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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. 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.

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.

CBER and the Centers for Disease Control & Prevention (CDC) jointly manage the Vaccine Adverse Event Reporting System (VAERS), a cooperative program for vaccine safety. VAERS is a post-marketing safety surveillance program, collecting information about adverse events (side effects) that occur after the administration of US licensed vaccines. Reports to the VAERS program are welcome from all concerned individuals: patients, parents, health care providers, pharmacists, and vaccine manufacturers.

Additional information concerning preventive vaccines and vaccine preventable diseases is available at the CDC National Immunization Program WWW site: http://www.cdc.gov/nip/



HIV Vaccine - Pre-Clinical Info - NIAID

Notice to Readers: Manufacturer's Recall of Human Rabies Vaccine

Development of a Novel Vaccinia Neutralization Assay Based on Reporter Gene Expression

All About Vaccines for Kids

Vaccines Provide Effective Protection


Adverse Event Reporting

Advisory Committee (VRBP)


Approval Process

Bovine Spongiform Encephalopathy


Flu Vaccine

Licensed Vaccines

Publications / Transcripts



Vaccines and Autism

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