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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. 

New Delhi, Jul 30: Preparing for a long haul in the Eastern Ladakh sector in extreme winters, the Indian Army has an edge over the Chinese as it has deployed 35,000 troops there who have already done tenures in high altitude and cold conditions.

The Indian troops deployed there are mentally prepared for tackling the weather and terrain.
In contrast, the Chinese troops deployed along the Line of Actual Control (LAC) are not used to these conditions as they have been brought from mainland China and are not accustomed to high altitude extreme cold weather conditions.

"We are preparing to provide extreme cold weather portable cabins for around 35,000 troops that have been deployed in the Eastern Ladakh sector," government sources said.

"Our soldiers deployed there have already done a tenure or two in Siachen, Eastern Ladakh or Northeast and they are physically and mentally prepared for a longer deployment there," they said.

The Chinese soldiers deployed on the Indian front include mainly conscripts who join the PLA for a period of 2-3 years and then return to their normal lives, sources said.

Indian and Chinese troops are engaged in a standoff situation all along the LAC in Eastern Ladakh from sub-sector north with both sides having deployed around 40,000 troops against each other over there.

The two sides have disengaged at three friction points including Patrolling Point 14, PP-15 and PP-17 and PP-17A.

At PP-17 and 17A, the Chinese have now maintained a small element of close to 50 troops and the remaining elements have gone back into their permanent locations.

The sources said the Army is also not much bothered about the Chinese build-up along the LAC as it has got more than two additional divisions from outside Ladakh sector.

India Army has more troops than what the Chinese have brought there, they said.

For the winter deployment, the Army already has a sizeable stock of clothes and habitat for troops as the Indian army deploys troops at the world's highest battlefield Siachen glacier and is prepared.

For additional requirements, the force is in the process of placing orders for additional tents and shelters from indigenous as well as foreign vendors.

The time for summer stocking is on and we are going to get the additional cabins and tents by that time, the sources.

Months of June, July, and August are considered to be the best time for stocking winter rations and ammunition. The snowfall is expected to start soon in the Eastern Ladakh area where the temperature is already low.

Prime Minister Narendra Modi's government has given financial powers of Rs 500 crore per procurement to the defence forces to address any type of shortages of weapons, ammunition, and habitat.