provide the non-live shingles vaccine, Shingrix, to all eligible individuals who are clinically contraindicated from receiving the live vaccine Zostavax due to immunocompromising conditions. 

The European Medicines Agency (EMA) issued an approval EMEA/H/C/004336 on March 21, 2018. On April 24, 2023, GSK confirmed that Shingrix was approved in India for adults aged 50 and above. Beginning in January 2024, Zhifei will have exclusive rights to import and distribute Shingrix in the Chinese market. GSK announced on October 9, 2023, that it had reached an exclusive agreement with Chongqing Zhifei Biological Products, Ltd. (Zhifei) to co-promote Shingrix in China for an initial three-year period, with the potential to extend the partnership should all parties agree. Beginning September 1, 2023, about 900,000 adults in the United Kingdom became eligible for Shingrix vaccinations. 

London, England-based GlaxoSmithKline is the producer of Shingrix. GSK's top priority is patient safety. 

World Health Organization Recommendation for Shingrix

In March 2025, the WHO Strategic Advisory Group of Experts (SAGE) recommended that countries where herpes zoster is an essential public health problem consider using the recombinant herpes zoster vaccine (Shingrix) in a two-dose schedule with a minimum 2-month interval between doses to prevent the disease in older adults, those with chronic conditions, and the immunocompromised. SAGE advised countries to conduct cost-effectiveness analyses to inform decision-making.

Shingles Herpes Zoster Vaccine Protection

The Annals of Internal Medicine published a study on October 13, 2025, that concluded the Recombinant zoster vaccine is effective in older adults, including immunocompromised adults, and two doses were more effective than 1. Prior ZVL recipients should be revaccinated with RZV. A real-world study published in Clinical Infectious Diseases on June 23, 2025, estimated that it was 74% effective against herpes zoster infection and 84% effective against postherpetic neuralgia in adults aged 50 and older. The Annals of Internal Medicine published the findings from a U.S. CDC-funded study - Effectiveness of Recombinant Zoster Vaccine Against Herpes Zoster in a Real-World Setting - on January 9, 2024. After a single dose, VE was 70% during the first year, 45% during the second year, 48% during the third year, and 52% after the third year. After two doses, VE was 79% in the first year, 75% in the second year, and 73% in the third and fourth years. A study published by the BMJ in September 2023 concluded that the effectiveness of the live zoster vaccine (ZOSTAVAX™) waned substantially. After ten years, protection was low against herpes zoster but higher against postherpetic neuralgia.

GSK announced on October 19, 2022, that interim data from a phase 3 clinical trial demonstrated overall efficacy of greater than 80% over the follow-up period of approximately six to 10 years after the initial vaccination. On January 21, 2022, the CDC's Morbidity and Mortality Weekly Report confirmed the Advisory Committee on Immunization Practices' previously recommended two doses (0.5 mL each) for the prevention of herpes zoster and related complications in immunocompromised or immunosuppressed adults aged 19 years and older. Additionally, the US CDC has published updated Shingrix vaccination schedules for 2022.

Shingrix Vaccine Efficacy

While numerous studies have found Shingrix to be highly effective, its protection may not last for the entirety of one's life. For many people, Shingrix provides at least 85% protection against shingles for up to four years after completing the two-dose series. Protection wanes over time and may reach 70% after ten years. Administering a third dose is investigational. Adding a third dose of the Shingrix vaccine may improve immune response and protection in patients.

Shingrix Vaccination and Dementia

On December 2, 2025, the journal Cell published the results from a study that found that, among individuals living with dementia at baseline, HZ vaccination not only led to a decrease in deaths due to dementia but also a reduction in overall mortality. Specifically, we observed a decrease, which was larger among women than men, in both deaths due to dementia and all-cause mortality, but no effect on fatalities for which dementia was not mentioned as the underlying or a contributing cause on the death certificate. Our findings thus imply that HZ vaccination among individuals living with dementia increased remaining life expectancy. This reduction in deaths due to dementia is unlikely to be a result of averted shingles episodes, given that shingles has a low mortality rate.56 Instead, this study suggests that the HZ vaccine may slow dementia disease progression. Nonetheless, identifying the exact mechanism for this effect is, in our view, an important area of future research.

