The Drugs Controller General of India has rejected Russia’s proposal to test Phase III of the Sputnik 5 vaccine in the laboratories of pharma company Dr Reddy’s as initial trials have been seen using only a small group of foreign populations. Russia claimed to have made the first effective vaccine of Kovid-19. Dr. Reddy’s Lab then joined hands with the Russian Direct Investment Fund (RDIF) for the clinical trials of Sputnik V vaccine as well as its distribution.
However, global experts raised concerns about the safety of the vaccine as it was rolled out within a short time. Union Health Minister Harsh Vardhan had recently indicated that India has not given Dr. Reddy his permission to proceed with the vaccine testing among the Indian population. Since September 1, phase-3 trials of Sputnik V are underway in Russia on about 40 thousand subjects.
No final decision on #SputnikV vaccine developed by Russia has been taken yet. #ModiGovt will take a decision which is in the best interest of the people of India.@MoHFW_INDIA #sundaysamvaadwithdrhv #VaccineSafety pic.twitter.com/gCuAWBf9bs
– Dr Harsh Vardhan (@drharshvardhan) October 4, 2020
The committee looking into the case of Dr. Reddy said, “After detailed deliberations, the committee recommended that the firm should comply with the regulatory requirements and with appropriate monitoring for humor and cell mediated immune response in the country at stage 2 /. 3 must test. “
Also read- First wave of Corona is calming in India, 20% drop in peak, doubling rate also improves
what next ?
Doctor Reddy has been advised to consider a smaller test rather than a large-scale test.
Other vaccine updates
Three vaccine candidates are currently under examination in India. Pune-based Serum Institute of India, which has partnered with AstraZeneca to produce the Oxford Kovid-19 vaccine candidate. Vaccine developed by Bharat Biotech in collaboration with ICMR and another Zydus Cadila Ltd. Developed by humans are in the second phase of testing.
.
