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 22,2020

New Delhi, May 22: Reserve Bank Governor Shaktikanta Das on Friday extended the moratorium on payment of loans by another three months till August to provide much-needed relief to borrowers whose income has been hit due to the coronavirus crisis.

In March, the central bank had allowed a three-month moratorium on payment of all term loans due between March 1, 2020, and May 31, 2020.

Accordingly, the repayment schedule and all subsequent due dates, as also the tenor for such loans, were shifted across the board by three months.

As a result of this moratorium, individuals’ EMI repayments of loans taken were not deducted from their bank accounts, providing much-needed liquidity.

The EMI payments will restart only once the moratorium time period expires on August 31.

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News Network
May 19,2020

New Delhi, May 19: Spitting at workplace will be punishable with fine, the Personnel Ministry has said, citing the national directives for COVID-19 management.

In an order issued to all central government departments, it has asked their heads to ensure strict compliance of this and other directives in this regard.

This order is likely to bring about changes in and around government and private work places, where one can easily spot stains of 'pan' and 'gutka' spitted at some of the corners of walls or areas not frequented by many employees/public.

"Spitting in public and work places shall be punishable with fine, as may be prescribed in accordance with its laws, rules and regulations by the state/union territory local authority," said the national directives issued by the Home Ministry and shared by the Personnel Ministry with all central government departments.

It said wearing 'face cover' is compulsory in all public and work places.

In additional directives for the work places, the ministry said as far as possible, the practice from work from home should be followed.

"Staggering of work/business hours shall be followed in offices, work places, shops, markets and industrial and commercial establishments. Provision for thermal scanning, hand wash and sanitiser will be made at all entry and exit points and common areas," the directives said.

Frequent sanitization of the entire workplace, common facilities and all points which come into human contact e.g. door handles etc., shall be ensured, including between shifts, it said.

"All persons in charge of work places shall ensure social distancing through adequate distance between workers, adequate gaps between shifts, staggering the lunch breaks of staff, etc," the directive said.

The Centre on Monday asked 50 per cent of its junior employees, below the level of deputy secretary, to join work in office.

Till now, only 33 per cent of such employees were asked to attend office due to the novel coronavirus lockdown.

Central government employees were asked to work from home due to the lockdown that came into force from March 25.

All officers of the level of deputy secretary and above have already been asked to attend office on all working days.

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News Network
April 9,2020

Thiruvananthapuram, Apr 9: Kerala, which was among the first state in the country to report a Corona positive case, has turned its entire public healthcare system into a single interconnected grid to generate uninterrupted information and provide flawless services, thanks to the daily zoom or video conferences of top health authorities for chalking out a dynamic strategy to tackle the COVID-19 pandemic.

The daily zoom or remote conferences held by Health Minister K K Shailaja and top health sector officials with the medical and paramedical personnel on the ground have lent a cutting edge to the state government’s all out efforts in monitoring the situation on the ground and formulating effective responses to address the various needs and concerns of the people, an official release said on Thursday.

The Minister is joined in this meticulous exercise by top administrators and planners, including Dr Rajan N Khobragade, Principal Secretary, Health; Dr. Rathan U Kelker, State Mission Director, National Health Mission, Dr Saritha, Director of Health Services, Dr Ramla Beevi, Director of Medical Education and other senior officials.

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