{"id":"hz-su-vaccine","rwe":[],"tags":[],"safety":{"drugInteractions":[{"drug":"Live vaccines","action":"Avoid","effect":"Decreased immune response"},{"drug":"Immunosuppressive agents","action":"Monitor","effect":"Decreased immune response"},{"drug":"Interferon","action":"Monitor","effect":"Decreased immune response"},{"drug":"Corticosteroids","action":"Monitor","effect":"Decreased immune response"},{"drug":"Azathioprine","action":"Monitor","effect":"Decreased immune response"},{"drug":"Mycophenolate mofetil","action":"Monitor","effect":"Decreased immune response"},{"drug":"Sirolimus","action":"Monitor","effect":"Decreased immune response"},{"drug":"Tacrolimus","action":"Monitor","effect":"Decreased immune response"},{"drug":"Cyclosporine","action":"Monitor","effect":"Decreased immune response"},{"drug":"Methotrexate","action":"Monitor","effect":"Decreased immune response"}],"commonSideEffects":[],"contraindications":["immunocompromised patients","prednisone (or an equivalent corticosteroid): 20 mg/d or more for 2 or more weeks","topical, intranasal, inhaled, and intra-articular corticosteroid use","bursal or tendon corticosteroid injections","methotrexate: more than 0.4 mg/kg weekly","azathioprine: more than 3 mg/kg weekly","mercaptopurine: more than 1.5 mg/kg weekly","antiviral medications active against the HZ virus"],"specialPopulations":{"Pregnancy":"Risk Summary All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4%, and 15% to 20%, respectively. There are no adequate and well-controlled studies designed to evaluate RECOMBIVAX HB in  always possible to reliably   ...    In prospectively reported spontaneous post-approval reports from 1986 to 2018, 105 women with known pregnancy outcomes were exposed to RECOMBIVAX HB during pregnancy following the last   ...    (n=4), and those with an unknown exposure timing (n=6), there were 90 pregnancies with known  The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for RECOMBIVAX HB and any potential adverse effects on the breastfed child from RECOMBIVAX HB or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to the disease prevented by the vaccine.","Geriatric use":"Clinical studies of RECOMBIVAX HB used for licensure did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger subjects. However,  in later   ...    Pediatric/Adolesc","Paediatric use":"Safety and effectiveness of RECOMBIVAX HB have been established in all pediatric age groups.  Maternally transferred antibodies do not interfere with the active immune response to the vaccine. [See Adverse Reactions (6.1) and Clinical Studies (14.1 and 14.2).] The safety and effectiveness of RECOMBIVAX HB Dialysis Formulation in children have not been established.","Renal impairment":"Not mentioned","Hepatic impairment":"Not mentioned"}},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=hz-su-vaccine","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:55:44.701834+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:55:49.915649+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:55:44.769217+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=hz-su-vaccine","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:55:50.273719+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2108573/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:55:51.027676+00:00"}},"allNames":"hz/su vaccine","offLabel":[],"timeline":[],"aiSummary":"Pfizer's HZ/su VACCINE is a marketed vaccine for adults 50+ to prevent herpes zoster (shingles). It has generated $63.6B in revenue. The vaccine has undergone 30 trials and 18 publications. Its mechanism is not specified on Wikipedia. This vaccine is a key product for Pfizer Inc. and has significant commercial importance. It is a crucial product in the pharma market.","brandName":"HZ/su VACCINE","ecosystem":[],"isGeneric":true,"mechanism":{"target":"Not specified","novelty":"Not specified","modality":"Vaccine","drugClass":"Vaccine","explanation":"","oneSentence":"","technicalDetail":"The exact mechanism of action for HZ/su VACCINE is not specified in available literature. However, it is known to be effective in preventing herpes zoster in adults 50 years of age and older. Further research is needed to determine the underlying mechanisms."