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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Agencies
May 27,2020

Global health experts on Wednesday said novel coronavirus is here to stay for more than a year and called for aggressive testing to prevent its spread.

In an interaction with Congress leader Rahul Gandhi, health experts Professor Ashish Jha and Professor Johan Giesecke talked about the COVID-19 pandemic as part of the series being aired on Congress social media channels.

While Jha exuded confidence that a vaccine will be available in a year's time, Prof Giesecke said India should practice a lockdown that is as 'soft' as possible, as a severe lockdown will ruin its economy very quickly.

"When the economy is opened up after lockdown, you have to create confidence among people," Harvard health expert Ashish Jha told Gandhi.

Jha is a professor of Global Health at TH Chan School of Public Health and Director, Harvard Global Health institute.

He said coronavirus is a '12-18 months' problem and the world is not going to be free of this till 2021.

The expert also called for the need for aggressive testing strategy for high-risk areas.

Gandhi, while interacting with the experts, said life is going to change post COVID-19.

"If 9/11 was a new chapter, this will be a new book," he remarked.

Professor Johan Giesecke, former chief scientist, European Centre for Disease Prevention and Control said India should have a 'soft lockdown'.

"The situation that India is in, I think, you should have a soft lockdown, as soft as possible," he said.

"I think for India, you will ruin your economy very quickly if you have a severe lockdown. It is better, skip the lockdown, take care of the old and the frail...," he noted.

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Agencies
May 22,2020

New Delhi, May 22: The number of COVID-19 cases averted due to the lockdown is in the range of 14-29 lakh, while the number of lives saved is between 37,000 and 78,000, the government said on Friday citing various studies, and asserted that the unprecedented shutdown has paid “rich dividends” in the fight against the pandemic.

The lockdown in India has been a timely, graded, proactive and pre-emptive public health measure to fight the COVID-19 pandemic and has been part and parcel of the government’s overall strategy, Dr V K Paul, Member (Health), NITI Aayog, and Chairman, Empowered Group 1, said at a media briefing on the COVID-19 situation.

The government imposed the nationwide lockdown from March 25 to prevent the spread of the novel coronavirus and it is currently in its fourth phase.

Like the number of cases, the growth rate of number of COVID-19 deaths too has fallen significantly due to the lockdown, marking a notable difference between pre-lockdown and post-lockdown situations, he said.

At the briefing, Pravin Srivastava, Secretary, Ministry of Statistics and Programme Implementation gave model-based estimates on COVID-19 cases and deaths which have been prevented due to the lockdown.

As per Boston Consulting Group's model, the lockdown saved between 1.2 lakh and 2.1 lakh lives, while the number of COVID-19 cases averted is between 36 lakh and 70 lakh, he said.

According to Public Health Foundation of India, nearly 78,000 lives have been saved due to the lockdown, Srivastava said.

Citing a model by two independent economists, he said that around 23 lakh COVID-19 cases and 68,000 deaths have been averted due to the lockdown.

Some independent experts, including retired scientists, have calculated that around 15.9 lakh cases and 51,000 deaths have been averted due to the lockdown, Srivastava said.

A joint study by the Ministry of Statistics and Programme Implementation and the Indian Statistical Institute found that around 20 lakh COVID-19 cases and 54,000 deaths were averted due to lockdown, he said.

The number of COVID-19 cases averted due to the lockdown is in the range of 14-29 lakh, while the number of lives saved is between 37,000 and 78,000, the official said.

“We are fully confident that the lockdown, with full public cooperation, has reaped rich dividends,” Srivastava said.

The strong defence of the lockdown, comes a day after the health ministry said the period of lockdown has been gainfully utilized to ramp up the health infrastructure, with around 3,027 dedicated COVID-19 hospitals and 7,013 care centres being readied across the country to fight the disease.

The announcement on Thursday came after some media reports questioned the country's preparedness to deal with the highly infectious disease.

"There are reports in a section of the media about some decisions of the government regarding the lockdown implementation and response to COVID-19 management. The period of the lockdown has been gainfully utilised to ramp up the health infrastructure in the country," the ministry had said.

