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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: An Air India Express flight from Dubai with 190 people on board overshot the Kozhikode tabletop runway on landing there today. The Boeing 737 “fell off” the runway into the valley, broke into two causing death and devastation. 

According to reports, around 20 people were dead including two pilots.

An Air India spokesperson said: “Air India Express flight IX 1344 operated by Boeing 737 aircraft from Dubai to Calicut overshot the runway at Kozhikode at 7.41 pm Friday. No fire reported at the time of landing. There are 174 passengers, 10 infants, two pilots and five cabin crew on board. Rescue operations are on and passengers are being taken to hospital for medical care. We will soon share the update in this regard.”

The Directorate General of Civil Aviation (DGCA) is probing this accident. “Prima facie, the aircraft landed beyond the touchdown point and fell into a valley. It has broken into two. We suspect some casualties. More information is awaited,” said a senior DGCA official.

Taking to twitter, defence minister Rajnath Singh wrote: “Devastating news from Kozhikode, Kerala. I am deeply anguished by the loss of lives due to an accident carrying several passengers on Air India flight. In this hour of grief, my thoughts are with the bereaved families. I pray for the speedy recovery of the injured.”

Foreign minister S Jaishankar tweeted: “Deeply distressed to hear about the Air India Express tragedy at Kozhikode. Prayers are with the bereaved families and those injured. We are ascertaining further details.”

While, senior BJP leader from Kerala K J Alphons tweeted: “Second tragedy of the day in Kerala: Air India Express skids off the run way at Kozhikode, front portion splits , pilot dies and lots of passengers injured . All passengers evacuated. Very lucky the aircraft didn’t catch fire.”

More details are awaited.

Watch video | Air India flight from Dubai skids off runway in Kerala, splits into two pic.twitter.com/qgGxEEG2e3

— coastaldigest.com (@coastaldigest) August 7, 2020