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 26,2020

New Delhi, May 26: With India now in the bracket of top 10 nations worst hit by the novel coronavirus, experts have attributed the surge in cases to easing of travel restrictions and movement of migrants besides enhanced testing capacity.

According to AIIMS Director, Randeep Guleria, the present rise in cases has been reported predominantly from hotspot areas but there is a possibility of further rise in the number of COVID-19 cases in the coming few days due to increased travel.

"Those who are asymptomatic or are in presymptomatic stage will pass through screening mechanisms and may reach areas where there have been minimal or less cases," Guleria said.

He said there was a need for more intense surveillance and monitoring in areas where migrants have returned to contain the spread of the disease.

If proper social distancing and hand hygiene is not maintained at a time when people are out on roads, the coronavirus infection will transmit much faster, he said.

Guleria also noted that testing capacity has been significantly ramped up which is reflecting in the increasing number of cases being detected.

Commenting on the partial resumption of rail and road transport services and migrants returning to their native places, Dr Chandrakant S Pandav, former president of the Indian Public Health Association and Indian Association of Preventive and social medicine, said the floodgates have been opened.

"This is a classic case of creating an enabling environment for coronavirus to spread like wildfire. In the coming few days, the number will rise dramatically. While it is true that lockdown cannot go on forever, the opening up should have been in a measured, calibrated and informed manner," he said.

"Travelling leads to spread of the infection. Now, the government will have to ensure even stronger surveillance to curb the infection but if that will be done is something to be observed," he said.

The death toll due to COVID-19 rose to 4,167 and the number of cases climbed to 1, 45,380 in the country, registering an increase of 146 deaths and 6,535 cases since Monday 8 am, according to the Union Health Ministry.

Dr K K Aggarwal, President of the Confederation of Medical Association of Asia and Oceania (CMAAO), and former IMA President, said there will be a further surge in cases in the coming days if migration continues without any proper social distancing.

"Within the next ten days, the cases will cross two lakh. The very fact that number of cases was rising before the end of the third lockdown and continuing during the fourth lockdown means that people are not following physical distancing as required," he said.

"Even in the last week of May when the temperature is very high, the rising number of cases would mean that human-to-human transmission is more important than surface-to-human transmission. Normally in heat the surface-to-human transmission should have reduced the new cases by half which has not happened," Aggarwal said.

However, Professor K Srinath Reddy, president of the Public Health Foundation of India, said an increase in the number of cases reflects both an increase in testing rates and an increase in spread.

"What we need to see is the number of new tests performed per day and the number of new cases that were identified from them. That gives a better idea of the rate of spread than the total number of new cases alone.

"We also have to see if the testing criteria has remained the same between the two periods of comparison.We may open up gradually but will have to continue case detection, contact tracing and follow personal protection measures as vigorously as possible," he added.

A total of 31,26,119 samples have been tested as on May 26, 9 am and 92,528 samples have been tested in the last 24 hours, ICMR officials said.

India is the tenth most affected nation by the pandemic after the US, Russia, UK, Spain, Italy, Brazil, Germany, Turkey and France, as per the John Hopkins University data.

The country has recorded 6,088, 6,654, 6,767 and 6977 cases on May 22, 23, 24 and 25 respectively. Also, the number of RT-PCR tests for detection of COVID-19 in the country crossed the 30-lakh mark on Monday.

The first two phases of the lockdown led to 14-29 lakh COVID-19 cases being averted, while the number of lives saved in that period was between 37,000 and 78,000, the government said last Friday, citing various studies, and asserted that the unprecedented shutdown has paid "rich dividends" in the fight against the pandemic.

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News Network
February 26,2020

Feb 26: In his first reaction to incidents of violence in Delhi which have left at least 20 people dead, Prime Minister Narendra Modi on Wednesday appealed for peace and brotherhood, and said he has held an extensive review of the prevailing situation in various parts of the national capital.

He also said it was important that calm and normalcy was restored at the earliest.

“Had an extensive review on the situation prevailing in various parts of Delhi. Police and other agencies are working on the ground to ensure peace and normalcy,” Modi tweeted.

Stressing that peace and harmony are “central to our ethos”, Modi said, “I appeal to my sisters and brothers of Delhi to maintain peace and brotherhood at all times.”

At least 20 people have been killed since Sunday in communal violence in Northeast Delhi, triggered after clashes between pro and anti-CAA protestors over the Citizenship (Amendment) Act.

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News Network
May 28,2020

May 28: Congress President Sonia Gandhi on Thursday asked the central government to unlock its coffers and help the needy affected by the coronavirus-induced lockdown.

In a video message posted as part of the Congress' 'Speak Up India' campaign, she lamented that even though the country is passing through a serious economic crisis with loss of livelihood due to the pandemic and the lockdown, the central government has not heard the cries of pain and trauma of people.

"We again urge the Centre to unlock its coffers and help the needy. Put direct cash of Rs 7,500 per month in the account of every family for the next six months and provide Rs 10,000 immediately; ensure safe and free travel of labourers back home, employment opportunity and rations; and also increase the number of work days under MNREGA to 200 days to facilitate jobs in villages," Gandhi said.

"Instead of loans, provide financial relief to small and medium industry so that crores of jobs are saved and the country progresses," she said in her video message on the party's social media handles.

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