News archive - European Medicines Agency starts first rolling review of a COVID-19 vaccine
The European Medicines Agency has started the first ‘rolling review’ of a COVID-19 vaccine, in which it is evaluating the preclinical data on the vaccine being developed by AstraZeneca in collaboration Oxford University.
Rolling review is one of the ways EMA can speed up the assessment of drugs or vaccines during a public health emergency. Normally, all data on effectiveness, safety and quality must be collected and submitted in a single file once clinical trials are completed, but in a rolling review, EMA reviews data as they become available from ongoing studies.
The decision to start the rolling review of the vaccine is based on preliminary results from preclinical and early clinical studies suggesting it triggers production of antibodies and T cells that target the virus.
EMA will complete the assessment according to its usual standards. While the overall review timeline cannot be forecast, the process should be shorter. The rolling review route was used in assessing the first therapeutic to be approved for treating COVID-19, Gilead Sciences’ Veklury (remdesivir).
- European Union (EU 27)
- Western Balkans
- Cross-thematic/Interdisciplinary
Entry created by Admin WBC-RTI.info on October 3, 2020
Modified on October 3, 2020
