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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. 

The Civil Aviation Ministry announced an initial assistance of Rs 10 lakh to the dependents of the deceased in the Kozhikode AIE plane crash, while the Kerala government also announced a compensation of Rs 10 lakh each.

Minister of Civil Aviation, Hardeep Singh Puri, who visited the mishap spot on Saturday, said that a detailed probe is already on and the pilot and co-pilot were highly experienced.

He also announced a compensation of Rs 2 lakh each to the injured and Rs. 50,000 each to those who suffered minor injuries. The other normal compensations would be decided in due course.

Puri said that Captain Deepak Vasant Sathe, aged 59, who commandeered the AIE flight, had a flying experience of 10,848 hours, while co-pilot Akhilesh Kumar, aged 32, had a flying experience of 1,723 hours.

"Deepak was one of the most distinguished and experienced pilots. He had a commanding experience of 6,662 hours and was commander of B-737 aircraft for 4,244 hours. He had also operated to Kozhikode international airport 27 times. He joined AIE in 2013 and prior to that he served with the IAF and HAL. He was a figher pilot and a recipient of prestigious sword of honour and a gold medalist," said Puri.

Puri said that even as the flight slipped down to around 35 feet, a major disaster was averted due to timely rescue operations. Local people played an exemplary role and the fire brigade's timely action of cutting the plane body and rescuing the passengers minimised the casualties, he said.

Chief Minister Pinarayi Vijayan also said that the local people and all rescue and relief agencies did a well co-ordinated job. The state government would also meet the entire treatment expenses of the injured.

Till Saturday afternoon, the total number of deaths was 18. While 149 were still in hospitals, 23 were discharged.