During the XI session on Pharmacovigilance of the 58th AFI Symposium, Mrs. Finizia from GSK illustrated in detail the correct approach to vaccines, a particularly hot topic for the presence of a large group of people, especially parents, with positions no-VAX.
The starting point of Mrs. Finizia’s intervention was the definition of vaccinovigilance, that is the science and the activities concerning the collection, evaluation, analysis and communication of adverse events following immunization (AEFI) and other events related to vaccine or immunization, aimed at preventing undesirable effects of the vaccine or immunization.
First of all, it should be highlighted that vaccines are different from drugs. Vaccinovigilance and Pharmacovigilance share the same objectives and the same methods, but:
- vaccines are given to healthy subjects including children
- large groups of subjects are vaccinated, therefore comparisons cannot be made without populations of the same number
- some populations (e.g. immunosuppressed subjects) may be more at risk, combined vaccines may make it more difficult to establish a causal link
- the complexity of the production process can lead to considerable differences in the lots
- the perception of a true or presumed risk in relation to a vaccine can have a significant impact on the social acceptance of the vaccine programs and on the confidence in the utility of the vaccine.
Vaccines, as well as drugs, require continuous and stringent surveillance. Vaccinovigilance aims to:
- analyze each individual case correctly
- establish the causal link (adverse reaction vs simple temporal relationship)
- identify potential signals and confirm them
- identify risks and mitigation actions
- update security information
- provide appropriate communication and correct information on the benefit-risk profile of vaccines and on the frequency and severity of AEFI.
The analysis systems require targeted methodologies and a more continuous and meticulous evaluation frequency.
The actors who contribute to assessing the safety of vaccines (MAHs and National/International Regulatory Authorities, specific Institutions/Authorities Vaccinovigilance) must have more rapid and effective collaboration and exchange of information as well as common classification and evaluation criteria AEFI.