Vaccine pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding, prevention, and communication of adverse events following immunization (AEFIs), or of any other vaccine or immunization-related issues.
We all may be aware that vaccines are among the most important medical interventions for prevention of illness and life-threatening conditions especially in emergency situations like the ongoing COVID-19 pandemic. In current era of COVID-19 vaccine research, many reputed pharma giants like GSK, Roche, Pfizer, Novartis, J & J, Sanofi along with reputed universities like Oxford, Miami, Queensland had started many multicentric clinical trials with large no of population.
Why Vaccine safety is important
Along with research, all these sponsors are also much aware that these anti COVID-19 vaccines are not completely risk-free and adverse events do occur which can range from minor side-effects to more severe reactions or may result into death.
Since the majority of vaccines are administered to vulnerable as well healthy population a mandatory safety supervision is necessary for getting the most safe and effective vaccine in the market, as some safety issues with the vaccine may result into negative rumours and loss of general confidence of public in the final product and ultimately may result into dramatic consequences on immunization coverage and disease incidence. Hence for maintaining an accurate benefit risk assessment of any Vaccine, proper recording of AEFIs is required in an efficient safety database.
Ultimate Goal
The ultimate goal of vaccine pharmacovigilance (PV) in current COVID-19 pandemic is the early detection and timely response to adverse events following immunization (AEFI) in both clinical and post-marketing stage, in order to minimize negative effects to the health of individuals and lessen the potential negative impact on immunization of population.
Current developments in COVID-19 vaccine research
As the various regulatory authorities (EMA, MHRA, US-FDA, and DCGI etc) had released their latest guidelines for encouraging faster clinical trials of COVID-19 vaccines for the fast track approval of new vaccine candidates. Many pharmaceutical & biopharma giants had already started enrolling multiple no. of patients for their multicentric trials for testing of their respective vaccine candidates against COVID-19 for assessing their safety and efficacy in broad populations around the globe, which in few days will result in tremendous flow of safety data of AEFIs for various COVID-19 vaccine candidates in clinical trials and after post approval in very short notice.
Need for an efficient safety database
In order to maintain accurate record and performing regulatory reporting of this expected huge amount of AEFIs data of vaccines against COVID-19, we need to have an efficient, automated & robust safety platform which should be regulatory compliant.
Sarjen’s PvEdge®-Vaccine Safety, a quality-driven integrated advanced software solution for management & collection of large number of serious & non-serious adverse events following immunization (AEFIs) with COVID-19 vaccine candidates, can become a boon for many sponsors and PV service providers in order to handle the huge inflow of AEFIs (in clinical/post-marketing stage).
PvEdge®-Vaccine Safety’s USPs (In COVID-19 vaccine research)
- VAERS, CIOMS and XML submissions (VigiFlow-Global WHO database)
- End to end vaccine case processing module
- Enhanced support for aggregate reports via generation of listings & summary reports
- Capacity to handle large number of AEFIs in a short period of time in this pandemic
- Easy assessment of vaccine failures or reversal of virulence for live attenuated vaccine
- Accuracy and efficiency to identify, assess and analyse vaccine signals
- Fully compliant with complex global regulatory requirements for vaccine
- Supports regulatory submissions of reports via accepted pathways to FDA
- Provides in depth information regarding vaccine administration details and vaccine history
- Provides the feasibility of crating cluster vaccine cases
- Tracking of submission compliance
- Analysis of delayed submissions, if any
- Confirming acknowledgments (positive and negative) after submissions
- Creating follow-ups alerts
- Review of vaccine submission report for timelines, case summary, submission details, country, and type of submission etc
PvEdge® vaccine safety solution had successfully passed many on-site sponsor & global regulatory agency audits (MHRA, US FDA, Health Canada, and ANVISA etc).
