Global Health Press
U.S. Food and Drug Administration

Authorized Vaccines

Trade NameProduct Name / DiseasesManufacturerLast Label UpdateInitial U.S. ApprovalPackage InsertLast Approval Letter Update
ACAM2000Smallpox (Vaccinia) Vaccine, LiveEmergent Product Development GaithersburgMarch 20182007pdf iconMay 2 2017
ActHIBHaemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)Sanofi PasteurMarch 20221993pdf iconOctober 13, 2022
AdacelTetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, AdsorbedSanofi PasteurNot indicated in package insert2005pdf iconJanuary 9, 2023
AfluriaInfluenza Virus Vaccine
(Trivalent, Types A and B)
SeqirusMarch 20222007pdf iconJuly 1, 2022
Afluria Southern HemisphereInfluenza Virus Vaccine (Trivalent, Types A and B)SeqirusSeptember 2021
2007pdf iconJuly 1, 2022
Afluria QuadrivalentInfluenza Virus Vaccine (Trivalent, Types A and B)SeqirusMarch 2022
2016pdf iconJuly 1, 2022
Afluria Quadrivalent Southern HemisphereInfluenza Virus Vaccine (Trivalent, Types A and B)SeqirusSeptember 2021
2016pdf iconJuly 2 2021
AgrifluInfluenza Virus Vaccine
(Trivalent, Types A and B)
Seqirus10 January 20202009pdf iconJanuary 28 2020
AUDENZ Influenza A (H5N1) Monovalent Vaccine, AdjuvantedSeqirusNovember 20212020pdf iconNovember 17 2021
BCG VaccineBCG VaccineOrganon Teknika CorpNot indicated in package insertNot indicated in package insertpdf icon13 January 2011
BexseroMeningococcal Group B VaccineNovartis Vaccines and DiagnosticsNot indicated in package insert2015pdf iconJanuary 6 2022
BiothraxAnthrax Vaccine AdsorbedEmergent BioDefense Operations Lansing November 20151970pdf icon23 November 2015
BoostrixTetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, AdsorbedGlaxoSmithKline BiologicalsNot indicated in package insert2005pdf iconNovember 23, 2022
COMIRNATY (Purple Cap)COVID-19 Vaccine, mRNABioNTech Manufacturing GmbHJuly 2022
2021pdf iconDecember 16 2021
COMIRNATY (Grey Cap)COVID-19 Vaccine, mRNABioNTech Manufacturing GmbHAugust 20222021pdf iconDecember 16 2021
CervarixHuman Papillomavirus Bivalent (Types 16, 18) Vaccine, RecombinantGlaxoSmithKline BiologicalsNot indicated in package insert2009pdf iconApril 25, 2016
DaptacelDiphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine AdsorbedSanofi PasteurNot indicated in package insert2002pdf iconJuly 21 2022
DENGVAXIADengue Tetravalent Vaccine, LiveSanofi PasteurJanuary 20232019pdf iconJanuary 25 2023
Engerix-BHepatitis B Vaccine (Recombinant)GlaxoSmithKline BiologicalsNot indicated in package insert1989pdf iconDecember 19 2018
ERVEBOEbola Zaire Vaccine, LiveMerck Sharp & Dohme CorpNot indicated in package insert2019pdf iconSeptember 16, 2022
FLUADInfluenza Vaccine, AdjuvantedSeqirusAugust 20222020pdf iconJuly 2 2021
FLUAD QUADRIVALENTInfluenza Vaccine, AdjuvantedSeqirusAugust 20222020pdf iconFebruary 24, 2023
FluarixInfluenza Virus Vaccine
(Trivalent, Types A and B)
GlaxoSmithKline BiologicalsNot indicated in package insert 2005pdf iconNovember 18, 2016
Fluarix QuadrivalentInfluenza Virus Vaccine (Quadrivalent, Types A and Types B)Glaxosmithkline BiologicalsFebruary 20232012pdf iconMarch 1, 2023
FlublokInfluenza Vaccine (Trivalent)Protein Sciences CorporationMarch 20172013pdf iconJuly 7 2017
Flublok QuadrivalentInfluenza Vaccine (Trivalent)Protein Sciences Corporation20222013pdf iconJuly 1 2022
Flucelvax QuadrivalentInfluenza VaccineSeqirusNot indicated in package inser2016pdf iconFebruary 28, 2023
FluLavalInfluenza Virus Vaccine
(Trivalent, Types A and B)
ID Biomedical Corp of QuebecNovember 20162006pdf iconFebruary 6 2020
FluLaval
Quadrivalent
Influenza Virus Vaccine
