25 Nov 2020, PTI: RDIF continues expanding existing agreements with international manufacturing partners to produce the vaccine for more than 500 million people in 2021 MOSCOW, Nov. 24, 2020 /PRNewswire/ -- The cost of one dose of the Sputnik V vaccine for international markets will be less than 10. Sputnik V is a two dose vaccine.
Therefore, Sputnik V will be two or more times cheaper than mRNA vaccines with similar efficacy levels.[1] Vaccination with Sputnik V will be free of charge for Russian citizens.
RDIF and partners have launched production of the lyophilized (dry) form of the vaccine, which is stored at a temperature of +2 to +8 degrees Celsius. Such a regime enables the distribution of the vaccine in international markets, as well as expanding its use in hard-to-reach regions, including areas with tropical climates.
The current agreements between RDIF and leading foreign pharmaceutical companies allow the Sputnik V vaccine to be produced abroad for 500 million people per year, starting from 2021. RDIF is currently considering additional applications from a number of countries and companies to further increase production capacity.
The first international deliveries of the Russian Sputnik V vaccine will be made to customers in January 2021 based on the existing partnerships with foreign manufacturers. Those customers, who have recently submitted their requests, will be able to receive the first batches of the vaccine starting from March 2021.
Second interim analysis of clinical trial data showed a 91.4% efficacy for the Sputnik V vaccine on day 28 after the first dose; vaccine efficacy is over 95% 42 days after the first dose.
Currently, 40,000 volunteers are taking part in the Phase III double-blind, randomized, placebo-controlled clinical post-registration study of the Sputnik V vaccine in Russia, of whom more than 22,000 volunteers were vaccinated with the first dose and more than 19,000 volunteers with the first and second doses.
There were no unexpected adverse events during the trials. Monitoring of the participants is ongoing.
The Sputnik V vaccine is based on a well-studied human adenoviral vector platform that has proven safe and effective with no long-term side effects in more than 250 clinical trials globally conducted during the past two decades - while the history of the use of human adenoviruses in vaccine development began in 1953. More than 100,000 people have received approved and registered drugs based on human adenoviral vectors.
The uniqueness of the Russian vaccine lies in the use of two different human adenoviral vectors which allows for a stronger and longer-term immune response as compared to the vaccines using one and the same vector for two doses.
The Russian Direct Investment Fund (RDIF, Russia's sovereign wealth fund), announces the cost of the Russian Sputnik V vaccine for international markets will be less than 10 per dose starting from February 2021, which is less than 20 for the two doses necessary to vaccinate one person. Thus, Sputnik V will be two or more times cheaper than foreign vaccines based on mRNA technology with similar efficacy rates. For Russian citizens, vaccination with Sputnik V will be free of charge.
Currently, RDIF and partners have launched production of the lyophilized (dry) form of the vaccine, which is stored at a temperature of +2 to +8 degrees Celsius. Such a regime enables the distribution of the vaccine in international markets, as well as expanding its use in hard-to-reach regions, including areas with tropical climates.
Current agreements between RDIF and leading foreign pharmaceutical companies allow production of the vaccine abroad for 500 million people per year starting from 2021. RDIF is currently considering additional applications from a number of countries and companies to further increase production capacity.
The first foreign deliveries of the Russian Sputnik V vaccine will be made to customers in January 2021 based on existing partnerships with foreign manufacturers. Those customers, who have recently submitted their requests, will be able to receive the first batches of the vaccine starting from March 2021.
Kirill Dmitriev, CEO, Russian Direct Investment Fund, said: "The Gamaleya Center has developed one of the most efficient vaccines against coronavirus in the world with an efficacy rate of more than 90% and a price that is two times lower than that of other vaccines with similar efficacy rate. The uniqueness of the Russian vaccine lies in the use of two different human adenoviral vectors which allows for a stronger and longer-term immune response as compared to the vaccines using one and the same vector for two doses. We are ready to start deliveries of the Sputnik V vaccine to foreign markets thanks to partnerships with manufacturers in India, Brazil, South Korea, China and four other countries." As of November 24 more than 22,000 volunteers were vaccinated with the first dose and more than 19,000 volunteers with the first and the second dose of the vaccine at 29 medical centers in Russia as part of the ongoing clinical trials. Currently Phase III clinical trials are approved and are ongoing in Belarus, the UAE, Venezuela and other countries, as well as Phase II-III in India.
As of November 24, no unexpected adverse events were identified as part of the research. Some of those vaccinated had short-term minor adverse events such as pain at the injection point and flu-like symptoms including fever, weakness, fatigue, and headache.
During the clinical trials, the safety of the vaccine is constantly being monitored; information is analyzed by the Independent Monitoring Committee comprising leading Russian scientists. Collection, quality control and data processing is conducted in line with ICH GCP standards and involves the active participation of Moscow's Health Department and Crocus Medical, the contract research organization (CRO).
The safety of vaccines based on human adenoviruses has been confirmed in more than 75 international publications and more than 250 clinical trials conducted during the past two decades - while the history of use of human adenoviruses in vaccine development started in 1953. Adenovirus vectors are genetically modified viruses of the regular flu that cannot reproduce in a human body. When the Sputnik V vaccine is used, the coronavirus itself does not enter the body as the vaccine only contains genetic information about part of its outer protein coat, the so called "spikes" forming its crown. This completely eliminates the possibility of getting infected as a result of vaccination while also causing the body's stable immune response.
On September 4, The Lancet, one of world's leading medical journals, published a research paper on the results of Phase I and Phase II clinical trials of the vaccine that showed no serious adverse events and an effective immune response of those vaccinated.
Requests for more than 1.2 billion doses of Sputnik V vaccine came from more than 50 countries. The vaccine supplies for the global market will be produced by RDIF's international partners in India, Brazil, China, South Korea and other countries.
On August 11, the Sputnik V vaccine developed by the Gamaleya Center was registered by Russia's Health Ministry and became the world's first registered vaccine against COVID-19. Detailed information on the Sputnik V vaccine, its human adenoviral vectors technological platform, and other details are available at sputnikvaccine.com Be the first to learn about Sputnik V on social networks: Twitter Facebook Instagram Youtube Russian Direct Investment Fund (RDIF) is Russia's sovereign wealth fund established in 2011 to make equity co-investments, primarily in Russia, alongside reputable international financial and strategic investors. RDIF acts as a catalyst for direct investment in the Russian economy. RDIF's management company is based in Moscow. Currently, RDIF has experience of the successful joint implementation of more than 80 projects with foreign partners totaling more than RUB1.9 trillion and covering 95% of the regions of the Russian Federation. RDIF portfolio companies employ more than 800,000 people and generate revenues which equate to more than 6% of Russia's GDP. RDIF has established joint strategic partnerships with leading international co-investors from more than 18 countries that total more than 40 bn. Further information can be found at rdif.ru [1] Based on the mRNA vaccines which announced pricing & interim Phase III results.
