Russian Covid Vaccine clinical test on Indian volunteers |
The Drug Controller General of India on Thursday said that the Russian COVID-19 vaccine Sputnik V will be first tested in India on 100 volunteers before extensive trials. Pharmaceutical giant Dr Reddy`s Laboratories has been given permission to conduct the tests. The date and time of the test will be determined by the company. Sputnik V Vaccine has been developed in Russia where it has also undergone phase 1 and 2 clinical trials. The clinical trial in India will be a multi-centre and randomized controlled study which will primarily focus on safety and immunogenicity. Earlier last month, Dr. Reddy`s and RDIF entered into a partnership to conduct clinical trials of the Sputnik 5 vaccine and its distribution in the country. The vaccine is currently undergoing phase 3 clinical trials in Russia along with simultaneous trails in the UAE. The Indian drug maker joined hands with the Russian Direct Investment Fund to conduct clinical trials of the Sputnik V vaccine as well as its distribution. Dr Reddy`s Lab has stated that in phase 2 clinical trial -- "it would include 100 subjects and for phase 3, it would take 1400 subjects". Last month, Kirill Dmitriev, CEO, RDIF informed that Russia is in close dialogue with the Indian government and drug manufacturers of India regarding localization of production of its Sputnik V vaccine in India. On August 11, 2020, the Sputnik V vaccine candidate was registered by the Ministry of Health of Russia, and became the world`s first registered vaccine against COVID-19.
|
|
|
|