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 2,2020

Kolkata, Jan 2: In what could spark fresh tensions between West Bengal Chief Minister Mamata Banerjee and the BJP-led centre, the Union Ministry of Defence on Wednesday rejected her state's tableau proposal for the Republic Day parade on January 26.

"The tableau proposal of West Bengal government was examined by the expert committee in two rounds of meetings. The tableau proposal of the West Bengal government was not taken forward for further consideration by the committee after deliberations in the second meeting," the ministry said in its statement.

Twenty two proposals comprising 16 states and union territories and six ministries and departments have been shortlisted for the parade. The shortlist was compiled from as many as 56 tableau proposals - 32 from states and union territories and 24 from various ministries and departments - received by the central government.

"The expert committee examines the proposals on the basis of theme, concept, design and visual impact before making its recommendations. Due to time constraints arising out of the overall duration of the parade, only a limited number of tableaux can be shortlisted for participation in the parade," the statement read, adding that West Bengal was shortlisted for the 2019 Republic Day parade through a similar process.

"The rejection of the West Bengal tableau for the Republic Day parade is discriminatory. It has been done because West Bengal has been opposing the centre's CAA (Citizenship Amendment Act) and the NRC (National Register of Citizens) plans," Trinamool Congress MP Saugata Roy told news agency.

"West Bengal is known to be living state as far as culture, including arts, music and other things are concerned. So obviously, this is a discriminatory step taken by the central government against West Bengal," Mr Roy added.

The Trinamool Congress-led Bengal government is at loggerheads with the central government over several issues, and the expanding presence of the BJP in the eastern state ahead of the 2021 assembly elections has further intensified their rivalry.

Mamata Banerjee has repeatedly said that she will not allow Bengal to be a part of the proposed nationwide National Register of Citizens, an assertion that the BJP claims is proof of her minority appeasement strategy. Last month, a four-member delegation of Trinamool Congress politicians that visited BJP-ruled Uttar Pradesh to meet families of those killed in violent protests against the Citizenship Amendment Act were stopped by police personnel at the Lucknow airport.

The BJP leadership has now decided to launch a campaign blitzkrieg in West Bengal to counter what it claims is the Trinamool's "misinformation programmes" against the amended citizenship law and reach out to refugees. Protests across the country have currently put the party on the backfoot.

The Citizenship Amendment Act, for the first time, makes religion the test of citizenship in India. The government says it will help minorities from three Muslim-dominated countries get citizenship if they fled to India because of religious persecution before 2015. Critics say it is designed to discriminate against Muslims and violates the secular principals of the Constitution.

Brazilian President Jair Bolsonaro will be the chief guest at the Republic Day celebrations.

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Agencies
June 2,2020

Singapore, Jun 2: Moody's Investors Service on Tuesday downgraded 11 Indian banks along with as many non-financial companies and infrastructure majors besides four government-related issuers following a downgrade of the Indian government's issuer rating to Baa3 from Baa2 with a negative outlook.

The rapid and widening spread of the coronavirus outbreak, deteriorating global economic outlook, volatile oil prices and asset price declines are creating a severe and extensive credit shock across many sectors, regions and markets, said Moody's.

The Indian banking sector has been affected given the disruptions to India's economic activity from the coronavirus outbreak, which is weakening borrowers' credit profiles, it added.

The 11 lenders include Bank of Baroda, Bank of India, Canara Bank, Central Bank of India, Export-Import Bank of India, HDFC Bank, Indian Overseas Bank, IndusInd Bank, Punjab National Bank, State Bank of India and Union Bank of India.

The 11 non-finance companies are Oil and Natural Gas Corporation, Hindustan Petroleum Corporation, Oil India, Indian Oil Corporation, Bharat Petroleum Corporation, Petronet LNG, Tata Consultancy Services, Infosys, Reliance Industries, UPL Corporation and Genpact.

The 11 infrastructure companies are NTPC, NHPC, National Highways Authority of India, Power Grid Corporation, Gail India, Adani Green Energy Restricted Group (RG-2), Adani Transmission Restricted Group, Adani Ports and Special Economic Zone, Adani Transmission, Adani Electricity Mumbai and Azure Power Solar Energy.

The four Indian government-related issuers are Indian Railway Finance Corporation, Housing and Urban Development Corporation, Power Finance Corporation and REC Ltd.

"Government-related issuers in India have been affected because of disruptions to India's economy which will weaken borrowers' credit profiles," said Moody's.

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News Network
March 3,2020

Daman, Mar 3: A BJP councillor was shot dead on Monday in the Union Territory of Daman, police said.

Salim Memon was sitting in his motorcycle showroom when three to four unidentified persons shot four to five bullets after asking a visitor there to move out, an official said quoting eye-witnesses.

While fleeing, they also shot two rounds close to this visitor who was standing outside, he said.

"Memon was rushed to a hospital in Marwad area but was declared dead on arrival. CCTV footage is being scanned to nab the culprits," said Daman Superintendent of Police Vikramjit Singh.

Memon was elected to Daman municipality as a Congress candidate but then switched over to the BJP.

Sources said Memon, who also has a land brokerage business, had come out of jail a few months back in connection with a case of rivalry.

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