Vaccines

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, 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. Additional information concerning preventive vaccines and vaccine preventable diseases is available at the CDC National Immunization Program.

Vaccine Safety

Counterterrorism

Pandemic

Seasonal Information

Slide Presentations - US Regulatory Perspective on Preventive Vaccine Development - 10/30/2007

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Updated: December 19, 2007