The Comptroller General of Medicines of India has given an approval to the Serum Institute of India for conducting Phase 2 and 3 clinical trials on the Covid-19 vaccine candidate from the University of Oxford in the country, to the Ministry of Health.
Government officials told PTI that DR. DCGI’s V G Somani granted approval Sunday night after a thorough evaluation of the recommendations of the Committee of Experts on Covid-19.
“The company will need to send protection data, evaluated through the Data Security Monitoring Board, to CDSCO before completing the Phase 3 clinical trials,” a senior official said, referring to the Central Drug Standards Control Organization.
Depending on the design of the study, the topic will be given two doses over a 4-week period (first dose on the first day and immediate dose on day 29), after which protection and immunogenicity will be evaluated at predefined periods,” the officer said.
DCGI has the SII, Pune, to conduct phase II-III clinical trials of the Covid-19 vaccine at the University of Oxford-Astra Zeneca in India, which will drive the progression of the Covid-19 vaccine, the Ministry of Health said in a statement.
In a rapid regulatory response, the CDSCO panel on Friday, after detailed deliberation and taking into account the knowledge generated on the Candidate Vaccine for Phase 1 and 2 of the Oxford University trial, to be granted approval for Phase 2 and 3 clinical trials. “Covishield” vaccine in healthy adults in India, authorities 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.
Officials also said the IRS submitted a revised proposal Wednesday after the SEC on July 28, after deliberating on its application, asked it to review its protocol for Phase 2 and 3 clinical trials in addition to more information.
The organization also recommended that the clinical trial sites proposed for the review be disseminated in India.
Under the revised IRS proposal, another 1,600 people over the age of 18 will participate in the trials at 17 decided sites, adding AIIMS-Delhi, BJ Medical College in Pune, Rajendra Memorial Research Institute of Medical Sciences at Patna, Post Graduate Institute of Medical and Research in Chandigarh, AIIMS-Jodhpur, Nehru Hospital in Gorakhpur, Andhra Medical College in Visakhapatnam 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 partnered with AstraZeneca to manufacture the Oxford candidate vaccine for Covid-19, submitted its first application to DCGI on July 25 for approval for 2 and 3 prospective vaccine trials.
The initial effects of the first two stages of vaccine trials at five control sites in the UK showed that it had an appropriate protective profile and a homologous accumulation in the antibody response, Resources said.
To present the vaccine, SII, the world’s largest vaccine manufacturer in terms of number of doses produced and sold, has signed an agreement to manufacture the vaccine developed through the Jenner Institute (University of Oxford) in collaboration with the Anglo-Swedish pharmaceutical company. Astrazeneca.