The Russian development of the Gamaleya Center "Gam-COVID-Vac" (Coronavirus vaccine "Sputnik V") has demonstrated high rates of efficacy, immunogenicity and safety during the third phase of clinical trials.
The data presented by the developers have been confirmed by independent experts, according to The Lancet.
An international independent examination found that the Sputnik V vaccine provides complete protection against severe cases of coronavirus disease (for example, Pfizer's RNA vaccine provides only 75% protection in this indicator).
The Russian two-component drug was created on adenoviral vectors (weakened bases of adenoviruses) with an embedded gene for the SARS-CoV-2 spike protein.
As the developers note, this well-researched and highly efficient platform has been proven to be safe for decades.
"Sputnik V" was included in the top three vaccines with an efficiency above 90%, its efficiency was 91.6%.
The corresponding figures are presented based on the analysis of data from the Sputnik V study on 19,866 volunteers.
According to this indicator, the Russian vaccine is one of the three drugs with an efficiency higher than 90%, along with Pfizer and Moderna RNA vaccines.
At the same time, Sputnik V compares favorably with its main competitors in price, storage and transportation conditions.
“The vaccine is 100% effective in preventing serious cases of illness or death, and this is the most important parameter - we can all cope with a mild runny nose, the main thing is not to be in the hospital and not have serious complications.
Even after the first injection of this two-component vaccine, the disease protection rate was 87.6%.
Thus, Sputnik V is more effective than vaccines from AstraZeneca or Johnson & Johnson.
Sputnik V, which, unlike the equally effective Pfizer and Moderna RNA vaccines, can be refrigerated, will go a long way in fighting the global COVID-19 pandemic, ”said MD, professor, Center for Vaccines and Immunotherapy , Wistar Institute (USA) Hildegund Ertl.
For older people (60+), the effectiveness of vaccination was not lower than for other age groups, and amounted to 91.8%.
The efficacy analysis was based on the distribution of 78 confirmed cases of coronavirus: 62 cases in the placebo group and 16 among those who received the vaccine.
Sputnik V was included in the top three vaccines with an efficiency above 90%
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According to the research results, the immune response was developed in the overwhelming number of subjects: the humoral (antibody) response was formed in more than 98%, and cellular immunity - in 100% of the volunteers.
“The publication of an international peer review of Sputnik V clinical trials is a great success in the global fight against the pandemic.
The safety and high efficacy of the Russian vaccine is confirmed by the presented reliable scientific data, and I am glad to congratulate the whole team ... on this outstanding achievement, ”said Alexander Gintsburg, director of the Gamaleya Center.
Among other advantages of the vaccine, scientists noted a significant level of antibodies produced by the body (1.3-1.5 times more than that of those who have had COVID-19), as well as high safety indicators.
Thus, most of the adverse events (94%) were mild and were reduced to colds, reactions at the injection site, headache and general weakness.
At the same time, those vaccinated with "Sputnik V" did not have undesirable effects, such as strong allergic reactions, anaphylactic shock.
Also, according to the developers, the value of Sputnik V as a vaccine for mass vaccination of the population is confirmed by simple logistics and relatively low cost: the storage temperature of the drug is + 2 + 8 ° C, the price of one injection is less than $ 10.
For comparison, the storage temperature for the Pfizer vaccine is -80-60 ° C, for the Moderna it is -25-15 ° C.
In terms of financial indicators, the most effective foreign vaccines are also inferior to the Russian development: the cost of one Pfizer injection is $ 19.5, an injection with Moderna vaccine costs $ 37.
“The interim results of the third phase of clinical trials of a COVID-19 vaccine based on human adenoviral vectors“ Sputnik V ”are impressive.
This vaccine has proven to be very effective and highly immunogenic for different age groups.
This is undoubtedly good news as this dual-formula vaccine is relatively easy to manufacture and deploy in the face of anticipated global vaccine shortages and logistical challenges in the distribution and initiation of vaccinations with a number of more temperature-sensitive vaccines recently approved for emergency use. ” said Cecil Cherkinski, MD, Director of Research, National Institute for Health and Medical Research (Inserm), France.
State Duma deputy, former chief sanitary doctor of Russia Gennady Onishchenko commented on the results of the international expert assessment of the Sputnik V vaccine in The Lancet.
“This is not an accidental phenomenon, because our country has vast experience in vaccine production.
I had no doubt that the Sputnik V vaccine would be okay, despite the aggressive, vicious information attack.
The Lancet is a respected authoritative publication in the scientific community that does not deal with market conditions and publishes always verified, weighted data.
This assessment really deserves attention. "
According to the Gamaleya Center and the Russian Direct Investment Fund (RDIF), Sputnik V is registered in 16 countries: Russia, Belarus, Serbia, Argentina, Bolivia, Algeria, Palestine, Venezuela, Paraguay, Turkmenistan, Hungary, United Arab Emirates, Iran, the Republic of Guinea, Tunisia and Armenia.
In Russia, on January 18, the vaccination campaign entered the stage of a mass vaccination.
Since January 31, an appointment for vaccination with Sputnik V has become available on the portal of state services.
“Today there was a big event in the fight against the coronavirus pandemic.
The data published by The Lancet prove that Sputnik V is not just the world's first registered vaccine, but also one of the best, "summed up the head of the RDIF Kirill Dmitriev.