The Start Of Sputnik V
Sputnik V was developed by Moscow-based Gamaleya Research Institute of Epidemiology and Microbiology. They took charge of manufacturing the vaccine due to their expertise in studying the vaccines for MERS and Ebola, the other two pandemics of the past.
The clinical trials for Sputnik V were conducted on animals such as rhesus macaque monkeys, rabbits, rats, guinea pigs and mice. However, the efficacy of Sputnik V on marmoset monkeys and Gamaleya’s own immune-suppressed Syrian golden hamsters was noted to provide 100 per cent protection against a high degree of coronavirus infection, as said by Denis Logunov, the lead author of the study “The arrival of Sputnik V” published in The Lancet. [1]
The study was, however, criticized by Sheena Cruickshank, an immunologist at the University of Manchester (UK) saying that the study is non-randomised and open-labelled.
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A vaccinologist Peter Hotez from Baylor College of Medicine, Texas, USA pointed out that Sputnik V freeze-dried formulation is much similar to the smallpox vaccine developed in the 1970s, thus allowing Sputnik V to easily get transported to varying locations.
It was also noticed that the tolerability of Sputnik V is similar to other adenovirus vectored vaccines. Overall, the vaccine’s antibodies neutralising effect is similar to other vaccines which are developed for adenovirus, a virus type that mainly causes respiratory problems such as pneumonia and common cold in humans.
As COVID-19 is also known for primarily causing respiratory problems, chances are that Sputnik V could be effective against the virus.
However, the variables and insignificant levels of neutralising antibodies in the first trial was still concerning, leading to the beginning of its phase 3 trial.
How Is Sputnik V Made?
Another Lancet study has shown that phase 3 trial results of Sputnik V caused consistent strong protective effects against coronavirus in people of all age groups. [2]
Sputnik V, also known as Gam-COVID-Vac is developed using a heterologous recombinant adenovirus approach, meaning using two types of adenovirus; adenovirus 26 (Ad26) and adenovirus 5 (Ad5) as vectors for the expression of the COVID-19 spike protein. To note, that adenovirus is a commonly found virus that can infect anyone.
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The two varying serotypes in the vaccine are given in two doses 21 days apart, with the possibility that the vaccine can overcome any pre-existing adenovirus immunity in affected people.
It is to be noted that Sputnik V is the only COVID-19 vaccine developed to date which is based on using two different viral serotypes, unlike Oxford-AstraZeneca’s Covishield and Serum’s Covaxin that uses the same material for both doses.
How Does Sputnik V Work?
The adenovirus in Sputnik V is modified in such a way that it carries the gene of the spike protein of COVID-19. In this way, it can help mark the virus inside the body by recognising its spike proteins and initiating an immune response.
However, that is not enough, as the spike protein only helps to enter the host body, while the RNA of the virus is the primary harmful material that helps in the replication and causing symptoms. [3]
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But, as per the study results, scientists also believe that the vaccine has the capability to eventually bring out the required immunity needed for COVID-19.
Also, the vaccine vectors can accommodate large genetic payloads, meaning they could be genetically modified in many ways and according to different actions of the COVID-19 infection, making the vaccine perform a range of activities to defend the virus.
This may help trigger innate immunity and build a robust immune system engagement against the virus.
How Is Sputnik V Stored?
Based on the physical robustness of Sputnik V, the vaccine can be stored at a temperature of +2 to +8 degrees Celsius. It means that the vaccines can easily be stored in conventional refrigerators and distributed at distant places worldwide, without any need for a cold-chain infrastructure.
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What Is The Efficacy of Sputnik V?
Based on the administration of the first dose of Sputnik V on confirmed COVID-19 cases, the vaccine efficacy is reported to be 91.6 per cent. The high reduction in the severity of the condition after the administration of only the first dose is really encouraging in the case of this Russian vaccine.
Another study points out that Gamaleya later announced that Sputnik V is in fact 97.6 per cent effective in preventing the COVID-19 infection, based on an analysis of unpublished data from 3.8 million people who were fully vaccinated in Russia. [4]
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Reasons Why Sputnik V Was Criticised
- The emergency use of Sputnik V in Russia was announced before the publication of the results of its phase 1 and phase 2 clinical trials and without completion of the phase 3 trial.
- Inconsistencies in the published paper for phase 1 and 2 trial related to similar antibody counts in participants. However, that was cleared later by the developers of the vaccine saying that the data were rounded off.
- The outcomes of the third trial were reported early, after the first dose rather than both the doses.
- Larger sized particles are used to make recombinant adenovirus-based vaccines, which means large demands for manufacturing at a global level.
- Some researchers criticised the vaccine saying that it can cause a rare blood clotting syndrome called cerebral venous sinus thrombosis in a small number of people. Though, comprehensive analysis during mass vaccination and clinical trials show no such cases in people, the denial was not supported by any evidence.
- The absence of transparency on the full data related to clinical trials and unseemly haste in vaccine development is also among the main causes of criticism.
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Testing And Manufacturing Of Sputnik V In India
Testing And Manufacturing Of Sputnik V In India
India has reached total COVID-19 cases of 2.3 crores, with 1.9 crores recovered cases and 2.5 lakh deaths. The cases in India are rising at a rate of 180000 people per day.
To cope with the increasing cases of coronavirus in India, the Ministry of Health and Family Welfare has fast-tracked many COVID-19 vaccines made available around the world, and authorised Sputnik V among the list seeing its efficacy compared to other vaccine candidates. [5] Like this, India became the 60th nation in the world to approve the vaccine for mass use.
In Russia, the Russian Direct Investment Fund (RDIF) is the partner and manufacturer for Sputnik V. The Hyderabad-based Dr Reddy’s Laboratories has made an agreement with RDIF to conduct the clinical trials again in the country for the second and third phase of the vaccine.
The RDIF also has agreements with India’s Hetero Biopharma, Stelis Biopharma, Gland Pharma, Panacea Biotec and Virchow Biotech to produce around 850 million doses of Sputnik V in the country in a year.
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What Will Be The Cost Of Sputnik V In India?
According to reports, the vaccine is sold globally at a price of less than 10 dollars, which equals Rs 734. However, the price for India has not been decided yet.
To Conclude
According to the several trial studies which are in progress for Sputnik V, it is believed that the vaccine could also be effective against the new mutated strain of COVID-19. Also, as per May reports, around 1.5 lakh doses of Sputnik V have already reached India and are set for bulk production.
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