A body of experts studying Serum Institute of India’s request to start late-stage human trials in India for the Covid-19 vaccine candidate developed by the University of Oxford has deferred its decision on the matter, until the Pune-headquartered firm revises the details of its proposed plan.
Serum has a tie-up with one of the vaccine’s developers – Swedish-British drugmaker AstraZeneca – and is expected to produce around a billion doses for low- and middle-income countries next year.
According to the minutes of a meeting held by the Subject Expert Committee for Covid-19 related proposals on Tuesday, Serum has been asked to submit a “revised protocol” for evaluation. Following detailed deliberation, the committee had recommended around eight amendments to the firm’s proposal.
“The protocol designed by Serum proposed a phase II/III trial on around 1,600 participants,” said a senior government official aware of the development on condition of anonymity. “The committee is asking for additional information,” the official added.
According to the minutes, the SEC has asked Serum to demarcate the phase II and Phase III part of the protocol. It has also recommended that the clinical trial sites being proposed for the study be “distributed across pan India”.
It further told the Pune firm to revise the dropout rate of 41 per cent proposed in the study “to keep the rate at par with other vaccine studies”.
“Immunogenicity shall be either primary or secondary objective,” stated the SEC in its minutes. It added that cellular immunity — the ability of the body to develop cells that specifically target and protect against the virus– should be a part of the immunogenicity assessment.
Immunogenicity, which is the study of the ability of the vaccine to invoke an immune response, is one of the main objectives in a clinical trial for a new vaccine.
The committee has also said that an interim analysis of the participants being studied for an immune response may be carried out “only after day 58 both for safety and immunogenicity.”
Another aspect that the committee has asked Serum to mention in its protocol is the basis of the calculation it has carried out to determine the sample size it will be studying for safety and immunogenicity.
It has further asked Serum to “specify” the role of the Indian Council of Medical Research in the study along with a copy of a Memorandum of Understanding.
The Indian Express is awaiting responses to queries sent to Serum Institute of India and will update this article once it receives them.
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