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.
Biologics License Applications (BLA) Process (CBER) CDC National Immunization Program
Centers for Disease Control and Prevention
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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
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 and Vaccines MMWR - Guillain-Barr� Syndrome Among Recipients of Menactra Meningococcal Conjugate Vaccine
MMWR Weekly Report, Centers for Disease Control, October 20, 2006