{ "_meta": { "description": "Per branded vaccine product composition from FDA package inserts / DailyMed Section 11. Structured fields: antigens, adjuvants, preservatives, excipients, encapsulation, deliveryMethod.", "lastUpdated": "2026-07-09", "schemaVersion": "1.0.0", "sourcingRule": "Every list is per branded product from the official package insert (DailyMed or FDA/manufacturer PI). Formulations change — re-verify sourceUrl before clinical use." }, "products": { "mmr-vaccine": [ { "productId": "mmr-ii", "productName": "M-M-R II", "manufacturer": "Merck Sharp & Dohme LLC", "vaccineSlug": "mmr-vaccine", "platform": "live_attenuated", "deliveryMethod": { "route": "intramuscular_or_subcutaneous", "form": "lyophilized_powder_for_reconstitution", "doseVolume": "0.5 mL", "presentation": "single-dose vial + sterile diluent", "requiresReconstitution": true, "diluent": "sterile diluent supplied" }, "encapsulation": { "type": "none", "description": "No nanoparticle encapsulation; live attenuated virus suspension after reconstitution." }, "antigens": [ { "name": "Measles virus (live, attenuated)", "antigenType": "live_attenuated_virus", "amount": "≥3.0 log10 TCID50 per 0.5 mL", "strain": "Enders' attenuated Edmonston", "expressionSystem": "chick embryo cell culture" }, { "name": "Mumps virus (live, attenuated)", "antigenType": "live_attenuated_virus", "amount": "≥4.1 log10 TCID50 per 0.5 mL", "strain": "Jeryl Lynn (B level)", "expressionSystem": "chick embryo cell culture" }, { "name": "Rubella virus (live, attenuated)", "antigenType": "live_attenuated_virus", "amount": "≥3.0 log10 TCID50 per 0.5 mL", "strain": "Wistar RA 27/3", "expressionSystem": "WI-38 human diploid lung fibroblasts" } ], "adjuvants": [], "preservatives": [ { "name": "none", "slug": null, "present": false, "amount": "none", "presentationNote": "Single-dose presentation; label states no preservative." } ], "excipients": [ { "name": "Sorbitol", "slug": "sorbitol", "amount": "14.5 mg", "category": "stabilizer", "role": "stabilizer" }, { "name": "Sucrose", "slug": "sucrose", "amount": "1.9 mg", "category": "stabilizer", "role": "stabilizer" }, { "name": "Hydrolyzed gelatin", "slug": "gelatin", "amount": "14.5 mg", "category": "stabilizer", "role": "stabilizer" }, { "name": "Recombinant human albumin", "slug": "human-serum-albumin", "amount": "≤0.3 mg", "category": "stabilizer", "role": "stabilizer" }, { "name": "Fetal bovine serum", "slug": "fetal-bovine-serum", "amount": "<1 ppm", "category": "residual_manufacturing", "role": "residual from cell culture" }, { "name": "Neomycin", "slug": "neomycin", "amount": "≈25 mcg", "category": "antibiotic_residual", "role": "residual manufacturing antibiotic" }, { "name": "Other buffer and media ingredients", "slug": null, "amount": "not individually quantified on label", "category": "buffer", "role": "buffer/media" } ], "source": { "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0a9e384f-e717-436b-b9a0-15e53cef0862", "sourceType": "DailyMed", "lastVerified": "2026-07-09", "section": "11 DESCRIPTION", "setId": "0a9e384f-e717-436b-b9a0-15e53cef0862" }, "notes": "Live attenuated; no adjuvant. Product contains no preservative.", "ingredientSlugs": [ "sorbitol", "sucrose", "gelatin", "human-serum-albumin", "fetal-bovine-serum", "neomycin" ] }, { "productId": "priorix", "productName": "PRIORIX", "manufacturer": "GlaxoSmithKline Biologicals", "vaccineSlug": "mmr-vaccine", "platform": "live_attenuated", "deliveryMethod": { "route": "subcutaneous", "form": "lyophilized_powder_for_reconstitution", "doseVolume": "0.5 mL", "presentation": "single-dose vial", "requiresReconstitution": true }, "encapsulation": { "type": "none" }, "antigens": [ { "name": "Measles virus (live, attenuated)", "antigenType": "live_attenuated_virus", "amount": "≥3.4 log10 CCID50", "strain": "Schwarz", "expressionSystem": "chick-embryo fibroblasts" }, { "name": "Mumps virus (live, attenuated)", "antigenType": "live_attenuated_virus", "amount": "≥4.2 log10 CCID50", "strain": "RIT 4385 (Jeryl Lynn-derived)", "expressionSystem": "chick-embryo fibroblasts" }, { "name": "Rubella virus (live, attenuated)", "antigenType": "live_attenuated_virus", "amount": "≥3.3 log10 CCID50", "strain": "Wistar RA 27/3", "expressionSystem": "MRC-5 human diploid cells" } ], "adjuvants": [], "preservatives": [ { "name": "none", "slug": null, "present": false, "amount": "none", "presentationNote": "Single-dose presentation; label states no preservative." } ], "excipients": [ { "name": "Anhydrous lactose", "slug": null, "amount": "32 mg", "category": "stabilizer", "role": "stabilizer" }, { "name": "Sorbitol", "slug": "sorbitol", "amount": "9 mg", "category": "stabilizer", "role": "stabilizer" }, { "name": "Amino acids", "slug": null, "amount": "9 mg", "category": "stabilizer", "role": "stabilizer" }, { "name": "Mannitol", "slug": null, "amount": "8 mg", "category": "stabilizer", "role": "stabilizer" }, { "name": "Neomycin sulphate", "slug": "neomycin", "amount": "≤25 mcg residual", "category": "antibiotic_residual", "role": "residual antibiotic" }, { "name": "Ovalbumin", "slug": "egg-protein", "amount": "≤60 ng residual", "category": "culture_medium_residual", "role": "residual egg protein" }, { "name": "Bovine serum albumin", "slug": "fetal-bovine-serum", "amount": "≤50 ng residual", "category": "residual_manufacturing", "role": "residual BSA" } ], "source": { "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=95c6fdb6-b587-4413-92f9-d592b9f7a23e&type=display", "sourceType": "DailyMed", "lastVerified": "2026-07-09", "section": "11 DESCRIPTION", "setId": "95c6fdb6-b587-4413-92f9-d592b9f7a23e" }, "notes": "Contains no gelatin — relevant for gelatin allergy. Residual ovalbumin possible from chick-embryo manufacture.", "ingredientSlugs": [ "sorbitol", "neomycin", "egg-protein", "fetal-bovine-serum" ] } ], "hepatitis-b-vaccine": [ { "productId": "engerix-b", "productName": "Engerix-B", "manufacturer": "GlaxoSmithKline Biologicals", "vaccineSlug": "hepatitis-b-vaccine", "platform": "recombinant_protein", "deliveryMethod": { "route": "intramuscular", "form": "suspension_for_injection", "doseVolume": "0.5 mL pediatric / 1 mL adult", "presentation": "single-dose vial or prefilled syringe", "requiresReconstitution": false }, "encapsulation": { "type": "none" }, "antigens": [ { "name": "Hepatitis B surface antigen (HBsAg)", "antigenType": "recombinant_protein", "amount": "10 mcg / 0.5 mL pediatric; 20 mcg / 1 mL adult", "expressionSystem": "Saccharomyces cerevisiae (yeast)", "notes": "Subtype adw2 surface protein antigen" } ], "adjuvants": [ { "name": "Aluminum hydroxide", "slug": "aluminum-hydroxide", "class": "aluminum_salt", "amount": "adsorbed on aluminum hydroxide", "aluminumContent": "0.25 mg Al / 0.5 mL pediatric; 0.5 mg Al / 1 mL adult" } ], "preservatives": [ { "name": "none", "slug": null, "present": false, "amount": "none", "presentationNote": "Formulated without preservatives." } ], "excipients": [ { "name": "Sodium chloride", "slug": null, "amount": "9 mg/mL", "category": "buffer", "role": "tonicity" }, { "name": "Disodium phosphate dihydrate", "slug": null, "amount": "0.98 mg/mL", "category": "buffer", "role": "phosphate buffer" }, { "name": "Sodium dihydrogen phosphate dihydrate", "slug": null, "amount": "0.71 mg/mL", "category": "buffer", "role": "phosphate buffer" }, { "name": "Yeast protein", "slug": "yeast-protein", "amount": "trace residual", "category": "culture_medium_residual", "role": "residual from recombinant production" } ], "source": { "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=4d930f24-4ddb-488d-9e79-3f495972733b", "sourceType": "DailyMed", "lastVerified": "2026-07-09", "section": "11 DESCRIPTION", "setId": "4d930f24-4ddb-488d-9e79-3f495972733b" }, "ingredientSlugs": [ "aluminum-hydroxide", "yeast-protein" ] }, { "productId": "recombivax-hb", "productName": "Recombivax HB", "manufacturer": "Merck Sharp & Dohme LLC", "vaccineSlug": "hepatitis-b-vaccine", "platform": "recombinant_protein", "deliveryMethod": { "route": "intramuscular", "form": "suspension_for_injection", "doseVolume": "0.5 mL pediatric / 1 mL adult", "presentation": "single-dose vial or prefilled syringe", "requiresReconstitution": false }, "encapsulation": { "type": "none" }, "antigens": [ { "name": "Hepatitis B surface antigen (HBsAg)", "antigenType": "recombinant_protein", "amount": "5 mcg / 0.5 mL pediatric; 10 mcg / 1 mL adult (standard formulations)", "expressionSystem": "Saccharomyces cerevisiae (yeast)" } ], "adjuvants": [ { "name": "Amorphous aluminum hydroxyphosphate sulfate (AAHS)", "slug": "aluminum-hydroxyphosphate-sulfate", "class": "aluminum_salt", "aluminumContent": "≈0.25 mg Al / 0.5 mL pediatric (≈0.5 mg Al/mL)" } ], "preservatives": [ { "name": "none", "slug": null, "present": false, "amount": "none", "presentationNote": "Single-dose presentation; label states no preservative." } ], "excipients": [ { "name": "Formaldehyde", "slug": "formaldehyde", "amount": "<15 mcg/mL residual (label-dependent)", "category": "inactivating_agent_residual", "role": "residual from manufacturing" }, { "name": "Yeast protein", "slug": "yeast-protein", "amount": "trace residual", "category": "culture_medium_residual", "role": "residual from recombinant production" } ], "source": { "sourceUrl": "https://www.fda.gov/vaccines-blood-biologics/vaccines/recombivax-hb", "sourceType": "FDA package insert", "lastVerified": "2026-07-09", "section": "11 DESCRIPTION" }, "notes": "Aluminum salt is AAHS (chemically distinct from aluminum hydroxide used in Engerix-B).", "ingredientSlugs": [ "aluminum-hydroxyphosphate-sulfate", "formaldehyde", "yeast-protein" ] }, { "productId": "heplisav-b", "productName": "Heplisav-B", "manufacturer": "Dynavax