Long COVID: Implications for Clinical Developmentby Paul Oloo
CEPI welcomes announcement from Pfizer / BioNTech of positive interim data from Phase III trial of COVID-19 vaccine candidateby CEPI
Pfizer 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 Efficacyby Edde Loeliger and Bob Small
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
CONSIDERATIONS FOR EVALUATION OF COVID19 VACCINESby World Health Organization
Considerations for Inclusion of Risk Populations into COVID-19 Vaccine Efficacy Trialsby Paul Oloo & Edde Loeliger
Reporting of notifiable infectious diseases during the COVID-19 responseby Pawel Stefanoff et al.
Efficacy Endpoints in COVID-19 Vaccine Trials: SARS-CoV-2 Infectionby Amol Chaudhari & Edde Loeliger
Vaccine Efficacy Assessment for COVID-19by Edde Loeliger and Bob Small
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.
Priority List of Adverse Events of Special Interest: COVID-19by Barbara Law , Miriam Sturkenboom
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.