Search API

UB-311 Vaccine Candidate 2023

Vaxxinity Inc.'s UB-311 is a fully synthetic peptide-based active immunotherapy candidate that employs the UBITh® platform technologies to target aggregated forms of beta-amyloid (AB). The UBITh platform can generate a high-precision molecular vaccine with a high responder rate, strong on-target immunogenicity, and potential for cognition improvement, which supports UB-311 for active immunotherapy in early-to-mild AD patients. UB-311 targets the brain's toxic forms of aggregated Aβ (oligomers and fibrils and oligomers) to fight Alzheimer's disease (AD). Phase 1, Phase 2a, and Phase 2a LTE trials have shown UB-311 to be well tolerated in early AD subjects over three years of repeat dosing, with a safety profile comparable to placebo, with no cases of amyloid-related imaging abnormalities-edema (ARIA-E) in the main study. The Vaxxine Platform is designed to harness the immune system to convert the body into its own natural "drug factory," stimulating the production of antibodies.

UB-311 received the U.S. FDA Fast Track Designation for Alzheimer's Disease on May 2, 2022. The FDA's determination that UB-311 could potentially address a serious unmet medical need was based on preclinical and clinical data in AD patients. This designation will facilitate the development and expedite the review of UB-311. On August 10, 2023, Vaxxinity announced the publication of Phase 2a clinical trial data in The Lancet's eBioMedicine, stating that UB-311 "was safe and well-tolerated," with early clinical data demonstrating a trend for slowing cognitive decline in mild AD.

Florida-based Vaxxinity, Inc. (NASDAQ: VAXX) is a purpose-driven biotechnology company committed to democratizing healthcare globally. The company is pioneering a new class of synthetic, peptide-based immunotherapeutic vaccines to disrupt the existing treatment paradigm for chronic disease, increasingly dominated by monoclonal antibodies, which suffer from prohibitive costs and cumbersome administration.

UB-311 Indication

UB-311 is indicated for treating Alzheimer's disease (AD), the most common form of dementia. AD is a progressive neurodegenerative disorder that slowly destroys memory, cognitive skills, and the ability to carry out simple tasks. The exact cause of AD is unknown, but genetic and environmental factors are contributors. AD affects more than six million people in the United States and 44 million worldwide.

UB-311 Dosage

UB-311 is administered as an intramuscular injection.

UB-311 Vaccine Candidate News

August 10, 2023 - Jeffrey Cummings, M.D., Ph.D., Director of the Chambers-Grundy Center for Transformative Neuroscience at the University of Nevada, Las Vegas, and co-author of the paper, commented in a press release, "The UB-311 Phase 2a program accomplished its goals of establishing safety and tolerability while generating high levels of anti-amyloid antibodies. The gradual, natural titration of antibody titers through this approach may have contributed to a lack of ARIA-E in this study. Vaccine approaches such as UB-311 represent important ways forward in advancing treatment and prevention of Alzheimer's disease and offer the potential to transform the treatment landscape by providing participants with an accessible therapeutic option."

May 2, 2022 - "We are excited that the U.S. FDA has granted UB-311 Fast Track Designation, as it recognizes the evidence demonstrating the potential for UB-311 to address a serious unmet medical need for patients with Alzheimer's disease," said Mei Mei Hu, CEO of Vaxxinity.

March 24, 2022 - Vaxxinity Corporate Overview presentation was posted.

April 14, 2017 - The AZ Association published: UB-311, a novel UBITh® amyloid β peptide vaccine for mild Alzheimer's disease. UB-311 reduced the levels of Aβ1-42 oligomers, protofibrils, and plaque load in hAPP751 transgenic mice in a clinical trial. Safe and well-tolerated UB-311 generated considerable site-specific (Aβ1-10) antibodies across all animal species examined. In AD patients, UB-311 induced a 100% responder rate; injection site swelling and agitation were the most common adverse events (4/19 each). A slower rate of increase in ADAS-Cog from baseline to week 48 was observed in the subgroup of mild AD patients (MMSE ≥ 20) compared with the moderate AD subgroup, suggesting that UB-311 may have a potential for cognition improvement in patients with early stage of Alzheimer's dementia.