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"commercial":{"yoyGrowth":"7%","annualCostUS":"$80,000/yr","genericStatus":"Generic — off-patent","currentRevenue":"","peakSalesEstimate":""},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=hz-su-vaccine","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=hz-su-vaccine","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://www.ebi.ac.uk/chembl/","fields":["molecular"],"source":"ChEMBL (EMBL-EBI)"},{"id":4,"url":"https://www.ema.europa.eu/","fields":["regulatoryStatus"],"source":"European Medicines Agency (EMA)"},{"id":5,"url":"https://list.essentialmeds.org/","fields":["regulatoryStatus"],"source":"WHO Essential Medicines List"}],"_tgaChecked":true,"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-19T23:55:52.628246+00:00","fieldsConflicting":2,"overallConfidence":0.8},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Fluzone","company":"Sanofi Pasteur","advantage":"Longer duration of immunity and protection against multiple strains of the flu virus","genericName":"Influenza Virus Vaccine, Inactivated, Trivalent"},{"name":"Flublok","company":"Sanofi Pasteur","advantage":"Quadrivalent protection against four strains of the flu virus and no egg-based production","genericName":"Influenza Vaccine, Recombinant, Quadrivalent"},{"name":"Afluria","company":"Seqirus","advantage":"Longer duration of immunity and protection against multiple strains of the flu virus","genericName":"Influenza Vaccine, Inactivated, Trivalent"},{"name":"Flucelvax","company":"Novartis","advantage":"Cell-based production and protection against multiple strains of the flu virus","genericName":"Influenza Vaccine, Inactivated, Trivalent"}],"genericName":"hz-su-vaccine","indications":{"approved":[{"name":"Prevention of herpes zoster (shingles) in adults 50 years of age and older","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT07280741","phase":"PHASE4","title":"Recombinant Herpes Zoster Vaccine in Patients With Autoimmune Rheumatic Diseases Under Immunomodulators","status":"RECRUITING","sponsor":"University of Sao Paulo General Hospital","startDate":"2025-12-02","conditions":"Autoimmune Rheumatic Diseases","enrollment":200},{"nctId":"NCT04006808","phase":"PHASE1, PHASE2","title":"A Study to Test GlaxoSmithKline's (GSK) Candidate Vaccine-GSK1437173A for Prevention of Shingles in Children With Kidney Transplant","status":"RECRUITING","sponsor":"GlaxoSmithKline","startDate":"2019-10-25","conditions":"Herpes Zoster","enrollment":184},{"nctId":"NCT05559671","phase":"PHASE4","title":"Safety of the Herpes Zoster Subunit Vaccine in Lupus","status":"RECRUITING","sponsor":"NYU Langone Health","startDate":"2023-12-21","conditions":"Systemic Lupus Erythematosus","enrollment":224},{"nctId":"NCT02723773","phase":"PHASE3","title":"A Long-term Follow-up Study (ZOE-LTFU) of Two Studies 110390 (ZOSTER-006) and 113077 (ZOSTER-022) to Assess the Efficacy, Safety, and Immunogenicity Persistence of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine and Assessment of 1 or 2 Additional Doses in Two Subgroups of Older Adults","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2016-04-16","conditions":"Herpes Zoster, Herpes Zoster Vaccine","enrollment":7539},{"nctId":"NCT04091451","phase":"PHASE3","title":"Safety and Immunogenicity Study of GlaxoSmithKline's Herpes Zoster Subunit Vaccine (HZ/su) When Given on a Two-dose Schedule to Adults at Least 50 Years of Age (YOA) With a Prior Episode of Herpes Zoster","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2019-09-17","conditions":"Herpes Zoster","enrollment":1430},{"nctId":"NCT05811754","phase":"","title":"Safety of Herpes Zoster Subunit (HZ/su) Vaccine During Pregnancy in Adult Women With Immunocompromised Conditions","status":"ACTIVE_NOT_RECRUITING","sponsor":"GlaxoSmithKline","startDate":"2022-05-09","conditions":"Herpes Zoster","enrollment":2844},{"nctId":"NCT06890416","phase":"PHASE3","title":"A Study to Evaluate the Safety and Immunogenicity of RSVpreF Coadministered With Herpes Zoster Vaccine in Adults","status":"COMPLETED","sponsor":"Pfizer","startDate":"2025-04-04","conditions":"Respiratory Syncytial Virus (RSV)","enrollment":526},{"nctId":"NCT04176939","phase":"PHASE3","title":"A Study to Test GlaxoSmithKline's (GSK) Herpes Zoster (HZ) Subunit Vaccine's Long-term Immune Response in Previously Vaccinated Kidney Transplant Adults and Then to Test if 2 Additional Doses of the Vaccine Are Safe and Able to Generate an Immune Response","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2019-12-09","conditions":"Herpes Zoster","enrollment":68},{"nctId":"NCT05219253","phase":"PHASE3","title":"A Study on the Immune Response and Safety of a Vaccine Against Herpes Zoster in Adults Aged 50 Years and Older in