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 PTI that approval of phase 2 and 3 clinical trials through the IRS granted through DCGI Dr. V G Somani expired Sunday night after a thorough evaluation based on the recommendations of the Committee of Experts in COVID-19.
In a rapid regulatory response, the central Drug Control Organization (CDSCO) panel on Friday, after a detailed discussion and taking into account the knowledge generated on Phases 1 and 2 of the Oxford University trial, candidates for the vaccine, advised that authorization be granted. for phase 2 and 3 clinical trials of the prospective vaccine, “Covishield,” in healthy adults in India, authorities said.
“The company will need to send the 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.
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 Education and Medical Research in Chandigarh, AIIMS-Jodhpur, Nehru Hospital in Gorakhpur, Andhra Medical College in Visakhakhapatnam and JSS Academy of Higher Education and Research in Mysore.
Listen to the newest songs in JioSaavn.com
“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 partnered with AstraZeneca to manufacture the Oxford candidate vaccine opposed to COVID-19, submitted its first application to DCGI on 25 July for approval for 2 and 3 tests of the possible vaccine.
Follow the coronavirus pandemic in India and get the latest NEWS about COVID-19 from around the world in ndtv.com/coronavirus
Watch the live:
Follow:
………………………….. Advertising…………………………..