(Quadrivalent, Types A and Types B)
ID Biomedical Corporation of Quebec20222013pdf iconJuly 1, 2022
FluMistInfluenza Vaccine, Live, Intranasal
(Trivalent, Types A and B)
MedImmuneJuly 20152003pdf iconJuly 2, 2020
FluMist QuadrivalentInfluenza Vaccine,Live, Intranasal (Quadrivalent, Types A and Types B)MedImmuneNot indicated in package inser2003pdf iconJanuary 12, 2023
FluvirinInfluenza Virus Vaccine
(Trivalent, Types A and B)
Seqirus VaccinesMarch 20171988pdf iconJuly 7 2017
FluzoneInfluenza Virus Vaccine
(Trivalent, Types A and B)
Sanofi Pasteur20151980pdf iconJune, 29, 2018
Fluzone High-DoseInfluenza Virus Vaccine
(Trivalent, Types A and B)
Sanofi Pasteur29 March 20192009pdf iconJuly 2 2019
Fluzone IntradermalInfluenza Virus Vaccine
(Trivalent, Types A and B)
Sanofi Pasteur2 March 20172014pdf iconJuly 2 2019
Fluzone High-Dose Quadrivalent Influenza Virus Vaccine (Quadrivalent, Types A and Types B)Sanofi Pasteur20192009pdf iconFebruary 22, 2023
Fluzone Intradermal Quadrivalent Influenza Virus Vaccine (Quadrivalent, Types A and Types B)Sanofi PasteurNot indicated in package inser2014pdf iconJuly 2 2019
Fluzone Quadrivalent Influenza Virus Vaccine (Quadrivalent, Types A and Types B)Sanofi Pasteur20222013pdf iconNovember 2, 2022
Fluzone High Dose Quadrivalent Southern HemisphereInfluenza Virus Vaccine (Quadrivalent, Types A and Types B)Sanofi Pasteur20232013pdf iconFebruary 13, 2023
GardasilHuman Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, RecombinantMerck & Co.April 20152006pdf icon24 April 2015
Gardasil 9Human Papillomavirus 9-valent Vaccine, RecombinantMerck & Co.August 20202014pdf iconAugust 20 2020
HavrixHepatitis A Vaccine, InactivatedGlaxoSmithKline BiologicalsNot indicated in package insert1995pdf iconDecember 3, 2021
HEPLISAV-BHepatitis B Vaccine (Recombinant), AdjuvantedDynavax Technologies Corporation5 May 20202017pdf iconMay 6 2020
HIBERIXHaemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)GlaxoSmithKline BiologicalsApril 20182009pdf iconApril 30, 2018
ImovaxRabies VaccineSanofi PasteurOctober 2019Not indicated in package insertpdf iconOctober 25 2019
InfanrixDiphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine AdsorbedGlaxoSmithKline BiologicalsNot indicated in package insert1997pdf iconNovember 6 2019
IPOLPoliovirus Vaccine Inactivated (Monkey Kidney Cell)Sanofi PasteurNot indicated in package insertNot indicated in package insertpdf iconJune 2 2022
IxiaroJapanese Encephalitis Virus Vaccine, Inactivated, AdsorbedValnevaSeptember 20182009pdf iconOctober 4 2018
JE-VaxJapanese Encephalitis Virus Vaccine InactivatedResearch Foundation for Microbial Diseases of Osaka UniversityDecember 2005Not indicated in package insertpdf iconNot indicated
JYNNEOSSmallpox and Monkeypox Vaccine, Live, Non-ReplicatingBavarian Nordic April 20222019pdf iconSeptember 2, 2022
KinrixDiphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus VaccineGlaxoSmithKline BiologicalsNot indicated in package insert2008pdf iconNovember 23 2022
M-M-R IIMeasles, Mumps, and Rubella Virus Vaccine, LiveMerck & Co.March 20231978pdf iconFebruary 27, 2023
MenactraMeningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate VaccineSanofi Pasteur26 April 20182005pdf iconApril 27 2018
Menomune-A/C/Y/W-135Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 CombinedSanofi Pasteur14 March 20161981pdf icon3-Oct-13
MenQuadfiMeningococcal (Groups A, C, Y, W) Conjugate VaccineSanofi PasteurJune 20222020pdf iconJune 16 2022
MenveoMeningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate VaccineGlaxoSmithKline BiologicalsOctober 20222010pdf iconOctober 14, 2022