Technologies", "vaccineSlug": "hepatitis-b-vaccine", "platform": "recombinant_protein", "deliveryMethod": { "route": "intramuscular", "form": "solution_for_injection", "doseVolume": "0.5 mL", "presentation": "single-dose prefilled syringe", "requiresReconstitution": false }, "encapsulation": { "type": "none" }, "antigens": [ { "name": "Hepatitis B surface antigen (HBsAg)", "antigenType": "recombinant_protein", "amount": "20 mcg per 0.5 mL", "expressionSystem": "Hansenula polymorpha (yeast)" } ], "adjuvants": [ { "name": "CpG 1018", "slug": null, "class": "cpg", "amount": "3000 mcg per 0.5 mL", "notes": "22-mer phosphorothioate oligodeoxynucleotide TLR9 agonist; not aluminum-based." } ], "preservatives": [ { "name": "none", "slug": null, "present": false, "amount": "none", "presentationNote": "Formulated without preservatives." } ], "excipients": [ { "name": "Sodium chloride", "slug": null, "amount": "9.0 mg/mL", "category": "buffer", "role": "PBS vehicle" }, { "name": "Sodium phosphate, dibasic dodecahydrate", "slug": null, "amount": "1.75 mg/mL", "category": "buffer", "role": "PBS" }, { "name": "Sodium phosphate, monobasic dihydrate", "slug": null, "amount": "0.48 mg/mL", "category": "buffer", "role": "PBS" }, { "name": "Polysorbate 80", "slug": "polysorbate-80", "amount": "0.1 mg/mL", "category": "surfactant", "role": "surfactant" }, { "name": "Yeast protein", "slug": "yeast-protein", "amount": "≤5.0% of total protein residual", "category": "culture_medium_residual", "role": "residual" }, { "name": "Yeast DNA", "slug": null, "amount": "<20 pg residual", "category": "residual_manufacturing", "role": "residual" }, { "name": "Deoxycholate", "slug": null, "amount": "<0.9 ppm residual", "category": "residual_manufacturing", "role": "process residual" } ], "source": { "sourceUrl": "https://www.fda.gov/media/108745/download", "sourceType": "FDA package insert", "lastVerified": "2026-07-09", "section": "11 DESCRIPTION" }, "latex": "Tip caps and stoppers not made with natural rubber latex.", "ingredientSlugs": [ "polysorbate-80", "yeast-protein" ] } ], "dtap-vaccine": [ { "productId": "daptacel", "productName": "Daptacel", "manufacturer": "Sanofi Pasteur", "vaccineSlug": "dtap-vaccine", "platform": "combination", "deliveryMethod": { "route": "intramuscular", "form": "suspension_for_injection", "doseVolume": "0.5 mL", "presentation": "single-dose vial", "requiresReconstitution": false }, "encapsulation": { "type": "none" }, "antigens": [ { "name": "Diphtheria toxoid", "antigenType": "toxoid", "amount": "15 Lf" }, { "name": "Tetanus toxoid", "antigenType": "toxoid", "amount": "5 Lf" }, { "name": "Pertussis toxin (detoxified)", "antigenType": "subunit_protein", "amount": "10 mcg" }, { "name": "Filamentous hemagglutinin (FHA)", "antigenType": "subunit_protein", "amount": "5 mcg" }, { "name": "Pertactin (PRN)", "antigenType": "subunit_protein", "amount": "3 mcg" }, { "name": "Fimbriae types 2 and 3 (FIM)", "antigenType": "subunit_protein", "amount": "5 mcg" } ], "adjuvants": [ { "name": "Aluminum phosphate", "slug": "aluminum-phosphate", "class": "aluminum_salt", "amount": "1.5 mg aluminum phosphate", "aluminumContent": "0.33 mg aluminum per 0.5 mL" } ], "preservatives": [ { "name": "none", "slug": null, "present": false, "amount": "none", "presentationNote": "2-phenoxyethanol is present as a stabilizer, not as a preservative (label wording)." } ], "excipients": [ { "name": "2-Phenoxyethanol", "slug": "2-phenoxyethanol", "amount": "3.3 mg (0.6% v/v)", "category": "stabilizer", "role": "stabilizer (not labeled as preservative)" }, { "name": "Formaldehyde", "slug": "formaldehyde", "amount": "≤5 mcg residual", "category": "inactivating_agent_residual", "role": "residual" }, { "name": "Glutaraldehyde", "slug": null, "amount": "<50 ng residual", "category": "inactivating_agent_residual", "role": "residual" }, { "name": "Water for injection", "slug": null, "amount": "q.s.", "category": "diluent", "role": "vehicle" } ], "source": { "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=06f34d0f-4e72-41d3-967f-8abf3f2005c1", "sourceType": "DailyMed", "lastVerified": "2026-07-09", "section": "11 DESCRIPTION", "setId": "06f34d0f-4e72-41d3-967f-8abf3f2005c1" }, "ingredientSlugs": [ "aluminum-phosphate", "2-phenoxyethanol", "formaldehyde" ] }, { "productId": "infanrix", "productName": "Infanrix", "manufacturer": "GlaxoSmithKline Biologicals", "vaccineSlug": "dtap-vaccine", "platform": "combination", "deliveryMethod": { "route": "intramuscular", "form": "suspension_for_injection", "doseVolume": "0.5 mL", "presentation": "single-dose vial or prefilled syringe", "requiresReconstitution": false }, "encapsulation": { "type": "none" }, "antigens": [ { "name": "Diphtheria toxoid", "antigenType": "toxoid", "amount": "25 Lf" }, { "name": "Tetanus toxoid", "antigenType": "toxoid", "amount": "10 Lf" }, { "name": "Inactivated pertussis toxin (PT)", "antigenType": "subunit_protein", "amount": "25 mcg" }, { "name": "Filamentous hemagglutinin (FHA)", "antigenType": "subunit_protein", "amount": "25 mcg" }, { "name": "Pertactin (PRN)", "antigenType": "subunit_protein", "amount": "8 mcg" } ], "adjuvants": [ { "name": "Aluminum hydroxide", "slug": "aluminum-hydroxide", "class": "aluminum_salt", "aluminumContent": "≤0.625 mg aluminum per dose" } ], "preservatives": [ { "name": "none", "slug": null, "present": false, "amount": "none", "presentationNote": "Single-dose presentation; label states no preservative." } ], "excipients": [ { "name": "Formaldehyde", "slug": "formaldehyde", "amount": "≤100 mcg residual", "category": "inactivating_agent_residual", "role": "residual" }, { "name": "Polysorbate 80", "slug": "polysorbate-80", "amount": "≤100 mcg", "category": "surfactant", "role": "surfactant" }, { "name": "Sodium chloride", "slug": null, "amount": "label quantity", "category": "buffer", "role": "tonicity" } ], "source": { "sourceUrl": "https://www.fda.gov/vaccines-blood-biologics/vaccines/infanrix", "sourceType": "FDA package insert", "lastVerified": "2026-07-09", "section": "11 DESCRIPTION" }, "ingredientSlugs": [ "aluminum-hydroxide", "formaldehyde", "polysorbate-80" ] } ], "hpv-vaccine": [ { "productId": "gardasil-9", "productName": "Gardasil 9", "manufacturer": "Merck Sharp & Dohme LLC", "vaccineSlug": "hpv-vaccine", "platform": "vlp", "deliveryMethod": { "route": "intramuscular", "form": "suspension_for_injection", "doseVolume": "0.5 mL", "presentation": "single-dose vial or prefilled syringe", "requiresReconstitution": false }, "encapsulation": { "type": "virus_like_particle", "description": "Recombinant L1 major capsid proteins self-assemble into non-infectious virus-like particles (no viral DNA)." }, "antigens": [ { "name": "HPV Type 6 L1 protein", "antigenType": "virus_like_particle", "amount": "≈30 mcg", "expressionSystem": "Saccharomyces cerevisiae" }, { "name": "HPV Type 11 L1 protein", "antigenType": "virus_like_particle", "amount": "≈40 mcg", "expressionSystem": "Saccharomyces cerevisiae" }, { "name": "HPV Type 16 L1 protein", "antigenType": "virus_like_particle", "amount": "≈60 mcg", "expressionSystem": "Saccharomyces cerevisiae" }, { "name": "HPV Type 18 L1 protein", "antigenType": "virus_like_particle", "amount": "≈40 mcg", "expressionSystem": "Saccharomyces cerevisiae" }, { "name": "HPV Type 31 L1 protein", "antigenType": "virus_like_particle", "amount": "≈20 mcg", "expressionSystem": "Saccharomyces cerevisiae" }, { "name": "HPV Type 33 L1 protein", "antigenType": "virus_like_particle", "amount": "≈20 mcg", "expressionSystem": "Saccharomyces cerevisiae" }, { "name": "HPV Type 45 L1 protein", "antigenType": "virus_like_particle", "amount": "≈20 mcg", "expressionSystem": "Saccharomyces cerevisiae" }, { "name": "HPV Type 52 L1 protein", "antigenType": "virus_like_particle", "amount": "≈20 mcg", "expressionSystem": "Saccharomyces cerevisiae" }, { "name": "HPV Type 58 L1 protein", "antigenType": "virus_like_particle", "amount": "≈20 mcg", "expressionSystem": "Saccharomyces cerevisiae" } ], "adjuvants": [ { "name": "Amorphous aluminum hydroxyphosphate sulfate (AAHS)", "slug": "aluminum-hydroxyphosphate-sulfate", "class": "aluminum_salt", "aluminumContent": "≈500 mcg (0.5 mg) aluminum per 0.5 mL" } ], "preservatives": [ { "name": "none", "slug": null, "present": false, "amount": "none", "presentationNote": "Single-dose presentation; label states no preservative." } ], "excipients": [ { "name": "Sodium chloride", "slug": null, "amount": "9.56 mg", "category": "buffer", "role": "tonicity" }, { "name": "L-histidine", "slug": null, "amount": "0.78 mg", "category": "buffer", "role": "buffer" }, { "name": "Polysorbate 80", "slug": "polysorbate-80", "amount": "50 mcg", "category": "surfactant", "role": "surfactant" }, { "name": "Sodium borate", "slug": null, "amount": "35 mcg", "category": "buffer", "role": "pH stabilizer" }, { "name": "Yeast protein", "slug": "yeast-protein", "amount": "trace residual (<7 mcg/dose in related labeling)", "category": "culture_medium_residual", "role": "residual" }, { "name": "Water for injection", "slug": null, "amount": "q.s.", "category": "diluent", "role": "vehicle" } ], "source": { "sourceUrl": "https://www.fda.gov/vaccines-blood-biologics/vaccines/gardasil-9", "sourceType": "FDA package insert", "lastVerified": "2026-07-09", "section": "11 DESCRIPTION" }, "ingredientSlugs": [ "aluminum-hydroxyphosphate-sulfate", "polysorbate-80", "yeast-protein" ] } ], "polio-vaccine": [ { "productId": "ipol", "productName": "IPOL", "manufacturer": "Sanofi Pasteur", "vaccineSlug": "polio-vaccine", "platform": "inactivated", "deliveryMethod": { "route": "intramuscular", "form": "suspension_for_injection", "doseVolume": "0.5 mL", "presentation": "single-dose syringe or multi-dose vial", "requiresReconstitution": false }, "encapsulation": { "type": "none" }, "antigens": [ { "name": "Poliovirus Type 1 (Mahoney), inactivated", "antigenType": "inactivated_virus", "amount": "40 D-antigen units" }, { "name": "Poliovirus Type 2 (MEF-1), inactivated", "antigenType": "inactivated_virus", "amount": "8 D-antigen units" }, { "name": "Poliovirus Type 3 (Saukett), inactivated", "antigenType": "inactivated_virus", "amount": "32 D-antigen units" } ], "adjuvants": [], "preservatives": [ { "name": "2-Phenoxyethanol", "slug": "2-phenoxyethanol", "present": true, "amount": "0.5%", "presentationNote": "Present in IPOL formulation with residual formaldehyde." } ], "excipients": [ { "name": "Formaldehyde", "slug": "formaldehyde", "amount": "max 0.02%", "category": "inactivating_agent_residual", "role": "inactivating agent residual" }, { "name": "M-199 medium components", "slug": null, "amount": "diluent vehicle", "category": "culture_medium_residual", "role": "medium" }, { "name": "Neomycin", "slug": "neomycin", "amount": "trace residual", "category": "antibiotic_residual", "role": "residual antibiotic" }, { "name": "Streptomycin", "slug": null, "amount": "trace residual", "category": "antibiotic_residual", "role": "residual antibiotic" }, { "name": "Polymyxin B", "slug": null, "amount": "trace residual", "category": "antibiotic_residual", "role": "residual antibiotic" }, { "name": "Calf serum", "slug": "fetal-bovine-serum", "amount": "trace residual", "category": "residual_manufacturing", "role": "residual" } ], "source": { "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=6979f24b-5f49-4190-a4e6-c1523e0d3108", "sourceType": "DailyMed", "lastVerified": "2026-07-09", "section": "11 DESCRIPTION", "setId": "6979f24b-5f49-4190-a4e6-c1523e0d3108" }, "notes": "Inactivated whole-virus; no aluminum adjuvant.", "ingredientSlugs": [ "2-phenoxyethanol", "formaldehyde", "neomycin", "fetal-bovine-serum" ] } ], "influenza-vaccine": [ { "productId": "fluzone-quadrivalent", "productName": "Fluzone Quadrivalent", "manufacturer": "Sanofi Pasteur", "vaccineSlug": "influenza-vaccine", "platform": "inactivated", "deliveryMethod": { "route": "intramuscular", "form": "suspension_for_injection", "doseVolume": "0.25 mL or 0.5 mL (age-dependent)", "presentation": "single-dose prefilled syringe or multi-dose vial", "requiresReconstitution": false }, "encapsulation": { "type": "none" }, "antigens": [ { "name": "Influenza A (H1N1) hemagglutinin", "antigenType": "inactivated_virus", "amount": "15 mcg HA / 0.5 mL (strain changes seasonally)" }, { "name": "Influenza A (H3N2) hemagglutinin", "antigenType": "inactivated_virus", "amount": "15 mcg HA / 0.5 mL" }, { "name": "Influenza B (Victoria lineage) hemagglutinin", "antigenType": "inactivated_virus", "amount": "15 mcg HA / 0.5 mL" }, { "name": "Influenza B (Yamagata lineage) hemagglutinin", "antigenType": "inactivated_virus", "amount": "15 mcg HA / 0.5 mL", "notes": "Composition follows annual WHO/FDA strain selection; lineage may change." } ], "adjuvants": [], "preservatives": [ { "name": "Thimerosal", "slug": "thimerosal", "present": true, "amount": "25 mcg mercury per 0.5 mL from multi-dose vial only", "presentationNote": "Single-dose prefilled syringes: no thimerosal. Multi-dose vials: thimerosal as preservative." } ], "excipients": [ { "name": "Egg protein (ovalbumin)", "slug": "egg-protein", "amount": "residual from egg-based manufacture", "category": "culture_medium_residual", "role": "residual" }, { "name": "Formaldehyde", "slug": "formaldehyde", "amount": "residual", "category": "inactivating_agent_residual", "role": "inactivation residual" }, { "name": "Octylphenol ethoxylate (Triton X-100)", "slug": null, "amount": "residual", "category": "surfactant", "role": "splitting agent residual" }, { "name": "Sodium phosphate-buffered isotonic sodium chloride", "slug": null, "amount": "q.s.", "category": "buffer", "role": "vehicle" } ], "source": { "sourceUrl": "https://www.fda.gov/vaccines-blood-biologics/vaccines/fluzone-quadrivalent", "sourceType": "FDA package insert", "lastVerified": "2026-07-09", "section": "11 DESCRIPTION" }, "notes": "No longer distributed in the United States. From the 2024–25 season FDA approved only trivalent Fluzone formulations for US use; Sanofi distributes the quadrivalent vaccine outside the United States only (FDA approval letter, STN 103914/6841, 1 July 2024: https://www.fda.gov/media/179807/download). For the current US product see the trivalent Fluzone page. Always check vial type: preservative status differs between single-dose and multi-dose presentations.", "ingredientSlugs": [ "thimerosal", "egg-protein", "formaldehyde" ] }, { "productId": "fluzone", "productName": "Fluzone (Influenza Vaccine, trivalent)", "manufacturer": "Sanofi Vaccines US Inc.", "vaccineSlug": "influenza-vaccine", "platform": "inactivated", "deliveryMethod": { "route": "intramuscular", "form": "suspension_for_injection", "doseVolume": "0.25 mL or 0.5 mL for 6 through 35 months; 0.5 mL for 36 months and older", "presentation": "0.5 mL single-dose prefilled syringe (no preservative) or 5 mL multiple-dose vial (thimerosal; max 10 doses)", "requiresReconstitution": false, "notes": "Children 6 months through 8 years may need 2 doses at least 4 weeks apart (per ACIP); 9 years and older: one 0.5 mL dose. Store refrigerated 2-8 C; do not freeze." }, "encapsulation": { "type": "none" }, "antigens": [ { "name": "Influenza A (H1N1) hemagglutinin - A/Switzerland/6849/2025 IVR-278 (A/Missouri/11/2025 pdm09-like virus)", "antigenType": "inactivated_virus", "amount": "15 mcg HA / 0.5 mL (7.5 mcg HA / 0.25 mL)" }, { "name": "Influenza A (H3N2) hemagglutinin - A/Michigan/105/2025 SAN-049A (A/Darwin/1454/2025-like virus)", "antigenType": "inactivated_virus", "amount": "15 mcg HA / 0.5 mL (7.5 mcg HA / 0.25 mL)" }, { "name": "Influenza B (Victoria lineage) hemagglutinin - B/Tokyo/EIS13-175/2025", "antigenType": "inactivated_virus", "amount": "15 mcg HA / 0.5 mL (7.5 mcg HA / 0.25 mL)", "notes": "2026-2027 strains; 45 mcg HA total per 0.5 mL (22.5 mcg per 0.25 mL). No B/Yamagata component." } ], "adjuvants": [], "preservatives": [ { "name": "Thimerosal", "slug": "thimerosal", "present": true, "amount": "25 mcg mercury per 0.5 mL dose; 12.5 mcg mercury per 0.25 mL dose (multiple-dose vial only)", "presentationNote": "0.5 mL single-dose prefilled syringe is manufactured and formulated without thimerosal or any other preservative. 5 mL multiple-dose vial contains thimerosal as a preservative." } ], "excipients": [ { "name": "Egg protein (residual from embryonated chicken egg propagation)", "slug": "egg-protein", "amount": "not quantified in PI", "category": "culture_medium_residual", "role": "residual" }, { "name": "Formaldehyde", "slug": "formaldehyde", "amount": "<=100 mcg per 0.5 mL (<=50 mcg per 0.25 mL)", "category": "inactivating_agent_residual", "role": "inactivation residual" }, { "name": "Octylphenol ethoxylate (Triton X-100)", "slug": null, "amount": "<=250 mcg per 0.5 mL (<=125 mcg per 0.25 mL)", "category": "surfactant", "role": "splitting agent residual" }, { "name": "Sodium phosphate-buffered isotonic sodium chloride solution", "slug": null, "amount": "q.s.", "category": "buffer", "role": "vehicle" } ], "source": { "sourceUrl": "https://www.fda.gov/media/170019/download", "sourceType": "FDA package insert", "lastVerified": "2026-10-28", "section": "11 DESCRIPTION (Table 9)" }, "notes": "Trivalent egg-based split-virus vaccine; the US standard-dose Sanofi product that replaced Fluzone Quadrivalent from the 2024-2025 season. Antibiotics are not used in manufacture (no neomycin). No presentation is made with natural rubber latex. Sucrose is used in a density-gradient purification step but is not listed as an ingredient in Table 9. Check vial type: preservative status differs between prefilled syringe and multiple-dose vial.", "ingredientSlugs": [ "thimerosal", "egg-protein", "formaldehyde" ], "_provenance": { "piVersion": "Fluzone Prescribing Information, 2026-2027 Formula, 'Revised: 7/2026' (Highlights); Recent Major Change: Warnings and Precautions, Febrile Seizures (5.4) 3/2026", "formulaSeason": "2026-2027 (US Northern Hemisphere) trivalent formula", "piUrl": "https://www.fda.gov/media/170019/download", "fdaProductPage": "https://www.fda.gov/vaccines-blood-biologics/vaccines/fluzone-and-fluzone-high-dose", "fdaProductPageCurrentAsOf": "2026-07-02", "properName": "Influenza Vaccine (FDA page lists 'Influenza Virus Vaccine')", "stn": "BL 103914", "initialUSApproval": "1980 (PI Highlights)", "currentFormulaApproval": { "date": "2026-07-01", "what": "Supplement approval STN BL 103914/7104 adding the 2026-2027 United States formulation for Fluzone and Fluzone High-Dose", "url": "https://www.fda.gov/media/193439/download" }, "quadrivalentTransition": { "fact": "FDA's 1 July 2024 letter (STN 103914/6841) approved the 2024-2025 US formulation for (trivalent) Fluzone and Fluzone High-Dose, and the 2024-2025 Northern Hemisphere formulation for Fluzone Quadrivalent / Fluzone High-Dose Quadrivalent, noting Sanofi's statement that it 'will distribute the quadrivalent vaccines outside of the United States only'.", "url": "https://www.fda.gov/media/179807/download" }, "regulatoryStatus": "FDA-licensed (BLA)", "approvedAges": "6 months of age and older (PI section 1)", "contraindications": "History of severe allergic reaction (e.g., anaphylaxis) to any vaccine component, including egg protein, or after a previous dose of any influenza vaccine (PI section 4)", "ndc": "Multiple-dose vial 5 mL NDC 49281-645-78 (package of one NDC 49281-645-15); single-dose prefilled syringe 0.5 mL NDC 49281-426-88 (package of 10 NDC 49281-426-50) (PI 16.1)", "allergens": { "gelatin": "not listed in PI section 11 / Table 9", "egg": "Yes - propagated in embryonated chicken eggs; egg protein named in Contraindications; amount not stated", "yeast": "not listed", "polysorbate80": "not listed", "neomycin": "No - 'Antibiotics are not used in the manufacture of Fluzone' (PI section 11)", "latex": "No - 'No presentation of Fluzone is made with natural rubber latex' (PI section 11)", "thimerosal": "Multiple-dose vial only" }, "unverifiedFields": [ "Ovalbumin/egg protein quantity (not stated in PI)", "DailyMed SPL set ID / version for the 2026-2027 label (not checked; FDA PI used instead)", "Whether a 0.25 mL prefilled syringe exists for 2026-2027 (PI 16.1 lists only the 0.5 mL syringe and 5 mL MDV; 0.25 mL doses come from the MDV)" ] } } ], "covid-vaccine": [ { "productId": "comirnaty", "productName": "Comirnaty (Pfizer-BioNTech COVID-19 Vaccine, mRNA)", "manufacturer": "Pfizer Inc. / BioNTech", "vaccineSlug": "covid-vaccine", "platform": "mrna", "deliveryMethod": { "route": "intramuscular", "form": "suspension_for_injection", "doseVolume": "0.3 mL (standard adult/adolescent presentations)", "presentation": "single-dose vial or prefilled syringe (formulation-dependent)", "requiresReconstitution": false, "notes": "Dose volume and mRNA mass vary by age band and seasonal formula." }, "encapsulation": { "type": "lipid_nanoparticle", "description": "Nucleoside-modified mRNA encapsulated in lipid nanoparticles (LNP) for cellular delivery.", "components": [ { "name": "ALC-0315 ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate)", "slug": null, "role": "ionizable_lipid", "amount": "0.43 mg per 0.3 mL (30 mcg mRNA adult presentation)" }, { "name": "ALC-0159 (2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide)", "slug": null, "role": "pegylated_lipid", "amount": "0.05 mg per 0.3 mL (30 mcg presentation)" }, { "name": "DSPC (1,2-distearoyl-sn-glycero-3-phosphocholine)", "slug": null, "role": "helper_phospholipid", "amount": "0.09 mg per 0.3 mL" }, { "name": "Cholesterol", "slug": null, "role": "cholesterol", "amount": "0.19 mg per 0.3 mL" } ], "notes": "Lipid amounts scale with mRNA dose (e.g. lower for pediatric presentations)." }, "antigens": [ { "name": "Nucleoside-modified mRNA encoding SARS-CoV-2 spike (S) glycoprotein", "antigenType": "mrna", "amount": "30 mcg (12+ years standard); 10 mcg (5–11 years) — seasonal formula strain updates", "expressionSystem": "synthetic nucleoside-modified mRNA" } ], "adjuvants": [], "preservatives": [ { "name": "none", "slug": null, "present": false, "amount": "none", "presentationNote": "Single-dose presentation; label states no preservative." } ], "excipients": [ { "name": "Tromethamine", "slug": null, "amount": "0.06 mg (current tromethamine formulation)", "category": "buffer", "role": "buffer" }, { "name": "Tromethamine hydrochloride", "slug": null, "amount": "0.4 mg", "category": "buffer", "role": "buffer" }, { "name": "Sucrose", "slug": "sucrose", "amount": "31 mg", "category": "stabilizer", "role": "cryoprotectant/stabilizer" } ], "source": { "sourceUrl": "https://www.fda.gov/media/151707/download", "sourceType": "FDA package insert", "lastVerified": "2026-07-09", "section": "11 DESCRIPTION" }, "notes": "LNP lipids are the delivery system, not classical adjuvants. PEGylated lipid is structurally related to PEG.", "ingredientSlugs": [ "sucrose" ] }, { "productId": "spikevax", "productName": "Spikevax (Moderna COVID-19 Vaccine, mRNA)", "manufacturer": "ModernaTX, Inc.", "vaccineSlug": "covid-vaccine", "platform": "mrna", "deliveryMethod": { "route": "intramuscular", "form": "suspension_for_injection", "doseVolume": "0.5 mL or 0.25 mL (age/formula-dependent)", "presentation": "single-dose or multi-dose vial / prefilled syringe", "requiresReconstitution": false }, "encapsulation": { "type": "lipid_nanoparticle", "description": "mRNA embedded in SM-102 lipid nanoparticles.", "components": [ { "name": "SM-102 (heptadecan-9-yl 8-{(2-hydroxyethyl)[6-oxo-6-(undecyloxy)hexyl]amino}octanoate)", "slug": null, "role": "ionizable_lipid", "amount": "part of total lipid content (label)" }, { "name": "PEG2000-DMG (1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000)", "slug": null, "role": "pegylated_lipid", "amount": "part of total lipid content" }, { "name": "DSPC", "slug": null, "role": "helper_phospholipid", "amount": "part of total lipid content" }, { "name": "Cholesterol", "slug": null, "role": "cholesterol", "amount": "part of total lipid content" } ] }, "antigens": [ { "name": "Nucleoside-modified mRNA encoding SARS-CoV-2 spike (S) glycoprotein", "antigenType": "mrna", "amount": "varies by age and seasonal formula (e.g. 50 mcg / 25 mcg presentations)", "expressionSystem": "synthetic nucleoside-modified mRNA" } ], "adjuvants": [], "preservatives": [ { "name": "none", "slug": null, "present": false, "amount": "none", "presentationNote": "Single-dose presentation; label states no preservative." } ], "excipients": [ { "name": "Trometamol (tromethamine)", "slug": null, "amount": "label quantity", "category": "buffer", "role": "buffer" }, { "name": "Trometamol hydrochloride", "slug": null, "amount": "label quantity", "category": "buffer", "role": "buffer" }, { "name": "Acetic acid", "slug": null, "amount": "label quantity", "category": "buffer", "role": "pH" }, { "name": "Sodium acetate trihydrate", "slug": null, "amount": "label quantity", "category": "buffer", "role": "buffer" }, { "name": "Sucrose", "slug": "sucrose", "amount": "label quantity", "category": "stabilizer", "role": "stabilizer" }, { "name": "Water for injection", "slug": null, "amount": "q.s.", "category": "diluent", "role": "vehicle" } ], "source": { "sourceUrl": "https://www.fda.gov/media/155675/download", "sourceType": "FDA package insert", "lastVerified": "2026-07-09", "section": "11 DESCRIPTION" }, "ingredientSlugs": [ "sucrose" ] }, { "productId": "nuvaxovid", "productName": "Nuvaxovid (Novavax COVID-19 Vaccine, Adjuvanted)", "manufacturer": "Novavax, Inc.", "vaccineSlug": "covid-vaccine", "platform": "recombinant_protein", "deliveryMethod": { "route": "intramuscular", "form": "suspension_for_injection", "doseVolume": "0.5 mL", "presentation": "prefilled syringe", "requiresReconstitution": false }, "encapsulation": { "type": "protein_nanoparticle", "description": "Recombinant SARS-CoV-2 spike protein nanoparticles (non-infectious)." }, "antigens": [ { "name": "SARS-CoV-2 recombinant spike protein", "antigenType": "recombinant_protein", "amount": "5 mcg (typical labeled antigen mass; seasonal formula updates)", "expressionSystem": "Sf9 insect cells / baculovirus system" } ], "adjuvants": [ { "name": "Matrix-M", "slug": null, "class": "matrix_m", "amount": "50 mcg (typical)", "notes": "Saponin-based adjuvant from Quillaja saponaria." } ], "preservatives": [ { "name": "none", "slug": null, "present": false, "amount": "none", "presentationNote": "Single-dose presentation; label states no preservative." } ], "excipients": [ { "name": "Polysorbate 80", "slug": "polysorbate-80", "amount": "label quantity", "category": "surfactant", "role": "surfactant" }, { "name": "Sodium chloride and buffer salts", "slug": null, "amount": "label quantity", "category": "buffer", "role": "vehicle" } ], "source": { "sourceUrl": "https://www.fda.gov/vaccines-blood-biologics/vaccines/nuvaxovid", "sourceType": "FDA package insert", "lastVerified": "2026-07-09", "section": "11 DESCRIPTION" }, "notes": "Protein subunit + Matrix-M adjuvant — no mRNA, no LNP.", "ingredientSlugs": [ "polysorbate-80" ] }, { "productId": "mnexspike", "productName": "mNEXSPIKE (Moderna COVID-19 Vaccine, mRNA)", "manufacturer": "ModernaTX, Inc.", "vaccineSlug": "covid-vaccine", "platform": "mrna", "deliveryMethod": { "route": "intramuscular", "form": "suspension_for_injection", "doseVolume": "0.2 mL", "presentation": "single-dose prefilled syringe (carton of 10)", "requiresReconstitution": false, "notes": "Single 0.2 mL dose, at least 3 months after the last COVID-19 vaccine dose. Store refrigerated 2-8 C, do not freeze (frozen presentation removed from label 8/2026); may be held at 8-25 C for up to 12 hours. Do not shake." }, "encapsulation": { "type": "lipid_nanoparticle", "description": "Nucleoside-modified mRNA formulated in lipid particles that deliver the mRNA into host cells (PI 12.1).", "components": [ { "name": "SM-102", "slug": null, "role": "ionizable_lipid", "amount": "part of 0.2 mg total lipid per 0.2 mL dose (individual amount not stated in PI)" }, { "name": "PEG2000-DMG (polyethylene glycol [PEG] 2000 dimyristoyl glycerol)", "slug": null, "role": "pegylated_lipid", "amount": "part of 0.2 mg total lipid per 0.2 mL dose (individual amount not stated in PI)" }, { "name": "Cholesterol", "slug": null, "role": "cholesterol", "amount": "part of 0.2 mg total lipid per 0.2 mL dose (individual amount not stated in PI)" }, { "name": "DSPC (1,2-distearoyl-sn-glycero-3-phosphocholine)", "slug": null, "role": "helper_phospholipid", "amount": "part of 0.2 mg total lipid per 0.2 mL dose (individual amount not stated in PI)" } ], "notes": "Total lipid content 0.2 mg per dose (PI section 11)." }, "antigens": [ { "name": "Nucleoside-modified mRNA encoding the N-terminal domain (NTD) and receptor-binding domain (RBD) of the SARS-CoV-2 spike glycoprotein (JN.1-descendent variant XFG)", "antigenType": "mrna", "amount": "10 mcg per 0.2 mL dose (2026-2027 Formula)", "expressionSystem": "synthetic nucleoside-modified mRNA" } ], "adjuvants": [], "preservatives": [ { "name": "none", "slug": null, "present": false, "amount": "none", "presentationNote": "PI section 11: MNEXSPIKE does not contain a preservative." } ], "excipients": [ { "name": "Tromethamine", "slug": null, "amount": "0.09 mg", "category": "buffer", "role": "buffer" }, { "name": "Tromethamine