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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Agencies
March 6,2020

Thiruvananthapuram, Mar 6: A 12-member team from Telangana on Friday visited Kerala to study how the state contained the spread of novel coronavirus.

Interacting with the team, Kerala Health Minister KK Shailaja said, "The team will be given a presentation at National Health Mission and they will visit Alappuzha district to know how the health facilities are set up by Kerala Health Department on the grassroots level."

"The team comprising doctors and senior health officials will visit the control room set up by the Health Department and also will attend daily review meetings. They will also visit an isolation ward in the hospital and interact with doctors and nurses, " the minister said.

She added, "Kerala model is being followed by other states too. All states are working together and the country as a whole is fighting the coronavirus. They are sharing our experience. All of India is standing together. Contact tracing and isolation is the most important part."

Dr Mahaboob Khan, part of the Telangana team told media persons, that the discussion with the health minister was fruitful.

"Kerala was the first state in India where a positive coronavirus case was reported. All three positive cases reported have been discharged after testing negative. So we wanted to study how Kerala was able to contain it and the health system in place here, " he said.

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News Network
January 19,2020

Chennai, Jan 19: Amid ongoing nationwide protests against Citizenship (Amendment) Act, 2019, finance minister Nirmala Sitharaman on Sunday said that as many as 2838 people from Pakistan were given citizenship during the last six years.

"In the last six years, as many as 2838 Pakistani refugees, 914 Afghan refugees, 172 Bangladeshi refugees including Muslims have been given Indian citizenship. From 1964 to 2008, more than 4,00,000 Tamils (from Sri Lanka) have been given Indian citizenship," Sitharaman said at 'Programme on Citizenship (Amendment) Act, 2019' event here.

She added, "Till 2014, over 566 Muslims from Pakistan, Bangladesh and Afghanistan were given Indian citizenship. During 2016-18 under Modi government, around 1595 Pakistani migrants and 391 Afghanistani Muslims were given Indian citizenship."

The minister, further, said, "It was also during the same period in 2016, that Adnan Sami was given Indian citizenship, this is an example."    

Sitharaman added that people who came from East Pakistan have been settled at various camps in the country.

"They are still there and it's been 50-60 years now. If you visit these camps, your heart will cry. The situation is the same with Sri Lankan refugees who continue to live in camps. They're barred from getting basic facilities," she said.

Asserting that the government is not snatching away anyone's citizenship, the BJP leader said: "This Citizenship (Amendment) Act is an attempt to provide people with a better life. We are not snatching away anyone's citizenship, we are only providing them that."

"The National Population Register (NPR) will be updated every 10 years and is not involved with the National Register of Citizens (NRC). Some are involved in raising false allegations and triggering people unnecessarily without any base," she added.

Comments

indian
 - 
Monday, 20 Jan 2020

Hello Madam,

What Are you ?? Are you a Finance Minister or External Affairs Minister ??

when someone asked about the economy which well related to your ministry you won't even open your mouth, 

but now you are talking about a matter which is not at all your business...

WellWisher
 - 
Sunday, 19 Jan 2020

What a pefect  figure  given by our short time  finance minister. Hope  she wil feed them from her person income wthout ONION.

Fairman
 - 
Sunday, 19 Jan 2020

Stupid, dont know even what they talk.

 

 

It is not snatching anybody's nationality. You dont have right to do it.

 

 
The subject is not snatching,    the subject is disccimination while giving nationality.

 

 

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News Network
January 1,2020

Pune, Jan 1: Maharashtra Deputy Chief Minister Ajit Pawar and Vanchit Bahujan Aghadi president Prakash Ambedkar paid tributes at the 'Jay Stambh' near here on Wednesday on the 202nd anniversary of Koregaon Bhima battle.

Lakhs of people congregate every year at the 'Jay Stambh' (victory pillar) near Koregaon Bhima village to offer tributes on the anniversary of the battle, which was fought on January 1, 1818 between the British East India Company and the Peshwa faction of the Maratha Confederacy.

Violence broke out during the bicentenary celebrations of the Koregaon Bhima battle on January 1, 2018 in which one person was killed and several others were injured.

Police have made elaborate security arrangements to ensure no untoward incident takes place during the congregation at the victory pillar, an official said.

Talking to reporters after visiting the victory pillar, Pawar said he came to offer tributes on behalf of the people of Maharashtra.

"This pillar has history and every year lakhs of people come here. Some untoward incidents took place two years ago, but the government is taking utmost care and elaborate police bandobast has been made here to ensure that no untoward incident takes place," he said.

Pawar also urged people to visit the war memorial in a peaceful manner.

"I appeal to people to come here and offer their tributes, but maintain peace and do not believe in rumours," the NCP leader said.

Prakash Ambedkar also offered his tributes at the victory pillar.

Pune Police last week issued notices to several people, including right-wing leaders Milind Ekbote and Sambhaji Bhide, and members of Kabir Kala Manch, barring them from entering the district for four days from December 29.

The notices, as part of preventive action, were issued to all those against whom cases were registered in connection with the violence two years ago.

Ekbote was arrested in March 2018 for allegedly instigating and orchestrating the violence around Koregaon Bhima.

Bhide was also booked and named in the FIR, but never arrested.

The police attributed the violence to the Elgar Parishad conclave held here on December 31, 2017, where provocative speeches were allegedly made.

They are also probing the alleged "Maoist link" of some activists to the Elgar Parishad conclave.

Several Dalit groups observe the anniversary of the Koregaon Bhima battle, in which the British defeated the Peshwas of Maharashtra.

The memorial, located at Perne village on Pune- Ahmednagar road, was constructed by the British in the memory of soldiers who died in the battle.

Dalit leaders commemorate the British victory as soldiers from the Mahar community were part of the East India Company's forces.

The Peshwas were Brahmins, and the victory is seen as a symbol of assertiveness by Dalits.

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