NoneAdenovirus Type 4 and Type 7 Vaccine, Live, OralBarr LabsOctober 20192011pdf iconOctober 15 2019
NoneDiphtheria and Tetanus Toxoids AdsorbedSanofi PasteurJune 20181997pdf iconJune 6 2018
NoneInfluenza A (H1N1) 2009 Monovalent VaccineCSLNovember 20092007pdf icon10 November 2009
NoneInfluenza A (H1N1) 2009 Monovalent VaccineMedImmuneNot indicated in package insert2003pdf icon3 February 2010
NoneInfluenza A (H1N1) 2009 Monovalent VaccineID Biomedical Corporation of QuebecJanuary 20102006pdf icon10 November 2009
NoneInfluenza A (H1N1) 2009 Monovalent VaccineNovartis Vaccines and DiagnosticsSeptember 2009Not indicated in package insertpdf icon15 September 2009
NoneInfluenza A (H1N1) 2009 Monovalent VaccineSanofi Pasteur10 September 20091980pdf iconSeptember 15 2009
NoneInfluenza Virus Vaccine, H5N1 (for National Stockpile)Sanofi PasteurApril 20072007pdf icon17 April 2007
NoneInfluenza A (H5N1) Virus Monovalent Vaccine, AdjuvantedID Biomedical Corporation of QuebecNot indicated in package insert2013pdf icon22 November 2013
NoneDiphtheria & Tetanus Toxoids AdsorbedSanofi PasteurDecember 2005Not indicated in package insertpdf icon29 December 2003
NoneTetanus Toxoid AdsorbedSanofi PasteurJune 20181997pdf iconDecember 20 2018
PediarixDiphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed, Hepatitis B (recombinant) and Inactivated Poliovirus Vaccine CombinedGlaxoSmithKline BiologicalsNot indicated in package insert2002pdf iconNovember 6 2019
Liquid PedvaxHIBHaemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)Merck & Co.1998Not indicated in package insertpdf icon27 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) VaccineSanofi PasteurFebruary 20212008pdf iconOctober 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) VaccineSanofi PasteurDecember 20192008pdf iconOctober 21, 2022
Pneumovax 23Pneumococcal Vaccine, PolyvalentMerck Sharp & Dohme CorpApril 20211983pdf iconOctober 27 2021
PREHEVBRIOHepatitis B Vaccine (Recombinant)VBI Vaccines (Delaware) IncNot indicated in package insertNot indicated in package insertpdf iconNovember 30 2021
Prevnar 13Pneumococcal 13-valent Conjugate Vaccine
(Diphtheria CRM197 Protein)
Wyeth Pharmaceuticals20172010pdf iconAugust 22 2017
PREVNAR 20Pneumococcal 20-valent Conjugate VaccineWyeth PharmaceuticalsSeptember 20222021pdf iconSeptember 30 2022
PRIORIXPneumococcal 20-valent Conjugate VaccineGlaxoSmithKline BiologicalsJune 20222022pdf iconJune 3 2022
ProQuad (Frozen)Measles, Mumps, Rubella and Varicella Virus Vaccine LiveMerck Sharpe & Dohme CorpFebruary 20232005pdf iconFebruary 27, 2023
ProQuad (Frozen Formulation - Recombinant Human Albumin (RHA))Measles, Mumps, Rubella and Varicella Virus Vaccine LiveMerck Sharpe & Dohme CorpNot indicated in package insert2005pdf iconFebruary 27, 2023
ProQuad (Frozen Formulation - Human Serum Albumin (HSA))Measles, Mumps, Rubella and Varicella Virus Vaccine LiveMerck Sharpe & Dohme CorpNot indicated in package insert2005pdf iconFebruary 27, 2023
ProQuad (Refrigerated)Measles, Mumps, Rubella and Varicella Virus Vaccine LiveMerck Sharpe & Dohme CorpFebruary 20232005pdf iconFebruary 27, 2023
ProQuad (Refrigerator-Stable Formulation)Measles, Mumps, Rubella and Varicella Virus Vaccine LiveMerck Sharpe & Dohme CorpOctober 20182005pdf iconFebruary 27, 2023
Quadracel (inactivated poliovirus component grown in MRC-5 cells)Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus VaccineSanofi PasteurNot indicated in package insert2015pdf iconJuly 21 2022
