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Sputnik V, world' first COVID-19 vaccine from Russia, faced the criticism of experts all over the world as it was approved for distribution on 11th August, much before starting its Phase III clinical trial, a crucial stage in the development of any vaccine. Also, there was no published scientific data about its phase I and II clinical trials at the time of approval. In fact, WHO records suggest that Sputnik V, developed by Moscow-based Gamaleya Institute and funded by the Russian Direct Investment Fund (RDIF), was in Phase I clinical trial at that time. However, the Russian government had stated back then that Phase I and Phase II of clinical trials of Sputnik V had been completed on 1st August. In a recent development, scientific data from the findings of its Phase I and II clinical trials, conducted in two Russian hospitals, have been published by the Lancet journal and the results are promising.
The Lancet report, published yesterday, observed that all 76 volunteers involved in the clinical trials of Sputnik V developed antibodies against the novel coronavirus. The side effects have also been found to be mild, ranging from pain at the injection site, slightly high body temperature and headache to general weakness and muscle and joint pain. The peer reviewed report observed that the vaccine is capable of producing T cell response, an immune cell instrumental in driving away infections. Additionally, an ANI report reveals that the RDIF has stated in its recent press note that participants of Sputnik V trials had 1.4-1.5 times higher volumes of virus-neutralising antibodies than COVID-19 recovered patients. Though the findings of preliminary data are encouraging, a conclusive opinion can be formed only after large-scale Phase III trial.
This Russian vaccine is based on a weakened version of adenovirus which is incapable of multiplying itself. This genetically engineered vaccine has the Spike protein gene of the novel coronavirus inserted into its DNA. This two-jab shot uses two variants of adenovirus for two doses: rAd26 and rAd5. Adenovirus is being used by other COVID-19 vaccine manufacturers too as it can be easily modified.
Close on the heels of the Lancet report, Russia has disclosed that it is in "close dialogue" with the Indian Government and leading Indian vaccine manufacturers about local production of Sputnik V. According to an ANI report, Russia has in fact " achieved certain agreements with the leading companies" of India in this regard. The news agency has quoted Kirill Dmitriev, CEO of the Russian Direct Investment Fund (RDIF), saying, "We do recognise India and it's potential to become one of the support for the production of the vaccine not only in Indian markets but for other countries too. We very much appreciate the well- balanced approach expressed by the Indian partners as from the very beginning they started asking questions how our vaccine works and we appreciate it that they did not try to attack our vaccine but try to understand it."