New Delhi: The Oxford University-led Covid vaccine project, partnered by Swedish-British firm AstraZeneca and Pune-based Serum Institute of India (SII), Friday came one step closer to human trials in the country, ThePrint has learnt.
The subject expert committee, which advises regulator Drug Controller General of India (DCGI) on proposals seeking approvals for new drugs, vaccines or clinical trials, Friday approved the revised protocol submitted by SII to kick-start human trials in India.
The protocol will now be moved to DCGI V.G. Somani, who is likely to take a “decision by the end of the week” given the urgency of the Covid challenge.
“The SEC has accepted the revised protocol submitted by the company. It has recommended the company’s application for starting human trials across India to the DCGI,” said a senior government officer privy to the developments. “The final decision is likely to be taken before the end of this week.”
The Oxford vaccine candidate is among the frontrunners in the race to develop an effective preventive against Covid-19. 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.
The SEC’s nod follows a whirlwind three days where the panel asked SII to rework eight points on a protocol submitted this Tuesday. The SEC meeting Friday was called urgently as SII, it is learnt, sent a revised proposal “within hours” of the Central Drugs Standard Control Organisation (CDSCO) expert committee submitting its recommendation.
The panel had sought changes in eight parameters, including distribution of sites and dropout rate.
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Changes sought
The SEC is an advisory panel that studies the proposals for new drugs, vaccines or clinical trials and advises the DCGI, who heads the CDSCO, on final approvals.
According to the revised proposal, over 1,600 people will participate in the trials in 20 select cities across India.
The changes sought in the SII’s suggested protocol included incorporating a pan India distribution of trial sites. According to the minutes of the SEC’s meeting Tuesday, a copy of which has been accessed by ThePrint, the panel also instructed SII to “demarcate the phase II and phase III part of the protocol”.
The CDSCO panel also asked SII to “specify the role of the ICMR”.
“Immunogenicity shall be either primary or secondary objective,” the minutes said. Immunogenicity means the ability of a foreign substance to provoke the body and create an immune response.
It also asked for “interim analysis of immunogenicity cohort to be carried out only after day 58 both for safety and immunogenicity.”
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