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
April 27,2020

New Delhi, Apr 27: Prime Minister Narendra Modi on Monday held a video conference with chief ministers to discuss the situation arising due to the coronavirus pandemic in the country, which has been under a lockdown since March 25 to contain the spread of the virus, amid indications that the interaction would also focus on a graded exit from the ongoing lockdown.

This is Modi's fourth such interaction with state chief ministers since March 22 when he discussed coronavirus situation and steps taken both by the Centre and the states to contain the pandemic.

Two days later on March 24, Modi announced a 21-day nationwide lockdown. He extended the lockdown by 19 days on April 14, the last day of the initial three week shutdown, till May 3.

Sources in the government had on Sunday indicated that besides discussing the way forward in dealing with the pandemic, the prime ministers and chief ministers could also focus on a "graded" exit from the lockdown.

In a tweet on Monday, the Prime Minister's Office said Modi and the chief ministers will be discussing aspects relating to the COVID-19 situation.

In his monthly 'Mann ki Baat' radio address on Sunday, the prime minister said the country is in the middle of a 'yudh' (war) and asserted that people have to continue being careful and take precautions.

His note of caution came amidst gradual exemptions being granted by the Centre and states to revive economic activities.

"I urge you not to get overconfident. You should in your over-enthusiasm not think that if the coronavirus has not yet reached your city, village, street or office, it is not going to reach now. Never make such a mistake. The experience of the world tells us a lot in this regard," Modi said while referring to a popular Hindi idiom 'Sawdhani hati, durghatna ghati' (disaster strikes when you lower your concentration).

The Centre and the state governments have been giving gradual exemptions to boost economic activities as also to provide relief to people as some states want further relaxation in areas which have seen few or no coronavirus cases.

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News Network
June 3,2020

Jammu, Jun 3: A mob on Tuesday disrupted the last rites of a coronavirus victim in Jammu and Kashmir and forced his family members to flee with the half-burnt body, prompting intervention by the administration which later ensured the cremation at another place as per protocol.

A 72-year-old man, hailing from Doda district, became the fourth victim of the novel coronavirus to die in Jammu region. He breathed his last at the Government Medical College (GMC) hospital on Monday.

"We had set out for the funeral along with a revenue official and a medical team, and had lit the pyre at a cremation ground in Domana area when a large group of local residents appeared at the scene and disrupted the last rites," son of the deceased said.

Only close relatives of the deceased, including his wife and two sons, were present during the cremation. They had to flee with the half-burnt body in an ambulance to save their skin from the mob which pelted stones and attacked them with sticks.

"We had sought permission from the government to take the body to our home district for the last rites, but we were told that all necessary arrangements were in place, and that we would not face any trouble during the cremation," the victim's son said.

He also alleged that the security officials present at the scene were of no help.

Two policemen who were present there failed to act against the unruly crowd, while the accompanying revenue official went missing, he said.

"The ambulance driver and other staff from the hospital helped us a lot and managed to take us back to the GMC hospital with the body the government should have come out with a better plan to conduct the last rites of coronavirus victims, taking into consideration the past experience and problems encountered during the funeral of such victims," the victim's son said.

Later, the body was taken to a cremation ground at Bhagwati Nagar area of the city, where it was consigned to flames in the afternoon in presence of senior civil officials, including additional deputy commissioner and sub-divisional magistrate under tight security.

"My uncle was admitted in the hospital last week and died on Monday afternoon. He was suffering from various ailments, especially lungs and heart diseases. Before shifting him to GMC hospital Jammu, he underwent a coronavirus test in Doda which came negative," nephew of the deceased said.

However, he said, the victim's second test after his admission in the GMC hospital came positive on Sunday.

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News Network
May 25,2020

New Delhi, May 25: India witnessed the highest ever spike of 6,977 positive cases in the last 24 hours, taking the total number of COVID-19 to 1,38,845, according to the Union Ministry of Health and Family Welfare.

India is now among the top 10 countries in the world regarding the total number of COVID-19 cases.

With 154 deaths reported in the last 24 hours, the total number of deaths due to COVID-19 now stands at 4,021 in the country.

Out of the total number of cases, 77,103 are active cases and 57,721 have been cured/discharged/migrated.

Maharashtra continues to remain the worst affected state with 50,231 COVID-19 cases, followed by Tamil Nadu (16,277), Gujarat (14,056) and Delhi (13,418).

The fourth phase of the nationwide lockdown imposed as a precautionary measure to contain the spread of COVID-19 is scheduled to end on May 31.

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