Sputnik V COVID-19 Vaccine's First Batch, Ready for Phase 2, 3 Clinical Trials

Russia's first batch of Sputnik V COVID-19 vaccine will grasp Ganesh Shankar Vidyarthi Medical College in Kanpur by the coming week to undergo phase 2 and phase 3 human clinical trials. In an interview with Decan Herald, an official said that the decision to conduct the vaccine's human clinical trials was taken after Dr. Reddy's Laboratories received an endorsement from the Drugs Controller General of India (DCGI).

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(Photo: Alexandra_Koch)

As of November 15, 2020, about 53 million confirmed cases of COVID-19, including about 1 308 975 deaths reported to the World Health Organization (WHO). In an interview with the Press Trust of India (PTI) college principal, R B Kamal said that clinical trials of the Sputnik V vaccine would start next week. He also added that 180 volunteers have registered for the trials, and research head Saurabh Agarwal will be determining the dosage of the vaccine to be given or administered. He further said that one dose will be managed, and the volunteers' condition will be monitored in finding out whether the participants will need further doses.

Karmal added in the interview that the vaccine's effect on the volunteers would be studied for about seven months after the same is administered once, twice, or thrice within 21 days. He added that the effects would be observed after a month, then the authorities will be informed of the trial results, and from there, the authorities will decide accordingly.

It is remembered that the Russian Direct Investment Fund (RDIF), Russia's sovereign wealth fund, and Dr. Reddy's entered a partnership in conducting of Sputnik V vaccine and the distribution in India.

Expert's view

According to Nature, early data show that this controversial Russian vaccine is safe and works efficiently. Sputnik's release also claims that the vaccine has 92% effectiveness basing on 20 confirmed COVID-19 cases between vaccinated individuals and those who received a placebo. Although the result seems promising, researchers still urged cautions on the vaccine. In the release by Nature, the low number of cases reported in the Sputnik V trial suggests ambiguity about the vaccine's true efficacy. They added that the Russian drug analysis is based on the 20 cases of COVID among the 160,000 trial participants compared to the Pfizers BioNtech COVID vaccine basing on 94 cases of COVID-19 among 38,000 participants. Nature added that Sputnik V's procedure had not been made communal compared to those leading applicants in phase III trials. That is why it is indeterminate whether an interim analysis after identifying 20 COVID-19 cases is in the works.

Sputnik V

Gamaleya National Center of Epidemiology and Microbiology is the one behind the Sputnik V Vaccine development response to COVID-19. According to them, Sputnik V is the world's first registered vaccine based on the well-studied human adenoviral vector-based platform. They also emphasized that the said vaccine ranks among the top 10 candidate vaccines approaching the end of the clinical trial and mass production on the World Health Organization's (WHO) list.

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