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 Pasteur17 May 2019 1993pdf iconMay 24 2019
AdacelTetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, AdsorbedSanofi PasteurDecember 20202005pdf iconDecember 28 2020
AfluriaInfluenza Virus Vaccine
(Trivalent, Types A and B)
SeqirusDecember 20192007pdf iconFebruary 8 2021
Afluria Southern HemisphereInfluenza Virus Vaccine (Trivalent, Types A and B)SeqirusSeptember 20212007pdf iconFebruary 8 2021
Afluria QuadrivalentInfluenza Virus Vaccine (Trivalent, Types A and B)SeqirusMarch 20212016pdf iconJuly 2 2021
Afluria Quadrivalent Southern HemisphereInfluenza Virus Vaccine (Trivalent, Types A and B)SeqirusSeptember 20212016pdf 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 BiologicalsOctober 7 20222005pdf iconOctober 7 2022
COMIRNATY (Purple Cap)COVID-19 Vaccine, mRNABioNTech Manufacturing GmbHDecember 20212021pdf iconDecember 16 2021
COMIRNATY (Grey Cap)COVID-19 Vaccine, mRNABioNTech Manufacturing GmbHDecember 20212021pdf iconDecember 16 2021
CervarixHuman Papillomavirus Bivalent (Types 16, 18) Vaccine, RecombinantGlaxoSmithKline BiologicalsNot indicated in package insert2009pdf icon13 February 2015
DaptacelDiphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine AdsorbedSanofi PasteurNot indicated in package insert2002pdf iconSeptember 16 2016
DENGVAXIADengue Tetravalent Vaccine, LiveSanofi PasteurJune 20192019pdf iconJanuary 22 2020
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 iconDecember 19 2019
FLUADInfluenza Vaccine, AdjuvantedSeqirusNovember 2015October 2020pdf iconJuly 2 2021
FLUAD QUADRIVALENTInfluenza Vaccine, AdjuvantedSeqirusMarch 20202020pdf iconJuly 1 2022
FluarixInfluenza Virus Vaccine
(Trivalent, Types A and B)
GlaxoSmithKline BiologicalsNot indicated in package insert 2005pdf icon30 June 2015
Fluarix QuadrivalentInfluenza Virus Vaccine (Quadrivalent, Types A and Types B)Glaxosmithkline Biologicals20222012pdf iconJuly 1 2022
FlublokInfluenza Vaccine (Trivalent)Protein Sciences CorporationMarch 20172013pdf iconJuly 7 2017
Flublok QuadrivalentInfluenza Vaccine (Trivalent)Protein Sciences Corporation20222013pdf iconJuly 1 2022
FlucelvaxInfluenza VaccineSeqirusApril 20162012pdf iconAugust 31 2016
Flucelvax QuadrivalentInfluenza VaccineSeqirusMarch 20222016pdf iconAugust 31 2016
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 2 2020
FluMistInfluenza Vaccine, Live, Intranasal
(Trivalent, Types A and B)
MedImmuneJuly 20152003pdf iconJuly 2 2020 2020
FluMist QuadrivalentInfluenza Vaccine,Live, Intranasal (Quadrivalent, Types A and Types B)MedImmuneAugust 20212003pdf iconJuly 27 2022
FluvirinInfluenza Virus Vaccine
(Trivalent, Types A and B)
Seqirus VaccinesMarch 20171988pdf iconJuly 7 2017
FluzoneInfluenza Virus Vaccine
(Trivalent, Types A and B)
Sanofi Pasteur20151980pdf iconJuly 28 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 PasteurJuly 20222019pdf iconJuly 1 2022
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 PasteurJuly 20222013pdf iconJuly 1 2022
Fluzone Quadrivalent Southern HemisphereInfluenza Virus Vaccine (Quadrivalent, Types A and Types B)Sanofi Pasteur20212013pdf iconFebruary 14 2022
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 19 2018
HEPLISAV-BHepatitis B Vaccine (Recombinant), AdjuvantedDynavax Technologies Corporation05 May 20202017pdf iconMay 6 2020
HIBERIXHaemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)GlaxoSmithKline BiologicalsApril 20182009pdf iconDecember 19 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 iconJune 16 2021
KinrixDiphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus VaccineGlaxoSmithKline BiologicalsNot indicated in package insert2008pdf iconNovember 6 2019
M-M-R IIMeasles, Mumps, and Rubella Virus Vaccine, LiveMerck & Co.Not indicated in package insert1978pdf iconDecember 11 2020
MenactraMeningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate VaccineSanofi Pasteur26 April 20182005pdf iconApril 27 2018
MenHibrixMeningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate VaccineGlaxoSmithKline BiologicalsNot indicated in package insert2012pdf icon27 November 2013
Menomune-A/C/Y/W-135Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 CombinedSanofi Pasteur14 March 20161981pdf icon3 October 2013
MenQuadfiMeningococcal (Groups A, C, Y, W) Conjugate VaccineSanofi PasteurOctober 20212020pdf iconJune 16 2022
MenveoMeningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate VaccineGlaxoSmithKline BiologicalsJuly 20202010pdf iconApril 27 2018
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 iconFebruary 17 2021
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 iconFebruary 17 2021
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 CorpApril 20212005pdf iconApril 13 2021
ProQuad (Frozen Formulation - Recombinant Human Albumin (RHA))Measles, Mumps, Rubella and Varicella Virus Vaccine LiveMerck Sharpe & Dohme CorpNot indicated in package insert2005pdf iconSeptember 15 2020
ProQuad (Frozen Formulation - Human Serum Albumin (HSA))Measles, Mumps, Rubella and Varicella Virus Vaccine LiveMerck Sharpe & Dohme CorpNot indicated in package insert2005pdf iconSeptember 15 2020
ProQuad (Refrigerated)Measles, Mumps, Rubella and Varicella Virus Vaccine LiveMerck Sharpe & Dohme CorpApril 20212005pdf iconApril 13 2021
ProQuad (Refrigerator-Stable Formulation)Measles, Mumps, Rubella and Varicella Virus Vaccine LiveMerck Sharpe & Dohme CorpOctober 20182005pdf iconApril 13 2021
Quadracel (inactivated poliovirus component grown in MRC-5 cells)Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus VaccineSanofi PasteurFebruary 20212015pdf iconFebruary 17 2021
Quadracel (inactivated poliovirus component grown in Vero cells)Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus VaccineSanofi PasteurDecember 20192015pdf iconFebruary 17 2021
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
ROTARIXRotavirus Vaccine, Live, OralGlaxoSmithKline BiologicalsNot indicated in package insert2008pdf iconNovember 21 2019
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 iconJanuary 31 2022
TDVAX (NDC 13533-131)Tetanus & Diphtheria Toxoids, AdsorbedMassBiologicsNot indicated in package insertSeptember 2018pdf iconJanuary 31 2022
TenivacTetanus & Diphtheria Toxoids Adsorbed for Adult UseSanofi PasteurNovember 20192003pdf iconDecember 6 2019
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.September 20201995pdf iconSeptember 15, 2020
Varivax (Refrigerator)Varicella Virus Vaccine LiveMerck & Co.20131995pdf icon28 March 2014
Vaxchora (Frozen)Cholera Vaccine Live OralPaxVax Bermuda LtdNot indicated in package insert2016pdf iconNot indicated
Vaxchora Cholera Vaccine Live OralEmergent Travel Health IncDecember 20202016pdf icon23 December 2020
VAXELISDiphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B VaccineMSP Vaccine CompanyOctober 20202018pdf iconJanuary 31 2022
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 PasteurFebruary 2019Not indicated in package insertpdf iconJuly 16 2021
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 October 18, 2022