COVID-19 Efficacy Endpoints in Interventional Trials: What Constitutes an Incident Clinical Disease Case and What Triggers Diagnostic Work-Up V2.0by Edde Loeliger & Amol Chaudhari
General Core Elements for Early Phase Clinical Trials of COVID-19 Vaccine Candidates: Aspects to Considerby Amol Chaudhari
Consensus considerations on the assessment of the risk of disease enhancement with COVID-19 vaccines:by Coalition for Epidemic Preparedness Innovations (CEPI)
The SARS-CoV-2 pandemic presents an unprecedented challenge to global health with enormous health system, social and economic disruption and large numbers of deaths already experienced in many countries. Epidemiologic features confirm that ongoing spread to less affected areas is now a certainty.
To maximize the value of vaccine safety data in clinical trials given their relatively limited sample size, it is essential to standardize their collection, presentation and analysis when possible.Given serious adverse events following immunization (AEFIs) are fortuitously rare, this need for globally accepted standard case definitions that allow for valid comparisons extend to individual case reports, surveillance systems, and retrospective epidemiologic studies.