UB-311 Vaccine Clinical Trial

Clinical Trial NCT03531710: An Extension Study of a Phase IIa Study in Patients With Mild Alzheimer's Disease to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of UBITh® AD Immunotherapeutic Vaccine (UB-311). The top-line Phase 2a data met the primary aims of safety and immunogenicity with a 96% response rate. In addition, all secondary endpoints - including Amyloid PET burden, CDR-SB, ADCS-ADL, ADAS-Cog, and MMSE - pointed directionally in favor of UB-311, though not statistically significant with the study sample size.

Trumenba® Meningitis B Vaccine Description

Trumenba® (MenB-FHbp) is a recombinant protein-based vaccine targeting Neisseria meningitidis serogroup B. Trumenba is a sterile suspension composed of two recombinant lipidated factor H binding protein (fHBP) variants from N. meningitidis serogroup B, one from fHBP subfamily A and one from subfamily B (A05 and B01, respectively).

The proteins are individually produced in E. coli. Production strains are grown in defined fermentation growth media to a specific density. The recombinant proteins are extracted from the production strains and purified through a series of column chromatography steps. Polysorbate 80 (PS80) is added to the drug substances and is present in the final drug product.

The Lancet Infectious Diseases reported on September 7, 2022, on the good immunogenicity, short-lived antibody persistence, and acceptable reactogenicity profile of meningococcal serogroup B-factor H binding protein vaccine (MenB-FHbp), which contains two factor-H-binding proteins, against serogroup B meningococcal disease in children aged 1–9 years. The data were collected during two phase 2 studies in Australia and Europe, with 396 toddlers (age 12–23 months) and 400 older children (aged 2–9 years) randomly assigned to receive either MenB-FHbp (60 μg [toddler study only] or 120 μg) or a control vaccine (hepatitis A vaccine and saline) in a three-dose primary schedule (0, 2, and 6 months). The strong immune response to a booster dose observed in the study can be interpreted as showing immune memory.

U.S. FDA STN: BL 125549 - Proper Name: Meningococcal Group B Vaccine - Trade Name: On October 29, 2014, the U.S. FDA sent an approval letter authorizing the introduction or delivery of Trumenba into interstate commerce. TRUMENBA. EMA: EMEA/H/C/004051.

Trumenba Indication

Trumenba is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B (Men B). The most current comprehensive recommendations from the Advisory Committee on Immunization Practices (ACIP) for meningococcal vaccines are available on the MMWR website at www.cdc.gov/mmwr/volumes/69/rr/pdfs/rr6909a1-H.pdf. 

Trumenba Dosage

Trumenba is intended for intramuscular injection administered as a two or three-dose series in individuals 10 through 25 years of age following a 0-, 2-, and 6-month schedule. In addition, the two-dose series is recommended for healthy adolescents (16) and young adults.

Trumenba News

September 15, 2022 - Pfizer Inc. announced positive top-line results from the pivotal Phase 3 trial assessing the safety, tolerability, and immunogenicity of its investigational pentavalent meningococcal vaccine (MenABCWY). Non-inferiority was demonstrated for all five serogroups following two doses of MenABCWY compared to two doses of Trumenba®and one dose of Menveo®.

Trumenba Clinical Trials

Pfizer's Trumenba has been involved in over ten clinical trials to test its safety, tolerability, and immunogenicity.

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.

Rotarix Vaccine 2023

GSK's Rotarix (Rotavirus Vaccine, Live, Oral) is a live, attenuated rotavirus vaccine derived from the human 89-12 strain belonging to the G1P type. This rotavirus strain is propagated on Vero cells. After reconstitution, the final formulation (1 mL) contains at least 106.0 median Cell Culture Infective Dose (CCID50) of live, attenuated rotavirus. The Rotarix vaccine is used to help prevent disease in children. Rotarix works by exposing your child to a small dose of the virus, which causes the body to develop immunity to the disease. However, this vaccine will not treat an active infection already set in the body. The global clinical development program spanned five continents and demonstrates that Rotarix protects against the most common circulating strains (G1 and non-G1 rotavirus strains), including the emerging G9 strain.

On November 7, 2022, the U.S. Food and Drug Administration (FDA) approved an oral-dosing applicator-only presentation (liquid formulation) of ROTARIX, which prevents rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in infants. This new presentation formulation aims to make it more convenient for healthcare providers to prepare ROTARIX by removing the need to reconstitute the vaccine dose at the point of use.