hydrochloride", "slug": null, "amount": "0.51 mg", "category": "buffer", "role": "buffer" }, { "name": "Sucrose", "slug": "sucrose", "amount": "17 mg", "category": "stabilizer", "role": "stabilizer" } ], "source": { "sourceUrl": "https://www.fda.gov/media/186738/download", "sourceType": "FDA package insert", "lastVerified": "2026-10-28", "section": "11 DESCRIPTION" }, "notes": "Next-generation Moderna mRNA vaccine: encodes only the NTD and RBD of spike (not full-length spike) at 10 mcg in 0.2 mL. Section 11 lists no acetic acid or sodium acetate (unlike older Spikevax labels). The syringe's rubber tip cap and plunger are not made with natural rubber latex. LNP lipids are the delivery system, not adjuvants; PEG2000-DMG is a PEGylated lipid.", "ingredientSlugs": [ "sucrose" ], "_provenance": { "piVersion": "MNEXSPIKE Prescribing Information, 2026-2027 Formula, 'Revised: 8/2026' (Highlights); content approved under STN BL 125835/166 (PI submitted as amendment 3, dated 15 Jul 2026)", "formulaSeason": "2026-2027 Formula (monovalent, JN.1-descendent variant XFG)", "piUrl": "https://www.fda.gov/media/186738/download", "fdaProductPage": "https://www.fda.gov/vaccines-blood-biologics/mnexspike", "fdaProductPageCurrentAsOf": "2026-08-27", "properName": "COVID-19 Vaccine, mRNA", "stn": "BL 125835", "initialUSApproval": "2025 (PI Highlights); original BLA approval letter dated 30 May 2025: https://www.fda.gov/media/186740/download", "currentFormulaApproval": { "date": "2026-08-27", "what": "Supplement approval (STN BL 125835/166) adding the 2026-2027 Formula and labeling revisions", "url": "https://www.fda.gov/media/194510/download" }, "regulatoryStatus": "FDA-licensed (BLA), not EUA", "approvedAges": "65 years of age and older, or 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19 (PI section 1)", "dosing": "Single 0.2 mL IM dose; for previously vaccinated individuals, at least 3 months after last COVID-19 vaccine dose (PI 2.3)", "ndc": "Carton NDC 80777-401-60 (10 single-dose prefilled syringes); syringe NDC 80777-401-17 (PI section 16)", "contraindications": "Known severe allergic reaction (e.g., anaphylaxis) to any component of MNEXSPIKE, or after a previous dose of SPIKEVAX or any Moderna COVID-19 vaccine authorized for emergency use (PI section 4)", "allergens": { "gelatin": "not listed in PI section 11", "egg": "not listed in PI section 11", "yeast": "not listed in PI section 11", "polysorbate80": "not listed in PI section 11", "neomycin": "not listed in PI section 11", "latex": "No - 'The rubber tip cap and plunger used for the single-dose syringes are not made with natural rubber latex' (PI section 11)", "peg": "Yes - PEG2000-DMG lipid component (PI section 11)" }, "unverifiedFields": [ "Individual amounts of SM-102, PEG2000-DMG, cholesterol, DSPC (PI gives only 0.2 mg total lipid)", "DailyMed SPL set ID / version for the 2026-2027 label (not checked; FDA PI used instead)" ] } } ], "varicella-vaccine": [ { "productId": "varivax", "productName": "Varivax", "manufacturer": "Merck Sharp & Dohme LLC", "vaccineSlug": "varicella-vaccine", "platform": "live_attenuated", "deliveryMethod": { "route": "intramuscular_or_subcutaneous", "form": "lyophilized_powder_for_reconstitution", "doseVolume": "0.5 mL", "presentation": "single-dose vial + sterile diluent", "requiresReconstitution": true }, "encapsulation": { "type": "none" }, "antigens": [ { "name": "Varicella-zoster virus (live, attenuated)", "antigenType": "live_attenuated_virus", "amount": "≥1350 PFU per 0.5 mL", "strain": "Oka/Merck", "expressionSystem": "MRC-5 cells" } ], "adjuvants": [], "preservatives": [ { "name": "none", "slug": null, "present": false, "amount": "none", "presentationNote": "Single-dose presentation; label states no preservative." } ], "excipients": [ { "name": "Sucrose", "slug": "sucrose", "amount": "≈24 mg", "category": "stabilizer", "role": "stabilizer" }, { "name": "Hydrolyzed gelatin", "slug": "gelatin", "amount": "≈12.0 mg", "category": "stabilizer", "role": "stabilizer" }, { "name": "Sodium chloride", "slug": null, "amount": "≈3.1 mg", "category": "buffer", "role": "tonicity" }, { "name": "Monosodium L-glutamate", "slug": null, "amount": "≈0.5 mg", "category": "stabilizer", "role": "stabilizer" }, { "name": "Sodium phosphate dibasic", "slug": null, "amount": "≈0.44 mg", "category": "buffer", "role": "buffer" }, { "name": "Potassium phosphate monobasic", "slug": null, "amount": "≈0.08 mg", "category": "buffer", "role": "buffer" }, { "name": "Potassium chloride", "slug": null, "amount": "≈0.08 mg", "category": "buffer", "role": "buffer" }, { "name": "MRC-5 residual DNA/protein", "slug": null, "amount": "trace", "category": "residual_manufacturing", "role": "cell-substrate residual" }, { "name": "Neomycin", "slug": "neomycin", "amount": "trace", "category": "antibiotic_residual", "role": "residual" }, { "name": "Fetal bovine serum", "slug": "fetal-bovine-serum", "amount": "trace", "category": "residual_manufacturing", "role": "residual" }, { "name": "EDTA", "slug": null, "amount": "trace", "category": "residual_manufacturing", "role": "process residual" } ], "source": { "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=524cf052-e90e-4595-af0a-608edbe9bd31", "sourceType": "DailyMed", "lastVerified": "2026-07-09", "section": "11 DESCRIPTION", "setId": "524cf052-e90e-4595-af0a-608edbe9bd31" }, "ingredientSlugs": [ "sucrose", "gelatin", "neomycin", "fetal-bovine-serum" ] } ], "rotavirus-vaccine": [ { "productId": "rotateq", "productName": "RotaTeq", "manufacturer": "Merck Sharp & Dohme LLC", "vaccineSlug": "rotavirus-vaccine", "platform": "live_attenuated", "deliveryMethod": { "route": "oral", "form": "oral_solution", "doseVolume": "2 mL", "presentation": "single-dose ready-to-use oral tube", "requiresReconstitution": false }, "encapsulation": { "type": "none" }, "antigens": [ { "name": "Live reassortant rotavirus G1", "antigenType": "live_attenuated_virus", "amount": "≥2.2 × 10^6 infectious units" }, { "name": "Live reassortant rotavirus G2", "antigenType": "live_attenuated_virus", "amount": "≥2.8 × 10^6 infectious units" }, { "name": "Live reassortant rotavirus G3", "antigenType": "live_attenuated_virus", "amount": "≥2.2 × 10^6 infectious units" }, { "name": "Live reassortant rotavirus G4", "antigenType": "live_attenuated_virus", "amount": "≥2.0 × 10^6 infectious units" }, { "name": "Live reassortant rotavirus P1A[8]", "antigenType": "live_attenuated_virus", "amount": "≥2.3 × 10^6 infectious units" } ], "adjuvants": [], "preservatives": [ { "name": "none", "slug": null, "present": false, "amount": "none", "presentationNote": "Single-dose presentation; label states no preservative." } ], "excipients": [ { "name": "Sucrose", "slug": "sucrose", "amount": "label quantity", "category": "stabilizer", "role": "stabilizer/sweetener" }, { "name": "Sodium citrate / phosphate buffers", "slug": null, "amount": "label quantity", "category": "buffer", "role": "buffer" }, { "name": "Polysorbate 80", "slug": "polysorbate-80", "amount": "label quantity", "category": "surfactant", "role": "surfactant" }, { "name": "Fetal bovine serum", "slug": "fetal-bovine-serum", "amount": "trace residual", "category": "residual_manufacturing", "role": "residual" } ], "source": { "sourceUrl": "https://www.fda.gov/vaccines-blood-biologics/vaccines/rotateq", "sourceType": "FDA package insert", "lastVerified": "2026-07-09", "section": "11 DESCRIPTION" }, "ingredientSlugs": [ "sucrose", "polysorbate-80", "fetal-bovine-serum" ] }, { "productId": "rotarix", "productName": "Rotarix", "manufacturer": "GlaxoSmithKline Biologicals", "vaccineSlug": "rotavirus-vaccine", "platform": "live_attenuated", "deliveryMethod": { "route": "oral", "form": "oral_solution", "doseVolume": "1 mL", "presentation": "oral applicator (liquid) or lyophilized + diluent (historical)", "requiresReconstitution": false }, "encapsulation": { "type": "none" }, "antigens": [ { "name": "Live attenuated human rotavirus RIX4414 (G1P[8])", "antigenType": "live_attenuated_virus", "amount": "≥10^6.0 CCID50" } ], "adjuvants": [], "preservatives": [ { "name": "none", "slug": null, "present": false, "amount": "none", "presentationNote": "Single-dose presentation; label states no preservative." } ], "excipients": [ { "name": "Sucrose", "slug": "sucrose", "amount": "label quantity", "category": "stabilizer", "role": "stabilizer" }, { "name": "Dulbecco's Modified Eagle Medium components", "slug": null, "amount": "residual/media", "category": "culture_medium_residual", "role": "media" }, { "name": "Amino acids / salts", "slug": null, "amount": "label quantity", "category": "buffer", "role": "buffer" } ], "source": { "sourceUrl": "https://www.fda.gov/vaccines-blood-biologics/vaccines/rotarix", "sourceType": "FDA package insert", "lastVerified": "2026-07-09", "section": "11 DESCRIPTION" }, "ingredientSlugs": [ "sucrose" ] } ], "hib-vaccine": [ { "productId": "acthib", "productName": "ActHIB", "manufacturer": "Sanofi Pasteur", "vaccineSlug": "hib-vaccine", "platform": "conjugate", "deliveryMethod": { "route": "intramuscular", "form": "lyophilized_powder_for_reconstitution", "doseVolume": "0.5 mL", "presentation": "single-dose vial + saline diluent", "requiresReconstitution": true, "diluent": "0.4% sodium chloride" }, "encapsulation": { "type": "none" }, "antigens": [ { "name": "Haemophilus b capsular polysaccharide (PRP) conjugated to tetanus toxoid (PRP-T)", "antigenType": "conjugate", "amount": "10 mcg PRP", "carrierProtein": "tetanus toxoid" } ], "adjuvants": [], "preservatives": [ { "name": "none", "slug": null, "present": false, "amount": "none", "presentationNote": "Single-dose presentation; label states no preservative." } ], "excipients": [ { "name": "Sucrose", "slug": "sucrose", "amount": "≈8.5%", "category": "stabilizer", "role": "stabilizer" }, { "name": "Tris (trometamol)", "slug": null, "amount": "label quantity", "category": "buffer", "role": "buffer" }, { "name": "Sodium chloride diluent", "slug": null, "amount": "0.4%", "category": "diluent", "role": "diluent" } ], "source": { "sourceUrl": "https://www.fda.gov/vaccines-blood-biologics/vaccines/acthib", "sourceType": "FDA package insert", "lastVerified": "2026-07-09", "section": "11 DESCRIPTION" }, "notes": "Unadjuvanted conjugate (unlike PedvaxHIB).", "ingredientSlugs": [ "sucrose" ] }, { "productId": "pedvaxhib", "productName": "PedvaxHIB", "manufacturer": "Merck Sharp & Dohme LLC", "vaccineSlug": "hib-vaccine", "platform": "conjugate", "deliveryMethod": { "route": "intramuscular", "form": "suspension_for_injection", "doseVolume": "0.5 mL", "presentation": "single-dose vial", "requiresReconstitution": false }, "encapsulation": { "type": "none" }, "antigens": [ { "name": "Haemophilus b PRP conjugated to Neisseria meningitidis OMPC (PRP-OMP)", "antigenType": "conjugate", "amount": "7.5 mcg PRP", "carrierProtein": "meningococcal outer membrane protein complex (OMPC)" } ], "adjuvants": [ { "name": "Amorphous aluminum hydroxyphosphate sulfate", "slug": "aluminum-hydroxyphosphate-sulfate", "class": "aluminum_salt", "aluminumContent": "≈225 mcg aluminum per dose" } ], "preservatives": [ { "name": "none", "slug": null, "present": false, "amount": "none", "presentationNote": "Single-dose presentation; label states no preservative." } ], "excipients": [ { "name": "Sodium chloride", "slug": null, "amount": "label quantity", "category": "buffer", "role": "tonicity" }, { "name": "Sodium borate", "slug": null, "amount": "label quantity", "category": "buffer", "role": "buffer" } ], "source": { "sourceUrl": "https://www.merck.com/product/usa/pi_circulars/p/pedvax_hib/pedvax_pi.pdf", "sourceType": "Manufacturer prescribing information", "lastVerified": "2026-07-09", "section": "11 DESCRIPTION" }, "ingredientSlugs": [ "aluminum-hydroxyphosphate-sulfate" ] }, { "productId": "hiberix", "productName": "Hiberix", "manufacturer": "GlaxoSmithKline Biologicals", "vaccineSlug": "hib-vaccine", "platform": "conjugate", "deliveryMethod": { "route": "intramuscular", "form": "lyophilized_powder_for_reconstitution", "doseVolume": "0.5 mL", "presentation": "single-dose vial + saline diluent", "requiresReconstitution": true }, "encapsulation": { "type": "none" }, "antigens": [ { "name": "Haemophilus b PRP conjugated to tetanus toxoid (PRP-T)", "antigenType": "conjugate", "amount": "10 mcg PRP", "carrierProtein": "tetanus toxoid ≈25 mcg" } ], "adjuvants": [], "preservatives": [ { "name": "none", "slug": null, "present": false, "amount": "none", "presentationNote": "Single-dose presentation; label states no preservative." } ], "excipients": [ { "name": "Lactose", "slug": null, "amount": "≈12.6 mg", "category": "stabilizer", "role": "stabilizer" }, { "name": "Sodium chloride diluent", "slug": null, "amount": "0.9%", "category": "diluent", "role": "diluent" } ], "source": { "sourceUrl": "https://www.fda.gov/vaccines-blood-biologics/vaccines/hiberix", "sourceType": "FDA package insert", "lastVerified": "2026-07-09", "section": "11 DESCRIPTION" }, "ingredientSlugs": [] } ], "pcv-vaccine": [ { "productId": "prevnar-20", "productName": "Prevnar 20", "manufacturer": "Pfizer Inc.", "vaccineSlug": "pcv-vaccine", "platform": "conjugate", "deliveryMethod": { "route": "intramuscular", "form": "suspension_for_injection", "doseVolume": "0.5 mL", "presentation": "single-dose prefilled syringe", "requiresReconstitution": false }, "encapsulation": { "type": "none" }, "antigens": [ { "name": "Pneumococcal capsular polysaccharides (20 serotypes) conjugated to CRM197", "antigenType": "conjugate", "amount": "2.2 mcg each of 19 serotypes + 4.4 mcg serotype 6B (typical PCV20 labeling)", "carrierProtein": "CRM197 (diphtheria CRM197 protein ≈51 mcg)" } ], "adjuvants": [ { "name": "Aluminum phosphate", "slug": "aluminum-phosphate", "class": "aluminum_salt", "aluminumContent": "≈0.125 mg aluminum per 0.5 mL" } ], "preservatives": [ { "name": "none", "slug": null, "present": false, "amount": "none", "presentationNote": "Single-dose presentation; label states no preservative." } ], "excipients": [ { "name": "Polysorbate 80", "slug": "polysorbate-80", "amount": "≈100 mcg", "category": "surfactant", "role": "surfactant" }, { "name": "Succinate buffer", "slug": null, "amount": "≈295 mcg", "category": "buffer", "role": "buffer" }, { "name": "Sodium chloride", "slug": null, "amount": "label quantity", "category": "buffer", "role": "tonicity" }, { "name": "Yeast / growth medium residuals", "slug": "yeast-protein", "amount": "trace", "category": "culture_medium_residual", "role": "residual" } ], "source": { "sourceUrl": "https://labeling.pfizer.com/ShowLabeling.aspx?id=15428", "sourceType": "Manufacturer prescribing information", "lastVerified": "2026-07-09", "section": "11 DESCRIPTION" }, "ingredientSlugs": [ "aluminum-phosphate", "polysorbate-80", "yeast-protein" ] } ], "meningococcal-vaccine": [ { "productId": "menveo", "productName": "Menveo", "manufacturer": "GlaxoSmithKline Biologicals", "vaccineSlug": "meningococcal-vaccine", "platform": "conjugate", "deliveryMethod": { "route": "intramuscular", "form": "lyophilized_powder_for_reconstitution", "doseVolume": "0.5 mL", "presentation": "two-vial system (MenA lyophilized + MenCWY liquid) or ready-to-use presentations per current labeling", "requiresReconstitution": true }, "encapsulation": { "type": "none" }, "antigens": [ { "name": "Neisseria meningitidis serogroup A polysaccharide-CRM197 conjugate", "antigenType": "conjugate", "amount": "10 mcg oligosaccharide", "carrierProtein": "CRM197" }, { "name": "Serogroup C polysaccharide-CRM197 conjugate", "antigenType": "conjugate", "amount": "5 mcg", "carrierProtein": "CRM197" }, { "name": "Serogroup W-135 polysaccharide-CRM197 conjugate", "antigenType": "conjugate", "amount": "5 mcg", "carrierProtein": "CRM197" }, { "name": "Serogroup Y polysaccharide-CRM197 conjugate", "antigenType": "conjugate", "amount": "5 mcg", "carrierProtein": "CRM197" } ], "adjuvants": [], "preservatives": [ { "name": "none", "slug": null, "present": false, "amount": "none", "presentationNote": "Single-dose presentation; label states no preservative." } ], "excipients": [ { "name": "Potassium dihydrogen phosphate", "slug": null, "amount": "label quantity", "category": "buffer", "role": "buffer" }, { "name": "Sucrose", "slug": "sucrose", "amount": "label quantity", "category": "stabilizer", "role": "stabilizer" }, { "name": "Sodium chloride", "slug": null, "amount": "label quantity", "category": "buffer", "role": "tonicity" }, { "name": "Sodium dihydrogen phosphate monohydrate / dibasic", "slug": null, "amount": "label quantity", "category": "buffer", "role": "buffer" } ], "source": { "sourceUrl": "https://www.fda.gov/vaccines-blood-biologics/vaccines/menveo", "sourceType": "FDA package insert", "lastVerified": "2026-07-09", "section": "11 DESCRIPTION" }, "ingredientSlugs": [ "sucrose" ] }, { "productId": "bexsero", "productName": "Bexsero", "manufacturer": "GlaxoSmithKline Biologicals", "vaccineSlug": "meningococcal-vaccine", "platform": "subunit", "deliveryMethod": { "route": "intramuscular", "form": "suspension_for_injection", "doseVolume": "0.5 mL", "presentation": "single-dose prefilled syringe", "requiresReconstitution": false }, "encapsulation": { "type": "outer_membrane_vesicle", "description": "Includes Neisseria meningitidis group B outer membrane vesicles (OMV) as antigen component." }, "antigens": [ { "name": "Neisseria meningitidis group B fHbp fusion protein", "antigenType": "recombinant_protein", "amount": "50 mcg" }, { "name": "NadA protein", "antigenType": "recombinant_protein", "amount": "50 mcg" }, { "name": "NHBA fusion protein", "antigenType": "recombinant_protein", "amount": "50 mcg" }, { "name": "Outer membrane vesicles (OMV) from NZ98/254", "antigenType": "outer_membrane_vesicle", "amount": "25 mcg measured as amount of total protein containing PorA P1.4" } ], "adjuvants": [ { "name": "Aluminum hydroxide", "slug": "aluminum-hydroxide", "class": "aluminum_salt", "aluminumContent": "≈0.5 mg aluminum hydroxide (≈0.519 mg aluminum as hydroxide form per labeling conventions — verify current PI)" } ], "preservatives": [ { "name": "none", "slug": null, "present": false, "amount": "none", "presentationNote": "Single-dose presentation; label states no preservative." } ], "excipients": [ { "name": "Sodium chloride", "slug": null, "amount": "label quantity", "category": "buffer", "role": "tonicity" }, { "name": "Histidine", "slug": null, "amount": "label quantity", "category": "buffer", "role": "buffer" }, { "name": "Sucrose", "slug": "sucrose", "amount": "label quantity", "category": "stabilizer", "role": "stabilizer" }, { "name": "Water for injection", "slug": null, "amount": "q.s.", "category": "diluent", "role": "vehicle" } ], "source": { "sourceUrl": "https://www.fda.gov/vaccines-blood-biologics/vaccines/bexsero", "sourceType": "FDA package insert", "lastVerified": "2026-07-09", "section": "11 DESCRIPTION" }, "ingredientSlugs": [ "aluminum-hydroxide", "sucrose" ] } ], "hepatitis-a-vaccine": [ { "productId": "vaqta", "productName": "Vaqta", "manufacturer": "Merck Sharp & Dohme LLC", "vaccineSlug": "hepatitis-a-vaccine", "platform": "inactivated", "deliveryMethod": { "route": "intramuscular", "form": "suspension_for_injection", "doseVolume": "0.5 mL pediatric / 1 mL adult", "presentation": "single-dose vial or prefilled syringe", "requiresReconstitution": false }, "encapsulation": { "type": "none" }, "antigens": [ { "name": "Hepatitis A virus, inactivated", "antigenType": "inactivated_virus", "amount": "25 U pediatric / 50 U adult", "strain": "CR326F" } ], "adjuvants": [ { "name": "Amorphous aluminum hydroxyphosphate sulfate", "slug": "aluminum-hydroxyphosphate-sulfate", "class": "aluminum_salt", "aluminumContent": "≈0.225 mg Al / 0.5 mL pediatric" } ], "preservatives": [ { "name": "none", "slug": null, "present": false, "amount": "none", "presentationNote": "Single-dose presentation; label states no preservative." } ], "excipients": [ { "name": "Sodium borate", "slug": null, "amount": "35 mcg (pediatric 0.5 mL)", "category": "buffer", "role": "pH stabilizer" }, { "name": "Sodium chloride 0.9%", "slug": null, "amount": "vehicle", "category": "buffer", "role": "vehicle" }, { "name": "Formaldehyde", "slug": "formaldehyde", "amount": "<0.8 mcg residual (50 U dose scale)", "category": "inactivating_agent_residual", "role": "residual" }, { "name": "Bovine albumin", "slug": "fetal-bovine-serum", "amount": "<10^-4 mcg residual (50 U scale)", "category": "residual_manufacturing", "role": "residual" }, { "name": "Neomycin", "slug": "neomycin", "amount": "trace residual", "category": "antibiotic_residual", "role": "residual" } ], "source": { "sourceUrl": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89191ae9-7f2b-4206-8397-bf7fce3436ac", "sourceType": "DailyMed", "lastVerified": "2026-07-09", "section": "11 DESCRIPTION", "setId": "89191ae9-7f2b-4206-8397-bf7fce3436ac" }, "latex": "Vial stopper contains natural latex rubber (check presentation).", "ingredientSlugs": [ "aluminum-hydroxyphosphate-sulfate", "formaldehyde", "fetal-bovine-serum", "neomycin" ] }, { "productId": "havrix", "productName": "Havrix", "manufacturer": "GlaxoSmithKline Biologicals", "vaccineSlug": "hepatitis-a-vaccine", "platform": "inactivated", "deliveryMethod": { "route": "intramuscular", "form": "suspension_for_injection", "doseVolume": "0.5 mL pediatric / 1 mL adult", "presentation": "single-dose vial or prefilled syringe", "requiresReconstitution": false }, "encapsulation": { "type": "none" }, "antigens": [ { "name": "Hepatitis A virus, inactivated", "antigenType": "inactivated_virus", "amount": "720 EL.U. pediatric / 1440 EL.U. adult", "strain": "HM175" } ], "adjuvants": [ { "name": "Aluminum hydroxide", "slug": "aluminum-hydroxide", "class": "aluminum_salt", "aluminumContent": "≈0.25 mg Al / 0.5 mL pediatric" } ], "preservatives": [ { "name": "none", "slug": null, "present": false, "amount": "none", "presentationNote": "Single-dose presentation; label states no preservative." } ], "excipients": [ { "name": "Amino acid supplement", "slug": null, "amount": "label quantity", "category": "stabilizer", "role": "stabilizer" }, { "name": "Phosphate-buffered saline components", "slug": null, "amount": "label quantity", "category": "buffer", "role": "buffer" }, { "name": "Polysorbate 20", "slug": null, "amount": "label quantity", "category": "surfactant", "role": "surfactant" }, { "name": "Formaldehyde", "slug": "formaldehyde", "amount": "≤0.1 mg residual", "category": "inactivating_agent_residual", "role": "residual" }, { "name": "Neomycin sulfate", "slug": "neomycin", "amount": "≤40 ng residual", "category": "antibiotic_residual", "role": "residual" } ], "source": { "sourceUrl": "https://www.fda.gov/vaccines-blood-biologics/vaccines/havrix", "sourceType": "FDA package insert", "lastVerified": "2026-07-09", "section": "11 DESCRIPTION" }, "ingredientSlugs": [ "aluminum-hydroxide", "formaldehyde", "neomycin" ] } ], "shingles-vaccine": [ { "productId": "shingrix", "productName": "Shingrix", "manufacturer": "GlaxoSmithKline Biologicals", "vaccineSlug": "shingles-vaccine", "platform": "recombinant_protein", "deliveryMethod": { "route": "intramuscular", "form": "lyophilized_powder_for_reconstitution", "doseVolume": "0.5 mL", "presentation": "antigen vial + AS01B adjuvant suspension vial", "requiresReconstitution": true, "diluent": "AS01B adjuvant suspension component" }, "encapsulation": { "type": "liposome", "description": "AS01B adjuvant is a liposomal formulation containing MPL and QS-21.", "components": [ { "name": "DOPC (dioleoyl phosphatidylcholine)", "slug": null, "role": "liposomal_phospholipid", "amount": "label quantity" }, { "name": "Cholesterol", "slug": null, "role": "cholesterol", "amount": "label quantity" } ] }, "antigens": [ { "name": "Recombinant varicella-zoster virus glycoprotein E (gE)", "antigenType": "recombinant_protein", "amount": "50 mcg", "expressionSystem": "CHO cells" } ], "adjuvants": [ { "name": "AS01B", "slug": null, "class": "as01_liposomal", "amount": "MPL 50 mcg + QS-21 50 mcg per dose", "components": [ { "name": "MPL (3-O-desacyl-4'-monophosphoryl lipid A)", "slug": null, "amount": "50 mcg", "category": "other", "role": "TLR4 agonist component of AS01B" }, { "name": "QS-21 (Quillaja saponaria Molina, fraction 21)", "slug": null, "amount": "50 mcg", "category": "other", "role": "saponin component of AS01B" } ] } ], "preservatives": [ { "name": "none", "slug": null, "present": false, "amount": "none", "presentationNote": "Single-dose presentation; label states no preservative." } ], "excipients": [ { "name": "Sucrose", "slug": "sucrose", "amount": "label quantity", "category": "stabilizer", "role": "stabilizer" }, { "name": "Polysorbate 80", "slug": "polysorbate-80", "amount": "label quantity", "category": "surfactant", "role": "surfactant" }, { "name": "Sodium dihydrogen phosphate dihydrate / dipotassium phosphate", "slug": null, "amount": "label quantity", "category": "buffer", "role": "buffer" }, { "name": "Sodium chloride", "slug": null, "amount": "label quantity", "category": "buffer", "role": "tonicity" } ], "source": { "sourceUrl": "https://www.fda.gov/vaccines-blood-biologics/vaccines/shingrix", "sourceType": "FDA package insert", "lastVerified": "2026-07-09", "section": "11 DESCRIPTION" }, "ingredientSlugs": [ "sucrose", "polysorbate-80" ] } ], "rsv-vaccine": [ { "productId": "arexvy", "productName": "Arexvy", "manufacturer": "GlaxoSmithKline Biologicals", "vaccineSlug": "rsv-vaccine", "platform": "recombinant_protein", "deliveryMethod": { "route": "intramuscular", "form": "lyophilized_powder_for_reconstitution", "doseVolume": "0.5 mL", "presentation": "antigen vial + AS01E adjuvant suspension", "requiresReconstitution": true }, "encapsulation": { "type": "liposome", "description": "AS01E is a liposomal adjuvant system (half-dose AS01 relative to AS01B).", "components": [ { "name": "DOPC", "slug": null, "role": "liposomal_phospholipid", "amount": "0.5 mg" }, { "name": "Cholesterol", "slug": null, "role": "cholesterol", "amount": "0.125 mg" } ] }, "antigens": [ { "name": "Recombinant RSV prefusion F glycoprotein (RSVPreF3)", "antigenType": "recombinant_protein", "amount": "120 mcg" } ], "adjuvants": [ { "name": "AS01E", "slug": null, "class": "as01_liposomal", "amount": "MPL 25 mcg + QS-21 25 mcg", "components": [ { "name": "MPL", "slug": null, "amount": "25 mcg", "category": "other", "role": "AS01E component" }, { "name": "QS-21", "slug": null, "amount": "25 mcg", "category": "other", "role": "AS01E component" } ] } ], "preservatives": [ { "name": "none", "slug": null, "present": false, "amount": "none", "presentationNote": "Single-dose presentation; label states no preservative." } ], "excipients": [ { "name": "Trehalose", "slug": null, "amount": "14.7 mg", "category": "stabilizer", "role": "stabilizer" }, { "name": "Sodium chloride", "slug": null, "amount": "4.4 mg", "category": "buffer", "role": "tonicity" }, { "name": "Potassium dihydrogen phosphate", "slug": null, "amount": "0.83 mg", "category": "buffer", "role": "buffer" }, { "name": "Dipotassium phosphate", "slug": null, "amount": "0.26 mg", "category": "buffer", "role": "buffer" }, { "name": "Polysorbate 80", "slug": "polysorbate-80", "amount": "0.18 mg", "category": "surfactant", "role": "surfactant" }, { "name": "Disodium phosphate anhydrous", "slug": null, "amount": "0.15 mg", "category": "buffer", "role": "buffer" } ], "source": { "sourceUrl": "https://www.fda.gov/vaccines-blood-biologics/vaccines/arexvy", "sourceType": "FDA package insert", "lastVerified": "2026-07-09", "section": "11 DESCRIPTION" }, "ingredientSlugs": [ "polysorbate-80" ] }, { "productId": "abrysvo", "productName": "Abrysvo", "manufacturer": "Pfizer Inc.", "vaccineSlug": "rsv-vaccine", "platform": "recombinant_protein", "deliveryMethod": { "route": "intramuscular", "form": "lyophilized_powder_for_reconstitution", "doseVolume": "0.5 mL", "presentation": "single-dose vial + sterile water diluent / prefilled presentations per labeling", "requiresReconstitution": true }, "encapsulation": { "type": "none" }, "antigens": [ { "name": "RSV prefusion F (bivalent: subgroup A and B)", "antigenType": "recombinant_protein", "amount": "60 mcg each antigen (120 mcg total)", "expressionSystem": "CHO cells" } ], "adjuvants": [], "preservatives": [ { "name": "none", "slug": null, "present": false, "amount": "none", "presentationNote": "Single-dose presentation; label states no preservative." } ], "excipients": [ { "name": "Tromethamine / tromethamine hydrochloride", "slug": null, "amount": "label quantity", "category": "buffer", "role": "buffer" }, { "name": "Sucrose", "slug": "sucrose", "amount": "label quantity", "category": "stabilizer", "role": "stabilizer" }, { "name": "Mannitol", "slug": null, "amount": "label quantity", "category": "stabilizer", "role": "stabilizer" }, { "name": "Polysorbate 80", "slug": "polysorbate-80", "amount": "label quantity", "category": "surfactant", "role": "surfactant" }, { "name": "Sodium chloride", "slug": null, "amount": "label quantity", "category": "buffer", "role": "tonicity" } ], "source": { "sourceUrl": "https://www.fda.gov/vaccines-blood-biologics/vaccines/abrysvo", "sourceType": "FDA package insert", "lastVerified": "2026-07-09", "section": "11 