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.
Vaccines Licensed for Immunization and Distribution in the US with Supporting Documents Biologics License Applications (BLA) Process (CBER) Vaccine and Related Biological Product Guidances Vaccine Notices, Proposed and Final Rules Vaccines and Related Biological Products Advisory Committee Questions about Vaccines Vaccines
FDA Consumer Updates
CDC National Immunization Program
Centers for Disease Control and Prevention
Vaccine Safety & Availability
Common Ingredients in U.S. Licensed Vaccines Vaccine Adverse Events
Report adverse events (side effects) related to the administration of U.S. licensed vaccines
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 FDA and CDC Issue Alert on Menactra Meningococcal Vaccine and Guillain Barre Syndrome[ARCHIVED]
FDA Press Release, September 30, 2005
MMWR - Guillain-Barr� Syndrome Among Recipients of Menactra Meningococcal Conjugate Vaccine
MMWR Weekly Report, Centers for Disease Control, October 20, 2006
Institute of Medicine (IOM) - Immunization Safety Review: Vaccines and Autism
Slide Presentations - U.S. Regulatory Perspective on Preventive Vaccine Development
October 30, 2007
IND Overview(PDF - 409KB)
LCDR Vada Perkins
Regulatory Considerations for the Manufacture of Investigational Vaccines for Clinical Trials(PDF - 495KB)
CDR Jon R. Daugherty, PhD
Regulatory Aspects of the Nonclinical Safety Assessment of Adjuvanted Preventive Vaccines(PDF - 453KB)
Steven Kunder, PhD, DABT
Regulatory Perspective on Development of Preventive Vaccines for Global Infectious Diseases(PDF - 618KB) Rosemary Tiernan, MD, MPH