Long COVID: Implications for Clinical Development
by Paul OlooPfizer and BioNTech have announced that their vaccine candidate against COVID-19 achieved success in the first interim analysis from the phase 3 COVID-19 vaccine trial.
Evaluating the Burden-of-Disease Endpoint to Assess Vaccine Efficacy
by Edde Loeliger and Bob SmallCOVID-19 Efficacy Endpoints in Interventional Trials: What Constitutes an Incident Clinical Disease Case and What Triggers Diagnostic Work-Up V2.0
by Edde Loeliger & Amol ChaudhariCONSIDERATIONS FOR EVALUATION OF COVID19 VACCINES
by World Health OrganizationConsiderations for Inclusion of Risk Populations into COVID-19 Vaccine Efficacy Trials
by Paul Oloo & Edde LoeligerReporting of notifiable infectious diseases during the COVID-19 response
by Pawel Stefanoff et al.Efficacy Endpoints in COVID-19 Vaccine Trials: SARS-CoV-2 Infection
by Amol Chaudhari & Edde LoeligerVaccine Efficacy Assessment for COVID-19
by Edde Loeliger and Bob SmallGeneral 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.