An expert committee studying Serum Institute of India’s request to start late-stage human trials in India for a Covid-19 vaccine candidate developed by the University of Oxford has deferred its decision on the matter until the Pune-headquartered firm revises its proposal. Serum has an agreement with AstraZeneca — one of the vaccine’s developers — to manufacture it for low- and middle-income countries.
According to minutes of a meeting held by the Subject Expert Committee for Covid-19 on Tuesday, Serum has been told to submit a “revised protocol” for evaluation. The committee had recommended around eight amendments to the firm’s proposal to conduct late stage trials.
It is unclear how long Serum’s request for an approval will be delayed as a result. The firm said it did not have any comments on this development as of now.
“The protocol designed by Serum proposed a phase II/III trial in around 1,600 participants,” said a senior government official. “The committee is asking for additional information,” the official added.
One of the revisions the SEC has sought is a demarcation of 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”. The SEC’s other recommendations related to how the trials would test for the ability of the vaccine to invoke an immune response, Serum’s calculations to determine the sample size it would be studying and the dropout rates it had proposed. It sought clarity on the role of Indian Council of Medical Research in the study, along with a copy of the Memorandum of Understanding signed between the two.
Serum CEO Adar Poonawalla earlier told The Indian Express the firm intended to conduct phase III trials on 4,000-5,000 participants in Pune and Mumbai in August.
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