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Oxford (England), Sep 10 (Canadian-Media): The Phase 3 clinical trial for a COVID-19 vaccine being developed by the University of Oxford and pharmaceutical company AstraZeneca was put on hold due to a potentially unexplained illness in one of its trials in the U.K, a statement on AstraZeneca Oxford said.
AstraZeneca. Image credit: Twitter handle
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology.
The following statement was issued Sep 9 on AstraZeneca Oxford SARS-CoV-2 vaccine, AZD1222, COVID-19 vaccine trials temporary pause:
"As part of the ongoing randomised, controlled clinical trials of the AstraZeneca Oxford coronavirus vaccine, AZD1222, a standard review process has been triggered, leading to the voluntary pause of vaccination across all trials to allow an independent committee to review the safety data of a single event of an unexplained illness that occurred in the UK Phase III trial.
"This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.
In large clinical trials, illnesses will happen by chance and must be independently reviewed. AstraZeneca is working to expedite the review of the single event to minimise any potential impact on the trial timeline. We are committed to the safety of our participants and the highest standards of conduct in our trials.
Pascal Soriot, Chief Executive Officer, said: “At AstraZeneca we put science, safety and the interests of society at the heart of our work. This temporary pause is living proof that we follow those principles while a single event at one of our trial sites is assessed by a committee of independent experts. We will be guided by this committee as to when the trials could restart, so that we can continue our work at the earliest opportunity to provide this vaccine broadly, equitably and at no profit during this pandemic.”
Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
AstraZeneca said Wednesday that the patient had neurological symptoms associated with a spinal inflammatory disorder called transverse myelitis, pending a final diagnosis, Reuters reported.
It was concluded by an independent review panel the illness was not related to the vaccine.
Dr. Samir Gupta, associate professor of medicine at the University of Toronto, said that "it's not a routine thing to stop a massive trial mid-course like this."
Dr. Sumon Chakrabarti, an infectious disease specialist at Trillium Health Partners in Toronto, told CBC News Network that if the patient does have transverse myelitis, he or she will likely be tested for different types of infections to see if a cause can be determined.
"I've seen many of these cases myself, and we often come up with viral causes," he said.
Dr. Andrew Morris, an infectious disease specialist at Sinai Health, the University Health Network and the University of Toronto said he was concerned there wouldn't be access to the vaccine, which is in advanced stages of development, reported CBC News.
Morris said three billion doses have been reserved by governments around the world and by the COVAX Facility, which aims to provide access to 172 countries, including many in the developing world and added that many countries are pinning their hopes on this vaccine.
Morris also expressed his concern that the media coverage will discourage people from enrolling in vaccine studies.