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)
Smallpox & Mpox: Jynneos Package Insert
Bavarian Nordic A/S
Smallpox: ACAM2000 Package Insert
Emergent Biosolutions
Tdap: Adacel Package Insert
Sanofi U.S.
Tdap: Boostrix Package Insert
Tick-borne encephalitis: Ticovac Package Insert
Typhoid: Typhim Vi Package Insert
Sanofi U.S.
Typhoid: Vivotif Package Insert
Emergent BioSoulutions
Varicella (chickenpox): Varivax Package Insert
Merck & Co., Inc.
Yellow Fever: YF-Vax Package Insert
Sanofi U.S.
Zoster (shingles): Shingrix Package Insert

This page was updated on .