On June 25, 2025, a study was published, "Lower risk of dementia with AS01-adjuvanted vaccination against shingles and respiratory syncytial virus infections," suggesting that the AS01 adjuvant itself plays a direct role in reducing the risk of dementia. AS01 might protect against dementia via specific immunological pathways. In particular, stimulation of toll-like receptor 4 with monophosphoryl lipid A (MPL; one of the components of the AS01 system) has been shown to improve Alzheimer's disease pathology in mice. In addition, the two main ingredients of AS01, MPL and QS-21 (a purified plant extract derived from Quillaja saponaria), act synergistically to activate macrophages and dendritic cells19 and trigger an age-independent cytokine cascade that culminates in the production of interferon gamma (IFN-γ). IFN-γ might attenuate amyloid plaque deposition and is negatively correlated with cognitive decline in cognitively unimpaired older adults. These neuroprotective mechanisms may reach their full potential at or below the AS01 dose administered in a single vaccine. This saturation effect could also explain why the level of protection against dementia appears similar between the AS01 shingles vaccine (given in two doses) and the AS01 RSV vaccine (administered as a single dose).

In March 2025, Reuters reported that GSK's Chief Scientific Officer, Tony Wood, said data from the state-run National Health Service's database would be used to examine whether the Shingrix vaccine reduces the risk of dementia. In July 2024, a University of Oxford-led study concluded that receiving the recombinant Shingrix vaccine is associated with a 17% increase in diagnosis-free time, translating into 164 additional days lived without a diagnosis of dementia in those subsequently affected.

On May 25, 2023, a study reported causal evidence that herpes zoster vaccination reduces the risk of dementia.

Zoster Vaccination and Cardiovascular Events

On August 30, 2025, an analysis concluded that HZ vaccination (ZVL or RZV) was associated with a significantly lower rate of CV events. The potential cardioprotective effect of HZ vaccination could further reduce the disease burden in adults, warranting additional research. A study published in May 2025 showed that among people who received the live vaccine, there was a 23% lower risk of cardiovascular events overall, with a 26% lower risk of major cardiovascular events (a stroke, heart attack or death from heart disease), a 26% lower risk of heart failure and a 22% lower risk of coronary heart disease. The protective effect was most substantial two to three years after the shingles vaccine was given, but researchers found that the protection lasted for up to eight years.

Shingrix Co-Administration with RSV Vaccine

A GSK plc-sponsored Phase 3 clinical trial (NCT05966090) met the primary endpoint, demonstrating a non-inferior immune response for RSVPreF3 OA and Shingrix vaccines when co-administered compared with separate vaccine administration.

Shingrix Vaccine Price

In May 2024, a research letter published in JAMA: The Journal of the American Medical Association disclosed that shingles vaccinations covered by Part D rose by 46% compared to the previous year before the implementation of the IRA policy in January 2023. "These findings add to the robust evidence base that lowering patient out-of-pocket costs increases the uptake of high-value clinical services," commented study co-author A. Mark Fendrick, professor of internal medicine and public health at the University of Michigan.

Shingrix Availability 2025

The Shingrix vaccine is available in 45 countries as of 2025, including India, Japan, Finland, the UK, the US, and China. On July 17, 2025, GSK announced that the US FDA approved a prefilled syringe presentation of Shingrix. The new prefilled syringe eliminates the need to reconstitute separate vials before administration, simplifying the process for healthcare professionals. 

NHS England has announced that, starting in September 2025, immunosuppressed adults aged 18 to 49 will become newly eligible to receive the vaccine from their GP. The vaccine is currently available to people aged 65 to 79 and to severely immunosuppressed individuals aged over 50, following the NHS's expansion of the program two years ago.

Shingrix Indication

Shingrix is a non-live vaccine used to prevent shingles (herpes zoster). Shingrix is not used to avoid primary varicella infection (chickenpox).

Shingrix Vaccination For Zostavax Patients

The CDC recommends considering the patient's age and the time since they received Zostavax to determine when to vaccinate with Shingrix. Studies examined the safety of Shingrix vaccination five or more years after the Zostavax vaccination. Shorter intervals were not studied, but no theoretical or data concerns indicate that Shingrix would be less safe or effective if administered less than five years after a patient received Zostavax.

