Package Inserts & EUAs
FDA’s Center for Biologics Evaluation and Research regulates biological products, including vaccines, for human use. As part of their responsibility of ensuring that these products are safe and effective, they also approve product labeling, or package inserts.
Here we provide package inserts, product approvals, and other supporting documents listed alphabetically by vaccine, or use the filter to choose a specific vaccine.
Manufacturer’s contact information
Results (75)
Adenovirus: Adenovirus Package Insert
Barr Labs Inc.
Anthrax: BioThrax Package Insert
Emergent BioSolutions
Anthrax: Cyfendus Package Insert
Emergent BioSolutions
BCG Package Insert
Organon Teknica (Merck)
COVID-19: Comirnaty Package Insert
Pfizer-BioNTech
COVID-19: EUA Full Prescribing Information
Moderna
COVID-19: EUA Full Prescribing Information
Novavax, Inc
COVID-19: EUA Full Prescribing Information - Pfizer-BioNTech
Pfizer-BioNTech
COVID-19: Spikevax Package Insert
Moderna
Chikungunya virus (CHIKV): Chikungunya Package Insert
Valneva
Cholera: Vaxchora Package Insert
Emergent BioSolutions
Combination Vaccine: Kinrix Package Insert
GSK
Combination Vaccine: Pediarix Package Insert
GSK
Combination Vaccine: Pentacel Package Insert
Sanofi U.S.
Combination Vaccine: ProQuad Package Insert
Merck & Co.
Combination Vaccine: Quadracel Package Insert
Sanofi U.S.
Combination Vaccine: Vaxelis Package Insert
MSP Vaccine Company
DTaP: Daptacel Package Insert
Sanofi U.S.
DTaP: Infanrix Package Insert
GSK
Dengue: Dengvaxia Package Insert
Sanofi U.S.
Diphtheria & Tetanus: Td (generic) Package Insert
MassBiologics
Diphtheria & Tetanus: Tenivac Package Insert
Sanofi U.S.
Ebola virus disease (EVD): Ervebo Package Insert
Merck & Co, Inc.
Hepatitis A & Hepatitis B: Twinrix Package Insert
GSK
Hepatitis A: Havrix Package Insert
GSK
Hepatitis A: Vaqta Package Insert
Merck & Co., Inc.
Hepatitis B: Engerix-B Package Insert
GSK
Hepatitis B: Heplisav-B Package Insert
Dynavax Technologies
Hepatitis B: PreHevbrio Package Insert
VBI Vaccines Inc.
Hepatitis B: Recombivax HB Package Insert
Merck & Co., Inc.
Hib: ActHIB Package Insert
Sanofi U.S.
Hib: Hiberix Package Insert
GSK
Hib: PedvaxHIB Package Insert
Merck & Co., Inc.
Human papillomavirus (HPV): Gardasil 9 Package Insert
Merck & Co., Inc.
Influenza: Afluria Trivalent Package Insert
Seqirus
Influenza: FluLaval Trivalent Package Insert
ID Biomedical Corporation
Influenza: Fluad Trivalent Package Insert
Seqirus
Influenza: Fluarix Trivalent Package Insert
GSK
Influenza: Flublok Trivalent Package Insert
Protein Sciences Corporation
Influenza: Flucelvax Trivalent Package Insert
Seqirus
Influenza: Fluzone High Dose Trivalent Package Insert
Sanofi U.S.
Influenza: Fluzone Trivalent Package Insert
Sanofi U.S.
Japanese encephalitis: IXIARO Package Insert
Valneva
Measles, Mumps, Rubella: MMR II Package Insert
Merck & Co., Inc.
Measles, Mumps, Rubella: Priorix Package Insert
GSK
Meningococcal ABCWY: Penbraya Package Insert
Pfizer
Meningococcal ACWY: MenQuadfi Package Insert
Sanofi U.S.
Meningococcal ACWY: Menveo Package Insert
GSK
Meningococcal B: Bexsero Package Insert
GSK
Meningococcal B: Trumenba Package Insert
Pfizer
Pneumococcal (PCV): Capvaxive Package Insert
Merck & Co., Inc.
Pneumococcal (PCV): Prevnar 13 Package Insert
Pfizer
Pneumococcal (PCV): Prevnar 20 Package Insert
Pfizer
Pneumococcal (PCV): Vaxneuvance (PCV15) Package Insert
Merck & Co, Inc.
Pneumococcal (PPSV): Pneumovax 23 Package Insert
Merck & Co., Inc.
Polio: IPOL Package Insert
Sanofi U.S.
RSV: Abrysvo Package Insert
Pfizer
RSV: Arexvy Package Insert
GSK
RSV: Beyfortus Package Insert
Sanofi
RSV: Mresvia Package Insert
Moderna
Rabies: Imovax Package Insert
Sanofi U.S.
Rabies: RabAvert Package Insert
Bavarian Nordic
Rotavirus: RotaTeq Package Insert
Merck & Co., Inc.
Rotavirus: Rotarix Package Insert
GSK
Smallpox & Mpox: EUA Full Prescribing Information - Jynneos
Jynneos