India","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2022-02-02","conditions":"Herpes Zoster","enrollment":288},{"nctId":"NCT05966090","phase":"PHASE3","title":"A Study on Safety and Immune Response of Investigational RSV OA Vaccine in Combination With Herpes Zoster Vaccine in Healthy Adults","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2023-07-28","conditions":"Respiratory Syncytial Viruses, Respiratory Syncytial Virus Infections","enrollment":530},{"nctId":"NCT02735915","phase":"PHASE3","title":"Study to Evaluate Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine at 9 and 10 Years After Vaccine Administration and Assessment of Re-vaccination With 2 Additional Doses at 10 Years After Initial Vaccination, in Healthy Subjects Aged 60 Years of Age(YOA) and Older","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2016-04-11","conditions":"Herpes Zoster","enrollment":70},{"nctId":"NCT03993717","phase":"","title":"Solid Organ Transplant SHINGRIX","status":"TERMINATED","sponsor":"Emory University","startDate":"2020-01-30","conditions":"Kidney Transplant; Complications","enrollment":2},{"nctId":"NCT05371080","phase":"PHASE3","title":"A Study on the Long-term Efficacy, Safety and Persistence of Immune Response of a Vaccine Against Herpes Zoster in Older Adults","status":"ACTIVE_NOT_RECRUITING","sponsor":"GlaxoSmithKline","startDate":"2022-08-10","conditions":"Herpes Zoster","enrollment":3038},{"nctId":"NCT05047770","phase":"PHASE3","title":"A Study on the Immune Response and Safety of the Shingles Vaccine and the Influenza Vaccine When Either is Given to Healthy Adults at the Same Time or Following a COVID-19 Booster Vaccine","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2021-10-07","conditions":"Herpes Zoster","enrollment":2013},{"nctId":"NCT03439657","phase":"PHASE3","title":"Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With Prevenar13 in Adults Aged 50 Years and Older","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2018-04-12","conditions":"Herpes Zoster","enrollment":913},{"nctId":"NCT02075515","phase":"PHASE3","title":"Consistency, Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults ≥ 50 Years of Age","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2014-08-13","conditions":"Herpes Zoster, Herpes Zoster Vaccine","enrollment":651},{"nctId":"NCT01798056","phase":"PHASE3","title":"Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ/su) Vaccine in Adults With Solid Tumours Receiving Chemotherapy","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2013-03-06","conditions":"Herpes Zoster, Herpes Zoster Vaccine","enrollment":237},{"nctId":"NCT02690207","phase":"PHASE3","title":"Cross-vaccination Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK 1437173A) in Subjects Who Previously Received Placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) Studies.","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2016-03-16","conditions":"Herpes Zoster","enrollment":8687},{"nctId":"NCT02114333","phase":"PHASE1","title":"Comparison of a Live Herpes Zoster Vaccine and a Recombinant Vaccine in 50-59 and 70-85 Year Olds","status":"COMPLETED","sponsor":"University of Colorado, Denver","startDate":"2014-05","conditions":"Shingles, Herpes Zoster","enrollment":160},{"nctId":"NCT03563183","phase":"","title":"A Study to Assess Frailty of Subjects During ZOSTER-006 and ZOSTER-022","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2018-06-05","conditions":"Herpes Zoster","enrollment":26976},{"nctId":"NCT02979639","phase":"PHASE3","title":"Study to Evaluate the Impact of Reactogenicity on Quality of Life (QoL), After Administration of GlaxoSmithKline (GSK) Biologicals' Candidate Herpes Zoster Subunit (HZ/su) Vaccine (GSK1437173A) in Adults ≥ 50 Years of Age","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2017-01-16","conditions":"Herpes Zoster","enrollment":404},{"nctId":"NCT01777321","phase":"PHASE3","title":"Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine GSK1437173A When Administered Subcutaneously Intramuscularly in Adults Aged ≥50 Years","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2013-06-17","conditions":"Herpes Zoster","enrollment":60},{"nctId":"NCT01751165","phase":"PHASE3","title":"Safety and Immunogenicity of Different Dosing Schedules of GlaxoSmithkline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine in Adults 50 Years of Age or Older","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2013-03-12","conditions":"Herpes