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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. 

Chennai, Jul 30: Tamil Nadu government on Thursday extended the Covid-19 lockdown till August 31, giving only a few relaxations like allowing delivery of non-essential goods by e-commerce sites. The ban on public transport has been extended till August 31, while availing of e-pass for inter-district and inter-state travel will continue to be in force.

In a detailed statement, Chief Minister Edappadi K Palaniswami announced a “complete lockdown” during which only essential services would continue to be in force on all Sundays during the month of August across the state.  

In Chennai, restaurants will be allowed to open dine-in facilities at 50 percent of its total capacity from 6 am to 7 pm from August 1, while vegetable shops, grocery outlets and standalone commercial establishments will also be allowed to remain open from 6 am to 7 pm.

E-commerce sites have been allowed to begin delivery of non-essential goods from August 1, while the ban on public transport, temples in urban areas and towns, cinema halls, shopping malls, and gyms would continue till August 31.

It also said companies or factories in Chennai that have been allowed to function with 50 percent of staff can increase their strength to 75 percent from August 1.

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The government also asked companies to encourage its employees to work from home and advised commercial establishments to follow the Standard Operating Procedure (SOP) as advised by it. Inter-state or inter-district travel will be allowed only with e-pass, while ban on metro and suburban trains continues.

The decision to extend the lockdown till August 31 comes as Tamil Nadu continues to grapple with an increasing number of coronavirus cases. The prevalence of the virus is no more limited to one city or region of the state with almost all districts reporting fresh cases, some of them over 200 new patients, every day.

On Thursday morning, Tamil Nadu’s Covid-19 tally was 2,34,114 including 1,72,883 discharges and 3,741 deaths. The active cases stood at 57,490.