The Pune-based Serum Institute of India (SII) has received the green signal to conduct Phase II and III clinical trials of Covid19 candidate vaccine developed by the University of Oxford and British-Swedish pharma major AstraZeneca in the country.
The Drug Controller General of India (DCGI) gave the go-ahead to SII, the world's largest vaccine maker, on Sunday after a thorough evaluation based on the recommendations of the Subject Expert Committee (SEC) on Covid19.
SEC in its meeting on July 28 had asked the firm, which is one of the major manufacturers of ChAdOx1 nCoV-19 vaccine, to submit a revised clinical trials protocol for its proposed trials involving 1,600 healthy volunteers. The DCGI decision to approve came in after an SEC meeting on July 31 the revised clinical trial protocol submitted by the firm was found satisfactory.
While recommending the grant of permission, the committee is believed to have called for meeting certain conditions. Apart from clearly defining the parameters for safety assessment in primary and secondary objectives, it wanted immunogenicity assessment under secondary objective and omission of immunoglobulin G assessment, as the same is already included in the primary objective. It also suggested that paracetamol shall be given to the trial participants post-dosing on SOS basis.
The committee also said that market authorisation of the vaccine would be based on clinical data generated during the trial as well as the data from other countries, as available.
Meanwhile, a news agency report quoting an official said that the firm would have to submit safety data from Phase II trials for evaluation by Data Safety Monitoring Board (DSMB), before proceeding to Phase II clinical trials.
"As per the study design, each subject will be administered two doses four weeks apart (first dose on day one and second dose on day 29) following which the safety and immunogenicity will be assessed at predefined intervals," the official said.
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