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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: A family of five, returning to their hometown at Koducalli in Kozhikode from Dubai, were aboard the fateful Air India Express flight that crash-landed at the Kozhikode airport claiming at least 18 lives on Friday.

Saifudheen, 40, is a businessman in Dubai. During the vacation when schools were closed here, his wife Fasalunnisa travelled, along with their children Muhammad Shahil, Fathima Sana and Aysha Shanza, to meet her husband.

On Friday, they were all travelling in the Air India aircraft to Kozhikode.

All five have received injuries and have been admitted to Baby Memorial Hospital Kozhikode except Sana, who is admitted to Al Shifa Hospital at Perinthalmanna in Malappuram.

"Saifudheen is my uncle. He and his family members were returning from Dubai when this unfortunate incident occurred. We were informed about the mishap at 8 pm. Now the family members have been shifted to Baby Memorial Hospital and everyone is fine now," Muhammad Salih, nephew of Saifudheen said.

The death toll in the flight crash landing incident at Kozhikode International Airport in Kerala rose to 18, including two pilots, Civil Aviation Minister Hardeep Singh Puri said on Saturday.

The minister said that he will visit the Kozhikode airport to take stock of the situation.

Two special relief flights have been arranged from Delhi and one from Mumbai for rendering humanitarian assistance to all the passengers and the family members.

Aircraft Accident Investigation Bureau (AAIB), Directorate General of Civil Aviation (DGCA) and Flight Safety Departments have reached to investigate the incident, the Air India Express stated.