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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 27: Congress leader Rahul Gandhi on Monday said he is not going to lie about Chinese transgressions in eastern Ladakh even if it costs him politically, asserting he will say the truth as far as Indian territory is concerned.

Gandhi made these remarks in a tweet, along with an over-a-minute-long video, as part of a series launched by him on the India-China face-off along the Line of Actual Control(LAC) in eastern Ladakh.

Asked in the video how he would react to people who say his questions to Prime Minister Narendra Modi on China weakened India, the former Congress chief said, "If you want me to lie that the Chinese have not entered this country, I am not going to lie. I will simply not do it. I do not care if my whole career goes to hell. I am not going to lie."

"This disturbs me. Frankly, it makes my blood boil. How can some other nation just come into our territory?"

"Hiding the truth is anti-national. Bringing it to people's attention is patriotic," Gandhi said.

"So frankly, I do not care if it costs me politically. I do not care if I have no political career at all after that. But I am going to say the truth as far as Indian territory is concerned," he added.

Gandhi has been repeatedly attacking the prime minister and the government over Chinese transgressions on the LAC in eastern Ladakh.

"As an Indian, my number one priority is the nation and its people," he said on Monday.

The Bharatiya Janata Party (BJP) has hit back at Gandhi over his attack on the government on the Ladakh face-off, alleging he is seeking to politicise defence and foreign policy matters and "wash their past sins of 1962 and weaken India".

BJP president JP Nadda has also alleged that for years, a dynasty has been trying to destroy Modi, while adding that those who want to destroy the prime minister will only end up causing further damage to their own party.