Covid-19 vaccine: Russia ties up with Indian pharma major for large-scale trials
The Russian Direct Investment Fund (RDIF) is in talks with Indian company for large scale human trials of SputnikV vaccine
Russia has reportedly reached a stage of agreement with India’s Dr. Reddy laboratory for clinical trial of COVID19 vaccine Sputnik, in India.
According to a report published by the Hindustan Times, the Russian sovereign wealth fund said on Wednesday, that Russia is looking forward to clinical trials of their SputnikV vaccine over the Indian population. However, the total process is yet to be cleared by the Drugs Controller General of India (DCGI).
The report by the Hindustan Times quoted the Russian Direct Investment Fund (RDIF) saying, “Upon regulatory approval in India, RDIF shall supply to Dr Reddy’s 100 million doses of the vaccine.”
On the part of the Indian officials, it has been reported that India will finalise the trial only after thorough review and also the results of the previous trials presented before them. It will not proceed on the basis of just a mere application, as reported by an official closely related to the procedures by DCGI.
The report further states that any vaccine which has not crossed the phase 3 trial is not to be approved as per instructions by WHO. However, Russia not having completed the phase 3 trial, and just have entered the phase, scientists are yet not sure about the large scale application of SputnikV.
The Russian Direct Investment Fund (RDIF) said in a statement, “Upon regulatory approval in India, RDIF shall supply to Dr Reddy’s 100 million doses of the vaccine.”
Though the report submitted by Russia after the phase 1 and 2 trials did not show any side effects of the drug on the volunteers, there are some scientists who have raised questions on the authenticity, marking certain similarities between the 76 volunteers.
GV Prasad, the co-chairman and the MD of Dr. Reddy’s Laboratories has said that the company is pleased to partner with RDIF to bring the vaccine to India for large scale application and phase 3 trial, maintaining full safety of the volunteers to be applied on. He also added that they are expecting to see this vaccine as one of the major weapons against COVID19 in India.
Answering all the questions raised about the safety of SPUTNIK V, as no phase 3 trials have been conducted, the RDIF stated that the vaccine is safe and well studied on humans, which has proven safety. He further added, “Deliveries could potentially begin in late 2020 subject to completion of successful trials and registration of the vaccine by regulatory authorities in India.”