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
First teach your own men to stop intolerance.
Are you people blind not seeing surge in oppression of poor.
You don't want people to raise their concern when you do all harms to poor and minorities.
Teach patriotism and tolerance to your own men.
Teach them to Denounce Godse who killed the father of Nation who gave you an identity to call you as proud Indian.
Muslims do not need any extra teaching from others.
They have full guidance from their God
Now if you are a true concerned of your nation, then at least learn what is teaching of Islam, just adapt in your routine life.
RSS should come forward to punish the killer of mahatma gandhi. They should ban Nathuram Godse's supporters.
RSS founder and its founding members already proved their patriotism during the time of India's freedom struggle!! We Muslims in India proved our patriotism from Shaheed Tippu Sultan\s time till now, we no need any advice from RSS. A Muslim is not a complete Muslim unless he is not patriotic to his country where he/she live, this is our Prophet's word."
Dear Mr. Indresh Kumar,
Please make sure that loving one's country and its people is a good traits of the Muslims as our beloved Prophet Muhammed (peace be upon him) has said: \Love of your country (patriotism) is a part of your faith.
Never be under the opinion that Madarasas are not teaching patriotism. We love our country as you love.
Patriotism is love of one's country, loyalty and devotion to it, desire to grow and prosper collectively or as a community, and you need to understand that we muslims are being dignified citizens of India proud to say that many of our patriotic ancestors have sacrificed their blood and life during the freedom struggles of our great nation. Please make sure that Islam does not forbid a Muslim to love his homeland or the country in which he lives or grows up.
Almighty Allah says: \"O Mankind! we have created you from a male and a female, and made you into nations and tribes, that you may know one another. Verily the most honorable of you with Allah is that (believer) who has Taqwa, Muttaqoon (pious)\". Verily Allah is all knowing all aware (Quran Chapter Hujuraat, verse No. 13).
May God help all of us to live in peace in this great Nation, INDIA."
RSS should learn what is PATRIOT not the muslims or madrasa childrens.
RSS - Stop making communal voilences,bomb explosions and divie an disturbences in the society.
Preach the patriotism to thier affialitaions like VHP, Bajrangees and Goodaisms groups.
ont question Muslims patriotism.
Yes thats why you are alive.....................
we know how to LOVE our country ,Quran teaches us very nicely , we are all patriotic Indian muslims, our country is our home
Muslims love India more than you do......unlike Nathuram Godse who killed Gandhiji....
Killer of Mahatma Gandhi speaking of Patriot..
No Need Advice from RSS For Muslim
Love your country is part of islam .....
Add new comment