How does FDA assess the safety of vaccines?
Vaccines undergo rigorous and extensive testing to determine their safety and effectiveness. Highly trained scientists and medical personnel at FDA carefully review all of the information in a marketing application before a vaccine can be approved for use by the public.
Following approval, FDA also carefully monitors the quality of vaccines—all manufactured lots must pass tests before they can be used. And as with all manufacturers of medical products, vaccine manufacturers must follow strict manufacturing standards. In addition, FDA conducts routine inspections of manufacturing sites.
FDA also works closely with the Centers for Disease Control and Prevention (CDC) to monitor reports of side effects (adverse events) of vaccines. FDA and CDC take all reports seriously, and work together to evaluate and address any potential problems.
- What is a biological product?
- Webinar on FDA’s Safety Monitoring of Approved Vaccines
- FDA Basic Video: Dianne Murphy Discusses Effective and Proper Uses of Medicines and Devices in Children (Video)
- FDA Basic Video: Norman Baylor Discusses Vaccines (Video)
- FDA Webinar on Safety of the Blood Supply
- FDA Webinar on Protecting Your Child's Health Through Safe and Effective Vaccines
- What are stem cells? How are they regulated?
- What is thimerosal? Is it safe when used in some vaccines?
- How can I get my name removed from a donor deferral list?
- How does FDA regulate tissue products? What safeguards are in place for recipients?
- How do I know if I’m eligible to donate blood?
- How do I report an adverse event related to a vaccine?
- What is the Vaccine Adverse Event Reporting System (VAERS)?
- How does FDA assess the safety of vaccines?
- What is the approval process for a biological product?
How helpful was this information?