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. 

Comments

Add new comment

  • Coastaldigest.com reserves the right to delete or block any comments.
  • Coastaldigset.com is not responsible for its readers’ comments.
  • Comments that are abusive, incendiary or irrelevant are strictly prohibited.
  • Please use a genuine email ID and provide your name to avoid reject.
News Network
January 21,2020

Amaravati, Jan 21: Telugu Desam Party president N Chandrababu Naidu and at least 17 MLAs of his party were taken in police custody late on Monday as they tried to conduct a foot march from the state assembly to nearby Mandadam village in violation of prohibitory orders.

TDP leaders started off on the march after staging a sit-in near the assembly main entrance following the suspension of 17 MLAs from the House for the day.

They were protesting the AP Decentralisation and Inclusive Development of All Regions Bill, 2020, that was passed by the assembly, enabling the establishment of three capitals for the state.

The TDP leaders were taken to the Mangalagiri police station.

Meanwhile, tensions prevailed at the Jana Sena Party headquarters at Mangalagiri as police prevented its president Pawan Kalyan from proceeding to the Amaravati region to speak to protesters fighting for the retention of only one capital for the state.

DIG Kanti Rana Tata and other senior police officials reached the Sena office and blocked the exit of Kalyan and political affairs committee chairman Nadendla Manohar, resulting in an argument.

Kalyan asked how could police impose restrictions within his own office.

Scores of Sena workers gathered outside the office even as a large posse of police was posted to thwart Kalyan and other leaders' plans.

Comments

Add new comment

  • Coastaldigest.com reserves the right to delete or block any comments.
  • Coastaldigset.com is not responsible for its readers’ comments.
  • Comments that are abusive, incendiary or irrelevant are strictly prohibited.
  • Please use a genuine email ID and provide your name to avoid reject.
News Network
April 23,2020

New Delhi, Apr 23: Congress president Sonia Gandhi on Thursday accused the BJP of spreading the virus of communal prejudice and hatred in the country, asserting that "grave damage" is being done to social harmony

Addressing a meeting of the Congress Working Committee, Gandhi said it should worry every Indian and her party will have to work hard to repair this damage.

"Let me also share with you something that should worry each and every one of us as Indians. When we should be tackling the coronavirus unitedly, the BJP continues to spread the virus of communal prejudice and hatred," she said.

"Grave damage is being done to our social harmony. Our party, we will have to work hard to repair that damage," the Congress president added

Former prime minister Manmohan Singh, former Congress president Rahul Gandhi and top Congress leaders attended the meeting through video conference

This is the second time the CWC, the Congress' top decision-making body, is meeting through video-conferencing in the past three weeks ever since the lockdown was enforced to contain the coronavirus threat.

The Congress president said the coronavirus pandemic has increased disturbingly in the past three weeks and called upon the government to increase testing for it

Gandhi said she has written several times to the prime minister since the lockdown was enforced and suggested several measures and constructive cooperation

"Unfortunately, they have been acted upon only partially and in a miserly way. The compassion, large-heartedness and alacrity that should be forthcoming from the central government is conspicuous by its absence," she said

The Congress chief said the focus of the party must continue to be on successfully engaging with health, food security and livelihood issues.

She claimed that around 12 crore people have lost jobs in the first phase of the lockdown and urged the government to provide a relief package for the MSME sector, which accounts for one-third of the GDP

Gandhi called upon the government to provide food and financial security to migrants and jobless stranded at various places and were desperate to reach back home

"We have repeatedly urged PM there is no alternative to testing, tracing and quarantine. Unfortunately, testing still remains low, testing kits still in short supply," she noted

Gandhi said trade, commerce and industry have come to a virtual halt and crores of livelihoods have been destroyed.

