Recommendations of EMA and ongoing combo studies support mix&match approach pioneered by Sputnik team to fight COVID
MOSCOW, Dec. 7, 2021 /PRNewswire/ –The European Medicines Agency (EMA) today announced the heterologous vaccination (mix&match) approach (pioneered by the Russian Sputnik vaccine) can be used for both initial vaccination courses and boosters providing for better immunity against coronavirus.
The heterogeneous boosting approach (“vaccine cocktail” using human adenovirus serotype 26 as the first component and human adenovirus serotype 5 as the second component) was at the core of Sputnik V, the world’s first registered vaccine against coronavirus. This approach had proven successful in creating a longer and more durable immunity against the coronavirus as demonstrated by the real-world data from Hungary, San Marino, Argentina, Serbia, Bahrain, Mexico, UAE and other countries.
“Evidence from studies on heterologous vaccination suggests that the combination of viral vector vaccines and mRNA vaccines produces good levels of antibodies against the COVID-19 virus (SARS-CoV-2) and a higher T-cell response than using the same vaccine (homologous vaccination) whether in a primary or booster regimen”, EMA says as the EU is currently experiencing a rising number of infections, as well as an increase in hospitalisation rates. The latest recommendations of the European regulator are published at:
https://www.ema.europa.eu/en/news/ema-ecdc-recommendations-heterologous-vaccination-courses-against-covid-19
EMA experts are also noting: “While research is ongoing to provide more evidence on long-term safety, duration of immunity and effectiveness, the use of heterologous schedules may offer flexibility in terms of vaccination options <…>”
As shown by the latest data from the EU member state Hungary, Sputnik V had demonstrated the best results among five vaccines (Sputnik V, Moderna, Pfizer-BioNTech, Sinopharm and AstraZeneca) administered in the country between January and June 2021 with the highest (98%) efficacy in preventing COVID-related mortality and 85.7% efficacy against coronavirus infection (leading alongside the vaccine by Moderna).
The real-world data of the Ministry of Health of San Marino on Sputnik V has demonstrated it is 80% effective against coronavirus infection from 6th to 8th months after administering the second dose. Thus efficacy of Sputnik V on 6-8 months is much higher than officially published efficacy of mRNA vaccines.
In order to create herd immunity in a short time frame and provide a flexible re-vaccination schedule, the one-shot Sputnik Light vaccine based on human adenovirus serotype 26 (the first component of the Sputnik V vaccine) has been developed and is already authorized as a universal booster in a number of countries, including San Marino, Bahrain, UAE and Philippines. Sputnik Light as a booster helps other vaccines to increase their efficacy and has a high safety profile.
A study in Argentina on heterogeneous regimens combining Sputnik Light and vaccines produced by AstraZeneca, Sinopharm, Moderna and Cansino has demonstrated Sputnik Light is an effective universal booster. Each “vaccine cocktail” combination with Sputnik Light provided higher antibody titer on 14th day after administering the second dose as compared to original homogenous (same vaccine as first and second dose) regimens of each of the vaccines.
The data also demonstrated high safety profile of using Sputnik Light in combinations with all other vaccines with no serious adverse events following the vaccination in any combinations. The study has provided a strong scientific evidence supporting the mix&match approach with 5 vaccines involved.
Results of a separate joint clinical trial of a combination of Sputnik Light with the AstraZeneca vaccine have demonstrated that it induces strong immunity and has a high safety profile.
Kirill Dmitriev, CEO of the Russian Direct Investment Fund (RDIF), said:
“The heterologous boosting approach pioneered by the Gamaleya Center in Sputnik vaccine has proven to be the best choice and the most efficient way to fight COVID and its new variants, despite the fact that it was met with skepticism when the vaccine was rolled-out.
While there is generally high level of vaccination in Europe, producers of mRNA vaccines have acknowledged their waning efficacy and the mix&match approach is the solution to support the high immunity level and to reduce the infection rate.
Sputnik V vaccine has demonstrated excellent results in European countries (Hungary, San-Marino). RDIF reiterates its offer to producers and countries to join efforts in protecting population through supplies of Sputnik V and Sputnik Light and their combination with other vaccines.”
Logo – https://mma.prnewswire.com/media/1698158/Russian_Direct_Invest_Fund_Logo.jpg
