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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. 

New Delhi, Aug 2: The Ministry of Health and Family Welfare on Sunday issued fresh guidelines for international passengers coming to India amid the COVID-19 pandemic. The new guidelines will be implemented from 12:01 am on August 8.

The ministry has also asked all passengers to submit a self-declaration form online at least 72 hours before travel.

"All travellers should submit self-declaration form on the on the online portal (www.newdelhiairport.in) at least 72hours before the scheduled travel," the guidelines said.

It also said that those coming to India must give an undertaking that they would undergo mandatory quarantine for 14 days as prescribed by the government. "They should also give an undertaking on the portal that they would undergo mandatory quarantine for 14 days i.e. 7 days paid institutional quarantine at their own cost, followed by 7 days isolation at home with self-monitoring of health," it added.

Giving exemptions in some cases, the guidelines mentioned, "Only for compelling reasons/cases of human distress such as pregnancy, death in the family. Serious illness and parent (s) with children of 10 years or below, home quarantine may be permitted for 14 days."

"If they wish to seek such exemption, they shall apply to the online portal at least 72 hours before boarding. The decision taken by the government as communicated on the online portal will be final," it said further.

The guidelines further said that travellers could request for exemption from institutional quarantine by submitting a negative RT-PCR test report on arrival.

"This test should have been conducted within 96 hours prior to undertaking the journey. The test report should be uploaded on the portal for consideration," it added.

Passengers have also been asked to download the Aarogya Setu app on their mobile phones.