Vaccines, Blood & Biologics
Resources for You
Vaccines
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 Information
- Vaccines Licensed for Immunization and Distribution in the US with Supporting Documents
- Biologics License Applications (BLA) Process (CBER)
- Vaccines Guidances
- Vaccines Proposed & Final Rules
- Vaccines and Related Biological Products Advisory Committee
- A Parent's Guide to Kids' Vaccines
- Vaccines
FDA Consumer Updates - HIV Vaccine - Pre-clinical Toxicology Testing (National Institute of Allergy and Infectious Diseases)
- CDC National Immunization Program
Centers for Disease Control and Prevention
Vaccine Safety & Availability
- 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
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
Pandemic
- Pandemic Influenza Information
- FDA/NIH/WHO Public Workshop: Immune Correlates of Protection Against Influenza A Viruses in Support of Pandemic Vaccine Development
December 10 - 11, 2007 - HHS Unveils Two New Efforts to Advance Pandemic Flu Preparedness (HHS)
Department of Health and Human Services Press Release, February 1, 2007
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
Recalls & Alerts
Related Information
Contact Us
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448