SII gets DCGI approval to resume Covid-19 vaccine trials
“The permission has been given to restart the trials with certain conditions,” said a senior official aware of the developments in the DCGI office, asking not to be named. The conditions include ‘extra care during screening, additional information [for] informed consent and close monitoring for similar events during the study follow-up’.Updated: Sep 17, 2020 05:29 IST
Pune-based Serum Institute of India (SII) can resume clinical trials for the Covid-19 vaccine candidate developed by United Kingdom’s Oxford University and AstraZeneca after it received new approvals from the Drugs Controller General of India (DCGI) following a suspension after an adverse reaction in a volunteer in UK.
“The permission has been given to restart the trials with certain conditions,” said a senior official aware of the developments in the DCGI office, asking not to be named. The conditions include ‘extra care during screening, additional information [for] informed consent and close monitoring for similar events during the study follow-up’.
The trials in India were paused last week after a trial subject in the United Kingdom developed an unexplained severe adverse reaction. On September 11, DCGI, Dr VG Somani, directed SII to pause recruitment of trial participants in India till all safety concerns were addressed. He asked the company to submit for clearances afresh after obtaining clearances from the data safety monitoring boards of both the UK and India.
On Saturday, Oxford University announced that the trial was being resumed. After carefully examining SII’s response, DCGI granted the approval to recommence the trial on Tuesday. Director General of Indian Council of Medical Research (ICMR), Dr Balram Bhargava, earlier said that SII completed phase II-B3 trials in India, and was preparing to start phase 3 trials.
“Serum Institute of India (SII) has completed Phase II-B3 trials, for which 100 participants have been given the vaccine dose. There’s a seven-day pause and after that they plan to begin Phase 3 trials with about 1,500 participants across 14 sites,” he had said during the Covid-19 media briefing on Tuesday.
The Oxford-AstraZeneca vaccine candidate, called the AZD1222, is being tested in the largest number of Indian volunteers yet. It has also been given to more volunteers across the world than some of the other front runners, making it the most watched vaccine candidates.
SII, the largest vaccine maker in the world, got DCGI’s permission on August 2 to conduct Phase 2 and 3 clinical trials in India. The pharma company also has a production deal for 1 billion doses for low and middle income countries, 300 million of which will be delivered by the end of 2020.
The vaccine is made from a weakened version of a common cold adenovirus taken from chimps and genetically modified. The first dose of the vaccine as part of the phase 2 human trials to check its efficacy began at Bharatiya Vidyapeeth Deemed University Medical College and Hospital in Pune last month.