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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THERE IS ALREADY A FILM CALLED "THE MESSAGE" DO YOU HAVE PATIENCE TO WATCH?
THERE IS ALREADY A FILM CALLED THE MESSAGE
Let this jungli ignorant ask his PAKODA Janata Party (PJP) LEADER who financed the film Padmavat.
Prophet Muhammed is the last and final messenger of ALLAH, Who conveyed the message of Oneness of GOD almighty who is worthy of Worship....God sent many prophets including Abraham, moses, jesus and many others to convey this message prior to the last prophet of Mankind... Prophet Muhammad pbuh is not just for muslims but he came to convey to the whole of Mankind. Many people in arabia were worshipping manmade gods like idols, statues, images and animals instead of TRUE ONE GOD (which is NA TASYA PRATIMA ASTI).
Quran is the book revealed to Prophet Muhammad pbuh which is unchanged since its revelation... I request non muslims to Open up the QURAN ( U can also try quranproject online) to understand WHO GOD is? If U are honest in looking for the CREATOR of all that exist ... U will surely find him . Then
It is very EASY to find out how such criminal evil minded politicians are PLAYING in your minds... to keep away from the REAL issues of the SOCIETY>>>
A film already exists. The Message. Plz watch it.
Oye Minister Ji, Y Prophet Mohammed is coming into this picture. Dont dare to create communal voilence by shitting thru your mouth. Tomorrow you will say about "Jesus" too. Blast the guy who made padmavati, dont create communal tension by commenting non-related matter here. Indian public wasting money on films, if public stops watching no film will make money & every star will be like a common man. We as people should understand. Better dont watch any movie, let all starts come to common level.
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