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 20,2020

May 20: Prime Minister K P Sharma Oli on Tuesday asserted that Lipulekh, Kalapani and Limpiyadhura belong to Nepal and vowed to "reclaim" them from India through political and diplomatic efforts, as his Cabinet endorsed a new political map showing the three areas as Nepalese territory.

Addressing Parliament, Oli said the territories belong to Nepal “but India has made it a disputed area by keeping its Army there”. “Nepalis were blocked from going there after India stationed its Army,” he said.

“India has deployed its troops in Kalapani since 1962 and our rulers in the past hesitated to raise the issue,” he said, asserting, “We will reclaim and get them back.”

The prime minister asserted that the Nepal government will make political and diplomatic efforts to reclaim the territory.

Oli also expressed the hope that India will “follow the path of truth, shown by Satya Meva Jayate, which is mentioned in the Ashoka Chakra, the national symbol of India”.

The prime minister’s remarks came a day after the Cabinet headed by him endorsed a new political map showing Lipulekh, Kalapani and Limpiyadhura under Nepal’s territory.

Foreign Minister Pradeep Kumar Gyawali said the official map of Nepal will soon be made public by the Ministry of Land Management. The move announced by Gyawali came weeks after he said that efforts were on to resolve the border issue with India through diplomatic initiatives.

Nepal''s ruling Nepal Communist Party lawmakers have also tabled a special resolution in Parliament demanding return of Kalapani, Limpiyadhura and Lipulekh to Nepal.

The Lipulekh pass is a far western point near Kalapani, a disputed border area between Nepal and India. Both India and Nepal claim Kalapani as an integral part of their territory - India as part of Uttarakhand’s Pithoragarh district and Nepal as part of Dharchula district.

Gyawali last week summoned the Indian Ambassador Vinay Mohan Kwatra and handed over a diplomatic note to him to protest against the construction of a key road connecting the Lipulekh pass with Dharchula in Uttarakhand.

India has said that the recently-inaugurated road section in Pithoragarh district in Uttarakhand lies completely within its territory. Indian Army chief Gen MM Naravane last week said that there were reasons to believe that Nepal objected to India''s newly-inaugurated road linking Lipulekh Pass with Dharchula in Uttarakhand at the behest of "someone else", in an apparent reference to a possible role by China on the matter.

He said there was no dispute whatsoever between India and Nepal in the area and road laid was very much within the Indian side.

The 80-KM-long strategically crucial road at a height of 17,000 KM along the border with China in Uttarakhand was thrown open by Defence Minister Rajnath Singh earlier this month.

Nepal has raised objection to the inauguration of the road, saying the "unilateral act" was against the understanding reached between the two countries on resolving the border issues. China on Tuesday said the Kalapani border issue is between India and Nepal as it hoped that the two neighbours could refrain from "unilateral actions" and properly resolve their disputes through friendly consultations.

After the endorsement of Nepal’s new map senior ruling party leader and member of Nepal Communist Party Standing Committee Ganesh Shah said the new move may escalate unnecessary tension between Nepal and India at a time when the country is fighting the coronavirus.

"The Nepal government should soon start a dialogue with India to resolve the matter through political and diplomatic moves," he said.

The new map includes 335-km land area including Limpiyadhura in the Nepalese territory.

The new map was drawn on the basis of the Sugauli Treaty of 1816 signed between Nepal and then the British India government and other relevant documents, which suggests Limpiyadhura, from where the Kali river originated, is Nepal''s border with India, The Kathmandu Post quoted an official at the Ministry of Land Reform and Management as saying.

India and Nepal are at a row after the Indian side issued a new political map incorporating Kalapani and Lipulekh on its side of the border in October last year.

The tension further escalated after India inaugurated the road link connecting Kailash Mansarovar, a holy pilgrimage site situated at Tibet, China, that passes through the territory belonging to Nepal.

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News Network
April 9,2020

Patna, Apr 9: In a horrifying incident, a migrant woman was sexually abused in a Gaya hospital where she was kept in an isolation ward. Three days later, she died due to excessive bleeding.

The matter came to light on Tuesday when her mother-in-law informed the authorities concerned about the shocking incident.

The 25-year-old victim had returned to Bihar’s Gaya district from Ludhiana (in Punjab) along with her husband on March 25. Before returning to her in-laws’ place, she had undergone abortion at Ludhiana just when she was two months pregnant.

On reaching Gaya, she complained of excessive bleeding. Her husband admitted her to Anugrah Narain Magadh Medical College and Hospital (ANMMCH) on March 27 where she was kept in the emergency ward.

Later, on April 1, on being suspected to be coronavirus patient, she was kept in an isolation ward. Her family members alleged that it was in this isolation ward where a doctor attending to her overnight outraged her modesty for two successive nights on April 2 and 3.

“The following day, she was discharged from the hospital after her coronavirus test report was found to be negative. However, after returning home, she remained aloof and struck by fear. On questioning, she revealed how a doctor had sexually abused her in the isolation ward. On April 6, she passed away due to excessive bleeding,” said her mother-in-law.

On receiving the information, the local police asked the mother-in-law to come to the hospital on Tuesday and identify the doctor (about whom the victim had given a description). However, the accused was not identified.

“Prima facie, the matter is serious. We are verifying the allegations. We will dig out the CCTV footage in the hospital and take strict action after identifying the culprit,” said Dr VK Prasad, the hospital superintendent.

Meanwhile, the Gaya police have arrested two people who posed as doctors and entered the isolation ward using doctors’ kits. One of the apprehended people works in a private.

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News Network
March 3,2020

New Delhi, Mar 3: Delhi's Tihar Prison authorities had made all necessary preparations for the hanging of four convicts in the Nirbhaya gangrape-and-murder case which was scheduled for Tuesday, officials said Monday.

However, on Monday evening, a city court deferred the hanging till further orders.

Postponing the execution, Additional Sessions Judge Dharmender Rana said the hanging cannot be carried out pending disposal of Pawan Gupta's mercy plea before the President, observing any condemned convict must not meet his "Creator" with grievance against courts for not acting fairly on the opportunity to exhaust legal remedies.

"We had made all the necessary arrangements for the execution of the four convicts which was scheduled for Tuesday at 6 AM. Now, the execution has been postponed and we are waiting for the further order by the court," a senior jail official said.

The hanging of the four men -- Mukesh Kumar Singh (32), Vinay Kumar Sharma (26), Akshay Kumar Singh (31) and Pawan -- who are lodged in Tihar jail, was fixed for March 3 in Tihar jail on a court order.

"We had checked the ropes. Hangman was called and dummy executions were carried out," another senior jail official said.

Barring Pawan, the other three had in the previous weeks moved curative petitions and mercy pleas which were all dismissed.

The first date of execution -- January 22 -- fixed on January 7 was postponed by the court to February 1. But on January 31, the court indefinitely postponed the hanging. On February 17, the court again issued fresh date for execution of death warrants for March 3 at 6 AM.

The court in its orders observed that the four convicts cannot be hanged since a mercy plea of one or the other convict was pending.

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