Oxford, AstraZeneca resume COVID-19 vaccine trials after UK regulator’s confirmation

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AstraZeneca said that it is committed to the safety of trial participants and the highest standards of conduct in clinical trials

Pharmaceutical giant AstraZeneca on Saturday said that clinical trials for the AstraZeneca Oxford coronavirus vaccine resumed in the UK after it received the confirmation from the authorities concerned.

“Clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed in the UK following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so,” AstraZeneca said in a statement on Saturday.

On Wednesday, AstraZeneca announced that it had "voluntarily paused" its trial of the coronavirus vaccine being developed with Oxford University after a volunteer developed an adverse reaction.

AstraZeneca said that it is committed to the safety of 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,” AstraZeneca said.

On 6 September, 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 pharma company said.

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

“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,” said the company.

The COVID-19 vaccine 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.

On Thursday, Pune-based Serum Institute of India (SII), which is manufacturing Oxford University’s Covishield vaccine in collaboration with UK’s AstraZeneca in India, also suspended the human trials of the vaccine after a notice from the Drug Controller General of India (DCGI).

While trials of the vaccine were stopped in four countries as a precautionary measure, the DCGI asked SII as to why it was continuing with the trials and why it had not sent a detailed report about the UK patient.

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