Vaccines licensed for use in the United States undergo rigorous evaluation by the FDA to ensure safety and efficacy. Each approval represents a significant milestone in public health, providing essential protection against infectious diseases. These authorized vaccines reflect years of scientific research and remain vital tools for disease prevention.
Vaccines licensed for use in the United States undergo rigorous evaluation by the FDA to ensure safety and efficacy. Each approval represents a significant milestone in public health, providing essential protection against infectious diseases. These authorized vaccines reflect years of scientific research and remain vital tools for disease prevention.
| NO. | Product Name | Trade Name |
| 1 | Adenovirus Type 4 and Type 7 Vaccine, Live, Oral | No Trade Name |
| 2 | Anthrax Vaccine Adsorbed, Adjuvanted | CYFENDUS |
| 3 | Anthrax Vaccine Adsorbed | Biothrax |
| 4 | BCG Live | BCG Vaccine |
| 5 | BCG Live | TICE BCG |
| 6 | Chikungunya Vaccine, Recombinant | VIMKUNYA |
| 7 | Chikungunya Vaccine, Live | IXCHIQ |
| 8 | Cholera Vaccine Live Oral | Vaxchora |
| 9 | COVID-19 Vaccine, mRNA | MNEXSPIKE |
| 10 | COVID-19 Vaccine, Adjuvanted | NUVAXOVID |
| 11 | COVID-19 Vaccine, mRNA | Comirnaty |
| 12 | COVID-19 Vaccine, mRNA | SPIKEVAX |
| 13 | Dengue Tetravalent Vaccine, Live | DENGVAXIA |
| 14 | Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed | Infanrix |
| 15 | Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed | DAPTACEL |
| 16 | Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed, Hepatitis B (recombinant) and Inactivated Poliovirus Vaccine Combined | Pediarix |
| 17 | Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine | KINRIX |
| 18 | Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine | Quadracel |
| 19 | Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine | VAXELIS |
| 20 | Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine | Pentacel |
| 21 | Ebola Zaire Vaccine, Live | ERVEBO |
| 22 | Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) | PedvaxHIB |
| 23 | Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) | ActHIB |
| 24 | Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) | Hiberix |
| 25 | Hepatitis A Vaccine, Inactivated | Havrix |
| 26 | Hepatitis A Vaccine, Inactivated | VAQTA |
| 27 | Hepatitis A Inactivated and Hepatitis B (Recombinant) Vaccine | Twinrix |
| 28 | Hepatitis B Vaccine (Recombinant) | Recombivax HB |
| 29 | Hepatitis B Vaccine (Recombinant) | PREHEVBRIO |
| 30 | Hepatitis B Vaccine (Recombinant) | Engerix-B |
| 31 | Hepatitis B Vaccine (Recombinant), Adjuvanted | HEPLISAV-B |
| 32 | Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant | Gardasil |
| 33 | Human Papillomavirus 9-valent Vaccine, Recombinant | Gardasil 9 |
| 34 | Human Papillomavirus Bivalent (Types 16, 18) Vaccine, Recombinant | Cervarix |
| 35 | Influenza A (H1N1) 2009 Monovalent Vaccine | No Trade Name |
| 36 | Influenza A (H1N1) 2009 Monovalent Vaccine | No Trade Name |
| 37 | Influenza A (H1N1) 2009 Monovalent Vaccine | No Trade Name |
| 38 | Influenza A (H1N1) 2009 Monovalent Vaccine | No Trade Name |
| 39 | Influenza A (H1N1) 2009 Monovalent Vaccine | No Trade Name |
| 40 | Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted | AREPANRIX |
| 41 | Influenza Virus Vaccine, H5N1(for National Stockpile) | No Trade Name |
| 42 | Influenza A (H5N1) Monovalent Vaccine, Adjuvanted | AUDENZ |
| 43 | Influenza Vaccine, Adjuvanted | Fluad Quadrivalent |
| 44 | Influenza Vaccine, Adjuvanted | Fluad |
| 45 | Influenza Vaccine | Afluria Quadrivalent, Afluria Quadrivalent Southern Hemisphere |
| 46 | Influenza Vaccine | Flucelvax Quadrivalent |
