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Topics Covered
- Mode of action of the Oxford/AstraZeneca DNA vaccine
- Two potential adverse events reported in patients enrolled in the vaccine’s phase 3 trial
- Steps undertaken to determine possible causality between the adverse events and the vaccine
- Differences between RNA and DNA vaccine properties and mechanism of action
- Current status of the trial
- Please note that since the recording of this interview it was determined that "The serious adverse events observed during the trial in these study groups were judged to be unrelated to the study vaccines and occurred at frequencies expected for these conditions in the general population. None of the participants included in this report had any suspected unexpected serious adverse reactions." (Ramasamy et al., The Lancet, November 18, 2020, https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32466-1/fulltext).
Biography
Prof. Saad Shakir is a leading pharmacoepidemiologist and drug safety expert, best known for his 26 years as Director of the independent Drug Safety Research Unit (DSRU), affiliated with the University of Portsmouth. Trained in clinical pharmacology and with a background in hospital medicine and general practice, he joined the UK Medicines Control Agency before taking up the DSRU role in 1999. Under his leadership, the unit expanded its methodologies from Prescription Event Monitoring to innovative real-world approaches, including registries, data linkage studies, and benefit–risk assessments, strengthening its global reputation in pharmacovigilance. A Fellow of multiple Royal Colleges and the Faculty of Pharmaceutical Medicine, and an active contributor to international journals and postgraduate education, Prof. Shakir has made influential contributions to drug safety science and training worldwide.
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Talk Citation
Shakir, S. (2020, November 18). Oxford/AstraZeneca COVID-19 vaccine trial: adverse patient event reports [Audio file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved August 31, 2025, from https://doi.org/10.69645/WRSL8173.Export Citation (RIS)
Publication History
- Published on November 18, 2020
Financial Disclosures
- Prof. Saad Shakir has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.