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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. 

Kochi, Jul 30: The Kerala High Court on Thursday refused to grant the extension for the stay of a 74-year-old US citizen, Johnny Paul Pierce, who had earlier said that he felt safer to remain in India than in the United States amid the COVID-19 pandemic.

The single-judge bench of Justice CS Dias, which considered the writ petition, observed that the grant or extension of visa to foreign nationals fall exclusively within the domain of the Government of India (GoI) and that judicial review in such matters is minimal.

The power of the GoI to expel foreigners is absolute and unlimited, the bench said.

"In view of the categoric declaration of law by the Supreme Court, the plea of the petitioner to permit him to stay back in India cannot be accepted, as it falls within the purview of the guidelines and the discretion of the Government of India," the order said.

"The petitioner cannot be heard that the guidelines/policies/regulations formulated by the Government of India, that an American national though has been granted a visa having validity of five years has to leave India within 180 days, is irrational or unreasonable," it added.

The High Court, which was hearing a plea to permit the US citizen to stay in India for a further period of six months, said that the petitioner does not have a case that there is an infraction of Article 21 of the Constitution of India.

"The petitioner was well aware of the visa conditions when he arrived in India, and it is too late in the day for him to raise a grievance on the visa conditions," the bench said noting that the petitioner's love for India was heartening.

The High Court also directed the Foreigners Registration Officer to consider the petitioner's representation within a period of two weeks in accordance with the applicable guidelines and policies.