 |
U.S. Food and Drug Administration |
Authorized Vaccines
| Trade Name | Product Name / Diseases | Manufacturer | Last Label Update | Initial U.S. Approval | Package Insert | Last Approval Letter Update |
|---|---|---|---|---|---|---|
| ACAM2000 | Smallpox (Vaccinia) Vaccine, Live | Emergent Product Development Gaithersburg | March 2018 | 2007 |  | May 2 2017 |
| ActHIB | Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) | Sanofi Pasteur | March 2022 | 1993 | | October 13, 2022 |
| Adacel | Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed | Sanofi Pasteur | Not indicated in package insert | 2005 | | January 9, 2023 |
| Afluria | Influenza Virus Vaccine (Trivalent, Types A and B) | Seqirus | March 2022 | 2007 | | July 1, 2022 |
| Afluria Southern Hemisphere | Influenza Virus Vaccine (Trivalent, Types A and B) | Seqirus | September 2021 | 2007 | | July 1, 2022 |
| Afluria Quadrivalent | Influenza Virus Vaccine (Trivalent, Types A and B) | Seqirus | March 2022 | 2016 | | July 1, 2022 |
| Afluria Quadrivalent Southern Hemisphere | Influenza Virus Vaccine (Trivalent, Types A and B) | Seqirus | September 2021 | 2016 | | July 2 2021 |
| Agriflu | Influenza Virus Vaccine (Trivalent, Types A and B) | Seqirus | 10 January 2020 | 2009 | | January 28 2020 |
| AUDENZ | Influenza A (H5N1) Monovalent Vaccine, Adjuvanted | Seqirus | November 2021 | 2020 | | November 17 2021 |
| BCG Vaccine | BCG Vaccine | Organon Teknika Corp | Not indicated in package insert | Not indicated in package insert | | 13 January 2011 |
| Bexsero | Meningococcal Group B Vaccine | Novartis Vaccines and Diagnostics | Not indicated in package insert | 2015 | | January 6 2022 |
| Biothrax | Anthrax Vaccine Adsorbed | Emergent BioDefense Operations Lansing | November 2015 | 1970 | | 23 November 2015 |
| Boostrix | Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed | GlaxoSmithKline Biologicals | Not indicated in package insert | 2005 | | November 23, 2022 |
| COMIRNATY (Purple Cap) | COVID-19 Vaccine, mRNA | BioNTech Manufacturing GmbH | July 2022 | 2021 | | December 16 2021 |
| COMIRNATY (Grey Cap) | COVID-19 Vaccine, mRNA | BioNTech Manufacturing GmbH | August 2022 | 2021 | | December 16 2021 |
| Cervarix | Human Papillomavirus Bivalent (Types 16, 18) Vaccine, Recombinant | GlaxoSmithKline Biologicals | Not indicated in package insert | 2009 | | April 25, 2016 |
| Daptacel | Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed | Sanofi Pasteur | Not indicated in package insert | 2002 | | July 21 2022 |
| DENGVAXIA | Dengue Tetravalent Vaccine, Live | Sanofi Pasteur | January 2023 | 2019 | | January 25 2023 |
| Engerix-B | Hepatitis B Vaccine (Recombinant) | GlaxoSmithKline Biologicals | Not indicated in package insert | 1989 | | December 19 2018 |
| ERVEBO | Ebola Zaire Vaccine, Live | Merck Sharp & Dohme Corp | Not indicated in package insert | 2019 | | September 16, 2022 |
| FLUAD | Influenza Vaccine, Adjuvanted | Seqirus | August 2022 | 2020 | | July 2 2021 |
| FLUAD QUADRIVALENT | Influenza Vaccine, Adjuvanted | Seqirus | August 2022 | 2020 | | February 24, 2023 |
| Fluarix | Influenza Virus Vaccine (Trivalent, Types A and B) | GlaxoSmithKline Biologicals | Not indicated in package insert | 2005 | | November 18, 2016 |
| Fluarix Quadrivalent | Influenza Virus Vaccine (Quadrivalent, Types A and Types B) | Glaxosmithkline Biologicals | February 2023 | 2012 | | March 1, 2023 |
| Flublok | Influenza Vaccine (Trivalent) | Protein Sciences Corporation | March 2017 | 2013 | | July 7 2017 |
| Flublok Quadrivalent | Influenza Vaccine (Trivalent) | Protein Sciences Corporation | 2022 | 2013 | | July 1 2022 |
| Flucelvax Quadrivalent | Influenza Vaccine | Seqirus | Not indicated in package inser | 2016 | | February 28, 2023 |
| FluLaval | Influenza Virus Vaccine (Trivalent, Types A and B) | ID Biomedical Corp of Quebec | November 2016 | 2006 | | February 6 2020 |
