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.
- Vaccines Licensed for Immunization and Distribution in the US
- Approval Process
- Guidances, Rules and Other Publications
- HIV Vaccine - Pre-Clinical Info - NIAID
- Vaccines and Related Biological Products Advisory Committee
- Vaccines Provide Effective Protection and FDA Makes Sure They are Safe
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 Adverse Event Reporting (VAERS)
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.
- Alert on Menactra Meningococcal Vaccine and Guillain Barre Syndrome
- Institute of Medicine (IOM) - Immunization Safety Review: Vaccines and Autism
- MMWR - Guillain-Barré Syndrome Among Recipients of Menactra Meningococcal Conjugate Vaccine
- Recommendations for the Use of Vaccines Manufactured with Bovine-Derived Materials
- Pandemic Influenza
- HHS Unveils Two New Efforts to Advance Pandemic Flu Preparedness
- Immune Correlates of Protection Against Influenza A Viruses in Support of Pandemic Vaccine Development - FFDA/NIH/WHO Public Workshop
Slide Presentations - US Regulatory Perspective on Preventive Vaccine Development - 10/30/2007>
- IND Overview (PDF - 409 KB) - LCDR Vada Perkins
- Regulatory Considerations for the Manufacture of Investigational Vaccines for Clinical Trials (PDF - 495 KB) - CDR Jon R. Daugherty, Ph.D.
- Regulatory Aspects of the Nonclinical Safety Assessment of Adjuvanted Preventive Vaccines (PDF - 454 KB) - Steven Kunder, Ph.D., DABT
- Regulatory Perspective on Development of Preventive Vaccines for Global Infectious Diseases (PDF - 618 KB) - Rosemary Tiernan, MD, MPH