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
March 7,2020

New Delhi, Mar 7: Prime Minister Narendra Modi turned emotional on Saturday when a woman beneficiary of his government's generic medicine programme told him that she had seen God in him.

Dehradun-resident Deepa Shah, who suffered paralysis in 2011, was interacting with the prime minister through video-conference on the occasion of Jan Aushadhi Diwas.

"I have not seen god, but I have seen God in you," she said, tears rolling down her eyes.

Modi was visibly emotional as the woman repeated her remark.

She also thanked the Uttarakhand chief minister and others who had helped her all along and said doctors had once told her that she cannot be cured.

"But on hearing your voice I have become better," she told Modi while profusely thanking the prime minister for his efforts to reduce the cost of medicines.

An emotional prime minister paused for a moment before telling her that it was her courage that had won over her disease and that she must carry on with the spirit.

Shah was expressing her plight and how she had suffered due to high cost of medicines after she suffered from paralysis in 2011 and has now started saving Rs 3,500 every month after benefitting from the government's low-cost generic medicines programme.

Soon after Shah rose to express her views, Modi asked her to sit and speak as he said she was uncomfortable while standing.

"You have defeated disease with your own will power. Your courage is your god and that same courage has given you the strength to emerge from such a big crisis. You should carry on this confidence in you," Modi told her.

He said some people still keep spreading rumours about generic medicines, going by their past experience, wondering how can medicines be available so cheap and that there must be something wrong with the medicine.

"But, by seeing you countrymen would gain confidence that there is nothing wrong in generic medicines. These medicines are not at all of inferior quality than any other medicine. These medicines have been certified by the best laboratories. These medicines are made in India and is 'Make in India' and are cheap," the prime minister said.

He said there is demand for generic medicines from India across the world and the government has made it mandatory for doctors to prescribe generic medicines to patients, unless necessary.

Comments

Sameeksha
 - 
Monday, 9 Mar 2020

Wowww so emotional... Lol .really god in you??? Drama king and queen

angry indian
 - 
Sunday, 8 Mar 2020

in 2002 riot we have seen shaitan in you..how come shaitan become GOD...

 

did he put atleat one tear for his mother, did he feel sad when pregnant muslim woman brutally murdered..

this guy is 21st century dajjal..

Suresh SS
 - 
Sunday, 8 Mar 2020

Big Nautanki, Dramebaz

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News Network
April 28,2020

Kozhikode, Apr 28: The remains of seven people who died in the Gulf countries were airlifted from Dubai by a cargo flight which arrived here Tuesday, ending the uncertainty over bringing back the bodies of those who died following non-Covid-19 reasons.

Airport sources said the flight reached the airport by around noon.

The bodies include natives of Kerala, one each of people from Goa and Sivaganga in Tamil Nadu.

"Karipur in among the few airports where cargo flights are operating in South India.

This is the reason why the bodies of those belonging to Goa and Sivaganga and other parts of Kerala have all been brought here for onward transport to respective destinations by road," an airport official said.

"As per information received from the airport, the bodies are of John Johannan of Kollam, David Shamy of Punnakkal, Kannur, Sathyan of Cheranelloor, Thrissur, O C Mathai and Sijo Joy, both of Pathanamthitta, Sreenivasan of Sivaganga and Henrick D Soza of South Goa," said Thomas, Assistant Sub Inspector, Special Branch CID, Malappuram.

Special passes have been issued to ambulances to transport the bodies to their destinations after the formalities at the airport are over, a senior police officer said.

There had been some confusion on bringing back the bodies from the Gulf region for about a week for want of clearance from the embassy authorities.

Chief Minister Pinarayi Vijayan had written to Prime Minister Narendra Modi last week seeking his intervention in ensuring that bodies of Keralites, who die in Gulf countries due to no non COVID-19 reasons, should be broughtto the state without any delay forenabling family members to perform their last rites.

Vijayan also wanted Modi to direct Indian Embassies to issue necessary clearances without seeking individual approvals from the Ministry of Home Affairs and avoid any delay.

The mortal remains are now being broughtin cargo planes as passenger flights are not being operated due to the COVID-19 lockdown.

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Agencies
June 14,2020

New Delhi, Jun 14: Petrol price on Sunday was hiked by a record 62 paise per litre and that of diesel by 64 paise as oil companies for the eighth day in a row adjusted retail rates in line with cost since ending an 82-day hiatus in rate revision.

Petrol price in Delhi was hiked to Rs 75.78 per litre from Rs 75.16 while diesel rates were increased to Rs 74.03 a litre from Rs 73.39, according to a price notification of state oil marketing companies.

Rates have been increased across the country and vary from state to state depending on the incidence of local sales tax or VAT.

The 62 paise a litre increase in petrol and 64 paise hike in diesel price is the highest surge in rates since the daily price revision was started in June 2017.

This is the eighth daily increase in rates in a row since oil companies on June 7 restarted revising prices in line with costs, after ending an 82-day hiatus.

In eight hikes, petrol price has gone up by Rs 4.52 per litre and diesel by Rs 4.64 -- a record increase in rates in any eight days since the daily price revision was introduced.

The freeze in rates was imposed in mid-March soon after the government hiked excise duty on petrol and diesel to shore up additional finances.

Oil PSUs Indian Oil Corp (IOC), Bharat Petroleum Corp Ltd (BPCL) and Hindustan Petroleum Corp Ltd (HPCL), instead of passing on the excise duty hikes to customers, adjusted them against the fall in the retail rates that was warranted because of international oil prices falling to two-decade lows.

The government had first raised excise duty on petrol and diesel by Rs 3 per litre each on March 14 and then again on May 5 by a record Rs 10 per litre in case of petrol and Rs 13 on diesel. The two hikes gave the government Rs 2 lakh crore in additional tax revenues.

State-owned fuel retailers IOC, BPCL and HPCL had frozen petrol and diesel prices since March 16, as if anticipating the government move and set off gains they accrued from continuing drop in international oil prices against the excise duty hike.

They, however, promptly passed the increase in local sales tax or VAT by state governments such as Rs 1.67 increase in VAT on petrol and Rs 7.10 in diesel by the Delhi government on May 4.

The total incidence of excise duty on petrol has risen to Rs 32.98 per litre and that on diesel to Rs 31.83. The excise tax on petrol was Rs 9.48 per litre when the Narendra Modi government took office in 2014 and that on diesel was Rs 3.56 a litre.

The government had between November 2014 and January 2016 raised excise duty on petrol and diesel on nine occasions to take away gains arising from plummeting global oil prices.

In all, duty on petrol rate was hiked by Rs 11.77 per litre and that on diesel by 13.47 a litre in those 15 months that helped government's excise mop up more than double to Rs 2,42,000 crore in 2016-17 from Rs 99,000 crore in 2014-15.

It cut excise duty by Rs 2 in October 2017 and by Rs 1.50 a year later. But it raised excise duty by Rs 2 per litre in July 2019.

It again raised excise duty on March 14 by Rs 3 per litre.

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