FDA Package Inserts | Immunize.org
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Official Guidance
FDA
FDA Package Inserts & EUAs
Package Inserts & EUAs
FDA’s
Center for Biologics Evaluation and Research
regulates biological products, including vaccines, for human use. As part of their responsibility to ensure that these products are safe and effective, they also approve product labeling, package inserts, and issue emergency use authorizations (EUAs).
Here we provide package inserts, product approvals, EUAs, and other supporting documents listed alphabetically by vaccine. You may use the filter to choose a specific vaccine.
Manufacturer’s contact information
All results
Vaccine or Disease Name
Results (79)
Adenovirus: Adenovirus Package Insert
Barr Labs Inc.
View PDF
Adenovirus Product Approval
Anthrax: BioThrax Package Insert
Emergent BioSolutions
View PDF
BioThrax Product Approval
Anthrax: Cyfendus Package Insert
Emergent BioSolutions
View PDF
Cyfendus Product Approval
BCG Package Insert
Organon Teknica (Merck)
View PDF
BCG Product Approval
COVID-19: Comirnaty Package Insert
Pfizer-BioNTech
View PDF
Comirnaty Product Approval
COVID-19: Mnexspike Package Insert
Moderna
View PDF
Mnexspike Product Approval
COVID-19: Nuvaxovid Package Insert
Novavax, Inc
View PDF
Nuvaxovid Product Approval
COVID-19: Spikevax Package Insert
Moderna
View PDF
Spikevax Product Approval
Chikungunya virus (CHIKV): Chikungunya Vaccine, Recombinant Vimkunya Package Insert
Bavarian Nordic A/S
View PDF
Vimkunya Product Approval
Cholera: Vaxchora Package Insert
Bavarian Nordic A/S
View PDF
Vaxchora Product Approval
Combination Vaccine (DTaP-HepB-IPV): Pediarix Package Insert
GSK
View PDF
Pediarix Product Approval
Combination Vaccine (DTaP-IPV): Kinrix Package Insert
GSK
View PDF
Kinrix Product Approval
Combination Vaccine (DTaP-IPV): Quadracel Package Insert
Sanofi U.S.
View PDF
Quadracel Product Approval
Combination Vaccine (DTaP-IPV-Hib-HepB): Vaxelis Package Insert
MSP Vaccine Company
View PDF
Vaxelis Product Approval
Combination Vaccine (DTaP-IPV/Hib): Pentacel Package Insert
Sanofi U.S.
View PDF
Pentacel Product Approval
Combination Vaccine (HepA-HepB): Twinrix Package Insert
GSK
View PDF
Twinrix Product Approval
Combination Vaccine (MMRV): ProQuad Package Insert
Merck & Co.
View PDF
ProQuad Product Approval
DTaP: Daptacel Package Insert
Sanofi U.S.
View PDF
Daptacel Product Approval
DTaP: Infanrix Package Insert
GSK
View PDF
Infanrix Product Approval
Dengue: Dengvaxia Package Insert
Sanofi U.S.
View PDF
Dengvaxia Product Approval
Diphtheria & Tetanus: Td (generic) Package Insert
MassBiologics
View PDF
Td (generic) Product Approval
Diphtheria & Tetanus: Tenivac Package Insert
Sanofi U.S.
View PDF
Tenivac Product Approval
Ebola virus disease (EVD): Ervebo Package Insert
Merck & Co, Inc.
View PDF
Ervebo Product Approval
Hepatitis A: Havrix Package Insert
GSK
View PDF
Havrix Product Approval
Hepatitis A: Vaqta Package Insert
Merck & Co., Inc.
View PDF
Vaqta Product Approval
Hepatitis B: Engerix-B Package Insert
GSK
View PDF
Engerix-B Product Approval
Hepatitis B: Heplisav-B Package Insert
Dynavax Technologies
View PDF
Heplisav-B Product Approval
Hepatitis B: PreHevbrio Package Insert
VBI Vaccines Inc.
View PDF
PreHevbrio Product Approval
Hepatitis B: Recombivax HB Package Insert
Merck & Co., Inc.
View PDF
Recombivax HB Product Approval
Hib: ActHIB Package Insert
Sanofi U.S.
View PDF
ActHIB Product Approval
Hib: Hiberix Package Insert
GSK
View PDF
Hiberix Product Approval
Hib: PedvaxHIB Package Insert
Merck & Co., Inc.
