Sputnik V Covid-19 vaccine gets nod for clinical trials in India

Modesto Morganelli
Ottobre 18, 2020

The PMO said, Coronavirus vaccine will not be affected as no major mutation was in the virus.

There had been concerns in some quarters that any major mutation detected in the novel coronavirus could hinder the development of an effective vaccine. However, some recent global studies have said the vaccines now being developed for COVID-19 should not be affected by recent mutations. It is to note that when a virus replicates, there may be some changes in the new strains that have formed.

Union health minister Harsh Vardhan had earlier this month said the Centre had set a rough estimate of vaccinating around 250 million people across India by July 2021.

"This narrative is part of the on-going pro-Kremlin disinformation on coronavirus aiming to promote the Sputnik V vaccine and present Russian Federation as a 'leader in the COVID-19 management". He went on to suggest developing a vaccine delivery system on the lines of conduct of polls and disaster management while involving all levels of government and citizen groups.

Russian Federation became the first country to give approval to the vaccine but came in for criticism for going ahead with Sputnik V without a large-scale trial. At the same time, he also cautioned against any complacency at the decline and called for keeping up the efforts to contain the pandemic.

According to SII's Dr. Suresh Jadhav, India is heading fast toward vaccine development, with two manufacturers in Phase III trials and one in Phase II trials.

The Drugs Controller General of India (DCGI), a department in India's drug regulator that is responsible for licensing vaccines, has given its approval for a domestic clinical study of the Russian candidate vaccine dubbed "Sputnik V", Indian and Russian partners have announced in a joint statement.

Sputnik V, the world's first registered vaccine developed by Russian Federation against Covid-19, has been approved for conducting an adaptive phase 2 and 3 trial in India. RDIF had entered into an agreement with the Hyderabad-based pharma giant in September this year to carry out Phase-3 clinical trials of Sputnik V in India and distribute 100 million doses of the vaccine in the Indian market after regulatory approvals. Sputnik V, which has been developed by Gamaleya National Research Institute of Epidemiology and Microbiology and RDIF, became the first Covid-19 vaccine to be registered in the world based on the human adenoviral vectors platform on August 11, 2020.

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