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
July 15,2020

New Delhi, Jul 14: India's COVID-19 tally has reached 9,36,181 as 29,429 new coronavirus cases were reported in the last 24 hours, informed the Union Ministry of Health and Family Welfare on Wednesday.

The death toll went up to 24,309, including 582 fatalities in the last 24 hours.

Out of the total cases, 3,19,840 are currently active and 5,92,032 are cured/discharged/migrated.

As per the Ministry, Maharashtra -- the worst-affected state from the infection -- has a total of 2,67,665 COVID-19 cases and 10,695 fatalities. While Tamil Nadu has a tally of 1,47,324 cases and 2,099 deaths due to COVID-19.

Delhi has reported a total of 1,15,346 cases and 3,446 deaths due to COVID-19.

As per the information provided by the Indian Council of Medical Research (ICMR) 3,20,161 samples have been tested for COVID-19 till July 14, of these 1,24,12,664 samples were tested on Tuesday.

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Agencies
January 9,2020

Kashmir, Jan 9: US Ambassador to India Kenneth I Juster along with envoys from 15 other countries arrived in Srinagar on a two-day visit to Jammu and Kashmir on Thursday, the first visit by diplomats since the abrogation of the erstwhile state's special status in August last year.

The Delhi-based envoys arrived in Srinagar by a special chartered flight at Srinagar's technical airport where top officials from the newly carved out union territory received them, officials said.

Later in the day, they would be going to Jammu, the winter capital of the newly created Union Territory, for an overnight stay. They will meet Lt Governor G C Murmu as well as civil society members, they said.

Besides the US, the delegation will include diplomats from Bangladesh, Vietnam, Norway, Maldives, South Korea, Morocco, and Nigeria, among others.

Brazil's envoy Andre Aranha Correa do Lago was also scheduled to visit Jammu and Kashmir. However, he backed out because of his preoccupation here, the officials said on Wednesday.

Envoys from the European Union (EU) countries are understood to have conveyed that they will visit the union territory on a different date and are also believed to have stressed on meeting the three former chief ministers -- Farooq Abdullah, Omar Abdullah and Mehbooba Mufti -- who are under detention.

Officials said envoys of several countries had requested the government for a visit to Kashmir to get a first-hand account of the situation in the Valley following the August 5 decision to abrogate provisions of Article 370 and bifurcate it into two union territories, Jammu and Kashmir, and Ladakh.

This is the second visit of a foreign delegation to Jammu and Kashmir since August 5. Earlier, Delhi-based think tank International Institute for Non-Aligned Studies, a Delhi-based think tank took 23 EU MPs on a two-day visit to assess the situation in the union territory.

The government had distanced itself from the visit with Minister of State for Home G Kishan Reddy informing Parliament that the European parliamentarians were on a "private visit".

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Agencies
May 3,2020

Lucknow, May 3:Holding the Tablighi Jamaat responsible for the spread of COVID-19, Uttar Pradesh Chief Minister Yogi Adityanath on Saturday said that being infected with a virus is not a crime but to hide it is definitely a crime.

Speaking at a programme of a news channel, Adityanath said, "The role of Tablighi Jamaat was most condemnable. To get a disease is not a crime but to hide a disease which is infectious is definitely a crime. And this crime has been done by those associated with the Tablighi Jamaat."

"In Uttar Pradesh and other places where the spread of the coronavirus has been seen, Tablighi Jamaat is behind it. Had they not hidden the disease and went about like its carriers, then perhaps we would have controlled the coronavirus outbreak to a large extend," he said.

The chief minister said action would be taken against them for the "crime that they have committed".

A Tablighi Jamaat congregation in Delhi in March turned out to be a major source of COVID-19 cases, with those who attended the meet returned home in different parts of the country after being infected with the deadly virus.

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