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 9,2020

Mumbai, Jan 9: India's weddings are famously lavish -- lasting days and with hundreds if not thousands of guests -- but this season many families are cutting costs even if it risks their social standing.

It is symptomatic of a sharp slowdown in the world's fifth-largest economy, with Indians spending less on everything from daily essentials to once-in-a-lifetime celebrations.

Growth has hit a six-year low and unemployment a four-decade high under Prime Minister Narendra Modi. Prices are rising too, squeezing spending on everything from shampoo to mobile data.

Chartered accountant Palak Panchamiya, for example, has already slashed the budget on her upcoming Mumbai nuptials by a third, trimming spending on clothing and the guest list.

"Initially I chose a dress that cost 73,000 rupees ($1,000)," Panchamiya told news agency as she picked through outfits at a recent marriage trade fair.

"But my partner felt it was too expensive, and so now I am here reworking my options and looking for something cheaper."

India's massive wedding industry is worth an estimated $40-50 billion a year, according to research firm KPMG.

The celebrations can last a week and involve several functions, a dazzling variety of cuisines, music and dance performances, and lots of gifts.

Foreigners can even buy tickets to some events.

But these days, except for the super-rich -- a recent Ambani family wedding reportedly cost $100 million -- extravagance is out and frugality is in as families prioritise saving.

"Earlier Indian weddings were like huge concerts, but now things have changed," said Maninder Sethi, founder of Wedding Asia, which organises marriage fairs around the country.

Cracks emerged in 2016 when the Indian wedding season, which runs from September to mid-January, was hit by the government's shock withdrawal of vast amounts of banknotes from circulation in a bid to crack down on undeclared earnings.

Mumbai-based trousseau maker Sapna Designs Studio shut for months as the economy was turned on its head by Modi's move.

"No exhibitions were happening and there were no avenues for us to sell either," said Vishal Hariyani, owner of the clothing studio.

Hopes for a recovery proved short-lived when the cash ban was followed by a botched rollout of a nationwide goods and services tax (GST) in 2017 that saw many small-scale businesses close.

Since then, keeping his studio afloat has been a challenge, with consumers increasingly reluctant to spend too much, says Hariyani.

"We customise our clothes as per their budgets, and now week-long weddings have been converted to just a 36-hour ceremony," he told news agency.

"We have to pay GST, pay workers and even offer discounts to customers," he added.

"The whole economy has slowed down and reduced spending on weddings is a by-product of that. Everyone except the super-rich are affected," Pradip Shah from IndAsia Fund Advisors told news agency.

"It is reflective of how sombre the mood is," he said.

In a country where families traditionally spend heavily on weddings -- including taking on debt in some cases -- the downturn is also a source of sadness and shame, with elaborate celebrations often seen as a measure of social status.

"We haven't even invited our neighbours. It is embarrassing but the current situation doesn't offer us much respite," 52-year-old Tara Shetty said ahead of her son's wedding.

"In my era, we always spent a lot and had thousands of people attending the weddings," she explained.

"My wedding was supremely grand, and now my son's is the polar opposite."

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News Network
May 6,2020

May 6: The government on Tuesday said that the Food Corporation of India, the nodal agency for procurement and distribution of foodgrains, has sufficient stocks in its godowns, even after meeting the requirement of additional wheat and rice provided free of cost during the lockdown period.

Food Minister Ram Vilas Paswan has given detailed information about the various steps taken by the government and the total stocks of food grains and pulses available with the government and sent to the states till now, an official statement said.

"FCI currently has 276.61 lakh tonnes rice and 353.49 lakh tonnes wheat. Hence a total of 630.10 lakh tonnes food grain stock is available," it said.

As against this, about 60 lakh tonnes of food grains is required for a month under the NFSA (National Food Security Act) and other welfare schemes.

Paswan said FCI stocks are comfortable even after fulfilling extra commitments during the lockdown.

Under the 'Pradhan Mantri Garib Kalyan Ann Yojana', the Centre is providing 5 kg of free food grains per month to 80 crore ration card holders. This free of cost wheat and rice will be provided for three months. Besides, 1 kg of pulses will also be supplied per family.

This is over and above the normal quota of 5 kg of food grains provided per month per person to about 80 crore people under the food law.

The minister informed that since the lockdown, about 69.52 lakh tonnes of food grains have been transported through 2,483 rail rakes.

Apart from rail route, transportation was also done through roads and waterways. A total of 137.62 lakh tonnes has been transported.

During the lockdown, NGOs and social institutions running relief camps can purchase wheat and rice directly from FCI Depots at Open Market Sales Scheme (OMSS) rate.

The state governments can also purchase food grains directly from FCI. Under the OMSS, the rate of rice is fixed at Rs 22 per kg and wheat at Rs 21 per kg.

Under the 'Pradhan Mantri Garib Kalyan Ann Yojana', for the next 3 months a total of 104.4 lakh tonnes rice and 15.6 lakh tonnes of wheat is required of which 59.50 lakh tonnes rice and 8.14 lakh tonnes wheat have been lifted by various states and UTs.

The Government of India is bearing 100 per cent financial burden of approximately Rs 46,000 crore under the scheme, the statement said.

For pulses, the total requirement for the next three months is 5.82 lakh tonnes.

So far, 2,20,727 tonnes of pulses have been dispatched, while 1,47,165 tonnes of pulses have reached the states/UTs and 47,490 tonnes have been delivered, it said.

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News Network
March 31,2020

Hyderabad, Mar 31: Six people from Telangana who attended a religious congregation in Delhi's Nizamuddin died due to the novel coronavirus, the state government said on Monday.

"Coronavirus has spread among some of those who attended a religious prayer meeting from March 13 to 15 at Markaz in Nizamuddin area in Delhi," according to an official release. "Among those who attended were some persons from Telangana."

Two of the six died at the Gandhi Hospital, one each in two private hospitals, and one each in Nizamabad and Gadwal towns, the statement said, without mentioning the time of their deaths.

The special teams under the collectors have identified the persons who came in contact with the deceased and they are shifted to the hospitals, it said.

Police and paramilitary personnel cordoned off a major area in Nizamuddin West in south Delhi on Monday and over 200 people have been kept in isolation in hospitals after several people who took part in a religious congregation there showed symptoms of coronavirus.

The Telagana government asked those who participated in the prayers to inform the authorities. It will conduct tests and offer treatment to them free of cost, according to the release.

The government also requested the people to alert if they come to know about those who participated in the prayers.

Earlier a separate government release said a person died of COVID-19 in Telangana, taking the toll to two and the total number touched 77 after six fresh cases were reported on Monday.

As many as 13 patients who underwent treatment for the virus were discharged on Monday, a media bulletin on COVID-19 issued by the state government said.

A techie, the first COVID-19 case in Telangana, has been discharged recently. The state now has 61 active cases, the bulletin said.

Chief Minister K Chandrashekar Rao had on Sunday said barring a 76-year-old person, who had other ailments, the other patients were doing well.

Rao had said 25,937 people were under surveillance and being watched by 5,746 teams and they would be out of watch after completing their mandated 14-day quarantine period. He had said all those who are under observation would be out of vigil by April 7 if there are no fresh suspected cases.

"From March 30, their time is nearing completion. After that, they do not need to be under any surveillance. By April 7, we will have a situation of zero... We pray God that we should not get new cases,"

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