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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. 

Kozhikode, Aug 8: Kerala Chief Minister Pinarayi Vijayan on Saturday announced a compensation of Rs 10 lakh to the next of kin of each passenger who died when an Air India Express flight veered off the runway while attempting to land at the Karipur International Airport here on August 7.

He was briefing the media after visiting the crash site at the airport and the injured at the Kozhikode Medical College Hospital.

Offering his condolences, the Chief Minister said, "Apart from the solatium for the victims, the state government would bear the treatment expenses of all those injured in this unfortunate plane crash irrespective of the hospitals they are in. The Civil Aviation Ministry and other Central Government agencies are expected to announce compensation for the air passengers. 

If any further assistance is required, the State Government will take an appropriate decision at that time to support them to get back to a normal life."

"However, the immediate task now is to ensure the best possible treatment for the survivors of the accident. The District Authority is coordinating the treatment of those rescued who are now in 16 hospitals across Kozhikode and Malappuram Districts," added Vijayan.

Of the 190 people on board the ill-fated plane, there were 184 passengers and six crew members. Of the 18 dead so far, 14 are adults (seven males and females each) and four are children. Both the Pilot and the Co-Pilot are among those dead. At present, 149 passengers are hospitalised, of them 23 with serious injuries. Till now, 23 passengers have been discharged. There are few passengers from Tamil Nadu and Telangana also.

All the dead have been identified, eight from Kozhikode district, six from Malappuram district and two from Palakkad district. The post mortem process has been expedited despite the Covid threat and is expected to finish before evening. All the accident victims will be tested for Covid including those who died in the crash. So far, only one victim has tested positive for coronavirus, the Chief Minister said.

He also appreciated the instant response by the local public living in the vicinity of the airport and also the local authorities to this tragedy which ensured the minimum loss of lives in a disaster of such large magnitude as a plane crash. The rescue operations were finished in the shortest possible time yesterday.

"Even though 18 precious lives have been lost due to the impact of the crash, the rescue operations were a miraculous work. The general public and the officials played a big role in spearheading the rescue operations," he said.

Vijayan along with Governor Arif Mohammad Khan reached Kozhikode this morning.

Governor Arif Mohammad Khan expressed his condolences and sympathies to the families of the accident victims and his best wishes for the speedy recovery of those injured.

The Chief Minister was accompanied by the Niyamasabha Speaker, P. Sreeramakrishnan; Minister for Industry E.P Jayarajan, Minister for Health and Social Justice, K K Shailaja; Minister for Agriculture V.S Sunilkumar; Minister for Ports Ramachandran Kadannappalli; Minister for Transport AK Saseendran, Minister for Excise T.P Ramakrishnan, Chief Secretary, Dr Vishwas Mehta; and State Police Chief, Loknath Behra, DGP. 

The Minister for Local Self Governments, A C Moideen and the Minister for Higher Education and Welfare of Minorities, Dr K T Jaleel were already present in Kozhikode.