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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Agencies
June 27,2020

Mumbai, Jun 27: The Shiv Sena on Saturday hit out at the BJP over its charge that the Rajiv Gandhi Foundation (RGF) had accepted donations from the Chinese embassy, and asked it whether the issue had any connection with intrusion by the neighbouring country in Ladakh and the martyrdom of 20 Indian soldiers.

The Sena also alleged that those raising questions against the government over the standoff with China were being labelled as Chinese agents by the BJP.

BJP chief J P Nadda had on Thursday targeted the Congress and the Gandhi family saying that the RGF had allegedly accepted donations from the Chinese embassy. Hitting back, the Congress had said that the RGF issue raised by the BJP government was a "manufactured charge" and "diversionary tactic" to deflect attention from the LAC crisis.

"What do you mean by Congress gets money from China? Instead of responding to the issues raised by Sonia Gandhi and Rahul Gandhi over the Chinese incursions, the BJP leaders accused the Congress of receiving funds from China," the Sena said in an editorial in party mouthpiece 'Saamana'.

"Will BJP's revelations about the donations stop the Chinese activities along the border? The BJP should tell what connection does these donations have with the Chinese incursion and the martyrdom of 20 soldiers," it added.

"In our country, many political leaders and parties, and not just the Congress, are beneficiaries of foreign countries. The BJP speaking about this is like throwing stones in the mud," it said.

The Uddhav Thackeray-led party said that Chinese President Xi Jinping visited India twice in the last six years.

"He was hosted in Gujarat. But it is a fact that China has betrayed. Holding talks on the one hand and continuing with the offensive along the border on the other hand is China's old policy," it said.

In the present scenario, the entire country stands firmly with PM Modi. This crisis is not for the BJP or the Congress, but for the entire country, whose prestige is at stake, it said.

"The BJP can fight with the Congress any time later.

But now is the time to fight against China. It should speak on that," the Sena said.

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Agencies
January 26,2020

Guwahati, Jan 26: Four powerful grenade explosions--three in Dibrugarh and one in Charaideo districts--rocked Assam Sunday morning as the country celebrated Republic Day, police said.

In Dibrugarh district, an explosion took place at Graham Bazar and another beside a gurudwara on A T Road, both under Dibrugarh police station.

Another explosion rocked the oil town of Duliajan whose details are still awaited, police said.

Another explosion rocked Teok Ghat under Sonari police station of Charaideo district, they said.

Senior officials have rushed to the explosion sites and details of casualty are awaited, police added.

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News Network
May 7,2020

Visakhapatnam, May 7: Unconscious children being carried by parents in their arms, people laying on roads, health workers scrambling to attend to those affected by the styrene vapour leak and residents fleeing were some of the scenes that played out near here on Thursday, bringing back grim memories of the 1984 Bhopal gas tragedy.

The leak of styrene, a chemical used to make synthetic rubber and resins, among others, occurred in the wee hours of Thursday while people were still fast asleep.

Women and children were seen lying on roads struggling to breath, reminiscent of the infamous Bhopal gas tragedy when a leak from the Union Carbide plant left around 3,500 dead and many maimed.

The worst-hit Gopalapatnam village reverberated with cries of people for help.

Many people fell unconscious during their sleep, a villager said.

Affected people, suffering writ large on their faces, were rushed to hospitals in autorickshaws and on two wheelers.

Visakhapatnam Collector Vinay Chand said 20 ambulances were pressed into service as soon information about the gas leak was received.

Exposure to styrene, also known as ethenylbenzene, vinylbenzene can affect the central nervous system (CNS), causing headache, fatigue, weakness, and depression.

It is primarily used in the production of polystyrene plastics and resins.

The gas leak took place at LG Polymers chemical plant.

LG Polymers was established in 1961 as "Hindustan Polymers" for manufacturing Polystyrene and its co-polymers at Visakhapatnam. It merged with McDowell & Co. Ltd of UB Group in 1978, according to the company's website.

Taken over by LG Chem (South Korea), Hindustan Polymers was renamed LG Polymers India Private Limited (LGPI) in July, 1997.

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