Lancet, a peer-reviewed medical journal, has validated the safety and effectiveness of Sputnik V Covid-19 vaccine, saying it is at 91.6 per cent.
The two-dose vaccine was developed by Gamaleya Research Institute of Epidemiology and Microbiology, a Russian medical-research institute headquartered in Moscow.
The interim report of the phase 3 data now presented includes results for more than 20,000 participants, who received both the first and second doses of the Sputnik V vaccine or placebo.
Comorbidities, a known risk for Covid-19 severity, were present in about a quarter of those who entered the trial.
The medical journal indicated that no adverse events considered related to the vaccine were recorded, but serious events unrelated to the vaccine were reported in 45 participants from the vaccine group and 23 participants from the placebo group.
The trial results show a consistent strong protective effect across all participant age groups, including those older than 60 years, from 21 days after the first dose of vaccine.
Recipients generated robust antibody responses to the spike protein, which included neutralising antibodies, the proportion of the total immunoglobulin that inhibits the virus binding to its receptor.
The data is encouraging given the current situation when countries are scrambling to immunise their citizens against the pandemic amid Covid-19 vaccine supply shortage, yet the pandemic has infected more than 100 million, and killed more than 2.2 million people globally, according to a tally from Johns Hopkins University.
It noted that the development of the Sputnik V vaccine has been criticised for unseemly haste, corner-cutting, and an absence of transparency.
Before the publication of the vaccine data in Lancet, researchers had expressed concern over its safety and efficacy, partly for being rolled out before phase 3 trial – the final trial stage of a vaccine.
"But the outcome reported here is clear and the scientific principle of vaccination is demonstrated, which means another vaccine can now join the fight to reduce the incidence of Covid-19,” Denis Logunov and colleagues said as they reported their interim results from a phase 3 trial of the Sputnik V Covid-19 vaccine in The Lancet.
Denis Logunov is a Corresponding Member of the Russian Academy of Sciences.
Sputnik V is one of the three vaccines in the world with efficacy of over 90% against Covid-19. Others are Pfizer and BioNTech’s Covid-19 vaccine with an efficacy rate of 95 percent, and that of Moderna's which proved to be 94.5 percent effective against the disease.
However, the results of this vaccine and the two others are based on trials that were carried out before the emergency of Covid-19 variants, such as one from the UK and the other from South Africa that might put up resistance against vaccine effectiveness.
More about the vaccine
Also known as Gam-Covid-Vac, Sputnik V is a combined vector vaccine which uses two different types of human adenovirus vectors (rAd26 and rAd5) for the first and second jabs, in order to ensure a lasting immunity. Human adenoviruses are viruses that cause the common cold.
The use of two vectors, which are given 21 days apart, is intended to boosting the effect of the vaccine.
"Vectors” are vehicles, which can induce a genetic material from another virus into a cell. The gene from adenovirus, which causes the infection, is removed while a gene with the code of a protein from another virus spike is inserted.
This inserted element is safe for the body but still helps the immune system to react and produce antibodies, which protect us from the infection
Among the major Covid vaccines in development to date, only Gam-Covid-Vac uses this approach; others, such as the Oxford–AstraZeneca vaccine, use the same material for both doses.
Cost, storage and distribution aspect
The Russian Direct Investment Fund (RDIF), Russia's sovereign wealth fund, jointly with partners and manufacturers is ramping up the production of Sputnik V.
The cost of one dose of the vaccine for international markets is less than $10, meaning $20 for two doses.
The lyophilised (or freeze-dried) form of the vaccine can be stored at a temperature of +2 to +8 degrees Celsius, which allows for easy distribution worldwide, including hard-to-reach regions.
Requests for vaccination of more than 1.2 billion people (2.4 billion doses as) with the Sputnik V vaccine came from more than 50 countries, according to the manufacturer.
The vaccine is named after the first Soviet space satellite. In 1957 the successful launch of the first space satellite Sputnik-1 by the Soviet Union reinvigorated space research and exploration around the world. The announcement of the new Russian Covid-19 vaccine created a so-called "Sputnik moment” for the global community. The vaccine is therefore called Sputnik V.