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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: Even as COVID-19 cases continue to surge in various parts of India, more than 1 million people have recovered and discharged till now, informed Rajesh Bhushan, Secretary, Ministry of Health, here on Thursday.

"More than 1 million people have recovered from COVID-19 in the country. This landmark recovery has been achieved because of the selfless work and dedication of our doctors, nurses and frontline workers," Bhushan said at a press conference.

Giving the number of cured persons, Bhushan said, "More than 1,020,000 patients have recovered. They have been discharged. It is a great achievement."

He said, "The recovery rate has shown positive trends. It was 7.85 per cent in April and today it is 64.4 per cent, which is another heartening news which tells us that whatever battle is put by the Union government in collaboration with state governments is showing results."

"Sixteen states of the country have a recovery rate that is more than the national average. Of these, Delhi has a recovery rate of 88 per cent, Ladakh 80 per cent, Haryana 78 per cent, Assam 76 per cent, Telangana 74 per cent, Tamil Nadu & Gujarat 73 per cent, Rajasthan 70 per cent, Madhya Pradesh 69 per cent and Goa 68 per cent," Bhushan said.

He said effective clinical management lead to a decrease in case fatality rate. In June it was 3.33 per cent and now 2.21 per cent.

Bhushan said the case fatality rate in India today is 2.21 per cent and it's among the lowest in the world. Twenty-four states and Union Territories have lesser fatality rate than that of the country.

Herd immunity in a country of the size and population of India can not be a strategic option. It can only be achieved through immunisation.

"Over 18,190,000 tests have been conducted in the country including RT-PCR and rapid antigen tests. There has been a week-on-week increase in average tests per day. India is conducting 324 test per 10 lakhs population per day," Bhushan said.

He added, three vaccine candidates, are in phase 3 clinical trial. These three are in the US, UK and China. In India, two indigenously developed vaccine candidates are in phase I and II of clinical trials. 

Trial of the first vaccine involves 1,150 subjects at eight sites, second on 1,000 subjects at five sites.