"The central government does not appear to have a clear idea on how the situation will be managed after May 3rd. A lockdown of the present nature after that date would be even more devastating," she said

Former prime minister Manmohan said the success of the lockdown will be judged finally on India's ability to tackle COVID-19

He also said the cooperation between the Centre and states was key to success of the country's fight against coronavirus

Singh said it is necessary to focus on a number of issues in the fight against coronavirus

The fight against COVID-19 would very much depend upon the availability of resources, he noted

Rajasthan chief minister Ashok Gehlot said unless the central government comes forward to financially help states, the fight against COVID-19 will get weakened

"Unless there is a big financial package for states, how will normalcy return to states post lockdown," he asked

Chhattisgarh chief minister Bhupesh Baghel said unless the Centre rises to the occasion and provides financial assistance to states, how will the fight against COVID-19 be won

Puducherry chief minister V Narayanasamy said the Union government has not given any assistance to the states

"How will states survive in times of crisis. We are not enemies but have to act and work together," Narayanasamy said at the CWC meet.

Comments

Add new comment

  • Coastaldigest.com reserves the right to delete or block any comments.
  • Coastaldigset.com is not responsible for its readers’ comments.
  • Comments that are abusive, incendiary or irrelevant are strictly prohibited.
  • Please use a genuine email ID and provide your name to avoid reject.
News Network
June 17,2020

New Delhi, Jun 17: Police Surender Jeet Kaur, Assistant Commissioner of Delhi Police Surender Jeet Kaur, has held herself responsible for the death of her husband Charan Jeet Singh, who succumbed to Covid at a hospital in Delhi.

“My husband didn’t step out of the house when the lockdown started, but I went out daily because of my job… I will never be able to forgive myself,” Kaur on Tuesday, a day after losing her husband.

54-year-old Singh, a resident of Lajpat Nagar and a businessman, is survived by his wife and their 26-year-old son who lives in Canada.

Kaur, 57, ACP (Crimes Against Women) in the South-East district of the Delhi Police, is also ACP (Covid Cell) of the district. On May 20, five days after Kaur tested positive for the virus, her husband Singh tested positive, followed by the ACP’s 80-year-old father on May 24.

All of them had symptoms and while Kaur and Singh were admitted to Indraprastha Apollo hospital, her father was admitted to Max hospital in Saket. On May 26, Kaur returned home after recovering from the virus.

Kaur said, “I last spoke to my husband on May 22 night, when we were both admitted in the hospital in different wards. The doctor called me and said that my husband needs to be put on ventilator support. I had a video call with my husband. He was breathless and told me that his oxygen level was dropping. He showed me the monitor, the doctors in the room, and then said he was having trouble speaking and that he would send me WhatsApp messages.”

A day after he passed away, Kaur recalled the messages that Singh sent her just before being put on ventilator support. “He started sending me details of our finances, accounts… I told him to stop and asked him why he was telling me all this. He said I needed to know… Maybe he feared he wouldn’t come back. I prayed every day, at temples, mosques, churches and gurdwaras for him. I am devastated that he’s gone. We were to move to Canada to live with our son in 2023 after my retirement. We had so many plans.”

Kaur’s brother Maninder Ahluwalia said the hospital tried plasma therapy but Singh didn’t respond to the treatment. “He had diabetes and high BP, but those were always under control. We were hopeful,” he said.

The couple’s son joined on video call from Canada to watch his father’s last journey from the ambulance to the entrance of the crematorium. “My son couldn’t attend his father’s last rites because there are no flights… It’s so unfortunate,” said Kaur.

Friends and family remember Singh as a “jolly, disciplined and brave man”, while Kaur said he was the “perfect partner”. She said, “When I was an SHO-rank officer, I would work for 36 hours straight some days, and he would handle the house and our son who was growing up. I would miss family functions and important occasions but he would always go and make up for my absence. I was able to do this job for decades because of his support.”

On Tuesday afternoon, Singh was cremated in the presence of close family and members of the police fraternity. “The DCP and the Joint CP called me daily to enquire about my husband, other police officers too. I am grateful for their support. They didn’t let me feel alone for a single day,” said Kaur.

Comments

Add new comment

  • Coastaldigest.com reserves the right to delete or block any comments.
  • Coastaldigset.com is not responsible for its readers’ comments.
  • Comments that are abusive, incendiary or irrelevant are strictly prohibited.
  • Please use a genuine email ID and provide your name to avoid reject.