Vaccines
Vaccines, as with all products regulated by FDA, undergo a rigorous review of laboratory and clinical data to ensure the safety, efficacy, purity and potency of these products. Vaccines approved for marketing may also be required to undergo additional studies to further evaluate the vaccine and often to address specific questions about the vaccine's safety, effectiveness or possible side effects.
According to the Centers for Disease Control and Prevention, vaccines have reduced preventable infectious diseases to an all-time low and now few people experience the devastating effects of measles, pertussis and other illnesses.
The Center for Biologics Evaluation and Research (CBER) regulates vaccine products. Many of these are childhood vaccines that have contributed to a significant reduction of vaccine-preventable diseases.
- Emergency Use Authorization for Vaccines Explained
- Biologics License Applications (BLA) Process (CBER)
- CDC National Immunization Program
- Questions about Vaccines
- Vaccines and Related Biological Products Advisory Committee
- Vaccine and Related Biological Product Guidances
- Vaccines Licensed for Use in the United States
- Vaccine Notices, Proposed and Final Rules
- Common Ingredients in FDA-Approved Vaccines
- Vaccine Adverse Events
- Vaccine Safety & Availability
- Influenza Virus Vaccine Safety & Availability
- Vaccine Safety Questions and Answers
- Recommendations for the Use of Vaccines Manufactured with Bovine-Derived Materials
- Thimerosal in Vaccines
- MMWR - Guillain-Barre Syndrome Among Recipients of Menactra Meningococcal Conjugate Vaccine
- Vaccines for Use During Pregnancy to Protect Young Infants from Disease - FDA Update
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Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3103
Silver Spring, MD 20993-0002
(800) 835-4709
(240) 402-8010
For Updates on Twitter, follow @fdacber