A unique comparative study conducted at the Italian Spallanzani Institute, the leading Italian research institute for infectious diseases, by a joint Italian-Russian team of researchers representing the Institute and the Gamaleya Center shows that the Sputnik V coronavirus vaccine demonstrates higher titers of virus neutralizing antibodies to Omicron (B.1.1.529) variant than 2 doses of Pfizer vaccine (2.1 times higher in total and 2.6 times higher 3 months after vaccination).
The study was conducted in the equal laboratory conditions in the Spallanzani Institute in Italy on comparable sera samples from individuals vaccinated with Sputnik V and Pfizer with a similar level of IgG antibodies and virus neutralizing activity (VNA) against Wuhan variant.
Sputnik V shows significantly smaller (2.6 times) reduction of virus neutralizing activity against Omicron as compared to reference Wuhan variant than Pfizer vaccine (8.1-fold reduction for Sputnik V in contrast to 21.4-fold reduction for Pfizer vaccine).
The study demonstrates that registered vaccine coronavirus RDIF Sputnik V neutralizes the Omicron variant by inducing robust antibody response associated with high levels of protection.
Among the top quartile of individuals with high RBD-specific IgG antibodies, 100% of those vaccinated with Sputnik V were able to neutralize Omicron variant in comparison to 83.3% of individuals vaccinated with Pfizer.
Among all samples, 74.2% of Sputnik V-vaccinated sera were able to neutralize Omicron vs 56.9% for Pfizer-vaccinated.
The study discusses several reasons for Sputnik V eliciting stronger virus neutralizing antibodies against Omicron, including:
Sputnik V develops a wider pool of antibodies to different epitopes in contrast to Pfizer vaccine, which utilizes the spike protein in a proline-stabilized form directed mainly to the specific epitopes, which were highly affected by the mutations in the Omicron variant;
Heterologous prime-boost vaccination regimen of Sputnik scheme;
Better mimicking of adenoviral vaccine platform of the infection.
The data supports the results of the recent laboratory study by the Gamaleya Center published in MedRxiv [i] demonstrating that Sputnik V induces robust neutralizing antibody response to Omicron variant, which is further strengthened by Sputnik Light booster:
As 80% of epitopes in the spike protein recognized by CD8+ T cells are not affected by the mutations in the Omicron variant, Sputnik V elicits strong and long-lasting T-cell response and is expected to provide durable protection against severe disease and hospitalization caused by Omicron.
Sputnik Light as a booster significantly increases virus neutralizing activity against Omicron, which is comparable to titers observed after Sputnik V against wild-type virus, associated with high levels of protection.
Sputnik Light is a universal booster to other vaccines thanks to the optimal configuration of Sputnik vaccine’s adenoviral platform which provides better protection against Omicron and other mutations as demonstrated in multiple studies.
Sputnik V vector vaccine coronavirus has been authorized in 71 countries with a total population of over 4 billion people, and Sputnik Light in more than 30 countries. Sputnik V and Sputnik Light have been developed using a safe technology that has been widely studied for over 30 years and have not been associated with rare serious side effects such as myocarditis or pericarditis. The highest safety and efficacy of Sputnik V and Sputnik Light was demonstrated in more than 30 studies and real-world data publications from more than 10 countries.
Sputnik V and Sputnik Light can be stored in a conventional refrigerator at +2 +8ºC for 6 months, making them available globally, including in remote territories, without any need to invest in additional cold-chain infrastructure.
Moscow, May 25, 2022 – The Gamaleya National Research Center of Epidemiology and Microbiology (Gamaleya Center) today announces that the Vaccines leading peer-reviewed medical journal has published the results of a unique independent comparative study conducted at the National Institute for Infectious Diseases Lazzaro Spallanzani (Italy) by a joint team of researchers of the Institute and the Gamaleya Center. The study shows that 2 doses of Sputnik V provide higher geometric mean titers (GMT) of virus neutralizing antibodies to the Omicron variant of COVID than 2 doses of Pfizer vaccine (2.1 times higher in total and 2.6 times higher 3 months after vaccination).
