On 2 April, the FDA posted the current updates on "Ensuring the Safety of vaccines in the United States" and on "Understanding the Vaccine Adverse Event Reporting System (VAERS)".
As the responsible authority for licensing vaccines in the United States, the FDA must ensures the safety, effectiveness, and availability of vaccines in the United States. Before the FDA licenses (approves) a vaccine, it is tested extensively by its manufacturer. The FDA scientists and medical professionals carefully evaluate all the available information about the vaccine to determine its safety and effectiveness. The published document "Ensuring the Safety of Vaccines in the United States" provides an overview about the different steps from development to postlicensure safety monitoring.
Especially for this post licensure monitoring, the Vaccine Adverse Event Reporting System (VAERS) is an important and effective system for scientists at the FDA and the Centers for Disease Control and Prevention (CDC) to collect reports of adverse events (possible side effects) that happen after vaccination. For more details, the authority posted a second document "Understanding the Vaccine Adverse Event Reporting System (VAERS)".
VAERS is a national vaccine safety surveillance program overseen by CDC and FDA. VAERS collects and analyzes reports of adverse events that happen after vaccination. Each year, VAERS receives around 30,000 reports. Most of these reports describe known mild side effects such as fever. Scientists at CDC and FDA monitor VAERS reports closely to identify reported adverse events that need to be studied further. Sometimes, it is only after a vaccine has been approved and used broadly that rare side effects can be detected by monitoring systems such as VAERS.
More information about vaccine safety and the regulatory requirements can be found at CDC's homepage.
Please pay attention to ECA's education course "GMP for Vaccine Manufacturers" in Berlin, Germany, from 25 -27. April 2012.
Axel H. Schroeder
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)