How to Handle a Sudden Tenfold Increase in ICSRs-Lessons Learned During the SARS-Cov-2 Pandemic

Introduction: The unprecedented vaccination efforts related to COVID-19 have strained PV systems and resources of stakeholders globally. Objective(s): The Norwegian Medicines Agency (NoMA) wishes to present lessons learned from changes implemented nationally before and during the vaccination campaign. Method(s): Anticipating a large increase in spontaneous reporting, improved tools and procedures simplifying reporting, case processing, and analysis were implemented. Resources for hiring additional temporary staff was made available. The overall aim was that of an agile preparedness with ability to replan and reprioritize activities to fulfil pharmacovigilance obligations of a national competent authority, while continuing NoMAs tradition of transparency towards the public. Result(s): NoMA experienced a tenfold increase in ICSRs from healthcare professionals and consumers during COVID-19 vaccination. Compared to normal vaccine reporting the increase was even higher. Case processing, signal detection and signal management procedures were stretched thin. Still, several international signals were detected and managed early. Despite additional resources supplied, a backlog in handling of non-serious reports accumulated while serious reporting was unaffected. Communication to the public was radically increased. Among measures put in place by NoMA before and during the vaccination campaign, the following were useful: * Electronic reporting forms. * Collection of unique patient identification number. * Daily status meetings, both internally and externally (i.e. Norwegian Institute of Public Health). * Daily triage of incoming ICSRs. * A clear order of priority for case processing. * Simplified processing of non-serious ICSRs. * Automated report generation to monitor special groups, events or outcomes, e.g. children, Adverse Events of Special Interest, fatal cases. * Weekly overviews of suspected adverse reactions associated with COVID-19 vaccination in Norway was made available to the public, both in Norwegian and English. Conclusion(s): By implementing various measures NOMA managed to prioritise processing of the ICSRs that added most value to detecting signals of possible new safety issues.

A STUDY OF DISPROPORTIONATELY AFFECTED POPULATIONS BY RACE/ETHNICITY DURING THE SARS-COV-2 PANDEMIC USING MULTI-POPULATION SEIR MODELING AND ENSEMBLE DATA ASSIMILATION

The disparity in the impact of COVID-19 on minority populations in the United States has been well established in the available data on deaths, case counts, and adverse outcomes. However, critical metrics used by public health officials and epidemiologists, such as a time dependent viral reproductive number (Rt), can be hard to calculate from this data especially for individual populations. Furthermore, disparities in the availability of testing, record keeping infrastructure, or government funding in disadvantaged populations can produce incomplete data sets. In this work, we apply ensemble data assimilation techniques which optimally combine model and data to produce a more complete data set providing better estimates of the critical metrics used by public health officials and epidemiologists. We employ a multi-population SEIR (Susceptible, Exposed, Infected and Recovered) model with a time dependent reproductive number and age stratified contact rate matrix for each population. We assimilate the daily death data for populations separated by ethnic/racial groupings using a technique called Ensemble Smoothing with Multiple Data Assimilation (ESMDA) to estimate model parameters and produce an Rt(n) for the nth population. We do this with three distinct approaches, (1) using the same contact matrices and prior Rt(n) for each population, (2) assigning contact matrices with increased contact rates for working age and older adults to populations experiencing disparity and (3) as in (2) but with a time-continuous update to Rt(n). We make a study of 9 U.S. states and the District of Columbia providing a complete time series of the pandemic in each and, in some cases, identifying disparities not otherwise evident in the aggregate statistics. © American Institute of Mathematical Sciences.

How to Handle a Sudden Tenfold Increase in ICSRs-Lessons Learned During the SARS-Cov-2 Pandemic: An International Journal of Medical Toxicology and Drug Experience

Introduction: The unprecedented vaccination efforts related to COVID-19 have strained PV systems and resources of stakeholders globally. Objective: The Norwegian Medicines Agency (NoMA) wishes to present lessons learned from changes implemented nationally before and during the vaccination campaign. Methods: Anticipating a large increase in spontaneous reporting, improved tools and procedures simplifying reporting, case processing, and analysis were implemented. Resources for hiring additional temporary staff was made available. The overall aim was that of an agile preparedness with ability to replan and reprioritize activities to fulfil pharmacovigilance obligations of a national competent authority, while continuing NoMAs tradition of transparency towards the public. Results: NoMA experienced a tenfold increase in ICSRs from healthcare professionals and consumers during COVID-19 vaccination. Compared to normal vaccine reporting the increase was even higher. Case processing, signal detection and signal management procedures were stretched thin. Still, several international signals were detected and managed early. Despite additional resources supplied, a backlog in handling of non-serious reports accumulated while serious reporting was unaffected. Communication to the public was radically increased. Among measures put in place by NoMA before and during the vaccination campaign, the following were useful: * Electronic reporting forms. * Collection of unique patient identification number. * Daily status meetings, both internally and externally (i.e. Norwegian Institute of Public Health). * Daily triage of incoming ICSRs. * A clear order of priority for case processing. * Simplified processing of non-serious ICSRs. * Automated report generation to monitor special groups, events or outcomes, e.g. children, Adverse Events of Special Interest, fatal cases. * Weekly overviews of suspected adverse reactions associated with COVID-19 vaccination in Norway was made available to the public, both in Norwegian and English. Conclusion: By implementing various measures NOMA managed to prioritise processing of the ICSRs that added most value to detecting signals of possible new safety issues.