The Comptroller General of Medicines of India (DCGI) has given an approval to the Serum Institute of India (SII) for conducting phase 2 and 3 human trials on a COVID-19 vaccine candidate developed through the University of Oxford in the country.
Government officials told the ITP that approval for Phase 2 and 3 clinical trials through the IRS granted through DCGI Dr. VG Somani expired on August 2, following a thorough evaluation based on the recommendations of the Committee of Experts in COVID-19.
In an immediate regulatory response, the central drug control organization (CDSCO) panel of experts on 31 July, after detailed deliberation and taking into account the knowledge generated on Phases 1 and 2 of the Oxford University trial, candidates for the vaccine, recommended approval for Phase 2 and 3 clinical trials of the possible “Covishield” vaccine , about healthy adults in India, authorities said.
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“The company will need to send protection data, evaluated through the Data Security Monitoring Board (DSMB), to CDSCO before moving on to Phase 3 clinical trials,” a senior official said.
“Depending on the design of the study, the topic will be given two doses 4 weeks apart (first dose on the first day and dose at the moment on the 29th), after which protection and immunogenicity will be evaluated at predefined intervals,” the official said. Said.
Phase 2 and 3 trials of the Oxford candidate vaccine are currently underway in the UK, a phase 3 trial in Brazil and phase 1 and 2 trials in South Africa.
Authorities said the IRS submitted a revised proposal Wednesday after Tuesday’s panel, after deliberating on its implementation, asked it to review its protocol for Phase 2 and 3 clinical trials and seek more information.
The organization also recommended that the clinical trial sites proposed for the review be disseminated in India.
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According to the revised proposal, another 1,600 people over the age of 18 will participate in the trials at 17 determined sites, adding AIIMS Delhi, BJ Medical College in Pune, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) in Patna, Postgraduate Institute of Medical Education and Research in Chandigarh, AIIMS-Jodhpur, Nehru Hospital in Gorakhpur, Andhra Medical College at Visakhakhapatnam and JSS Academy of Higher Education and Research in Mysore.
“According to the request, a randomized controlled blind examination of observers would be conducted for the protection and immunogenicity of “Covishield” in healthy Indian adults,” the official said.
The IRS, which has partnered with AstraZeneca, to manufacture the Oxford candidate vaccine that opposes COVID-19 submitted its first application to DCGI on 25 July for approval for 2 and 3 prospective vaccine trials.
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