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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. 

Ahmedabad, Aug 6: In a major incident, a fire broke out in a Covid-designated hospital in Ahmedabad killing eight coronavirus patients. The mishap occurred in the wee hours of Thursday.

All the victims were in the ICU ward, where the fire is said to have started. Officials said that they all died on the spot while 41 other patients were shifted to other hospitals following a rescue operation. One paramedic staff of the hospital who tried to douse the fire sustained burn injuries.  

Deputy Chief Minister Nitin Patel, who is also the health minister, said that primary information has revealed that fire was caused by the short circuit in the ICU ward where eight patients were under treatment. 

He said that 41 other patients were shifted to Sardar Vallabhbhai Patel hospital. The incident happened at Shrey Hospital in Navrangpura which is one of the Covid-19 designated hospitals. Over 300 patients have recovered at the hospital in the last two months.

Among the victims were five men and three women. They have been identified as Arif Mansuri, Narendra Shah, Manu Rami, Leelvati Shah, Navneet Shah, Jyoti Sindhi, Manu Rami and Ayesha Tirmizi  

Following the incident, Prime Minister Narendra Modi tweeted, "Saddened by the tragic hospital fire in Ahmedabad. Condolences to the bereaved families. May the injured recover soon. Spoke to CM @vijayrupanibjp Ji and Mayor
@ibijalpatel Ji regarding the situation. Administration is providing all possible assistance to the affected."

Soon after the tweet, Chief Minister Vijay Rupani ordered a probe into the matter to be conducted by Additional Chief Secretary (ACS), Home, Sangeeta Singh and ACS (Urban Development) Mukesh Puri. 

They have been asked to submit a report in three days. Meanwhile, the hospital building has been sealed for further investigation. 

The chief minister has ordered a report within three days.