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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 4: Various religious ceremonies have been conducted for the past 108 days by saints in Ayodhya and Prime Minister Narendra Modi will take part in `muhurat puja' at 12.44 pm on Wednesday as part of 'bhoomi pujan' for construction of a grand Ram temple.

PM Modi will arrive at 12:30 pm at the Ramjanmbhoomi and take part in various prayers including the main "bhoomi pujan".

Govind Giriji Maharaj, treasurer of Shri Ramjanmbhoomi Teerth Kshetra Trust, said that the religious ceremonies will begin from 8:30 am in the morning and will continue till 12:30 pm.

"The Prime Minister will arrive at 12:30 pm and he will offer `puja' for 15 minutes and take 'sankalp'. First Lord Ganesh will be worshipped then he will offer prayers of eight shilas. Some prayers at shilas we have conducted already," Giri told said.

"The muhrat of pooja is at 12: 44 pm. He will say words 'prathisthapayami' and it is crucial to be done in that muhrat," he said.

Elaborating on the rituals to be performed tomorrow by the Prime Minister, the trust member said that most important is `Kurm Shila' .

"The most important is Kurm Shila - this is right beneath the place where Ram Lalla will be seated. It is this ceremony that we are conducting tomorrow. A cone of Bakul tree wood will be kept in ceremony. This isn't an ordinary cone, it is made of various metals including gold and silver. 

A lotus with nine gems too will be part of pujan which will be offered to this cone by the Prime Minister," he said.

"These are intrinsic to main bhumi pujan. The first religious ceremony was of Devi Kali. There are two devi kalis here, `choti' and `badi'. She is kuldevi, family's goddess of Sita. Today we held Ramarchan ceremony," said Giri.

The Vedic pundits who are involved in religious ceremonies have come from Delhi, Mathura and Kashi.

Asked about the absence of Nepal's religious head of Janaki Mandir, he said that there are many, including 20 religious heads, who would not able to come because they can't leave their seat in Chaturmas.

On the design of temple, Giri said, the old design will remain as it is except a rise in height.

"The structure has become popular and we will keep it. Keeping in mind the modernisation of architecture, we have raised height from 128 feet to 161 feet and instead of three peaks we will have five peaks," he said.

Kanchi Pithadhishvar Maharaj has sent silver coins as souvenirs for every sadhu participating in it, Giri said.

Invitations have been sent to 175 people, including 135 saints of 35 religious organisations to attend the foundation stone-laying ceremony of Ram temple.

The construction of Ram temple will begin in Ayodhya after the ceremony to lay the foundation stone.