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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, Aug 4: Over 50 per cent of COVID-19 deaths in India have taken place among people aged 60 years and above and 37 per cent deaths have been reported among patients in the age group of 45 to 60 years, Health Ministry said on Tuesday.

Addressing a press conference, Rajesh Bhushan, Secretary, Health Ministry said that 11 per cent COVID-19 deaths took place in the age group of 26 to 44.

The 18 to 25 age group and those below 18 years reported one per cent deaths each.
"Currently, 5,86,298 active COVID-19 cases are in India and over 12 lakh people have recovered.

50 per cent deaths due to COVID19 have taken place among the age group of 60 years or above and 37 per cent deaths took place in the age group between 45 to 60 years," Bhushan said.

"A total of 11 per cent COVID-19 deaths took place in the age group of 26 to 44. Only 1 per cent in 18 to 25 age group and 1 per cent in below the age of 18 years," he added.

Bhushan said that 68 per cent of COVID-19 deaths have been reported among male patients and 32 per cent among female patients which is broadly in line with the global scenario.

The number of recovered COVID-19 patients in India is increasing daily and is now over double the number of active cases.

Bhushan said that the case fatality rate (CFR) is lowest since the first lockdown.

"More than 2 crore COVID-19 tests have been conducted, including more than 6.6 lakh tests in the last 24 hours. Recovered cases are now double of the active cases. 

The case fatality rate (CFR) is lowest since the first lockdown," he said
"This is the first time after the first lockdown that the fatality rate is at the lowest, at 2.10 per cent. The fatality rate has seen a progressive decline and it is continuing, which is a good sign," he added.

According to the World Health Organisation, CFR is a measure of the severity of a disease and is defined as the proportion of reported cases of a specified disease or condition which are fatal within a specified time.