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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. 

Rajouri, Aug 3: Ashfaq Mehmood Choudhary, a 17-year-old boy from Chattyear of Jammu and Kashmir's Rajouri district, has developed a file-sharing app 'Dodo Drop' which would enable users to share audios, videos, images, and texts between two devices without Internet access.

While speaking to media persons, Ashfaq Mehmood said that the 'Dodo Drop' application is an alternative to the Chinese 'SHAREit' app. "The Indian government has banned several Chinese apps due to data breaching, and among those apps was SHAREit which was used for sharing files.

Users faced a lot of problems due to the ban, and so I decided to make this file-sharing app. With 'Dodo Drop', users can share audios, videos, images, and even texts," he said.

Ashfaq said that it took him four weeks to develop the application, and it was launched on August 1 this year. The 'Dodo Drop' application has a transfer rate of up to 480 mbps, which is faster than the SHAREit app and is "quite easy" to use.

"Users can transfer data comprising photos, videos, audios, apps, texts, etc. between two devices with no Internet access. The transfers are fully encrypted and secure," he added.

"Our Prime Minister has always asserted the need for decreasing the dependency on foreign products and apps and to focus on the development of India-based apps. I tried to be part of the initiative of 'Aatmanirbhar Bharat' by developing an India-based file-sharing app. I want to develop global-standard apps for India," he added.

"We support and cooperate with him. He generates his own income by working on some projects and utilises it. We will continue to support him," said Parvez Ahmed Choudhary, Ashfaq's father.

In July, the Ministry of Electronics and Information Technology (MEITY) banned 47 apps, which were variants and cloned copies of the 59 apps banned earlier in June. These banned clones included SHAREit Lite, Tiktok Lite, Helo Lite, BIGO LIVE Lite, and VFY Lite.

The 59 apps had been banned by the Centre in June in view of the information available that they were engaged in activities which were "prejudicial to sovereignty and integrity and defence" of the country.

Almost all the apps banned had some preferential Chinese interest and the majority had parent Chinese companies.

The ban came amid border tensions with China in the Eastern Ladakh region.