An article by a team of 12 Italian and 10 Russian scientists led by Francesco Vaia, Director of the Spallanzani Institute and Alexander Gintsburg, Director of the Gamaleya Center, has been peer-reviewed and is available at:
https://www.mdpi.com/2076-393X/10/5/817/htm
The study was conducted in Spallanzani Institute in the equal laboratory conditions at the Italian Spallanzani Institute on comparable groups of sera from individuals vaccinated with Sputnik V and Pfizer, with no statistically significant difference in neutralizing activity against Wuhan variant.
According to the study’s findings, Sputnik vaccine provides for eliciting high titers of virus neutralizing antibodies to Omicron variant. Fast-spreading Omicron sub-variants BA.4 and BA.5 are currently causing surges of coronavirus cases in the United States, South Africa and 70 other countries.
The advantages of Sputnik V are the use of native S glycoprotein (spike protein without proline-stabilization and other modifications) and the use of a heterologous prime-boost vaccination regimen. The Pfizer vaccine utilizes the spike protein in a proline-stabilized form in contrast to Sputnik V. Proline-stabilization and other modifications may move an immune response predominantly to the actively mutating receptor-binding domain (RBD) of spike protein. In the Omicron variant, a substantial number of mutations were registered precisely in RBD, which is why such a significant drop in neutralizing activity against this variant may be observed in the sera of Pfizer-vaccinated.
Boosting with Sputnik Light as part of the “mix & match” approach may help address the lower efficacy of mRNA vaccines against Omicron as well as the documented, quickly waning, efficacy of mRNA vaccines against COVID-19. Partnerships between adenoviral and mRNA vaccines could provide for stronger protection against Omicron and other variants.
Based on the data collected by the Spallanzani Institute and results of previous studies, heterologous (“mix & match”) boosting with Sputnik Light is the best solution to increase other vaccines’ efficacy and extend the booster protection period as optimal adenoviral platform configuration provides better protection against Omicron and other mutations:
a. Sputnik Light as a booster significantly increases virus neutralizing activity against Omicron, which is comparable to titers observed after Sputnik V against wild-type virus, associated with high levels of protection. The study results were summarized in an article available at:
www.medrxiv.org/content/10.1101/2021.12.17.21267976v1
b. Sputnik Light has already shown strong results as a booster in “mix & match” trials in Argentina. A combination of Sputnik Light with vaccines produced by AstraZeneca, Sinopharm, Moderna and Cansino, conducted in 5 provinces (City and Province of Buenos Aires, as well as Córdoba, La Rioja and San Luis) has demonstrated that Sputnik Light induces stronger antibody and T-cell response as compared to a homologous regimen (two shots of the same vaccine). Each “vaccine cocktail” combination with Sputnik Light provided higher antibody titer on the 14th day after administering a second dose when compared to original homologous (same vaccine as first and second dose) regimens of each of the vaccines.
c. As duration of vaccine protection is key to avoid frequent boosting, authors of another study in Argentina have noted that protection against coronavirus remains stable following vaccination with the Russian Sputnik V vaccine as a consequence of antibody maturation, resulting in improved potency of antibodies to viral escape mutations:
https://www.medrxiv.org/content/10.1101/2021.08.22.21262186v1
d. The study conducted by a number of highly respected institutes in the US (Beth Israel Deaconess Medical Center, Harvard University, Ragon Institute of MGH, MIT and University of North Carolina) demonstrated that boosting Pfizer vaсcine with Ad26 vector produces optimal durable protection against Omicron with 4 times higher increase in Omicron-specific T-cells and 2.4 times in neutralizing antibody titers vs Pfizer booster. Sputnik Light is based on Ad26 vector and is the universal booster for other vaccines vs all mutations:
https://www.medrxiv.org/content/10.1101/2021.12.02.21267198v2
e. US study on 168 mln people showed that one-shot COVID vaccine based on Ad26 is superior against infections and hospitalizations to quickly waning two-shot mRNA vaccines. In the 6th month after vaccination, Pfizer protection against hospitalization waned 4 times, while there was no evidence of waning protection against hospitalization for Ad26 vector:
https://www.medrxiv.org/content/10.1101/2022.01.05.22268648v1
f. Another study conducted on almost 500,000 health care workers in South Africa demonstrated 85% efficacy of Ad26 booster against hospitalization caused by Omicron variant:
https://www.medrxiv.org/content/10.1101/2021.12.28.21268436v1.full-text
[i] https://www.medrxiv.org/content/10.1101/2021.12.17.21267976v1
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