Women activists enter Trimbakeshwar temple's inner sanctum

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, Aug 7: The Congress on Thursday demanded the removal of Karnataka minister KS Eshwarappa from the cabinet and his arrest for his statement that grand Krishna and Vishwanath temples would come up in Mathura and Kashi respectively after "liberating" them.

Mr Eshwarappa made the statement while reacting to Prime Minister Narendra Modi laying the foundation of the Ram temple in Ayodhya yesterday.

"By asking kar sevaks (volunteers) to launch a similar campaign, the minister (Eshwarappa) is trying to disturb peace in the society," Congress Karnataka unit chief DK Shivakumar said at a press conference in Ballari today.

"Such people should be arrested immediately, police officials should register a case against him and the Chief Minister should remove him from the cabinet,"he said.

Rural Development and Panchayat Raj minister Eshwarappa had said on Wednesday that he was of the firm opinion that "if not today, tomorrow, Mathura and Kashi temples will be liberated and grand temples would be built there."

"A place of devotion has to be built in both Kashi and Mathura. There too, grand temples have to be constructed. The mosques have to be removed from there," he said.

Mr Eshwarappa, a former BJP state president, said the centres of Hindu belief, Ayodhya, Kashi and Mathura were a kind of a symbol of "slavery" as "temples of our Rama, Krishna and Vishwanath were destroyed and mosques built."

Stating that Mr Eshwarappa is not an individual but a minister who represents the government, Mr Shivakumar on Thursday sought to know from the Chief Minister whether this was his government's stand.