Workshop Report: COVAX Vaccine Safety Working Group: Developer Needs Workshop
by Dr Julia GranerodEarly and Advanced Stage Clinical Development Core Elements- Comparison of the Guidance and Considerations
by Paul OlooCore Elements for Advanced Stage Clinical Trials of COVID-19 Vaccine Candidates: Aspects to Consider
by Amol ChaudhariEfficacy Endpoints in COVID-19 Vaccine Trials: SARS-CoV-2 Infection
by Amol Chaudhari & Edde LoeligerGeneral Core Elements for Early Phase Clinical Trials of COVID-19 Vaccine Candidates: Aspects to Consider
by Amol ChaudhariConsensus 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.
Priority List of Adverse Events of Special Interest: COVID-19
by Barbara Law , Miriam SturkenboomTo 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.