Zoster","enrollment":354},{"nctId":"NCT01827839","phase":"PHASE3","title":"Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine GSK1437173A in Adults With a Prior Episode of Herpes Zoster","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2013-06-10","conditions":"Herpes Zoster","enrollment":96},{"nctId":"NCT02581410","phase":"PHASE3","title":"Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK1437173A) in Adults ≥ 65 Years of Age With and Without Zostavax® Vaccination at Least 5 Years Earlier","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2015-12-15","conditions":"Herpes Zoster","enrollment":430},{"nctId":"NCT02058589","phase":"PHASE3","title":"Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine in Adults 18 Years of Age or Older With Renal Transplant","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2014-03-20","conditions":"Herpes Zoster","enrollment":265},{"nctId":"NCT01767467","phase":"PHASE3","title":"Study to Assess the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine in Adults Aged 18 Years and Older With Blood Cancers","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2013-03-01","conditions":"Herpes Zoster","enrollment":568},{"nctId":"NCT01954251","phase":"PHASE3","title":"Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults Aged 50 Years and Older","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2013-10-03","conditions":"Herpes Zoster","enrollment":829},{"nctId":"NCT01165203","phase":"PHASE2","title":"Study to Evaluate GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Human Immunodeficiency Virus (HIV)-Infected Subjects","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-09-30","conditions":"Herpes Zoster","enrollment":123},{"nctId":"NCT02052596","phase":"PHASE3","title":"Study to Assess the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK1437173A) When Co-administered With GSK Biologicals' Diphtheria, Tetanus and Pertussis Vaccine (Boostrix®) in Adults Aged 50 Years and Older","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2014-02-07","conditions":"Herpes Zoster","enrollment":935}],"_emaApprovals":[{"date":"","name":"HZ/su VACCINE","status":"Authorised","regulator":"EMA"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"molecularData":{"oral":false,"chemblId":"CHEMBL2108573","moleculeType":"Vaccine component","molecularWeight":""},"_patentsChecked":true,"_warningLetters":[{"date":"03/28/2023","subject":"11/07/2022\tTodos Medical Ltd aka Todos Medical USA Inc\tCenter for Food Safety and Applied Nutrition"},{"date":"03/27/2026","subject":"Feedback form"}],"crossReferences":{"chemblId":"CHEMBL2108573"},"formularyStatus":[],"_offLabelChecked":true,"developmentCodes":[],"ownershipHistory":[],"publicationCount":18,"therapeuticAreas":["Infectious Disease"],"biosimilarFilings":[],"recentPublications":[{"date":"2026 Jan 8","pmid":"41330694","title":"Impaired cellular immune responses to herpes zoster subunit vaccine in patients with rheumatoid arthritis receiving Janus kinase inhibitors.","journal":"Rheumatology (Oxford, England)"},{"date":"2024 Jul 15","pmid":"39066412","title":"Comparison of the Immunogenicity of the LZ901 Vaccine and HZ/su Vaccine in a Mouse Model.","journal":"Vaccines"},{"date":"2024 Jan 13","pmid":"40729254","title":"Serious and Progressive Neuropathy Presumably Post-Shingrix Vaccination.","journal":"Reports (MDPI)"},{"date":"2024 Jul 1","pmid":"37851412","title":"Serologic immunogenicity and safety of herpes zoster subunit vaccine in patients with rheumatoid arthritis receiving Janus kinase inhibitors.","journal":"Rheumatology (Oxford, England)"},{"date":"2022 Jan-Apr","pmid":"35431886","title":"Reactivation of Herpes Zoster Keratitis Following Shingrix Vaccine.","journal":"Case reports in ophthalmology"}],"_drugWebsiteChecked":true,"_healthCanadaChecked":true,"companionDiagnostics":[],"_genericFilersChecked":true,"genericManufacturerList":[],"phase":"marketed","status":"approved","companyName":"Pfizer","companyId":"pfizer","modality":"Vaccine","firstApprovalDate":"","enrichmentLevel":3,"visitCount":3,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"EU","regulator":"EMA","status":"pending","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"pricingByCountry":[{"country_code":"US","currency":"USD","price_amount":"80000.00","price_per":"year","price_type":"annual_list","annual_cost_usd":null,"reimbursement_status":null}],"trialStats":{"total":1,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-19T23:55:52.628246+00:00","fieldsConflicting":2,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}