| 47 | Influenza Vaccine | Flulaval Quadrivalent |
| 48 | Influenza Virus Vaccine(Trivalent, Types A and B) | Afluria, Afluria Southern Hemisphere |
| 49 | Influenza Virus Vaccine(Trivalent, Types A and B) | FluLaval |
| 50 | Influenza Vaccine, Live, Intranasal(Trivalent, Types A and B) | FluMist |
| 51 | Influenza Virus Vaccine(Trivalent, Types A and B) | Fluarix |
| 52 | Influenza Virus Vaccine(Trivalent, Types A and B) | Fluvirin |
| 53 | Influenza Virus Vaccine(Trivalent, Types A and B) | Agriflu |
| 54 | Influenza Virus Vaccine(Trivalent, Types A and B) | Fluzone, Fluzone High-Dose and Fluzone Intradermal |
| 55 | Influenza Virus Vaccine(Trivalent, Types A and B) | Flucelvax |
| 56 | Influenza Vaccine (Trivalent) | Flublok |
| 57 | Influenza Vaccine (Quadrivalent) | Flublok Quadrivalent |
| 58 | Influenza Vaccine,Live, Intranasal(Quadrivalent, Types A and Types B) | FluMist Quadrivalent |
| 59 | Influenza Virus Vaccine(Quadrivalent, Types A and Types B) | Fluarix Quadrivalent |
| 60 | Influenza Virus Vaccine(Quadrivalent, Types A and Types B) | Fluzone Quadrivalent |
| 61 | Japanese Encephalitis Virus Vaccine, Inactivated, Adsorbed | Ixiaro |
| 62 | Measles, Mumps and Rubella Vaccine, Live | PRIORIX |
| 63 | Measles, Mumps, and Rubella Virus Vaccine, Live | M-M-R II |
| 64 | Measles, Mumps, Rubella and Varicella Virus Vaccine Live | ProQuad |
| 65 | Meningococcal Groups A, B, C, W, and Y Vaccine | PENBRAYA |
| 66 | Meningococcal Groups A, B, C, W, and Y Vaccine | PENMENVY |
| 67 | Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine | MENVEO |
| 68 | Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine | Menactra |
| 69 | Meningococcal Group B Vaccine | BEXSERO |
| 70 | Meningococcal Group B Vaccine | TRUMENBA |
| 71 | Meningococcal (Groups A, C, Y, W) Conjugate Vaccine | MenQuadfi |
| 72 | Plague Vaccine | No trade name |
| 73 | Pneumococcal Vaccine, Polyvalent | Pneumovax 23 |
| 74 | Pneumococcal 13-valent Conjugate Vaccine(Diphtheria CRM197 Protein) | Prevnar 13 |
| 75 | Pneumococcal 15-valent Conjugate Vaccine | VAXNEUVANCE |
| 76 | Pneumococcal 20-valent Conjugate Vaccine | Prevnar 20 |
| 77 | Pneumococcal 21-valent Conjugate Vaccine | CAPVAXIVE |
| 78 | Poliovirus Vaccine Inactivated (Human Diploid Cell) | Poliovax |
| 79 | Poliovirus Vaccine Inactivated (Monkey Kidney Cell) | IPOL |
| 80 | Rabies Vaccine | Imovax |
| 81 | Rabies Vaccine | RabAvert |
| 82 | Rabies Vaccine Adsorbed | No Trade Name |
| 83 | Rotavirus Vaccine, Live, Oral | ROTARIX |
| 84 | Rotavirus Vaccine, Live, Oral, Pentavalent | RotaTeq |
| 85 | Respiratory Syncytial Virus Vaccine | MRESVIA |
| 86 | Respiratory Syncytial Virus Vaccine | ABRYSVO |
| 87 | Respiratory Syncytial Virus Vaccine, Adjuvanted | AREXVY |
| 88 | Smallpox and Monkeypox Vaccine, Live, Non-Replicating | JYNNEOS |
| 89 | Smallpox and Mpox (Vaccinia) Vaccine, Live | ACAM2000 |
| 90 | Tetanus & Diphtheria Toxoids, Adsorbed | TDVAX |
| 91 | Tetanus & Diphtheria Toxoids Adsorbed for Adult Use | TENIVAC |
| 92 | Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed | Adacel |
| 93 | Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed | Boostrix |
| 94 | Tick-Borne Encephalitis Vaccine | TICOVAC |
| 95 | Typhoid Vaccine Live Oral Ty21a | Vivotif |
| 96 | Typhoid Vi Polysaccharide Vaccine | TYPHIM Vi |
| 97 | Varicella Virus Vaccine Live | Varivax |
| 98 | Yellow Fever Vaccine | YF-Vax |
| 99 | Zoster Vaccine, Live, (Oka/Merck) | Zostavax |
| 100 | Zoster Vaccine Recombinant, Adjuvanted | SHINGRIX |
Content current as of:05/31/2025
Regulated Product(s)：Biologics/Vaccines
Source: FDA
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