| FluLaval Quadrivalent | Influenza Virus Vaccine (Quadrivalent, Types A and Types B) | ID Biomedical Corporation of Quebec | 2022 | 2013 | | July 1, 2022 |
| FluMist | Influenza Vaccine, Live, Intranasal (Trivalent, Types A and B) | MedImmune | July 2015 | 2003 | | July 2, 2020 |
| FluMist Quadrivalent | Influenza Vaccine,Live, Intranasal (Quadrivalent, Types A and Types B) | MedImmune | Not indicated in package inser | 2003 | | January 12, 2023 |
| Fluvirin | Influenza Virus Vaccine (Trivalent, Types A and B) | Seqirus Vaccines | March 2017 | 1988 | | July 7 2017 |
| Fluzone | Influenza Virus Vaccine (Trivalent, Types A and B) | Sanofi Pasteur | 2015 | 1980 | | June, 29, 2018 |
| Fluzone High-Dose | Influenza Virus Vaccine (Trivalent, Types A and B) | Sanofi Pasteur | 29 March 2019 | 2009 | | July 2 2019 |
| Fluzone Intradermal | Influenza Virus Vaccine (Trivalent, Types A and B) | Sanofi Pasteur | 2 March 2017 | 2014 | | July 2 2019 |
| Fluzone High-Dose Quadrivalent | Influenza Virus Vaccine (Quadrivalent, Types A and Types B) | Sanofi Pasteur | 2019 | 2009 | | February 22, 2023 |
| Fluzone Intradermal Quadrivalent | Influenza Virus Vaccine (Quadrivalent, Types A and Types B) | Sanofi Pasteur | Not indicated in package inser | 2014 | | July 2 2019 |
| Fluzone Quadrivalent | Influenza Virus Vaccine (Quadrivalent, Types A and Types B) | Sanofi Pasteur | 2022 | 2013 | | November 2, 2022 |
| Fluzone High Dose Quadrivalent Southern Hemisphere | Influenza Virus Vaccine (Quadrivalent, Types A and Types B) | Sanofi Pasteur | 2023 | 2013 | | February 13, 2023 |
| Gardasil | Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant | Merck & Co. | April 2015 | 2006 | | 24 April 2015 |
| Gardasil 9 | Human Papillomavirus 9-valent Vaccine, Recombinant | Merck & Co. | August 2020 | 2014 | | August 20 2020 |
| Havrix | Hepatitis A Vaccine, Inactivated | GlaxoSmithKline Biologicals | Not indicated in package insert | 1995 | | December 3, 2021 |
| HEPLISAV-B | Hepatitis B Vaccine (Recombinant), Adjuvanted | Dynavax Technologies Corporation | 5 May 2020 | 2017 | | May 6 2020 |
| HIBERIX | Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) | GlaxoSmithKline Biologicals | April 2018 | 2009 | | April 30, 2018 |
| Imovax | Rabies Vaccine | Sanofi Pasteur | October 2019 | Not indicated in package insert | | October 25 2019 |
| Infanrix | Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed | GlaxoSmithKline Biologicals | Not indicated in package insert | 1997 | | November 6 2019 |
| IPOL | Poliovirus Vaccine Inactivated (Monkey Kidney Cell) | Sanofi Pasteur | Not indicated in package insert | Not indicated in package insert | | June 2 2022 |
| Ixiaro | Japanese Encephalitis Virus Vaccine, Inactivated, Adsorbed | Valneva | September 2018 | 2009 | | October 4 2018 |
| JE-Vax | Japanese Encephalitis Virus Vaccine Inactivated | Research Foundation for Microbial Diseases of Osaka University | December 2005 | Not indicated in package insert | | Not indicated |
| JYNNEOS | Smallpox and Monkeypox Vaccine, Live, Non-Replicating | Bavarian Nordic | April 2022 | 2019 | | September 2, 2022 |
| Kinrix | Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine | GlaxoSmithKline Biologicals | Not indicated in package insert | 2008 | | November 23 2022 |
| M-M-R II | Measles, Mumps, and Rubella Virus Vaccine, Live | Merck & Co. | March 2023 | 1978 | | February 27, 2023 |
| Menactra | Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine | Sanofi Pasteur | 26 April 2018 | 2005 | | April 27 2018 |
| Menomune-A/C/Y/W-135 | Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined | Sanofi Pasteur | 14 March 2016 | 1981 | | 3-Oct-13 |
| MenQuadfi | Meningococcal (Groups A, C, Y, W) Conjugate Vaccine | Sanofi Pasteur | June 2022 | 2020 | | June 16 2022 |
| Menveo | Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine | GlaxoSmithKline Biologicals | October 2022 | 2010 | | October 14, 2022 |
| None | Adenovirus Type 4 and Type 7 Vaccine, Live, Oral | Barr Labs | October 2019 | 2011 | | October 15 2019 |