DESCRIPTION" }, "notes": "Unadjuvanted protein subunit RSV vaccine (contrast Arexvy AS01E).", "ingredientSlugs": [ "sucrose", "polysorbate-80" ] } ], "japanese-encephalitis-vaccine": [ { "productId": "ixiaro", "productName": "Ixiaro", "manufacturer": "Valneva Austria GmbH", "vaccineSlug": "japanese-encephalitis-vaccine", "platform": "inactivated", "deliveryMethod": { "route": "intramuscular", "form": "suspension_for_injection", "doseVolume": "0.5 mL", "presentation": "single-dose prefilled syringe", "requiresReconstitution": false }, "encapsulation": { "type": "none" }, "antigens": [ { "name": "Japanese encephalitis virus proteins, purified inactivated", "antigenType": "inactivated_virus", "amount": "≈6 mcg" } ], "adjuvants": [ { "name": "Aluminum hydroxide", "slug": "aluminum-hydroxide", "class": "aluminum_salt", "amount": "250 mcg aluminum hydroxide" } ], "preservatives": [ { "name": "none", "slug": null, "present": false, "amount": "none", "presentationNote": "No preservatives, stabilizers, or antibiotics added." } ], "excipients": [ { "name": "Phosphate-buffered saline", "slug": null, "amount": "vehicle", "category": "buffer", "role": "vehicle" }, { "name": "Formaldehyde", "slug": "formaldehyde", "amount": "≤200 ppm residual", "category": "inactivating_agent_residual", "role": "residual" }, { "name": "Bovine serum albumin", "slug": "fetal-bovine-serum", "amount": "≤100 ng/mL residual", "category": "residual_manufacturing", "role": "residual" }, { "name": "Host cell DNA", "slug": null, "amount": "≤200 pg/mL residual", "category": "residual_manufacturing", "role": "residual" }, { "name": "Sodium metabisulphite", "slug": null, "amount": "≤200 ppm residual", "category": "residual_manufacturing", "role": "process residual" }, { "name": "Protamine sulfate", "slug": null, "amount": "≤1 mcg/mL residual", "category": "residual_manufacturing", "role": "process residual" } ], "source": { "sourceUrl": "https://www.fda.gov/vaccines-blood-biologics/vaccines/ixiaro", "sourceType": "FDA package insert", "lastVerified": "2026-07-09", "section": "11 DESCRIPTION" }, "ingredientSlugs": [ "aluminum-hydroxide", "formaldehyde", "fetal-bovine-serum" ] } ], "rabies-vaccine": [ { "productId": "imovax", "productName": "Imovax Rabies", "manufacturer": "Sanofi Pasteur", "vaccineSlug": "rabies-vaccine", "platform": "inactivated", "deliveryMethod": { "route": "intramuscular", "form": "lyophilized_powder_for_reconstitution", "doseVolume": "1 mL", "presentation": "single-dose vial + diluent", "requiresReconstitution": true }, "encapsulation": { "type": "none" }, "antigens": [ { "name": "Rabies virus antigen (β-propiolactone inactivated)", "antigenType": "inactivated_virus", "amount": "≥2.5 IU", "strain": "PM-1503-3M", "expressionSystem": "MRC-5 human diploid cells" } ], "adjuvants": [], "preservatives": [ { "name": "none", "slug": null, "present": false, "amount": "none", "presentationNote": "Single-dose presentation; label states no preservative." } ], "excipients": [ { "name": "Human albumin", "slug": "human-serum-albumin", "amount": "<100 mg", "category": "stabilizer", "role": "stabilizer" }, { "name": "Neomycin sulfate", "slug": "neomycin", "amount": "<150 mcg", "category": "antibiotic_residual", "role": "residual" }, { "name": "Phenol red indicator", "slug": null, "amount": "20 mcg", "category": "other", "role": "indicator" } ], "source": { "sourceUrl": "https://www.fda.gov/vaccines-blood-biologics/vaccines/imovax", "sourceType": "FDA package insert", "lastVerified": "2026-07-09", "section": "11 DESCRIPTION" }, "ingredientSlugs": [ "human-serum-albumin", "neomycin" ] } ], "typhoid-vaccine": [ { "productId": "vivotif", "productName": "Vivotif", "manufacturer": "Bavarian Nordic / Emergent", "vaccineSlug": "typhoid-vaccine", "platform": "live_attenuated", "deliveryMethod": { "route": "oral", "form": "enteric_coated_capsule", "doseVolume": "1 capsule × 4 doses (days 1, 3, 5, 7)", "presentation": "blister of 4 capsules", "requiresReconstitution": false }, "encapsulation": { "type": "none", "description": "Enteric-coated capsule for gastric acid protection (not a nanoparticle system)." }, "antigens": [ { "name": "Salmonella typhi Ty21a (live attenuated)", "antigenType": "live_attenuated_bacteria", "amount": "2–10 × 10^9 CFU viable organisms per capsule" } ], "adjuvants": [], "preservatives": [ { "name": "none", "slug": null, "present": false, "amount": "none", "presentationNote": "Single-dose presentation; label states no preservative." } ], "excipients": [ { "name": "Sucrose", "slug": "sucrose", "amount": "label quantity", "category": "stabilizer", "role": "stabilizer" }, { "name": "Ascorbic acid", "slug": null, "amount": "label quantity", "category": "stabilizer", "role": "antioxidant" }, { "name": "Amino acids", "slug": null, "amount": "label quantity", "category": "stabilizer", "role": "stabilizer" }, { "name": "Lactose / magnesium stearate / capsule shell", "slug": null, "amount": "label quantity", "category": "other", "role": "capsule formulation" } ], "source": { "sourceUrl": "https://www.fda.gov/vaccines-blood-biologics/vaccines/vivotif", "sourceType": "FDA package insert", "lastVerified": "2026-07-09", "section": "11 DESCRIPTION" }, "ingredientSlugs": [ "sucrose" ] }, { "productId": "typhim-vi", "productName": "Typhim Vi", "manufacturer": "Sanofi Pasteur", "vaccineSlug": "typhoid-vaccine", "platform": "subunit", "deliveryMethod": { "route": "intramuscular", "form": "solution_for_injection", "doseVolume": "0.5 mL", "presentation": "single-dose syringe", "requiresReconstitution": false }, "encapsulation": { "type": "none" }, "antigens": [ { "name": "Salmonella typhi Vi capsular polysaccharide", "antigenType": "polysaccharide", "amount": "25 mcg" } ], "adjuvants": [], "preservatives": [ { "name": "Phenol", "slug": null, "present": true, "amount": "≤1.25 mg", "presentationNote": "Phenol used as preservative in Typhim Vi." } ], "excipients": [ { "name": "Sodium chloride", "slug": null, "amount": "label quantity", "category": "buffer", "role": "tonicity" }, { "name": "Sodium phosphate buffer", "slug": null, "amount": "label quantity", "category": "buffer", "role": "buffer" }, { "name": "Water for injection", "slug": null, "amount": "q.s.", "category": "diluent", "role": "vehicle" } ], "source": { "sourceUrl": "https://www.fda.gov/vaccines-blood-biologics/vaccines/typhim-vi", "sourceType": "FDA package insert", "lastVerified": "2026-07-09", "section": "11 DESCRIPTION" }, "ingredientSlugs": [] } ], "yellow-fever-vaccine": [ { "productId": "yf-vax", "productName": "YF-VAX", "manufacturer": "Sanofi Pasteur", "vaccineSlug": "yellow-fever-vaccine", "platform": "live_attenuated", "deliveryMethod": { "route": "subcutaneous", "form": "lyophilized_powder_for_reconstitution", "doseVolume": "0.5 mL", "presentation": "single-dose or multi-dose vial + sterile diluent (NaCl)", "requiresReconstitution": true, "diluent": "Sodium Chloride Injection USP (no preservative)" }, "encapsulation": { "type": "none" }, "antigens": [ { "name": "Yellow fever virus (live, attenuated)", "antigenType": "live_attenuated_virus", "amount": "≥4.74 log10 PFU per 0.5 mL", "strain": "17D-204", "expressionSystem": "living avian leukosis virus-free chicken embryos" } ], "adjuvants": [], "preservatives": [ { "name": "none", "slug": null, "present": false, "amount": "none", "presentationNote": "No preservative added." } ], "excipients": [ { "name": "Sorbitol", "slug": "sorbitol", "amount": "stabilizer (label quantity)", "category": "stabilizer", "role": "stabilizer" }, { "name": "Gelatin", "slug": "gelatin", "amount": "stabilizer (label quantity)", "category": "stabilizer", "role": "stabilizer" }, { "name": "Egg protein", "slug": "egg-protein", "amount": "residual from chick embryo culture", "category": "culture_medium_residual", "role": "residual — contraindicated in severe egg allergy" } ], "source": { "sourceUrl": "https://www.fda.gov/media/76015/download", "sourceType": "FDA package insert", "lastVerified": "2026-07-09", "section": "11 DESCRIPTION" }, "ingredientSlugs": [ "sorbitol", "gelatin", "egg-protein" ] } ], "cholera-vaccine": [ { "productId": "vaxchora", "productName": "Vaxchora", "manufacturer": "Emergent Travel Health / Bavarian Nordic", "vaccineSlug": "cholera-vaccine", "platform": "live_attenuated", "deliveryMethod": { "route": "oral", "form": "oral_solution", "doseVolume": "100 mL after reconstitution", "presentation": "buffer + active component sachets for reconstitution", "requiresReconstitution": true, "diluent": "buffer sachet in 100 mL purified bottled water (no chlorine)" }, "encapsulation": { "type": "none" }, "antigens": [ { "name": "Vibrio cholerae CVD 103-HgR (live attenuated)", "antigenType": "live_attenuated_bacteria", "amount": "4 × 10^8 to 2 × 10^9 CFU" } ], "adjuvants": [], "preservatives": [ { "name": "none", "slug": null, "present": false, "amount": "none", "presentationNote": "Single-dose presentation; label states no preservative." } ], "excipients": [ { "name": "Sucrose", "slug": "sucrose", "amount": "label quantity", "category": "stabilizer", "role": "stabilizer" }, { "name": "Ascorbic acid", "slug": null, "amount": "label quantity", "category": "stabilizer", "role": "antioxidant" }, { "name": "Hydrolyzed casein", "slug": null, "amount": "label quantity", "category": "stabilizer", "role": "stabilizer" }, { "name": "Buffer components (sodium bicarbonate, sodium carbonate, ascorbic acid, lactose)", "slug": null, "amount": "buffer sachet", "category": "buffer", "role": "gastric buffer" } ], "source": { "sourceUrl": "https://www.fda.gov/vaccines-blood-biologics/vaccines/vaxchora", "sourceType": "FDA package insert", "lastVerified": "2026-07-09", "section": "11 DESCRIPTION" }, "ingredientSlugs": [ "sucrose" ] } ] } }