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The Drugs Controller General of India (DCGI) has given nod to the Serum Institute of India (SII) for conducting phase 2 and 3 human clinical trials of the Oxford University developed Covid-19 vaccine candidate in the country.

Government officials said that the approval for conducting phase 2 and 3 clinical trials by the SII was granted by DCGI Dr V G Somani late Sunday night after a thorough evaluation based on the recommendations of the Subject Expert Committee (SEC) on Covid-19.

"The firm has to submit safety data, evaluated by the Data Safety Monitoring Board (DSMB), to the CDSCO before proceeding to phase 3 clinical trials," a senior official said.

"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.

As a rapid regulatory response, the expert panel at the Central Drugs Standard Control Organisation (CDSCO) on Friday, after a detailed deliberation and considering the data generated on the vaccine candidate in phase 1 and 2 of the Oxford University trial, had recommended granting permission for phase 2 and 3 clinical trials of the potential vaccine, 'Covishield', on healthy adults in India,  the officials said.

Currently, phase 2 and 3 clinical trials of the Oxford vaccine candidate is going on in the United Kingdom, phase 3 clinical trial in Brazil and phase 1 and 2 clinical trials in South Africa.

The officials said that the SII had submitted a revised proposal on Wednesday after the SEC on July 28, following deliberation over its application, had asked it to revise its protocol for the phase 2 and 3 clinical trials besides seeking some additional information.

The panel had also recommended that the clinical trial sites which have been proposed for the study be distributed across India.

According to the revised proposal by the SII, 1,600 people aged above 18 years will participate in the trials across 17 selected sites, including AIIMS-Delhi, B J Medical College in Pune, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) in Patna, Post Graduate Institute of Medical Education 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 application, it would conduct an observer-blind, randomised controlled study to determine the safety and immunogenicity of 'Covishield' on healthy Indian adults," the official said.

The SII, which has partnered with AstraZeneca, for manufacturing the Oxford vaccine candidate for Covid-19 had submitted its first application to the DCGI on July 25 seeking permission for conducting the phase 2 and 3 trials of the potential vaccine. 

Initial results of the first two-phases of trials of the vaccine conducted in five trial sites in the UK showed that it has an acceptable safety profile and homologous boosting increased antibody response, sources had said.

To introduce the vaccine, SII, the world's largest vaccine maker by number of doses produced and sold, has signed an agreement to manufacture the potential vaccine developed by the Jenner Institute (Oxford University) in collaboration with British-Swedish pharma company AstraZeneca. 

Ayodhya, Aug 5: Every street in Ayodhya was seen illuminated with earthen lamps ahead of the foundation stone laying ceremony of the Ram Temple on Wednesday.

People also lit diyas on the banks of Saryu river as part of the 'deepotsava' celebrations in the temple town which will see Prime Minister Narendra Modi and other dignitaries arrive today for the 'bhoomi pujan' ceremony of the Ram Temple.

The entire Ayodhya has been decked up and massive preparations have been made for this occasion with a festive air.

Earlier chief minister Yogi Adityanath had said that 11,000 diyas will be lit at Ram Ki Paidi on the banks of the Saryu river and that all houses and temples in Ayodhya will be celebrating with a 'deepotsava' (festival of lights) on the nights of August 4 and 5.

Adityanath burst firecrackers and lit earthen lamps at his official residence on in Lucknow as part of 'deepotsava'.

The construction work of Ram temple will begin after the foundation stone laying ceremony, in which dignitaries from various political and religious fields have been invited to participate.
Apart from Ayodhya other cities in like Kanpur were also illuminated to celebrate the grand event. Vishva Hindu Parishad (VHP) workers light earthen lamps in the city, as part of 'deepotsava'.

Chief Minister's residence in Uttarakhand will be decorated with 5100 diyas filled with Ghee on Wednesday evening to celebrate the occasion of the 'bhoomi pujan' of the Ram Temple in Ayodhya today by Prime Minister Narendra Modi.

Uttrakhand Chief Minister Trivendra Singh Rawat has said that Lord Ram Temple being built in Ayodhya is associated with "our belief". He also appealed to people in the state to light diyas at their homes on the occasion.

Earthen lamps were lit at Ujjain's Mahakaleshwar Temple in Madhya Pradesh and in Punjab too people lit lamps as part of 'deepotsava'.

Prime Minister Narendra Modi will perform 'pooja' at Hanumangarhi and Shree Ramlala Virajman before performing 'bhoomi pujan' of the Ram Temple in Ayodhya on Wednesday, informed Prime Minister's Office (PMO) on Tuesday.

He will unveil a plaque to mark the laying of the foundation stone and also release Commemorative Postage Stamp on 'Shree Ram Janmabhoomi Mandir'.