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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. 

Thiruvananthapuram, Jul 31: In Kerala, the prisoners will now work as employees in petrol pumps and take home a salary, as the Kerala government has rolled out Petrol Pumps from jail premises in association with Indian Oil Corporation.

Speaking to news agency, Rishiraj Singh, Jail DGP said that initiative to employ jail inmates in petrol pumps was taken as in Kerala there are many projects of which prisoners are a part of and are being employed.

"In petrol pumps, 15 jail inmates will be employed at each pump. The outlets of Thiruvananthapuram, Viyyur and Cheemeni jails have been started to function from today. 

Many express doubt whether the prisoners will try to escape. But my experience working with them prove otherwise. They are managing five cafeterias in the state and selling food prepared by them. We pay them Rs 220 per day for their work and the jail inmates are running it successfully particularly at COVID-19 times," he said.

The Indian Oil Corporation is investing around Rs 9.5 crore to set up four petrol pumps at the jail premises. The share of the jail department is Rs 30 lakh for setting up petroleum outlet. Other than the three presently, it will also be started in Kannur jail.

"The land has been leased to the Indian Oil Corporation for 30 years. The prisoners are employed here and for that, they underwent a training in petrol pump of IOC and the uniform will also be supplied by them, " said Rishiraj Singh About 25 cents in Thiruvananthapuram, 39 cents in Kannur, 25 cents in Viyur and 25 cents in Cheemeni open jail have been allotted.

Through this, the government will get Rs 5.9 lakh per month in rent. 

It also plans to expand the project in the future by setting up a CNG and electrical charging station. 

The petrol pumps will be also accompanied by public comfort stations.