The Serum Institute of India (SII), in Pune, received green approval through the Drugs Controller General of India (DCGI) for conducting phase 2 and 3 human clinical trials of vaccine candidate Covid-19 developed through the University of Oxford. PTI news firm reported.
The news firm reported, which he mentioned to unidentified government officials, saying that IRS approval had been granted through Dr. VG Somani on Sunday night following a thorough evaluation of the Committee of Experts’s (SEC) recommendations on Covid-19.
“The company will need to send the protection data, evaluated through the Data Security Monitoring Board (DSMB), to CDSCO before conducting Phase 3 clinical trials,” said a senior official cited through PTI.
“Depending on the design of the study, the subject will be given two doses 4 weeks apart (first dose on the first day and dose at the time on the 29th), after which protection and immunogenicity will be evaluated at predefined intervals,” the official said. Said.
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SII, the world’s largest vaccine manufacturer, has signed an agreement to manufacture the vaccine developed through the Jenner Institute of the University of Oxford in collaboration with the Anglo-Swedish company AstraZeneca.
Phase 2 and 3 trials of the Oxford candidate vaccine are underway in the UK, phase 3 in Brazil and phases 1 and 2 in South Africa.
Authorities, according to PTI, said the Serum Institute submitted a revised proposal Wednesday after the SEC on July 28 asked it to review its protocol for Phase 2 and 3 clinical trials and seek more information.
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The organization also recommended that the clinical trial sites proposed for the review be disseminated in India.
On Friday, the Central Drug Control Organization (CDSCO) panel of experts recommended, as a regulatory response, approval for phase 2 and 3 clinical trials of the prospective Covishield vaccine in healthy adults in India.
Serum Institute said in its revised proposal that another 1,600 people over the age of 18 would participate in trials at 17 determined sites, adding the All India Institute of Medical Sciences (AIIMS) in Delhi, BJ Medical College in Pune, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) in Patna, Postgraduate Institute of Medical Training and Research in Chandigarh, AIIMS at JopurdhArray Nehru Hospital in Gorakhpur , Andhra Medical College at Visakhapatnam and JSS Academy of Higher Education and Research in Mysore.
“According to the request, it would conduct a randomized controlled blind examination of observers for the protection and immunogenicity of ‘Covishield’ in healthy Indian adults,” the official said.
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