4 min readNew DelhiSep 13, 2020 01:14 AM IST
First published on: Sep 13, 2020 at 01:14 AM IST
After days of uncertainty following a safety alert in the global trials for one of the frontrunners in the Covid-19 vaccine race, AstraZeneca on Saturday said it is resuming human testing in the UK of the vaccine candidate it developed jointly with Oxford University.
The company said it will continue to work with health authorities “across the world” and will “be guided” as to when other clinical trials can resume.
The development may offer relief to the Pune-headquartered Serum Institute of India (SII), which had to pause testing of the vaccine here after a notice by India’s top drug regulator about the global issue.
On September 10, SII told the Drug Controller General of India Dr V G Somani that the Data Safety and Monitoring Board (DSMB), looking into follow-up data from the first set of volunteers vaccinated in India, had “noted no safety concerns”.
According to a statement by AstraZeneca on Saturday, an independent expert committee in the UK set up to review the issue had concluded its investigations and recommended to the Medicines Health Regulatory Authority (MHRA) that the trials are “safe to resume”. The MHRA, in turn, confirmed that the trials could resume, the Swedish-British drug giant added.
“As I’d mentioned earlier, we should not jump to conclusions until the trials are fully concluded. The recent chain of events are a clear example why we should not bias the process and should respect the process till the end,” SII CEO Adar Poonawalla tweeted on Saturday night after the announcement.
The SII has said that it would resume trials “once DCGI will give us the permission to restart the trials in India”.
On September 6, the standard review process in the ongoing trials of the vaccine candidate triggered a “voluntary pause to vaccination” across global sites so that independent committees and international regulators could review safety data related to the vaccine, AstraZeneca said.
This was reportedly flagged because a volunteer in the UK had developed a potentially serious adverse reaction.
“In large trials such as this, it is expected that some participants will become unwell and every case must be carefully evaluated to ensure careful assessment of safety,” Oxford University said in a statement. It stated that globally, some 18,000 individuals have received study vaccines as part of the trial.
“AstraZeneca and the University of Oxford, as the trial sponsor, cannot disclose further medical information. All trial investigators and participants will be updated with relevant information and this will be disclosed on global clinical registries, according to the clinical trial and regulatory standards,” the firm said.
According to instructions issued by DCGI following SII’s response on September 10, the Pune firm will only be able to resume vaccination in the Indian trials of this vaccine candidate once it submits safety clearances from DSMB in India as well as the UK board that reviewed the global safety issue. The firm will also have to “increase safety monitoring” of the volunteers who have already been vaccinated with this candidate here and report to the regulator on these follow ups.
Around 100 participants in the trials in India had been vaccinated before the Indian DSMB review, before which the voluntary pause on global vaccinations was called.
Queries to SII whether it had received and submitted the UK committee’s findings to the Indian regulator remained unanswered by Saturday late evening.
The vaccine candidate under trial by University of Oxford scientists in collaboration with pharmaceutical giant AstraZeneca is the furthest in the process of trials and, according to a report in "The Times' 
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