India trials on AZ-Oxford University vaccine to resume on DCGI nod

PT Jyothi Datta Mumbai | Updated on September 16, 2020 Published on September 16, 2020

Serum Institute of India (file photo) Reuters   -  REUTERS

Serum Institute to continue with trials; global experts call for greater transparency

Just days after AstraZeneca resumed trials on the AZ-Oxford University vaccine candidate against Covid-19, clinical trials look set to resume in India as well. The Drug Controller General of India (DCGI) is said to have given its green signal to Serum Institute of India to resume trials on the Covid-19 vaccine candidate, with greater attention on screening and monitoring for adverse events.

The vaccine trial had been paused in India after AZ had done the same globally, following an adverse event that was reported in one trial participant in the UK.

India should take the lead on vaccine delivery

AZ resumed trials after the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) had confirmed it was safe to do so. “The UK committee has concluded its investigations and recommended to the MHRA that trials in the UK are safe to resume,” a company statement said.

However, trials on the AZ-Oxford candidate are yet to resume in the US and reports suggest that US authorities are investigating the adverse event that had been reported in the UK. A source-based report indicated that approvals to resume the trial may not come in till mid-next week.

Drug controller instructs Serum Institute to revise protocol for Oxford Covid-19 vaccine clinical trial

Calls for transparency

AZ and Oxford University have not revealed the nature of the adverse event, though reports have linked it to transverse myelitis, an inflammation of the spinal cord that could lead to paralysis, bladder, bowel dysfunction. In fact, voices from the clinical research community have called for greater transparency on trial details, given the public funds invested and Government support behind fast-tracking the trial.

The company’s chief had briefed the investor community after the adverse event had required halting the vaccine trial. But global scientific voices have urged AZ to be more public with details on the trial and adverse event in the interest of greater trust in clinical research, especially since time lines on the vaccine-development have been shortened. Less transparency could lead to people having less confidence in taking the vaccine, they cautioned.

Serum to resume

While a statement from Serum Institute, on resuming trails, is awaited, the vaccine-maker had indicated it was set to resume once the DCGI gave its go-ahead.

About 100 people have already been given the first shot of the two-dose vaccine, and the trial had been paused for seven days as the DCGI wanted safety to be reviewed, a person familiar with the development told BusinessLine. The AZ adverse-event-linked pause coincided with this period, the person said.

The DCGI approval to resume trials echoes the MHRA’s directive on greater scrutiny and screening, the source said. The second dose of the vaccine-probable would be given after a 28-period gap from the first shot. And 28 days after the second dose, blood samples of the volunteers in the trial would be screened. A total of 1,700 persons would be recruited for the trial from 17 centres, the source said, adding that the trial would take three to four months.

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Published on September 16, 2020
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