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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. 

Aug 3: Iqbal Ansari, who was a litigant in the Ayodhya land dispute case, has decided to gift a 'Ram nami' stole and a copy of the Ramcharitmanas to Prime Minister Narendra Modi when he attends the bhoomi pujan ceremony for the Ram temple here on Wednesday.

"Yes, I have received the invitation from Shri Ram Janmabhoomi Teerth Kshetra Trust for the bhoomi pujan ceremony. I will certainly attend it. The dispute is over now after the court's verdict," Ansari, 69, told .

"Our Prime Minister is coming. I will meet him and give him a 'Ramnami' stole (with Ram's name written on it) and Ramcharitmanas as a present," Ansari said.

His father Hashim Ansari, the oldest litigant in the Babri Masjid-Ram Janmabhoomi land dispute case, died at the age of 95 in 2016 after which the son started pursuing the case in the court.

Talking about Wednesday's ground-breaking ceremony to mark the beginning of the construction of a grand Ram temple here, Ansari said, "I belong to Ayodhya. All this (temple's construction) will change the fate of Ayodhya. We all want our child to get better opportunities".

He further said, "I respect sadhus and saints. I am happy to have received the invitation for the ceremony. I think it is Lord Ram's will that I attend it".

When asked what he would have done had the court decided the case in his favour, Ansari said he had wanted the construction of a school and a hospital on the disputed land.

"I feel the city needs development. The future of our children should be safe and secure and they should get employment. Dispute in the name of religion should end now and we should let the city witness a new beginning," he said.

The Supreme Court had in November last year paved the way for the construction of a Ram temple by a Trust at the disputed site of the Babri Masjid's demolition in Ayodhya, and directed the Centre to allot an alternative 5-acre plot to the Sunni Waqf Board for building a new mosque at a "prominent" place in the holy town in Uttar Pradesh.

The state government has allotted a five-acre land in Dhannipur village in Sohaval Tehsil of Ayodhya for the mosque's construction.