Quadracel (inactivated poliovirus component grown in Vero cells)Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus VaccineSanofi PasteurNot indicated in package insert2015pdf iconJuly 21 2022
RabAvertRabies VaccineNovartis Vaccines and DiagnosticsNot indicated in package insertNot indicated in package insertpdf iconAugust 3 2018
Recombivax HBHepatitis B Vaccine (Recombinant)Merck & Co.December 20181986pdf iconDecember 21 2018
ROTARIX (Vial with Oral Dosing Applicator Presentation and Oral Dosing Applicator Only Presentation)Rotavirus Vaccine, Live, OralGlaxoSmithKline BiologicalsNot indicated in package insert2008pdf iconNovember 4, 2022
ROTARIX (Squeezable Tube Presentation)Rotavirus Vaccine, Live, OralGlaxoSmithKline BiologicalsNot indicated in package insert2008pdf iconNovember 4, 2022
RotaTeqRotavirus Vaccine, Live, Oral, PentavalentMerck & Co.August 20202006pdf iconAugust 14 2020
SHINGRIXZoster Vaccine Recombinant, AdjuvantedGlaxoSmithKline BiologicalsJuly 20212017pdf iconJuly 23 2021
SPIKEVAXCOVID-19 Vaccine, mRNAModerna USJanuary 20222022pdf iconJanuary 31 2022
TDVAX (NDC 14362-0111)Tetanus & Diphtheria Toxoids, AdsorbedMassBiologicsNot indicated in package insertSeptember 2018pdf iconNovember 15, 2018
TDVAX (NDC 13533-131)Tetanus & Diphtheria Toxoids, AdsorbedMassBiologicsNot indicated in package insertSeptember 2018pdf iconNovember 15, 2018
TenivacTetanus & Diphtheria Toxoids Adsorbed for Adult UseSanofi PasteurNot indicated in package insert2003pdf iconDecember 16, 2022
TICE BCGBCG LiveOrganon Teknika CorpFebruary 2009Not indicated in package insertpdf icon16 December 2010
TICOVACBCG LivePfizerNot indicated in package insertNot indicated in package insertpdf iconAugust 13 2021
TrumenbaMeningococcal Group B VaccineWyeth Pharmaceuticals20182014pdf iconNovember 19 2021
TwinrixHepatitis A Inactivated and Hepatitis B (Recombinant) VaccineGlaxoSmithKline BiologicalsMarch 20152001pdf iconDecember 18 2018
Typhim ViTyphoid Vi Polysaccharide VaccineSanofi PasteurMarch 2020Not indicated in package insertpdf iconMarch 20 2020
VAQTAHepatitis A Vaccine, InactivatedMerck & Co.Not indicated in package insert1996pdf iconOctober 23, 2020
Varivax (Frozen)Varicella Virus Vaccine LiveMerck Shark & Dohme Corp.February 20231995pdf iconFebruary 27, 2023
Varivax (Refrigerator)Varicella Virus Vaccine LiveMerck & Co.February 20231995pdf iconFebruary 27, 2023
Vaxchora Cholera Vaccine Live OralEmergent Travel Health IncDecember 20022016pdf iconDecember 12 2022
VAXELISDiphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B VaccineMSP Vaccine CompanyOctober 20202018pdf iconOctober 27, 2020
VAXNEUVANCEPneumococcal 15-valent Conjugate VaccineMerck Sharp & Dohme CorpNot indicated in package insert2021pdf iconJuly 17, 2022
VivotifTyphoid Vaccine Live Oral Ty21aBerna BiotechSeptember 2013Not indicated in package insertpdf iconNot indicated
YF-VaxYellow Fever VaccineSanofi PasteurNot indicated in package insertNot indicated in package insertpdf iconAugust 6, 2019
Zostavax
(Refrigerator Stable)
Zoster Vaccine, Live, (Oka/Merck)Merck & Co.August 20182006pdf iconFebruary 21 2019
Zostavax (Frozen)Zoster Vaccine, Live, (Oka/Merck)Merck & Co.January 20192006pdf iconFebruary 21 2019

 

Previously Authorized Vaccines

Trade NameProduct Name / DiseasesManufacturerLast Label UpdateInitial U.S. ApprovalPackage InsertLast Approval Letter Update
ComvaxHaemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) & Hepatitis B Vaccine (Recombinant)Merck & Co.2001Not indicated in package insertpdf icon20 April 2011
NoneTetanus ToxoidSanofi PasteurDecember 2005Not indicated in package insertpdf iconNot indicated

 

Updated 8 March, 2023