Vaccine Regulation
Because vaccines are given to healthy individuals, they undergo a more rigorous approval process than drugs which are given to cure sick people. Licensing of vaccines typically takes 15 years and an average of $800 million of manufacturers' money. The Food and Drug Administration (FDA) ensures the safety, purity, potency and effectiveness of vaccines.
But it doesn't stop there:
- Post-licensing monitoring is conducted - tracking any side-effects from the vaccine.
- Samples of every lot of medicine must be submitted to the FDA before it is sold. This ensures that each batch is as safe and effective as the last.
- Since 1990, the Vaccine Safety Datalink (VSD) has collected statistics from more than 7 million people in health plans who have received vaccines.
- In 1990, the Centers for Disease Control and Prevention (CDC) and the FDA established the Vaccine Adverse Event Reporting System (VAERS), which gathers information about any side effects patients have experienced. VAERS accepts any reported information without determining a cause and effect relationship. Clinical Immunization Safety Assessment Centers (CISA) were started in 2001. They conduct clinical research about vaccine adverse events (VAE) and the role of individual variation; provide clinicians with evidence-based counsel and empower them to make informed immunization decisions.