Oxford University in a statement Saturday has said it is resuming the ‘paused’ vaccine trial of the ChAdOx1 COVID vaccine in clinical trial sites in the United Kingdom.
The vaccine candidate developed by researchers at the University and in partnership with the U.K. biopharma company, AstraZeneca was paused earlier this week after reports emerged of a “serious adverse event” in a volunteer in the United Kingdom who was part of the trial. The trial is being conducted in the United States, Brazil, South Africa. The Serum Institute of India, which has partnered with AstraZeneca, had begun a trial in India that was also paused.
Meanwhile, Prime Minister Narendra Modi on Saturday cautioned people against lowering their guard till an effective anti-coronavirus medicine is developed. With a slogan to to drive home his point, Mr Modi said, “ Jab tak dawai nahi, tab tak dhilai nahi’ (No carelessness till a medicine is found).”
Adequate review
“On Sunday [06/09/2020] our standard review process triggered a study pause to vaccination across all of our global trials to allow the review of safety data by an independent safety review committee,and the national regulators. All routine follow-up appointments continued as normal during this period. The independent review process has concluded and following the recommendations of both the independent safety review committee and the UK regulator, the MHRA (Medical and Healthcare Products Regulator Agency), the trials will recommence in the UK,” the Oxford vaccine group said in a statement.
“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,” the statement said.
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Responding to the resumption, CEO of Serum Institute Adar Poonawala tweeted: “As I’d mentioned earlier, we should not jump to conclusions until the trials are fully concluded. The recent chain of events are a clear example why we should not bias the process and should respect the process till the end. Good news, @UniofOxford.”
There was no information on resumption of the India trials.
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The Oxford vaccine group said it could not disclose details about the illness because of “participant confidentiality." AstraZeneca CEO, Pascal Soriot had said that the afflicted volunteer had experiencedneurological symptoms akin to a serious spinal inflammatory disorder called transverse myelitis.
However post the Oxford group announcement it was unclear if the participant had actually got the vaccine or a placebo and if it was indeed the vaccine that triggered the adverse event.
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On July 12, another volunteer in the trial had reportedly contracted transverse myelitis, or a spinal cord inflammation. However it isn't known if this triggered a pause but trial recruitmentwas on until the pause this week.
On Saturday, Prime Minister Narendra Modi said everyone has to be on high alert till a vaccine was available. ‘Jab tak dawai nahi, tab tak dhilai nahi’ (No lapses till a medicine is found), the prime minister said while addressingthe virtual house warming ceremony of 1.75 lakh houses built in the rural parts of Madhya Pradesh under the Pradhan Mantri Awas Yojana.