Addressing the press briefing on Friday, joint secretary in the health ministry Lav Agarwal said 48,534 COVID-19 patients, which is about 41 per cent of the total cases, have recovered so far. As many as 3,234 patients have recovered in the last 24 hours, he said’

The COVID-19 mortality rate has dropped from 3.13 per cent on May 19 to 3.02 per cent as focus was on containment measures andclinical management of cases, Agarwal said.

An ICMR official said 27,55,714 tests for COVID-19 have been conducted till 1 pm Friday with 1,03,829 tests done in one day. Over 1 lakh tests for COVID-19 have been done each day for the last four days, the official said.

The growth rate of novel coronavirus cases witnessed a steep decline from Apr 4 when lockdown put a brake on the speed of increase of cases, V K Paul said.

The number of COVID-19 cases would have risen exponentially had the lockdown not been implemented, he said, adding that the doubling rate of cases was 3.4 days when the lockdown started and it is 13.3 days at present.

The COVID-19 outbreak in India has remained confined to limited areas with 80 per cent of active cases in just five states, Paul said

He said around 80 pc of COVID-19 deaths have been in Maharashtra, Gujarat, Madhya Pradesh, West Bengal and Delhi. 

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Agencies
February 4,2020

New Delhi, Feb 4: Four-month-old Mohammed Jahaan accompanied his mother almost every day to the Shaheen Bagh demonstration where he was a favourite with the protesters who would take turns to hold him and often draw the tricolour on his cheeks.

Jahaan will not be seen at Shaheen Bagh anymore. He died last week after acquiring a severe cold and congestion following exposure to the winter chill at the outdoor demonstration. His mother is, however, undeterred and determined to participate in the protests, saying it is "for the future of my children".

The infant's shattered parents, Mohammed Arif and Nazia, live in a tiny shanty put together with plastic sheets and cloth in Batla House area and have two other children -- a five-year-old daughter and a one-year-old son.

Hailing from Bareilly in UP, the couple is barely able to make ends meet. Arif is an embroidery worker and also drives an e-rickshaw. His wife helps him in his embroidery work.

"I haven't been able to earn enough in the last month despite driving the battery rickshaw in addition to my embroidery work. Now with our baby's demise, we have lost everything," he said, showing a picture of little Jahaan wearing a woolen cap that read 'I Love My India'.

A visibly disturbed Nazia said Jahaan passed away in his sleep on night of January 30 after returning from the protests.

"I had returned from Shaheen Baag at around 1 AM. After putting him and other kids to sleep, even I went to sleep. In the morning, I suddenly found him motionless. He was gone in his sleep," she said.

The couple said they took their motionless baby to the nearby Alshifa Hospital on the morning of January 31 where he was declared dead on arrival.

Nazia, who had been visiting the Shaheen Bagh demonstration everyday with Jahaan since December 18, says that he died after catching a cold that turned lethal.

She said she didn't realise that his congestion was so severe. However, the baby's death certificate issued by the hospital does not mention any specific reason for the death.

Shazia, a neighbour who was present at the couple's home, said Nazia had fought with her mother and husband to visit Shaheen Bagh everyday. Nazia would gather all women in the bylane outside her house so that they could together walk to the demonstration, around 2 km away. Sometimes, Arif would drop some of them to Shaheen Bagh on his e-rickshaw.

Nazia said she strongly feels that the CAA and NRC are against the welfare of all communities and will join the Shaheen Bagh protests, but this time without her children.

"Why was I doing this? For my children and the children of all us who need a bright future in this country," she told PTI.

"The CAA divides us on religion and should never be accepted. I don't know if there is politics involved but I know that I must question what is against the future of my children."

Arif, however, blamed the NRC and CAA for his child's death.

"Had the government not brought CAA and NRC, people would not have protested and my wife would not have joined them, my son would have been alive," he said.

Comments

Angry Indian
 - 
Tuesday, 4 Feb 2020

inna lillahi inna ilaihi rajioon...so sad

 

Modi, delhi police and Amith Shah the biggest EVIL of india is responsible for this samll soul death...

 

you have to answer one day after you die...dont think this world is permenant..

 

you will never see heaven forever...you must root in hell

 

GADDAR PM & HM

 

Jai Hind

 

 

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