New Delhi: India’s apex clinical trial regulation body has called an urgent meeting Friday to consider Serum Institute of India (SII)’s revised proposal to start human trials in India for the Covid-19 vaccine candidate developed by the University of Oxford, ThePrint has learnt.
According to the revised proposal, over 1,600 people will participate in the trials in 20 selected cities across India, said a top ranking government official privy to the development.
The meeting was called urgently as SII sent a revised proposal “within some hours” after the Central Drugs Standard Control Organisation (CDSCO)’s expert committee asked the company to make changes to its earlier proposal. The panel had sought changes in eight parameters, including distribution of sites and dropout rate.
In its meeting Tuesday, the expert panel had considered the vaccine maker’s proposal to start late-stage human trials in India, but had deferred its decision. This was communicated to SII Wednesday, prompting it to file a fresh proposal quickly.
“The company has come back with a revised proposal within some hours of sending the mail with requisite changes. Their prompt response is appreciable,” said the official. “An urgent meeting of the expert committee has been lined up for Friday where its revised proposal will be re-considered.”
The Pune-headquartered firm 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.
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What were the revisions?
According to the minutes of the meeting of CDSCO’s Subject Expert Committee for Covid-19 held Tuesday, the panel recommended amendments to the protocol SII had presented for Phase-II/III clinical trials of ChAdOx1 nCoV-19, the Covid vaccine developed by the University of Oxford.
ThePrint has a copy of the minutes. However, it doesn’t mention details about the SII’s earlier proposal.
Among the changes, the panel instructed 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 CDSCO panel had also asked SII to “specify the role of ICMR along with the copy of MoU”. The MoU signed with India’s apex health research body, the Indian Council of Medical Research (ICMR), “is about the clauses on funding of clinical trials and amount of expenditure ICMR will bear”, said the official without discussing the details further.
The company submitted this MoU in the revised proposal.
“The dropout rate of 41 percent should be revised to keep the rate at par with other vaccine studies,” said the minutes.
“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.”
While submitting all the requisite changes, SII “has added 5 more trial sites in the different parts of the country, taking the total to around 20 cites pan India to conduct trials”, said the official.
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