AstraZeneca and Oxford Uni’s COVID-19 vaccine trial resumes following safety review
pharmafile | September 14, 2020 | News story | Research and Development, Sales and Marketing | AstraZeneca, COVID-19, Oxford University, Vaccine
After sparking a wave of concern through industry and mainstream media with the news it had halted international studies investigating its COVID-19 vaccine on 6 September, AstraZeneca has now announced that clinical trial operations conducted alongside its partners at the University of Oxford are now back in full swing.
Research into the candidate, known as AZD1222 or the “Oxford vaccine”, across all global sites was put on hold when the findings of a standard review process found that a patient taking part in the trial had fallen ill with an unexplained illness.
The University of Oxford commented on the decision to put the brakes on the programme: “Globally some 18,000 individuals have received study vaccines as part of the trial. In large trials such as this, it is expected that some participants will become unwell and every case must be carefully evaluated to ensure careful assessment of safety.”
Following investigation from independent committees and international regulators of generated safety data, the trial programme has now received the green light to proceed from the UK’s Medicines Health and Regulatory Authority (MHRA).
However, no specific medical data was revealed “for reasons of participant confidentiality”, though relevant findings will be made available via global clinical trial registries, according to the study organisers.
During the week that the trial was on hold, vaccinated participants were invited to attend follow-up appointments as normal.
Before this latest announcement, AstraZeneca CEO Pascal Soriot had expressed optimism that the vaccine could still hit the market this year.
Matt Fellows
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