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
January 30,2020

Mumbai, Jan 30: Speaking at an event, Samajwadi Party (SP) leader Abu Azmi's son and businessman, Farhan Azmi said that if CM Uddhav Thackeray will build lord Ram's Temple at Ayodhya then he will build Babri Masjid there. He said, "My problem is with Uddhav Thackeray.

I respect him a lot and if in Shiv Sena somebody really deserves respect, then it is no other than Uddhav Thackeray. He never runs a government and I don't think he is running his party correctly.

If being the Chief Minister, Uddhav Thackeray says he is going to Ayodhya on 7th March, I will also go with him. He will build lord Ram's Temple and we will build Babri Masjid."

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Agencies
February 7,2020

Jammu & Kashmir, Feb 7: Former Jammu and Kashmir chief ministers Mehbooba Mufti and Omar Abdullah, besides two political stalwarts from NC and its arch-rival PDP were booked under the stringent Public Safety Act (PSA) by the administration on Thursday, officials said.

A magistrate accompanied by police served the order to Mufti at the bungalow where she has been detained, the officials said.

Abdullah was also booked under the PSA, they said.

National Conference general secretary and former minister Ali Mohammed Sagar, who wields a support base in downtown city, was served with a PSA notice public order by the authorities.

Similarly, senior PDP leader Sartaj Madani was booked under the PSA. Madani is the maternal uncle of former chief minister Mehbooba Mufti.

Both Sagar and Madani were detained in the aftermath of August 5 crackdown by the Centre on politicians following abrogation of special status of the erstwhile state, besides its bifurcation into two union territories.

Their six-month preventive custody was ending on Thursday.

Earlier, the officials had said that former NC legislator Bashir Ahmed Veeri was also booked under the PSA but later it turned out that he had been released.

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News Network
May 28,2020

May 28: Abdul Kareem was forced out of school and into a life of odd jobs like repairing bicycles before he finally managed to pull his family out of abject poverty transporting goods across Delhi in a mini truck.

The job, and the slim financial security that came with it, was the first stepping stone to a better life.

All that is now gone as India reels under the economic impact of its protracted coronavirus lockdown. Mr Kareem's out of a job and stranded in his village in Uttar Pradesh with his wife and two children. Their minuscule savings from his Rs 9,000 a month job have been exhausted, and the money he saved for books and school uniforms is spent.

"I don't know what the job situation will be in Delhi once we go back," Mr Kareem said. "We can't stay hungry so I will do whatever I find."

At least 49 million people across the world are expected to plunge into "extreme poverty" -- those living on less than $1.90 per day -- as a direct result of the pandemic's economic destruction and India leads that projection, with the World Bank estimating some 12 million of its citizens will be pushed to the very margins this year.

Some 122 million Indians were forced out of jobs last month alone, according to estimates from the Center for Monitoring Indian Economy, a private sector think tank. Daily wage workers and those employed by small businesses have taken the worst hit. These include hawkers, roadside vendors, workers employed in the construction industry and many who eke out a living by pushing handcarts and rickshaws.

For Prime Minister Narendra Modi, who came to power in 2014 promising to lift the poorest citizens out of poverty, the fallout from the lockdown brings with it significant political risk. He won an even larger second term majority last year on the strength of his government's popular social programs that directly targeted the poor, such as the provision of cooking gas cylinders, power and public housing. The breadth and depth of this renewed economic pain will only increase the pressure on his government as it works to steer the country's economy back on track.

"Much of the Indian government's efforts to mitigate poverty over the years could be negated in a matter of just a few months," said Ashwajit Singh, managing director of IPE Global, a development sector consultancy that advises several multinational aid agencies. Noting that he did not expect unemployment rates to improve this year, Singh said: "More people could die from hunger than the virus."

Desperate Times

Mr Singh points to a United Nations University study estimating 104 million Indians could fall below the World Bank-determined poverty line of $3.2 a day for lower-middle-income countries. This will take the proportion of people living in poverty from 60% -- or 812 million currently, to 68% or 920 million -- a situation last seen in the country more than a decade ago, he said.

A World Bank report found the country had been making significant progress and was close to losing its status as the country with the most poor citizens. The impact of PM Modi's lockdown risks reversing those gains.

The World Bank and the CMIE estimates were published in late April and early May respectively. Since then the situation has only become grimmer, with harrowing images of people making desperate attempts to reach their villages, on crowded buses, the flatbeds of trucks and even on foot or on bicycles dominating media coverage.

The Rustandy Center for Social Sector Innovation at the University of Chicago Booth School of Business analyzed the unemployment data from the CMIE, collected through surveys covering about 5,800 homes across 27 states in April.

Researchers found rural areas were the hardest hit, and the economic misery was the result of the lockdown, rather than the spread of infections in the hinterland. More than 80% of households had experienced a drop income and many won't survive much longer without aid, they wrote in a report.

The government has promised cheap credit to farmers, direct transfer of money to the poor and eased access to food security programs -- but these help people who have some documentation, which many of the poorest don't. With millions of impoverished people now in transit across the country, the food security situation is dire -- news reports are emerging of people foraging through piles of rotting fruit or eating leaves.

Shattered Economy

The economy was already growing at its slowest pace in over a decade when the virus struck. The lockdown, which came into effect on March 25, has hammered it, stalling business activity and putting a lid on consumption, pushing the economy to what may be its first full-year contraction in more than four decades.

It's dire enough to warrant the country exiting its lockdown, as it has been doing incrementally since May 4, even as its infections are surging. India is now Asia's virus hotspot with infections crossing 151,000 according to data from Johns Hopkins University.

PM Modi, who has come under criticism for the pain inflicted on the poor, has said his government will spend $265 billion or about 10% of its GDP to help Asia's third-largest economy weather the pandemic's fallout. But experts say only a part of it is direct fiscal stimulus, and probably smaller than the total damage done to the economy during the lockdown period.

"What is especially worrying is the government's response," said Reetika Khera, an economics professor at the Indian Institute of Technology in Delhi. "The epidemic will magnify existing -- and already high -- inequalities in India."

Still, the economic measures aren't going to kick in for some time and industry will likely struggle to restart because of the flight of labour from industrial hubs.

And as the harsh summer unfolds more pain lies in store in the villages now dealing with returning migrant workers.

"There are no factories or industries here, there are just hills," said Surendra Hadia Damor, who had walked nearly 100 km from Ahmedabad, Gujarat, before a voluntary organisation drove him to his village in the neighboring state of Rajasthan. "We can survive for a month or two and then try and find a job nearby -- we will see what happens."

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