| None | Diphtheria and Tetanus Toxoids Adsorbed | Sanofi Pasteur | June 2018 | 1997 | | June 6 2018 |
| None | Influenza A (H1N1) 2009 Monovalent Vaccine | CSL | November 2009 | 2007 | | 10 November 2009 |
| None | Influenza A (H1N1) 2009 Monovalent Vaccine | MedImmune | Not indicated in package insert | 2003 | | 3 February 2010 |
| None | Influenza A (H1N1) 2009 Monovalent Vaccine | ID Biomedical Corporation of Quebec | January 2010 | 2006 | | 10 November 2009 |
| None | Influenza A (H1N1) 2009 Monovalent Vaccine | Novartis Vaccines and Diagnostics | September 2009 | Not indicated in package insert | | 15 September 2009 |
| None | Influenza A (H1N1) 2009 Monovalent Vaccine | Sanofi Pasteur | 10 September 2009 | 1980 | | September 15 2009 |
| None | Influenza Virus Vaccine, H5N1 (for National Stockpile) | Sanofi Pasteur | April 2007 | 2007 | | 17 April 2007 |
| None | Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted | ID Biomedical Corporation of Quebec | Not indicated in package insert | 2013 | | 22 November 2013 |
| None | Diphtheria & Tetanus Toxoids Adsorbed | Sanofi Pasteur | December 2005 | Not indicated in package insert | | 29 December 2003 |
| None | Tetanus Toxoid Adsorbed | Sanofi Pasteur | June 2018 | 1997 | | December 20 2018 |
| Pediarix | Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed, Hepatitis B (recombinant) and Inactivated Poliovirus Vaccine Combined | GlaxoSmithKline Biologicals | Not indicated in package insert | 2002 | | November 6 2019 |
| Liquid PedvaxHIB | Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) | Merck & Co. | 1998 | Not indicated in package insert | | 27 April 2011 |
| Pentacel - (inactivated poliovirus component grown in MRC-5 cells) | Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine | Sanofi Pasteur | February 2021 | 2008 | | October 21, 2022 |
| Pentacel - (inactivated poliovirus component grown in Vero cells) | Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine | Sanofi Pasteur | December 2019 | 2008 | | October 21, 2022 |
| Pneumovax 23 | Pneumococcal Vaccine, Polyvalent | Merck Sharp & Dohme Corp | April 2021 | 1983 | | October 27 2021 |
| PREHEVBRIO | Hepatitis B Vaccine (Recombinant) | VBI Vaccines (Delaware) Inc | Not indicated in package insert | Not indicated in package insert | | November 30 2021 |
| Prevnar 13 | Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) | Wyeth Pharmaceuticals | 2017 | 2010 | | August 22 2017 |
| PREVNAR 20 | Pneumococcal 20-valent Conjugate Vaccine | Wyeth Pharmaceuticals | September 2022 | 2021 | | September 30 2022 |
| PRIORIX | Pneumococcal 20-valent Conjugate Vaccine | GlaxoSmithKline Biologicals | June 2022 | 2022 | | June 3 2022 |
| ProQuad (Frozen) | Measles, Mumps, Rubella and Varicella Virus Vaccine Live | Merck Sharpe & Dohme Corp | February 2023 | 2005 | | February 27, 2023 |
| ProQuad (Frozen Formulation - Recombinant Human Albumin (RHA)) | Measles, Mumps, Rubella and Varicella Virus Vaccine Live | Merck Sharpe & Dohme Corp | Not indicated in package insert | 2005 | | February 27, 2023 |
| ProQuad (Frozen Formulation - Human Serum Albumin (HSA)) | Measles, Mumps, Rubella and Varicella Virus Vaccine Live | Merck Sharpe & Dohme Corp | Not indicated in package insert | 2005 | | February 27, 2023 |
| ProQuad (Refrigerated) | Measles, Mumps, Rubella and Varicella Virus Vaccine Live | Merck Sharpe & Dohme Corp | February 2023 | 2005 | | February 27, 2023 |
| ProQuad (Refrigerator-Stable Formulation) | Measles, Mumps, Rubella and Varicella Virus Vaccine Live | Merck Sharpe & Dohme Corp | October 2018 | 2005 | | February 27, 2023 |
| Quadracel (inactivated poliovirus component grown in MRC-5 cells) | Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine | Sanofi Pasteur | Not indicated in package insert | 2015 | | July 21 2022 |
