KANPUR: The first batch of Russia’s Sputnik V vaccine for Covid-19 is likely to arrive at Ganesh Shankar Vidyarthi Medical College in Kanpur next week, where phase 2 and phase 3 human clinical trials of the vaccine.
The decision to conduct human clinical trials of the vaccine was made after Dr Reddy’s Laboratories obtained approval from the Controller General of Medicines of India (DCGI) in this regard, an official said.
Speaking to PTI, the university’s director, RB Kamal, said that human clinical trials of the vaccine will begin from next week.
“Up to 180 volunteers have been registered for the trials. The head of research, Saurabh Agarwal, will determine the dose of the vaccine to be administered. One dose will be administered and the condition of the volunteers will be monitored to determine if they need more doses or not.” , said.
Kamal said that the vital signs and condition of the volunteers will be checked periodically and the data will be analyzed to determine whether the vaccine is a success or not.
He said the vaccine’s effect on volunteers will be studied for seven months after the vaccine is administered once, twice or three times in a 21-day interval.
After observing the effects of the vaccine for a month, the authorities will be informed of the trial results and then they will make a decision accordingly.
The university’s Ethics Committee has also given permission for the trails, he said.
The vaccine should be kept at a temperature of -20 to -70 degrees Celsius.
In September, Dr. Reddy’s and the Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, partnered to conduct clinical trials of the Sputnik V vaccine and its distribution in India.
As part of the partnership, RDIF will supply 100 million doses of the vaccine to Dr. Reddy’s following regulatory approval in India.
On August 11, the Sputnik V vaccine was registered by the Russian Ministry of Health and became the world’s first registered vaccine against Covid-19 based on the human adenoviral vector platform.
The decision to conduct human clinical trials of the vaccine was made after Dr Reddy’s Laboratories obtained approval from the Controller General of Medicines of India (DCGI) in this regard, an official said.
Speaking to PTI, the university’s director, RB Kamal, said that human clinical trials of the vaccine will begin from next week.
“Up to 180 volunteers have been registered for the trials. The head of research, Saurabh Agarwal, will determine the dose of the vaccine to be administered. One dose will be administered and the condition of the volunteers will be monitored to determine if they need more doses or not.” , said.
Kamal said that the vital signs and condition of the volunteers will be checked periodically and the data will be analyzed to determine whether the vaccine is a success or not.
He said the vaccine’s effect on volunteers will be studied for seven months after the vaccine is administered once, twice or three times in a 21-day interval.
After observing the effects of the vaccine for a month, the authorities will be informed of the trial results and then they will make a decision accordingly.
The university’s Ethics Committee has also given permission for the trails, he said.
The vaccine should be kept at a temperature of -20 to -70 degrees Celsius.
In September, Dr. Reddy’s and the Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, partnered to conduct clinical trials of the Sputnik V vaccine and its distribution in India.
As part of the partnership, RDIF will supply 100 million doses of the vaccine to Dr. Reddy’s following regulatory approval in India.
On August 11, the Sputnik V vaccine was registered by the Russian Ministry of Health and became the world’s first registered vaccine against Covid-19 based on the human adenoviral vector platform.
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