Science

Clinical trials resume on AstraZeneca-Oxford Covid-19 vaccine candidate

Our Bureau Mumbai | Updated on September 12, 2020 Published on September 12, 2020

Serum Institute is also ready to restart trials once DCGI approves

Biopharmaceutical company AstraZeneca said that clinical trials on the AZ- Oxford coronavirus vaccine, AZD1222, have resumed in the United Kingdom following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so.

“On September 6, the standard review process triggered a voluntary pause to vaccination across all global trials to allow review of safety data by independent committees, and international regulators. The UK committee has concluded its investigations and recommended to the MHRA that trials in the UK are safe to resume”, a note from the company said.

AstraZeneca and the University of Oxford, as the trial sponsor, cannot disclose further medical information, it added. This announcement would allow other countries including India to resume trials, once the respective regulatory authorities are updated.

In fact, Serum Institute in a statement said: "Once (the) DCGI (Drug Controller General of India) will give us the permission to restart the trials in India, we will resume the trials. "

Serum Institute has a production and distribution alliance on this vaccine candidate in low and middle income countries. It too had “paused” clinical trials in India a day after AZ announced similar action globally, following an adverse event reported in the United Kingdom.

Meanwhile, AstraZeneca said all trial investigators and participants will be updated with the relevant information and this will be disclosed on global clinical registries, according to the clinical trial and regulatory standards.

The AZD1222 vaccine candidate was co-invented by the University of Oxford and its spin-out company, Vaccitech.

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Published on September 12, 2020
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