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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
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- 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 MB ChB LRCP&S FRCP FFPM MRCGP, has been working in pharmacovigilance & pharmacoepidemiology for more than a decade. He is the Director of the Drug Safety Research Unit (DSRU) in Southampton, an academic unit associated with the University of Portsmouth, where he leads a research team with an active program for monitoring and studying the safety of medicines. He has worked and advised on many drug safety issues including product withdrawals and major safety hazards. He is the author of many publications on pharmacovigilance and pharmacoepidemiology and a member of the editorial board of the journals of Pharmacoepidemiology and Drug Safety.
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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 May 8, 2024, from https://hstalks.com/bs/4463/.Export Citation (RIS)
Publication History
Financial Disclosures
- Prof. Saad Shakir has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.
Audio Interview
Oxford/AstraZeneca COVID-19 vaccine trial: adverse patient event reports
Published on November 18, 2020
15 min
A selection of talks on Respiratory Diseases
Transcript
Please wait while the transcript is being prepared...
0:00
Interviewer: Professor Saad Shakir, thank you very much for
taking the time to do this interview with us today to discuss
the occurrence of an adverse event reported in a patient in
the Oxford University and
AstraZeneca clinical trial for their new COVID-19 vaccine earlier this year.
Let me start by asking about first of all,
can you tell us a little bit about this specific vaccine just as a quick introduction,
and in particular regarding what is known of its mode of
action and projected safety profile?
Prof. Shakir: Thank you. The Oxford AstraZeneca vaccine is
a new platform where a DNA adenovirus introduces the DNA,
the sequence of a protein of the well-known spikes of the COVID-19 virus,
which gets transcribed to the messenger RNA.
Thus, it uses the cells natural machinery
to produce the spike protein antigen of SARS COVID-2.
This is a technology which is used to introduce genetic materials into human cells,
because if you inject DNA on its own,
it wouldn't get into the cell.
When these proteins are released into the bloodstream,
the human body then will produce an immune response
to these proteins by way of antibodies and cellular response,
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