New Delhi: Pune-based Serum Institute of India (SII) will soon start conducting human trials to test the Oxford University’s Covid vaccine candidate.
On Sunday, Drug Controller General of India (DCGI) V.G. Somani, India’s apex regulator of clinical trials, approved SII’s revised protocol to start the human trials here. The DCGI move came just a day after the subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) gave its nod to the SII proposal.
“Late (Sunday) night, the DCGI approved the recommendation submitted by the committee and final approval has been issued to SII,” a senior government official told ThePrint.
“DCGI has granted permission for phase 2 and 3 clinical trials of vaccine candidate named, Covishield,” said the official. Now, SII can start the process the begin the trials.
On Friday, the SEC had accepted the revised protocol submitted by the company. ThePrint had reported that “the final decision is likely to be taken before the end of this week”.
The CDSCO, which is led by the DCGI, has allowed the trial on 1,600 participants in India in over 20 selected trial sites.
The decision to allow this is based on the data submitted by SII on phase l and ll of the Oxford University trials. The Oxford candidate is among the frontrunners in the race to develop an effective vaccine against Covid-19.
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SII has a tie-up with Swedish-British pharma giant AstraZeneca for the Oxford vaccine. The company is expected to manufacture a billion doses for low- and middle-income countries by 2021.
How the protocol was cleared
The DCGI’s move came in quick five days after the expert panel asked SII to rework eight points in the protocol submitted Tuesday. The panel had sought changes in parameters including distribution of sites and dropout rate.
The SII revised its proposal “within hours”, leading CDSCO to call an urgent meeting of the SEC Friday.
In the final submitted protocol, “the company has added five more trial sites in the different parts of the country, taking the total to around 20 cites pan India to conduct trials”, the official quoted above had told ThePrint earlier.
It also attached a memorandum of understanding (MoU) signed with India’s apex health research body, the Indian Council of Medical Research (ICMR).
According to the minutes of the meeting of the expert panel held Tuesday, it had asked SII to “demarcate the phase II and phase III part of the protocol”. It also asked the company that the trial sites proposed for the study should be “distributed across pan India”.
The SII was also asked that the dropout rate of 41 per cent should be revised to keep the rate on par with other vaccine studies.
Further, the SEC had asked the firm that “immunogenicity shall be either primary or secondary objective”. Immunogenicity means the ability of a foreign substance to provoke the body and create an immune response.
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