Serum Institute of India to resume clinical trials of AstraZeneca-Oxford’s COVID-19 vaccine after DGCI nod

The Pune-based Serum Institute of India (SII) is all set to resume the clinical trials of AstraZeneca-Oxford’s COVID-19 vaccine candidate AZD1222 after receiving permission from the Drugs Controller General of India (DCGI), the company confirmed on Saturday.

Notably, AstraZeneca has resumed British clinical trials of its COVID-19 vaccine AZD1222, one of the most advanced in development in collaboration with the Oxford University, after receiving the green light from the Medicines Health Regulatory Authority (MHRA) safety watchdog.

“Once DCGI will give us permission to restart the trials in India, we will resume the trials,” Serum Institute of India said in a statement.

SII CEO Adar Poonawala said in a tweet, “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 of 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 the Serum Institute of India to suspend till further orders new recruitment in Phase-II and Phase-III clinical trials of the vaccine candidate.

The late-stage trials of the experimental vaccine, developed with researchers from the University of Oxford, were suspended this week after an illness in a study subject in Britain, casting doubts on an early rollout.

“On 6 September, the standard review process triggered a voluntary pause to vaccination across all global trials to allow the review of safety data by independent committees, and international regulators,” AstraZeneca said.

It added that safety reviewers had recommended to Britain`s Medicines Health Regulatory Authority (MHRA) that it was safe to resume the UK trials.

“AstraZeneca and the University of Oxford as the trial sponsor cannot 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,” it added.

The patient involved in the study had been reportedly suffering from neurological symptoms associated with a rare spinal inflammatory disorder called transverse myelitis.

AstraZeneca, based in Cambridge, said it could not disclose further medical information. However, AstraZeneca said that it is committed to the safety of the trial participants and the highest standards of conduct in clinical trials.

“The company will continue to work with health authorities across the world and be guided as to when other clinical trials can resume to provide the vaccine broadly, equitably and at no profit during this pandemic,” the company said.

Governments around the world are desperate for a vaccine to help end the pandemic, which has caused more than 900,000 deaths and global economic turmoil. The World Health Organization (WHO) had flagged AstraZeneca as the most promising.

AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein.

After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.

(With agency inputs)





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