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Sputnik V and India – One Hundred Participants, or One Hundred Scapegoats?

Russia’s latest addition to the global armory in the battle against COVID-19 – the Sputnik V vaccine – has been approved for trial in India, with a hundred candidates about to be given a dose of the vaccine before the mass production and distribution of the vaccination for larger trials, reported a government panel of experts. This statement was provided to Dr Reddy’s Laboratories, a leading established pharmaceutical company in India that have been given the opportunity to supply the said vaccine within the country.

Dr Reddy’s has teamed up with the Russian Direct Investment Fund – the sovereign wealth fund of Moscow – to ensure the supply and delivery of one hundred million doses of Sputnik V. Albeit the vaccination has had no history of causing severe and/or adverse health effects in its fight against the SARS-CoV-2 infection strain, the Russian vaccine had to go through rigorous regulatory clearances and the gauntlets of the Drug Control General of India before it was approved for mass distribution. The DCGI has also waved the green flag for Phases Two and Three of human clinical trials of the vaccination in the country.

The vaccination has been found to abide by the recommendations put out by the Subject Expert Committee, formed by the Central Drugs Standard Control Organization (CDSCO) of India, on vaccines and drugs related to COVID-19. For reference, the CDSCO is a subdivision of the health ministry that is responsible for the quality of drugs and vaccines across the nation, whereas the DCGI is responsible for being the gateway through which approval for manufacturing and supply of various drugs are obtained.

According to the summary uploaded in the CDSCO’s website, the SEC had decided in a meeting on the 16th of October, 2020, that “the firm should generate safety and immunogenicity data on one hundred subjects in Phase II clinical trials, and submit for evaluation before proceeding to Phase III clinical trials.” Given what we know about the increase in size of test subjects from Phase II to Phase III, this intermediary meeting and reapproval of the drug should serve as the required (and an important) filter, should Sputnik V begin to show signs of adversity when tested amongst a larger pool of candidates.

This report had been uploaded by the SEC panel ten days after their rejection of Dr Reddy’s Laboratories proposing that they conduct a Phase III trial directly. Given that the objective of clinical trials is to establish the safety of the vaccine – along with immunogenicity, the process of evoking an immune response by using a foreign substance – the SEC had ordered the company to conduct Phase II trials first, based on the Phase I trials conducted for the vaccine in Russia. The conduction of Phase III trials, and the subsequent mass manufacture of the vaccination, depends upon the results of Phase II trials, yet to be conducted. The approval for Phase II trials had been given by the SEC on October 5, 2020.

But what is Sputnik V, and how will the trials be conducted?

Sputnik V, now known around the globe as the first registered vaccine against COVID-19. Is an adenovirus vector-based vaccine – where SARS-CoV-2 is an adenovirus strain that infects your lungs and airways, and the strain can be grown into a culture and used as a vector to pinpoint infected cells in your body. Sputnik V uses this technique to target and insinuate an immune response against the presence of such cells, and can be used in the long-term provided that the adenovirus vector is a constant. “Once you make a viral vector, it is the same of all vaccines. It is just the genetic information in it that is different”, explains Florian Krammer, a vaccine specialist hailing from the Icahn School of Medicine at Mount Sinai.

Much like the appropriately named space shuttles before it, Sputnik V completes its mission by targeting first and activating next. And given its potence, the SEC panel has deliberated that the subjects taking part in the trials must undergo RT-PCR testing for detection of COVID-19 seventy-two hours prior to taking part. RT-PCR is currently the gold standard for detection of COVID-19 around the world, and is being used by almost all countries to detect and help infected persons present in their territory.

Whilst the Sputnik V website states that it is “the first registered COVID-19 vaccine on the market”, it still has to undergo various regulatory and testing processes, much like its announcement in July 2020. While it was met with skepticism and critique, it has eventually calmed down into being a feasible vaccine that might become the global vaccine standard for use against COVID-19 obliteration.

The SEC panel has also requested that the company distribute the sites of clinical trial across various states in the country, given that their geographical diversity is huge and that the trials must succeed under all conditions in order to produce minimal levels of adversity and harm. The panel had also suggested the use of Th1 v Th 2 optimization as an assessment for an exploratory objective, wherein such results could be utilized in future research. Given such directions, the success of the clinical trials now remain the only determining factor in the success of the vaccine itself.

 

 

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