Post-marketing Vaccine Safety Surveillance

Safety and adverse event monitoring don't stop when a vaccine is approved.

Studies of new vaccines do not stop at the point of licensure,” said Elisabeth Schuller, Global Head of Pharmacovigilance and Medical Information at Intercell AG, during her presentation on best practices in pharmacovigilance, specifically in relation to vaccines, at the 2010 World Vaccine Congress.

Schuller said that the acceptance of risks is generally very limited when it comes to vaccines. And although the implementation of a vaccination program may be uncontroversial, whether in Europe or worldwide, the public’s perceived risk of adverse events (AEs) following immunization is a significant threat to the overall success of a vaccination program. Accordingly, Schuller said that monitoring and assessing vaccine safety is a priority for public health and the marketing authorization holders (MAH), which assess safety both before and after vaccine authorization. However, the number of subjects in the clinical assessment trials during phases I-III may be too small to detect rare events.

Even after a vaccine is on the market and in use among the public, safety surveillance is still needed in order to detect rare adverse events, because in real-life administration, as compared to pre-licensure trials, there will be variability in vaccination schedules and covaccination, and vaccines will be used in different population groups than those that were enrolled in the pre-license studies.

During post-marketing settings (phase IV surveillance), the activities related to vaccine safety involve several different stakeholders. Schuller said that monitoring for previously unknown serious AEs must be assessed in a timely manner in order to avoid unnecessary individual exposure. She also said it is important to monitor for “batch issues” and effects in immunocompromised individuals.

The key elements of adverse event (AE) monitoring include pharmacovigilance for vaccine safety, implementing processes and policies for post-market safety research, andestablishing data requirements for vaccines adverse reaction reporting. Companies should focus on capturing safety information knowledge from a variety of other stakeholders (eg, scientific communities, academia, networks, users and regulators).

Effective post-market utilization and safety monitoring requires that companies “develop a culture wherein it is a natural behavior to collect, forward, and assess information, and to act accordingly,” Schuller said. This requires operational and communication excellence, case processing by well-trained personnel, and well-defined key performance indicators.