We all know what Pharmacovigilance is: “The science & activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems according to WHO(World Health Organisation).
But did you know there exists “Vaccine Pharmacovigilance” too!
Pharmacovigilance includes the development of standardized definitions relevant to the monitoring of the safety of vaccines during post marketing survilance.
Vaccine pharmacovigilance(VP) is defined as the science & activites realting to the detection, assessment, understanding, & communcation of adverse effects following immunization & other vaccine or immunization-related issues, & to prevent unwanted effects of the vaccine or immunization.
The aim of VP is early detection of the appropriate & timely response to patients suffering from adverse effects of vaccines/ immunizations to minimize negative effects on the health of individuals. Continuous risk-benefits assesment & risk management are intergral part of the VP process.
Elements to consider when conducting VP include the following:
- Vaccines are usually administered to healthy people, including infants.
- The benefits of immunization may not be immediately visible, particularly if the target disease incidence is low.
- Subpopulations may be more susceptible to experiencing certain AEFIs(Adverse effects following immunization).
- Due to the low acceptance of risks, intensive investigation of serious AEFIs, even if rare, is necessary.
- Vaccines are complex biological products that may include multiple antigens, live organisms, adjuvants, and preservatives. Each component may have unique safety implications. Variability and (even small) changes in the manufacturing process may have an impact on quality, protective effect, and safety. Batch information is of crucial importance…… etc
Do you think current vaccine pharmacovigilance systems are strong enough to detect rare AEFIs early?
MBH/AB