Shingrix For Immunocompromised People

The US CDC recommends two doses of RZV to prevent shingles and related complications in adults aged 19 years or older who are or will be immunodeficient or immunosuppressed due to disease or therapy. However, for adults who are or will be immunodeficient or immunosuppressed due to known disease or treatment and would benefit from a shorter vaccination schedule, the second dose can be administered 1 to 2 months after the first dose. In 2024, a systematic review of studies involving multiple patient groups found that the benefits of Shingrix vaccination outweigh the safety concerns in immunocompromised populations.

On June 25, 2021, the ACIP meeting reviewed the 'Zoster Vaccines Session: Burden of Herpes Zoster in Immunocompromised Adults' presentation. In addition, the American Academy of Dermatology Journal reported that among people who had a first-time shingles attack, approximately 4% had another outbreak.

The re-administration dose of RZV should be administered 6-12 months after hematopoietic stem cell transplant (HSCT) if the transplant was allogeneic and 3-12 months after HSCT if the transplant was autologous. In addition, the CDC stated on February 17, 2022, that the Shingrix vaccine is recommended for individuals 19 years old and older with altered immunocompetence. Vaccination of Contacts of Persons with Altered Immunocompetence Household contacts and other close contacts of persons with altered immunocompetence should receive all age-and exposure-appropriate vaccines, except for the smallpox vaccine.

During the ACIP meeting on October 20, 2021, Tara Anderson, DVM, MPH, Ph.D., presented an Interpretation of the EtR regarding the Use of RZV in Immunocompromised Adults, Considerations for Use, and Proposed Policy Options. The ACIP recommends two doses of the recombinant zoster vaccine for adults aged 19 years and older who are immunodeficient or immunosuppressed due to disease or therapy to prevent herpes zoster and its complications.

Previously, Camille Nelson Kotton, M.D., Chair, ACIP Herpes Zoster Work Group, presented the Introduction Zoster Vaccines Session on September 29, 2021; Ismael R. Ortega-Sanchez, Ph.D. presented 'E'onomics of vaccinating immunocompromised 19–49-years-old adults against herpes zoster in the USA; Tara Anderson, DVM, MPH, Ph.D. presented 'P'eliminary Evidence to Recommendations Framework Regarding Use of Recombinant Zoster Vaccine in Immunocompromised Adults and Next Steps.'

Shingrix Vaccination While Pregnant

The CDC does not recommend using Shingrix during pregnancy; therefore, providers should consider delaying vaccination until after pregnancy is complete. Furthermore, pregnancy testing before vaccination with Shingrix is not recommended.

Shingrix Dosage

Shingrix is a suspension for intramuscular injection only. It is supplied in 2 vials (0.5 mL each) that must be combined before administration. Two doses are necessary to provide strong protection, up to 90%, with the first dose administered at Month 0 and the second between 2 and 6 months. The Shingrix vaccine series is administered as an injection into the upper arm muscle. Therefore, it is essential to complete the 2‑dose series to help prevent shingles. The CDC has stated that if more than six months have elapsed since the 1st Shingrix dose, administer the 2nd dose as soon as possible. Do not restart the Shingrix vaccine series.

Shingrix Side Effects

A study reported in September 2024 highlighted the importance of ongoing monitoring and research into the immunomodulatory effects of RZV, as it underscored the occurrence of rare adverse events, such as dermatomal reactions. The US FDA issued a safety communication on March 24, 2021, to inform the public and healthcare providers that the FDA has required and approved safety labeling changes to the Prescribing Information for Shingrix (Zoster Vaccine Recombinant, Adjuvanted) based on post-marketing experience. The revised label includes Guillain-Barré Syndrome (GBS) in the " Warnings and Precautions "section. In addition, a case-series cohort study published in JAMA Internal Medicine on November 1, 2021, found an increased risk of GBS within 42 days of RZV vaccination in seniors, resulting in approximately three excess cases of GBS per million vaccinations. Therefore, clinicians and patients should be aware of this risk when weighing the benefits of a vaccine that reduces the risk of herpes zoster and its complications, as the risk-benefit balance remains in favor of vaccination.

