![]() |
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