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,RDIF CEO Kirill Dmitriev explained that the entity has been in touch with Indian partners to share best practices of their initiative. RDIF is in talks with Indian entities to produce vaccines in India.
Is RDIF in touch with Indian authorities over export of anti Covid drug and medicines?
RDIF is cooperating with Indian partners to share the most advanced practices to combat coronavirus, we have been in touch through the whole coronavirus period. We are open to producing the vaccine by Gamaleya National Research Center for Epidemiology and Microbiology in India and are currently discussing such a possibility with a number of Indian partners. We believe that the current and future pandemics can be successfully combated only through a fully cooperative, global approach. Countries around the globe must jointly put in place their best practice—including mandatory mask wearing, maintaining social distancing, and sharing the most effective drugs and other medicines.
What are your views about the allegation that Russia has hacked vaccine research from the UK and other countries when Russia itself has been involved in research to prepare vaccines and drugs to fight Covid.
The Russian vaccine by Gamaleya National Research Center for Epidemiology and Microbiology (Gamaleya Center) supported by RDIF is based on previously tested, safe and proven effective platform of adenovirus-based vectors. Gamaleya Center’s vaccine belongs to the class of so-called adenoviral vector based vaccines, which uses the gene of coronavirus implanted in a different type of virus. The same platform was successfully used by Gamaleya Center to develop effective Ebola vaccine in 2015 and then a vaccine against Middle East Respiratory Syndrome (MERS). The only change this time is that parts of the Ebola virus and the Middle Eastern Respiratory Syndrome (MERS) virus in the vaccine were replaced with the “spike” of the novel coronavirus SARS-CoV-2. This vaccine platform used by Gamaleya Center has been previously tested and has shown no side effects, including no negative impact on fertility. Thus it will be easier to mass produce this Russian vaccine than other vaccines currently undergoing trials in different countries which may take years to complete. Most vaccines from other countries have not received any approval earlier or their mechanisms have not been proven effective yet. On top of that the Gamaleya Center’s vaccine is more effective than others because it has two viral vectors (a viral vector is a tool of a vaccine which is necessary to deliver genetic material like coronavirus spike into cells) while many vaccines in other countries have only one viral vector. The Russian vaccine by Gamaleya Center can be the first to the market and potentially can be the most effective vaccine globally. We expect to get the regulatory approval for in August.
What is the stage of the vaccine trial in Russia? What role has RDIF played in the process?
There are more than 140 vaccines in the world (over 20 in clinical trials) against COVID-19 but we focus on Adenovirus-based vaccines that will be ready by September. Adenovirus-based vaccines have been developed since the 1980s. They have already received regulatory approval and have been efficiently used against the Ebola virus with a high degree of safety. There are also prospective mRNA and other innovative vaccines, but we need far more time to develop and test them in terms of fertility influence.
RDIF together with Russia’s top epidemiology and microbiology research center (Gamaleya Center) is working to produce Russia’s first own vaccine against COVID-19. Vaccine is needed for a decisive victory over the pandemic. The major advantage of the Gamaleya Center’s vaccine is prime-boost immunization with two different components – this approach allows to overcome immunity against vector part of the vaccine and leads to memory cell formation for longer immunity.
The Gamaleya Center’s vaccine is expected to be one of the first to market. Phase 1 is over. Phase 2 will be completed on August, 3. Mass production of the vaccine is expected by September 2020. Pre-trial of the Gamaleya Center’s vaccine shows very good results. The vaccine works. It utilizes a well-known platform of adenovirus-based vectors, but the product is an original development. The Gamaleya Center’s vaccine induces both antibody and cellular immunity, also vaccination leads to high level of virus-neutralizing antibodies. No one of participants in the current clinical trial got infected by COVID-19. Preclinical animal studies showed 100% protection on the Syrian hamster model of lethal infection and absence of lung-damage due to infection.
I personally developed a strong immunity in 20 days. After the first 20 days I already had IgG levels of 5.5 which is comparable to the average of people who got really sick with 6 being an average. But then already after the 2nd shot I developed more than 10 IgG level. Gamaleya’s specific test shows the increase in antibodies from 1:1,600 to 1:3,200 which is a very high level of antibodies.