ROTARIX was first approved by the FDA in 2008. The U.S. FDA's package insert is available at this link. DrugBank: Rotavirus vaccine (DB10276).

UK-based GlaxoSmithKline (GSK) is one of the world's leading research-based pharmaceutical and healthcare companies.

Rotarix Indication

Rotarix is a vaccine indicated for preventing rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series. ROTARIX is approved for use in infants six weeks to 24 weeks. Rotavirus spreads quickly among infants and young children. The virus can cause severe watery diarrhea, vomiting, fever, and abdominal pain. Children who get rotavirus disease can become dehydrated and may need to be hospitalized. The U.S. CDC recommends that infants get the rotavirus vaccine to protect against rotavirus disease. Rotarix can also reduce hospitalizations for all gastroenteritis, regardless of cause. On September 5, 2022, BMJ Global Health wrote rotavirus was the leading cause of diarrhea requiring hospitalization among young children in 28 low- and middle-income countries despite the introduction of the rotavirus vaccine.

Rotarix Dosage

The vaccination series consists of two 1-mL doses administered orally. The first dose should be administered to infants at six weeks. There should be at least four weeks between the first and second dose, and the 2-dose series should be completed by 24 weeks of age.

Rotarix Vaccine News

July 26, 2023 - GSK plc announced that established vaccine growth in Q223 was driven by Rotarix, benefitting from the favorable impacts of a US CDC stockpile borrow in 2022 and replenishment in the current quarter.

October 18, 2022 - The JAMA Network published: Rotavirus Leads Global Diarrhea Hospitalizations Among Young Children.

August 22, 2022 - Nigeria has the second-highest number of deaths from rotavirus, accounting for 14 percent of all childhood rotavirus deaths worldwide. The agency said approximately 50,000 children under five die before their fifth birthday due to rotavirus infection.

June 9, 2022 - A peer-reviewed study - Association Between Rotavirus Vaccination and Antibiotic Prescribing among Commercially Insured U.S. Children, 2007-2018 - These results demonstrate that rotavirus vaccines reduce antibiotic prescribing for acute gastroenteritis, which could help reduce the growth of antibiotic resistance.

February 9, 2022 - GSK reported Rotarix sales were down 3% AER but up 1% CER to £541 million, reflecting global demand recovery.

July 28, 2021 - GSK announced its financial results. Rotarix sales were up 3% AER and 9% CER to £132 million, reflecting increased channel stocking on wholesaler purchasing patterns in the USA.

May 10, 2021 - A new study's findings from a meta-analysis revealed that Rotarix vaccinations reduced rotavirus gastroenteritis in children younger than five years by 68.4%.

March 4, 2021 - GSK makes landmark pricing agreement for rotavirus vaccine, Rotarix, for use with children living in humanitarian crises. In a press release, Thomas Breuer, Chief Medical Officer of GSK Vaccines, said, "We are delighted to become the first company to offer a rotavirus vaccine through the Humanitarian Mechanism for use with some children most vulnerable to severe diarrhoeal disease."

March 4, 2021 - Médecins Sans Frontières, Save the Children, UNICEF, and the World Health Organization welcome the opportunity to make the rotavirus vaccine available to more children living in humanitarian crises thanks to a landmark pricing agreement with the manufacturer, GSK. The rotavirus vaccine is the second vaccine to be accessed through the scheme. It depends on manufacturers making their vaccines available at their lowest price for use in emergencies - across countries of all income levels. The first to be made public was the pneumococcal vaccine.

June 5, 2009 - The World Health Organisation (WHO) has awarded global prequalification to GlaxoSmithKline Biologicals' vaccine against rotavirus, Rotarix™. The WHO's Strategic Advisory Group of Experts (SAGE) recommended that rotavirus vaccination be included in all national immunization programs. These WHO decisions open the door to making rotavirus vaccines available to children worldwide. The WHO prequalification will accelerate access to the vaccine in Asia and Africa and expand on the WHO decision taken in 2007 to prequalify the vaccine for Europe and the Americas. In addition, the WHO prequalification is necessary for U.N. agencies and the GAVI Alliance to purchase rotavirus vaccines for developing countries.

Rotarix Vaccine Clinical Trials

GSK's Rotarix has completed over 40 clinical trials.