Serum Institute of India gets nod for phase 2,3 trials of Oxford covid vaccine

Agencies
August 3, 2020

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. 

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News Network
May 22,2020

New Delhi, May 22: Air India on Friday started booking for domestic flights amid the COVID-19 lockdown.

"We have started bookings for domestic flights," said Air India in a statement.

The airlines will operate a total of 8,428 flights each week for the next three months from May 25 to August 25 as the Central government has announced the resumption of domestic flights.

Civil Aviation Minister Hardeep Singh Puri on Thursday said that a minimum and maximum fare for three months has been set for the domestic flight services, which resume from May 25.

In the case of Delhi, Mumbai the minimum fare would be Rs 3,500 for a journey between 90-120 minutes. The maximum fare would be Rs 10,000.

"This is operative for three months -- till one minute to midnight on August 24," said Puri at a press conference here.

Puri said that guidelines have been issued for the passengers and airports, which are to be followed during flight operations.

He also said that self-declaration or Aarogya Setu App status on a compatible device would be obtained to ensure that a person does not have COVID-19 symptoms.

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News Network
March 19,2020

New Delhi, Mar 19: Former Chief Justice of India Ranjan Gogoi took oath as Rajya Sabha MP on Thursday.

Gogoi's wife Rupanjali Gogoi, daughter, and son in law were also present in Parliament.

Congress staged a walkout from the Rajya Sabha over Gogoi's membership to the House.

Meanwhile, Union Minister Ravishankar Prasad welcomed Gogoi in the Rajya Sabha.

President Ram Nath Kovind had nominated the former CJI to the Rajya Sabha on March 16.

Gogoi served as the 46th Chief Justice of India from October 3, 2018, to November 17, 2019.

On November 9, 2019, a five-judge Bench headed by him had delivered the verdict in the long-pending Ramjanmabhoomi case.

Comments

Fairman
 - 
Thursday, 19 Mar 2020

People lost trust in Judiciary because of such horrible criminals.

 

He betrayed the whole nation. Unless he is booked, the judiciary will not restore the lost faith. 

 

 

The loss may be momentary in nature, It is the promise of the Almighty, He will ensure the justice is served to everyone. 

 

Angry Indian
 - 
Thursday, 19 Mar 2020

Pure slave like goo mutur....nice life DDDDOOOOGGGGG

 

ayes p.
 - 
Thursday, 19 Mar 2020

Fixed from judgement of babri masjid to rajya sabha member

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News Network
January 7,2020

Mumbai, Jan 7: People protesting against the JNU violence were evicted from Gateway of India here on Tuesday morning as roads were getting blocked and tourists and common people were facing problems, a police official said.

Police had appealed to the protesters to shift but they didn't listen, so they were "relocated" to Azad Maidan, the official said.

Hundreds of people, including students, women and senior citizens - who assembled at the iconic Gateway of India since Sunday midnight - demanded action against the culprits and called for Union Home Minister Amit Shah's resignation.

Violence broke out in the Jawaharlal Nehru University (JNU) in Delhi on Sunday night as masked men armed with sticks and rods attacked students and teachers and damaged property on the campus.

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