AZD1222, a vaccine developed by AstraZeneca in collaboration with the University of Oxford, is under rolling review by the Committee for Medicinal Products for Human Use of the European Medicines Agency.
The decision by the EU Committee for Medicinal Products for Human Use (CHMP) to begin ongoing review of the vaccine is based on preliminary results from nonclinical and early clinical studies of AZD1222, which indicate that the vaccine triggers the production of antibodies and T- cells directed against SARS-CoV-2. Large-scale Phase III clinical trials involving several thousand people are currently underway. Efficacy and safety results are expected in the coming weeks and months. The CHMP would then review these in later cycles of the Rolling Review. The goal is to review all available data on vaccine safety and quality from these studies. The rolling review process is a regulatory tool used by the European Medicines Agency (EMA) to evaluate a promising drug in a medical emergency such as a pandemic. In this process, drug data are submitted step-by-step in a multi-step process. This procedure was already used by the EMA for remdesivir and resulted in the RNA polymerase inhibitor being available for the treatment of COVID-19 sufferers within a short time. In the EU, Remdesivir (Veklury®) has been available since July for use in adults and adolescents 12 years of age and older suffering from SARS-CoV-2-related pneumonia with supplemental oxygen requirements.
Source: “EMA starts first rolling review of a COVID-19 vaccine in the EU,” European Medicines Agency (EMA), Oct. 1, 2020.
HAUSARZT PRAXIS 2020; 15(11): 45
