Sputnik V induces robust neutralizing antibody response to Omicron variant, which is further strengthened by Sputnik Light booster, the Gamaleya Center preliminary study shows

MOSCOW,, Dec. 17, 2021 /PRNewswire/ --

- The Gamaleya Center's recent preliminary laboratory study shows that Sputnik V demonstrates high virus neutralizing activity (VNA) against the Omicron (B.1.1.529) variant and is expected to provide strong defense against severe disease and hospitalization.

- Sputnik V has demonstrated 3-7x less of a reduction in virus neutralizing activity against Omicron as compared to data from other vaccine producers: 11.8 times decrease of VNA for Sputnik V in contrast with 41 times decrease for Pfizer-BioNTech (according to the study led by scientists from Africa Health Research Institute published on Dec 7, 2021[i]) and 49-84 times decrease for Moderna (according to the study published by research group from scientific institutes including Vaccine Research Center on Dec 15, 2021[ii]). So far, Sputnik V is showing the best virus neutralization results against Omicron in comparison with other vaccines.

- The study was conducted using sera with a longer period after vaccination (more than 6 months after vaccination) as an indicator of Sputnik V's long-lasing protection, in contrast with short studied periods for other vaccines producers (12-27 days for Pfizer-BioNTech and 28 days for Moderna).

- Sputnik V elicits strong and long-lasting T-cell response, and as 80% of epitopes in the spike protein are not affected by the mutations in the Omicron variant, Sputnik V is expected to provide long-lasting protection against severe disease by Omicron. Sputnik V's long-lasting T-cell immunity contributes to 80% efficacy against Delta on months 6-8 compared with efficacy of less than 29% demonstrated by certain mRNA vaccines after 6 months.

- Sputnik Light as a booster significantly increases virus neutralizing activity against Omicron based on sera 2-3 months after revaccination. Virus neutralizing activity against Omicron 2-3 months after a Sputnik Light booster in this preliminary laboratory study is higher than VNA against the wild-type virus 6 months after Sputnik V vaccination. Based on these data the expected efficacy of Sputnik V with Sputnik Light booster against Omicron infection could be more than 80%, as Sputnik V showed efficacy of more than 80% against wild-type virus 6 month after vaccination.

- 100% of individuals revaccinated with Sputnik Light as a booster developed neutralizing antibodies against Omicron and demonstrated their high level 2-3 months after the revaccination in contrast with only 25% of Pfizer booster recipients showing detectable level of neutralizing antibodies 3 month after vaccination (as demonstrated in the study published by research group from scientific institutes including Institute for Medical Virology (Frankfurt) on Dec 13, 2021[iii]).

- Sputnik Light booster is expected to provide strong protection against infection, severe disease and hospitalization by Omicron. Sputnik Light booster is recommended to strengthen efficacy of vaccines against Omicron. Boosting by Sputnik Light can strengthen and lengthen the quickly waning efficacy of many vaccines in light of combined Delta and Omicron challenge. Sputnik Light is a universal booster to other vaccines, including Sputnik V. In Argentina, a combination of Sputnik Light with other vaccines has demonstrated its effectiveness as a universal booster inducing stronger antibody and T-cell response compared to a two-shots homologous regimen.

- Sputnik V and Sputnik Light were developed on the basis of a safe and well-studied over 30 years technology and have not been associated with rare serious side effects 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.

A preliminary laboratory study conducted by the Gamaleya Center has demonstrated that the Sputnik V vaccine and the one-shot Sputnik Light booster (based on human adenovirus serotype 26, the first component of Sputnik V) are effective against Omicron (B.1.1.529) variant of COVID, providing for better protection when compared to other vaccines.

Heterologous boosting with Sputnik Light is the solution to increase other vaccines' efficacy, including against Omicron, and extend the booster protection period.

Sputnik Light as a booster significantly increases virus neutralizing activity against Omicron based on sera 2-3 months after revaccination and is a universal booster to other vaccines inducing stronger antibody and T-cell response.

Efficacy of mRNA vaccines has proven to be waning, demonstrated by a number of scientific publications. A Swedish study in The Lancet journal[iv] has shown that Pfizer vaccine's efficacy against Delta is falling to 47% after 4 months, to 29% after 6 months and to 23% after 7 months. The recent study in US among 65+ years olds demonstrated the decrease in mRNA vaccine effectiveness accelerating against Delta after month 4, reaching a low of approximately 20% in months 5 through 7[v].

Recognizing the waning efficacy of mRNA vaccines, EU, UK, Greece, South Korea and other countries have recommended reducing the boosting period from 6 to 3 months.

Sputnik Light booster is recommended to strengthen efficacy of vaccines against Omicron. Boosting by Sputnik Light as well as heterologous boosting can strengthen and lengthen the quickly waning efficacy of many vaccines in light of combined Delta and Omicron challenge.

Sputnik Light has already been registered in more than 20 countries as a standalone vaccine and a universal booster to other vaccines helping to increase their efficacy (including in Argentina, UAE, Bahrain, Philippines, and San Marino). Sputnik V has been authorized in 71 countries with total population of over 4 billion people.

Sputnik Light has already shown strong results used 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 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 homogenous (same vaccine as first and second dose) regimens of each of the vaccines.

Authors of a study in Argentina have noted that protection against coronavirus remains stable over at least 4 months following vaccination with the Russian Sputnik V vaccine as a consequence of antibody maturation, resulting in improved potency of antibodies to viral escape mutations. The study results were summarized in an article at https://www.medrxiv.org/content/10.1101/2021.08.22.21262186v1

Sputnik Light efficacy data:

- Sputnik Light has been proven to be safe and highly effective by real-world vaccination data. In particular, data from the Ministry of Health of Buenos Aires (Argentina) has demonstrated standalone efficacy of Sputnik Light between 78.6-83.7% among the elderly (over 40,000 people of 60-79 years old), which is higher than that of many two-dose vaccines.

- Findings by the Gamaleya Center based on data collected in Moscow have demonstrated Sputnik Light vaccine administered standalone has 70% efficacy against infection from the Delta variant of coronavirus during the first three months after vaccination. The vaccine is 75% effective among subjects under the age of 60. Sputnik V and Sputnik Light are based on a safe and effective human adenoviral vector platform and have not been associated with rare serious adverse events following vaccination, such as myocarditis or pericarditis.

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[i] https://www.ahri.org/omicron-incompletely-escapes-immunity-induced-by-the-pfizer-vaccine/

[ii] https://www.medrxiv.org/content/10.1101/2021.12.15.21267805v1

[iii]  https://www.medrxiv.org/content/10.1101/2021.12.07.21267432v4

[iv] https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3949410

[v] https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2787183