View PDF
PedvaxHIB Product Approval
Human papillomavirus (HPV): Gardasil 9 Package Insert
Merck & Co., Inc.
View PDF
Gardasil 9 Product Approval
Influenza: Afluria Trivalent Package Insert
Seqirus
View PDF
Afluria Trivalent Product Approval (injectable)
Influenza: Arepanrix [Influenza A (H5N1) Monovalent Vaccine, Adjuvanted] Package Insert
ID Biomedical Corporation
View PDF
Influenza: Arepanrix [Influenza A (H5N1) Monovalent Vaccine, Adjuvanted] Package Insert
Influenza: FluLaval Trivalent Package Insert
ID Biomedical Corporation
View PDF
FluLaval Trivalent Product Approval (injectable)
Influenza: FluMist Trivalent Package Insert
MedImmune, Inc.
View PDF
FluMist Trivalent Product Approval (Intranasal)
Influenza: Fluad Trivalent Package Insert
Seqirus
View PDF
Fluad Trivalent Product Approval (injectable)
Influenza: Fluarix Trivalent Package Insert
GSK
View PDF
Fluarix Trivalent Product Approval (injectable)
Influenza: Flublok Trivalent Package Insert
Protein Sciences Corporation
View PDF
Flublok Trivalent Product Approval (injectable)
Influenza: Flucelvax Trivalent Package Insert
Seqirus
View PDF
Flucelvax Trivalent Product Approval (injectable)
Influenza: Fluzone High Dose Trivalent Package Insert
Sanofi U.S.
View PDF
Fluzone High Dose Trivalent Product Approval (injectable)
Influenza: Fluzone Trivalent Package Insert
Sanofi U.S.
View PDF
Fluzone Trivalent Product Approval (injectable)
Influenza: Audenz [Influenza A (H5N1) Monovalent Vaccine, Adjuvanted] Package Insert
Seqirus
View PDF
Audenz Product Approval
Japanese encephalitis: IXIARO Package Insert
Valneva
View PDF
IXIARO Product Approval
Measles, Mumps, Rubella: MMR II Package Insert
Merck & Co., Inc.
View PDF
MMR II Product Approval
Measles, Mumps, Rubella: Priorix Package Insert
GSK
View PDF
Priorix Product Approval
Meningococcal ABCWY: Penbraya Package Insert
Pfizer
View PDF
Penbraya Product Approval
Meningococcal ABCWY: Penmenvy Package Insert
GSK
View PDF
Penmenvy Product Approval
Meningococcal ACWY: MenQuadfi Package Insert
Sanofi U.S.
View PDF
MenQuadfi Product Approval
Meningococcal ACWY: Menveo Package Insert
GSK
View PDF
Menveo Product Approval
Meningococcal B: Bexsero Package Insert
GSK
View PDF
Bexsero Product Approval
Meningococcal B: Trumenba Package Insert
Pfizer
View PDF
Trumenba Product Approval
Pneumococcal (PCV): Capvaxive Package Insert
Merck & Co., Inc.
View PDF
Capvaxive Product Approval
Pneumococcal (PCV): Prevnar 13 Package Insert
Pfizer
View PDF
Prevnar 13 Product Approval
Pneumococcal (PCV): Prevnar 20 Package Insert
Pfizer
View PDF
Prevnar 20 Product Approval
Pneumococcal (PCV): Vaxneuvance (PCV15) Package Insert
Merck & Co, Inc.
View PDF
Vaxneuvance (PCV15) Product Approval
Pneumococcal (PPSV): Pneumovax 23 Package Insert
Merck & Co., Inc.
View PDF
Pneumovax 23 Product Approval
Polio: IPOL Package Insert
Sanofi U.S.
View PDF
IPOL Product Approval
RSV: Abrysvo Package Insert
Pfizer
View PDF
Abrysvo Product Approval
RSV: Arexvy Package Insert
GSK
View PDF
Arexvy Product Approval
RSV: Beyfortus Package Insert
Sanofi
View PDF
Beyfortus Product Approval
RSV: Enflonsia Package Insert
Merck
View PDF
Enflonsia Product Approval
RSV: Mresvia Package Insert
Moderna
View PDF
Moderna Product Approval
Rabies: Imovax Package Insert
Sanofi U.S.
View PDF
Imovax Product Approval
This page was updated on
August 19, 2025
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