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
March 7,2020

Mumbai, Mar 7: Maharashtra Chief Minister and Shiv Sena president Uddhav Thackeray visited Ayodhya on Saturday to commemorate 100 days in office and pledged Rs 1 crore towards the building of the Ram Temple.

Taking a dig at BJP, Uddhav said his party had separated from its erstwhile ally but not Hindutva.

Recollecting the contribution of his father Balasaheb Thackeray, uddhav said he was forced to skip the Sarayu River 'aarti' due to Coronavirus fears but he would continue visiting Ayodhya.

Earlier in the day, the Sena, which heads the tripartite dispensation in the state, said there was no change in its ideology.

Launching a veiled attack on BJP, an editorial in the Sena mouthpiece 'Saamana' also said that Lord Ram and Hindutva is not the sole property of any single political party.

The Sena also said the Maha Vikas Aghadi (MVA) government — which also comprises the NCP and the Congress — has completed 100 days, much to the chagrin of those who were claiming that the new dispensation will not survive more than 100 hours.

“Those whose government lasted for 80 hours were claiming that the Thackeray regime will not last for even 100 hours. But this MVA government not only thrived but has instilled trust in the minds of people during this period with its performance,” the editorial said.

The Sena was apparently referring to the second inning of the erstwhile Devendra Fadnavis government which lasted for only 80 hours in November last year.

"Hence, CM Thackeray's visit to Ayodhya has to be welcomed as he is offering the flowers of works (done by the government) at the feet of Lord Shriram," it said.

The Sena said Thackeray's visit to the temple town is out of devotion for Lord Shriram. "The government in Maharashtra comprising three ideologically different parties is working as per Constitution and Thackeray is leading such government," it said.

The edit said on this background various questions were raised over Thackeray's visit to Ayodhya by his political opponents. "The government maybe backed by anyone, but Uddhav Thackeray and the Shiv Sena remain the same from within and outside. There is no change in the ideology. Lord Shriram and Hindutva is not the property of any single party," it stated.

Referring to senior RSS leader Suresh 'Bhaiyyaji' Joshi's remark that the Hindu community is not synonymous with the BJP and that opposing the BJP does not amount to opposing Hindus, the Sena said similarly Ayodhya belongs to all.

"The political and cultural battle in Ayodhya is now over. The Supreme Court cannot be thanked enough for this (for its verdict in the Ram Janmabhoomi-Babri Masjid dispute case that allowed construction of the Ram temple)," it said.

Hailing the Supreme Court's November, 2019 verdict, the Sena said the country had to fight a big battle to prove that Ayodhya belonged to Lord Shriram.

"In that battle, several (people) were unmasked. But only (late) Shiv Sena president Balasaheb Thackeray stood behind the Ayodhya (temple) campaigners like a mountain," it said.

Bal Thackeray created trust among Hindus from across the world about the creation of the temple, the Sena said. The party further said late Thackeray's assertion that he was proud if the Babri mosque was razed by Sena workers and that the temple of Lord Ram would come up in Ayodhya was akin to the thunder of "thousands of lightnings" in the sky.

"The Hindu culture got lit up in the glow of that lightning. The resplendent rays showed the path of power to the Hindu community. Hence, no one can deny the contribution of the 'Hinduhridaysamrat' (Bal Thackeray) as good as that of Lord Shriram, in creating the current political order in the country," the Sena said.

"We have experienced several times that Balasaheb lives in the mind of Ayodhya. Now Uddhav Thackeray himself is going there with the same faith. He had gone there when not in power. He is going there now after becoming chief minister with the same humility. Lord Shriram is of everyone," the Sena said.

The party said Maharashtra is being run on the path shown by Lord Shriram and Chhatrapati Shivaji Maharaj. "A Ram Rajya entails fulfilling promises made to the people. This is precisely what Mahatma Gandhi wanted, and the government following this ideology is in place in Maharashtra. It will continue work on that line. Ultimately, Lord Shriram is there to support it," the Sena said.

Thackeray completed 100 days in the office on Friday. He had assumed office as the chief minister of the Sena-led Maha Vikas Aghadi (MVA) government on November 28 last year, after the Sena joined hands with the NCP and the Congress.

Senior Sena leader Sanjay Raut had said that Thackeray will not take part in the 'aarti' programme on the banks of river Sarayu in the temple town.

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News Network
March 11,2020

Jaipur, Mar 11: A 85-year-old man in Jaipur, who had returned from Dubai on February 28, has tested positive for coronavirus, a state government official said on Wednesday.

He was found presumptive positive in the first test on Tuesday and hence, a second test was conducted with fresh samples, the reports of which arrived late Tuesday night, Additional Chief Secretary, Medical and Health, Rohit Kumar Singh, said.

“The man who travelled to Dubai has been tested positive for coronavirus. It has been confirmed now,” Singh said.

“We have also got the manifest of the Spicejet flight he took from Dubai to Jaipur and are doing due diligence on that,” the official said, adding that intense contact tracing was underway.

The man has been kept in isolation at the SMS Hospital here.

“The man came to the hospital on Monday with symptoms of the virus. After the first test, his wife and son too have been kept in isolation at the hospital. The two, however, do not have coronavirus affliction symptoms,” Singh said.

A total of 235 people who came in contact with the octogenarian and his family have already been traced and are being monitored, he said.

Other contacts are also being traced, Singh added.

An Italian couple, who tested positive for COVID-19 last week, are also admitted in the hospital but their condition is improving, he said.

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News Network
May 27,2020

New Delhi, May 27: Professor Johan Giesecke of the Karolinska Institute, Sweden, on Wednesday claimed that India will ruin its economy very quickly if it had a severe lockdown.

Claiming that a strict lockdown may disrupt India's economic growth, Giesecke during an interaction with Congress leader Rahul Gandhi said: "In India, you will do more harm than good with strict lockdown measures. India will ruin its economy very quickly if it had a severe lockdown."

While calling for a soft lockdown approach in India, he suggested that India has to ease restrictions one by one. It may, however, take months to completely come out of lockdown, he said.

He further criticised countries across the globe for having no post-lockdown strategy.

Emphasising on the disease, the Swedish health expert said that coronavirus is spreading like a wildfire across the world. "It is a very mild disease. Ninety-nine per cent infected people will have very less or no symptoms," he added.

Meanwhile, Ashish Jha, Director Harvard Global Health Institute and a recognised public health official, in interaction with Gandhi, called for a need to go in for an 'aggressive' COVID-19 testing to create confidence among people.

"When the economy is opened post-lockdown, you have to create confidence. There is a need for aggressive testing strategy in high-risk areas," he said.

He asserted that COVID-19 is not the last pandemic in the world, adding that "We are entering the age of large pandemics".

Jha further said that countries like South Korea, Taiwan and Hong Kong have responded the best to COVID-19 pandemic, while Italy, Spain, the US and the UK have responded the worst.

A few days ago, the Gandhi scion had interacted with former Reserve Bank of India Governor Raghuram Rajan and Nobel Prize Winner Abhijit Banerjee to discuss various issues related to the COVID-19 crisis.

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