The National Institute on Aging says, 'The shingles vaccine is safe and easy, and it may keep people from getting shingles and ongoing pain called postherpetic neuralgia. GSK advises that people should not receive Shingrix if they are allergic to its ingredients or have experienced an allergic reaction to a previous dose.

Shingrix Billing Codes

SHINGRIX has broad insurance coverage for patients. The CPT Code (Product) is 90750. Additional codes are found at this GSK link. Additionally, the GSK Vaccines Reimbursement Support Center serves as a resource for physicians, physician office staff, and pharmacists to address billing, coding, and reimbursement issues related to GSK vaccines.

Shingles Herpes Zoster

Shingles, also known as herpes zoster (HZ), is a painful skin rash caused by the reactivation of the varicella-zoster virus, which also causes chickenpox, according to the US CDC. If you've had chickenpox, you are at risk for shingles.

Shingrix Vaccine News

July 17, 2025 - Brigid Groves, Vice President of Professional Affairs at the American Pharmacists Association, said, "The prefilled syringe presentation of GSK's shingles vaccine is good news, providing a convenient method of administration."

July 1, 2025 - Adults who received the recombinant shingles vaccine Shingrix or the respiratory syncytial virus (RSV) vaccine Arexvy — both of which contain the AS01 adjuvant — had a lower risk for dementia in the 18 months after vaccination.

July 25, 2024 - Dr. Maxime Taquet, NIHR Academic Clinical Lecturer in the Department of Psychiatry at Oxford, said: 'The size and nature of this study make these findings convincing and should motivate further research. They support the hypothesis that vaccination against shingles might prevent dementia. If validated in clinical trials, these findings could have significant implications for older adults, health services, and public health.'

April 17, 2024 - Phil Dormitzer, GSK Senior Vice President and head of Vaccines R&D, said: "These data go far beyond the typical long-term follow-up period for a trial, tracking the efficacy of vaccination for some participants as they aged into their 70s, 80s, and 90s..... these data add to the body of evidence on the extended long-term protection against shingles and provide further confidence to inform public immunization strategies."

January 31, 2024—Emma Walmsley, CEO of GSK, stated in a press release, "GSK delivered excellent performance in 2023, with clear highlights being the exceptional launch of Arexvy and continued progress in our pipeline. We plan for at least 12 major launches from 2025, with new Vaccines and Specialty Medicines for infectious diseases, HIV, respiratory, and oncology."

October 9, 2023 - GSK announced today that it has reached an exclusive agreement with Chongqing Zhifei Biological Products, Ltd. to co-promote GSK's shingles vaccine, Shingrix, in China for an initial three-year period, with the potential to extend the partnership should all parties agree.

April 24, 2023 - GlaxoSmithKline Pharmaceuticals Ltd announced the launch of Shingrix in India.

Shingrix Clinical Trials 

ZOSTER-049 is an open-label, long-term follow-up study from two pivotal phase III randomized clinical trials (ZOE-50, ZOE-70). 

The long-term results from ZOSTER-049 include 79.7% VE in adults aged ≥50 cumulatively within the period from year six to year 11 after vaccination; 82% VE in adults ≥50 at year 11, showing VE remains high in each year after vaccination; 73.1% VE in adults aged ≥70 cumulatively from six to 11 years after immunization showing high VE rates across all age groups.

In the interim analysis conducted over four>4 years of long-term follow-up, representing up to 10 years since immunization (mean: from 5.6 (±0.3) to 9.6 (±0.3) years post-vaccination), vaccine efficacy was 81.6%. From 1 month post-second dose in those initial studies up to ten years post-vaccination (mean: 9.6 (±0.3) years post-vaccination), vaccine efficacy was 89.0%. The safety profile observed in this extension study is consistent with the established safety profile of the vaccine. No new safety concerns were identified. The incidence of serious adverse events was consistent with the age of the study population. No deaths or other Safety Adverse Events related to vaccination were reported. Five HZ-related complications (PHN - 3 cases and HZ disseminated disease - 2 cases) were reported. A total of 7,413 participants were enrolled in the study's safety cohort. The participants were 60.7% female. Participants were 76% White-Caucasian/European heritage, 18.7% Asian, and 5.3% from Other Ethnic Backgrounds.