| Quadracel (inactivated poliovirus component grown in Vero cells) | Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine | Sanofi Pasteur | Not indicated in package insert | 2015 | | July 21 2022 |
| RabAvert | Rabies Vaccine | Novartis Vaccines and Diagnostics | Not indicated in package insert | Not indicated in package insert | | August 3 2018 |
| Recombivax HB | Hepatitis B Vaccine (Recombinant) | Merck & Co. | December 2018 | 1986 | | December 21 2018 |
| ROTARIX (Vial with Oral Dosing Applicator Presentation and Oral Dosing Applicator Only Presentation) | Rotavirus Vaccine, Live, Oral | GlaxoSmithKline Biologicals | Not indicated in package insert | 2008 | | November 4, 2022 |
| ROTARIX (Squeezable Tube Presentation) | Rotavirus Vaccine, Live, Oral | GlaxoSmithKline Biologicals | Not indicated in package insert | 2008 | | November 4, 2022 |
| RotaTeq | Rotavirus Vaccine, Live, Oral, Pentavalent | Merck & Co. | August 2020 | 2006 | | August 14 2020 |
| SHINGRIX | Zoster Vaccine Recombinant, Adjuvanted | GlaxoSmithKline Biologicals | July 2021 | 2017 | | July 23 2021 |
| SPIKEVAX | COVID-19 Vaccine, mRNA | Moderna US | January 2022 | 2022 | | January 31 2022 |
| TDVAX (NDC 14362-0111) | Tetanus & Diphtheria Toxoids, Adsorbed | MassBiologics | Not indicated in package insert | September 2018 | | November 15, 2018 |
| TDVAX (NDC 13533-131) | Tetanus & Diphtheria Toxoids, Adsorbed | MassBiologics | Not indicated in package insert | September 2018 | | November 15, 2018 |
| Tenivac | Tetanus & Diphtheria Toxoids Adsorbed for Adult Use | Sanofi Pasteur | Not indicated in package insert | 2003 |  | December 16, 2022 |
| TICE BCG | BCG Live | Organon Teknika Corp | February 2009 | Not indicated in package insert | | 16 December 2010 |
| TICOVAC | BCG Live | Pfizer | Not indicated in package insert | Not indicated in package insert | | August 13 2021 |
| Trumenba | Meningococcal Group B Vaccine | Wyeth Pharmaceuticals | 2018 | 2014 | | November 19 2021 |
| Twinrix | Hepatitis A Inactivated and Hepatitis B (Recombinant) Vaccine | GlaxoSmithKline Biologicals | March 2015 | 2001 | | December 18 2018 |
| Typhim Vi | Typhoid Vi Polysaccharide Vaccine | Sanofi Pasteur | March 2020 | Not indicated in package insert | | March 20 2020 |
| VAQTA | Hepatitis A Vaccine, Inactivated | Merck & Co. | Not indicated in package insert | 1996 | | October 23, 2020 |
| Varivax (Frozen) | Varicella Virus Vaccine Live | Merck Shark & Dohme Corp. | February 2023 | 1995 | | February 27, 2023 |
| Varivax (Refrigerator) | Varicella Virus Vaccine Live | Merck & Co. | February 2023 | 1995 | | February 27, 2023 |
| Vaxchora | Cholera Vaccine Live Oral | Emergent Travel Health Inc | December 2002 | 2016 | | December 12 2022 |
| VAXELIS | Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine | MSP Vaccine Company | October 2020 | 2018 | | October 27, 2020 |
| VAXNEUVANCE | Pneumococcal 15-valent Conjugate Vaccine | Merck Sharp & Dohme Corp | Not indicated in package insert | 2021 | | July 17, 2022 |
| Vivotif | Typhoid Vaccine Live Oral Ty21a | Berna Biotech | September 2013 | Not indicated in package insert | | Not indicated |
| YF-Vax | Yellow Fever Vaccine | Sanofi Pasteur | Not indicated in package insert | Not indicated in package insert | | August 6, 2019 |
| Zostavax (Refrigerator Stable) | Zoster Vaccine, Live, (Oka/Merck) | Merck & Co. | August 2018 | 2006 | | February 21 2019 |
| Zostavax (Frozen) | Zoster Vaccine, Live, (Oka/Merck) | Merck & Co. | January 2019 | 2006 | | February 21 2019 |
Previously Authorized Vaccines
| Trade Name | Product Name / Diseases | Manufacturer | Last Label Update | Initial U.S. Approval | Package Insert | Last Approval Letter Update |
|---|---|---|---|---|---|---|
| Comvax | Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) & Hepatitis B Vaccine (Recombinant) | Merck & Co. | 2001 | Not indicated in package insert | | 20 April 2011 |
| None | Tetanus Toxoid | Sanofi Pasteur | December 2005 | Not indicated in package insert | | Not indicated |
Updated 8 March, 2023
