The first batch of Russia’s Sputnik V vaccine for COVID-19 is likely to reach Kanpur by next week for the Phase 2 and Phase 3 human clinical trials at the Ganesh Shankar Vidyarthi Medical College for which 180 volunteers have registered.
Dr Reddy’s Laboratories will be conducting the trials after it got approval from the Drugs Controller General of India (DCGI), an official said.
As many as 180 volunteers have registered for the trials. The dosage of the vaccine for the trials will be determined by the head of the research Saurabh Agarwal. “One dose will be administered and the condition of volunteers will be monitored to determine whether they need further doses or not,” college principal R B Kamal said, reported PTI.
Kamal said the volunteers’ vitals and condition will be checked periodically and the data will be analysed to determine the vaccine’s effectiveness.
He said the effect on the volunteers will be studied for seven months after the vaccine is administered once, twice or thrice with an interval of 21 days.
After observing the effects for a month, authorities will be apprised of the results and they will then make a decision accordingly.
The Ethics Committee of the college has also given permission for the trails, Kamal said.
The vaccine has to 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, had entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India.
As part of the partnership, RDIF shall supply 100 million doses of the vaccine to Dr Reddy’s upon regulatory approval in India.
On August 11, the Sputnik V vaccine was registered by the ministry of health of Russia, becoming the world’s first registered vaccine for COVID-19 based on the human adenoviral vector platform.
Meanwhile, over 250 applications have been received for the trial of Covaxin, the the COVID-19 vaccine candidate being developed by Hyderabad-based Bharata Biotech, at the Jawaharlal Nehru Medical College Hospital of Aligarh Muslim University.
According to Professor Mohd Shameem, principal investigator, all applications will be screened as per the protocol and procedure laid down by the Indian Council of Medical Research (ICMR) before inclusion in the study/trial.
Resource persons from Bharat Biotech will visit AMU to train staff for the vaccine trials.
(With inputs from PTI)