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Thursday, September 24, 2020

Day after regulator notice, Serum says pausing Oxford vaccine India trials

The trials were halted by AstraZeneca after one participant, who reportedly took part in the phase 2/3 clinical trials underway in the United Kingdom, developed a "potentially unexplained illness".

Written by Prabha Raghavan | New Delhi | Updated: September 11, 2020 7:29:25 am
Reinfection was "very, very rare" with COVID-19, but it can happen as had been seen in a case in Hong Kong. (Express Photo by Amit Mehra)

Serum Institute of India has decided to halt ongoing clinical trials in India of the Covid-19 candidate developed by The University of Oxford until AstraZeneca restarts its own global trials of the vaccine. The development comes a day after the Pune-headquartered firm announced that the Swedish-British drug giant’s decision to pause the ongoing trials while it reviewed a potential safety concern would not impact the testing underway in India.

The development comes a day after the Drug Controller General of India (DCGI) issued a show-cause notice to the Pune-based Serum Institute of India for failing to share the information about the pause on AstraZeneca vaccine. On Tuesday evening, AstraZeneca had announced that it was temporarily halting the global trials after one participant developed a “potentially unexplained illness”.

“We are reviewing the situation and pausing India trials till AstraZeneca restarts them. We are following DCGI’s (Drug Controller General of India) instructions and will not be able to comment further on the same,” Serum Institute said.

SII is sponsoring mid- and late-stage human clinical trials for the vaccine candidate in India. The candidate, named Covishield in India, was administered to a first set of volunteers on August 26.

AstraZeneca said it had “voluntarily paused vaccination” in its ongoing global trials to “allow review of safety data by an independent committee” after the event triggered its standard review process.

Explained | What AstraZeneca vaccine trial’s pause means for vaccines

While the company did not specify which country had reported the adverse event, the issue is believed to have been flagged in the phase 2/3 clinical trials underway in the United Kingdom. A participant there reportedly had developed a serious spinal inflammatory syndrome called transverse myelitis.

One of the conditions for SII to conduct the trials in India had been that clinical data generated in India would be considered along with data from trials conducted by Oxford-AstraZeneca, the notice issued by DCGI Dr VG Somani on Wednesday had stated.

The regulator also noted that SII had not submitted a “causality analysis” of the serious adverse event “in light of safety concerns”. Dr Somani had then asked SII for an immediate response as to why the regulator’s permission to carry out the testing should not be suspended until patient safety was established. The chief had also threatened “action deemed fit” in the event that SII did not submit an immediate response.

Before this show-cause notice, SII’s spokesperson had said earlier on Wednesday that, as far as Indian trials were concerned, “it is continuing and we have faced no issues at all”.

The Pune firm, the world’s largest manufacturer of vaccines, has been contracted by AstraZeneca and the University of Oxford to manufacture the vaccine for low- and middle-income countries.

Phase 2/3 trials of the candidate, called AZD1222 globally, have been ongoing in the UK since the end of May. On September 3, AstraZeneca announced that centres were recruiting up to 30,000 participants for phase 3 trials in the United States. Late stage trials are also continuing in Brazil and South Africa, and the company has planned early- to mid-stage trials in Japan and Russia.

Recruitment of participants in the India trials has already been on hold for the past week, as SII prepares to send the data collected from the first 100 participants who were administered the shot for safety reviews, The Indian Express has learnt.

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