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 21,2020

Amaravati, Jan 21: Telugu Desam Party president N Chandrababu Naidu and at least 17 MLAs of his party were taken in police custody late on Monday as they tried to conduct a foot march from the state assembly to nearby Mandadam village in violation of prohibitory orders.

TDP leaders started off on the march after staging a sit-in near the assembly main entrance following the suspension of 17 MLAs from the House for the day.

They were protesting the AP Decentralisation and Inclusive Development of All Regions Bill, 2020, that was passed by the assembly, enabling the establishment of three capitals for the state.

The TDP leaders were taken to the Mangalagiri police station.

Meanwhile, tensions prevailed at the Jana Sena Party headquarters at Mangalagiri as police prevented its president Pawan Kalyan from proceeding to the Amaravati region to speak to protesters fighting for the retention of only one capital for the state.

DIG Kanti Rana Tata and other senior police officials reached the Sena office and blocked the exit of Kalyan and political affairs committee chairman Nadendla Manohar, resulting in an argument.

Kalyan asked how could police impose restrictions within his own office.

Scores of Sena workers gathered outside the office even as a large posse of police was posted to thwart Kalyan and other leaders' plans.

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Agencies
February 27,2020

New Delhi, Feb 27: The US Commission on International Religious Freedom (USCIRF) has said that the Delhi violence in which over 30 people were killed, was specifically targeted against the Muslims.

Expressing "grave concern over the ongoing violence taking place in Delhi", the USCIRF in a statement said that as President Donald Trump's inaugural visit to India winds down, North-East Delhi has been rocked by deadly rioting, with reports of violence and mobs specifically targeting Muslims.

"These incidents are even more concerning in the context of efforts within India to target and potentially disenfranchise Muslims across the country, in clear violation of international human rights standards," USCIRF Commissioner Anurima Bhargava said.

"According to reports, several mosques have also been set alight or vandalized. Many Muslim residents have been forced to flee the area. This unrest comes in the wake of widespread protests against the Citizenship (Amendment) Act following its passage in December 2019.

"The brutal and unchecked violence growing across Delhi cannot continue," Bhargava said adding that the Indian government must take swift action to ensure the safety of all of its citizens.

"Instead, reports are mounting that the Delhi police have not intervened in violent attacks against Muslims, and the government is failing in its duty to protect its citizens."

USCIRF Chair Tony Perkins said the ongoing violence in Delhi and the reported "attacks against Muslims, their homes and shops, and their houses of worship are greatly disturbing".

One of the essential duties of any responsible government, he said, is to provide protection and physical security for its citizens, regardless of faith.

"We urge the Indian government to take serious efforts to protect Muslims and others targeted by mob violence."

In its annual report last year, the USCIRF classified India as a "Tier 2" country for engaging in or tolerating religious freedom violations that meet at least one of the elements of the "systematic, ongoing, egregious standard for designations as a "country of particular concern (CPC)", under the International Religious Freedom Act.

The ongoing violence in North-East Delhi erupted after clashes between pro and anti-CAA protesters on Sunday.

Besides the casualties, over 200 others have been injured in the deadliest violence in the national capital in decades.

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News Network
January 1,2020

New Delhi, Jan 1: The new Army chief Lieutenant General MM Naravane on Wednesday said that India needs to pay more attention to its border along China and asserted that the force is capable of dealing with any security challenge.

"We have been giving attention to our western front in the past. The northern front now also requires an equal amount of attention... The Army is capable of tackling any dangers to the country," General Naravane told reporters after receiving the first Guard of Honour as the Army chief.

"In that context, we are now going in for capability development and enhancement of our capacities even in our northern borders which includes the northeastern part of our country," he said.

On the border dispute with China, the Army chief said that continuing peace along the border will pave the way for a solution.

He said: "We have been able to maintain peace and tranquility along borders and I'm sure that situation will prevail. By maintaining this, we will be able to set the stage for the eventual solution."

General Naravane said that operational readiness and modernisation will be among the top priorities of the Army under his leadership.

"Our priority will be to be ready to meet any challenge and to be operationally prepared at all times. This will happen as a result of modernisation. We will continue to build our capability especially in the North and Northeast region of our country," he said.

He said that the Indian Army will pay special attention to respect human rights. "We will also pay special emphasis on raising security awareness among ranks and file and pay special attention to respect human rights," the Army chief said.

Assuring the country on security, he said, "All three services — the Army, the Navy and the Air Force — are ready to defend the country."

He extended wishes to people in the new year and hoped that the country will make huge progress in this decade.

General Naravane took over as the 28th Chief of the Army Staff (COAS) on Tuesday, succeeding General Bipin Rawat who has become India's first Chief of Defence Staff (CDS).

General Naravane was previously the Vice Chief of Army Staff.

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