Long COVID: Implications for Clinical Development

CEPI welcomes announcement from Pfizer / BioNTech of positive interim data from Phase III trial of COVID-19 vaccine candidate

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.

A Comparison of Vaccine Efficacy Elements in Advanced Stage Clinical Trial Protocols

Evaluating the Burden-of-Disease Endpoint to Assess Vaccine Efficacy

COVID-19 Efficacy Endpoints in Interventional Trials: What Constitutes an Incident Clinical Disease Case and What Triggers Diagnostic Work-Up V2.0

CONSIDERATIONS FOR EVALUATION OF COVID19 VACCINES

Priority List of COVID-19 Adverse events of special interest: Quarterly update 1

Considerations for Inclusion of Risk Populations into COVID-19 Vaccine Efficacy Trials

Reporting of notifiable infectious diseases during the COVID-19 response

Efficacy Endpoints in COVID-19 Vaccine Trials: SARS-CoV-2 Infection

Vaccine Efficacy Assessment for COVID-19

General Core Elements for Early Phase Clinical Trials of COVID-19 Vaccine Candidates: Aspects to Consider

Consensus considerations on the assessment of the risk of disease enhancement with COVID-19 vaccines:

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

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.