Oxford, AstraZeneca to resume COVID vaccine trial; SII awaiting DCGI nod for India test

Oxford, AstraZeneca to resume coronavirus vaccine trial; SII awaiting DCGI nod for India test
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London: British clinical trials for the AstraZeneca and Oxford University coronavirus vaccine have resumed following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so, the company said on Saturday.

The late-stage trials of the experimental vaccine, one of the most advanced in development, were suspended this week after an illness in a study subject in Britain.

"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," AstraZeneca said.

"The UK committee has concluded its investigations and recommended to the MHRA that trials in the UK are safe to resume."

The company said it could not disclose further medical information.

"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."

Vaccine trials to resume after DCGI nod

Serum Institute of India will resume clinical trials of AstraZeneca's COVID-19 vaccine candidate after getting the permission from the Drugs Controller General of India(DCGI), the Pune-based vaccine maker said on Saturday.

Pharma giant AstraZeneca on Saturday said that clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed in the UK following confirmation by the Medicines Health Regulatory Authority (MHRA) that the trials were safe.

"Once DCGI will give us the permission to restart the trials in India, we will resume the trials,"Serum Institute of India (SII) said in a statement.

In a tweet, SII CEO Adar Poonawalla said: "As I'd mentioned earlier, we should not jump to conclusions until the trials are fully concluded. The recent chain of events is a clear example why we should not bias the process and should respect the process till the end. Good news, @UniofOxford."

The human trials resumed days after a pause had been announced in the trials after an adverse reaction in one of the participants.

Following the suspension, the DCGI directed Serum Institute of India to suspend till further orders new recruitment in phase 2 and 3 clinical trials of the vaccine candidate.

AstraZeneca and the University of Oxford, as the trial sponsor, on Saturday said that they cannot disclose further medical information but confirmed that independent investigations concluded that the trials were safe to restart.

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