How successful has been an anti Covid drug whose research and production has been backed by RDIF?
There are only two anti-COVID drugs in the world that have proven effective, one of them is Avifavir produced by RDIF and ChemRar Group. Avifavir is currently the world’s best drug against COVID-19. It is an improved coronavirus-specific version of the Japanese anti-influenza drug Avigan. Avifavir is better and more effective than the American drug Remdesivir from Gilead. This is confirmed by clinical trials. Avifavir is prodused in tablets and could become available in drug stores for people by prescription and taken on an outpatient basis at an early stage. This is impossible for Remdesivir (injections). Additionaly, Avifavir will be 5 times cheaper than Remdesivir.
Avifavir is the first anti-COVID-19 drug registered by the Ministry of Health of Russia. It is also the world’s first registered coronavirus drug based on the substance favipiravir. RDIF and ChemRar Group were the first to clinically prove efficacy of the drug to treat COVID-19. The Russian Ministry of Health has included Avifavir in its latest seventh edition of the guidelines for the prevention, diagnosis and treatment of new coronavirus infection COVID-19. Starting June 10, 2020, the drug has already been delivered to more than 50 Russian regions, helping to stop the spread of the virus and take control of the pandemic. Avifavir has demonstrated efficacy in clinical trials held in 35 medical centers across Russia involving 330 patients with confirmed COVID-19. The drug disrupts the reproduction mechanisms of the coronavirus, relieving symptoms and halving the treatment period compared to standard therapy.
What is Russia’s plan to export vaccines and drugs to partner countries?
RDIF sees high export potential of the Avifavir in the future. We received requests from 50 countries. While Remdesivir will not be available to be shipped internationally for some time due to massive purchases by the U.S. Government, RDIF and ChemRar Group have already launched the international distribution of Avifavir, and increased the production of Avifavir to 300,000 courses a month, to supply both local and international demand. Avifavir has already been bought not only by Russia’s neighbours Belarus and Kazakhstan but other nations around the globe. The geography of the demand is broadening. RDIF sees strong interest from Latin America and the Middle East. The orders came from Brazil, Colombia, Mexico, Peru and Saudi Arabia. Other generic versions similar to Avifavir can be produced by other nations as well, enabling the mass distribution of the drug around the world.
As for the vaccine RDIF is first and foremost aiming to fulfill Russia’s needs but international collaboration is important part for the product development and clinical programs. RDIF and its partners plan to conduct Phase 3 clinical trials in parallel in Middle East and other countries. We see strong global interest to the vaccine. RDIF has strategic partnerships with its portfolio companies R-Pharm and Alium to enable mass vaccine production and other five countries through Sovereign Wealth Funds.
By producing Gamaleya Center’s vaccine through manufacturing partnerships in several countries, we will be able to ramp up production to 200 million doses by the end of the year including 30 million doses in Russia. We expect that more than 3 billion doses of adenoviral vector-based vaccines will be produced in 2021.
What other measures does RDIF consider effective to combat coronavirus?
RDIF has focused on testing as it is a crucial factor to restore economic activity and resume safe international regular air services. Quick and precise tests are key to opening economies. This week together with Sheremetyevo International Airport we have launched express-testing for coronavirus for arriving and departing passengers. Sheremetyevo International Airport has become the first airport in the world where it is possible to take the fastest and most accurate PCR test for coronavirus infection, which is produced by our portfolio Russian-Japanese company EMG. The EMG diagnostic system, created with support from RDIF, is adapted for both fixed and unique mobile mini-laboratories (the portable system fits in two small suitcases).
Our testing system has already helped to quickly locate and prevent potential outbreaks at many of Russia’s largest industrial enterprises, as well as at offices and soccer competitions. EMG tests are also certified in the EU and in the Middle East. Unsurprisingly, other countries have purchased more than 13 million of our tests—indeed, they account for more than a third of all tests completed in the U.S. Rapid, accurate tests like ours will be essential to opening up the world economy.
Thus RDIF has focused on three key areas to combat coronavirus more effectively: testing, drugs and vaccines.
Can you give an update on RDIF-backed projects in India in infrastructure and other sectors?
RDIF continues to actively cooperate with Indian partners on various projects primarily to attract Indian investments to the Russian Federation. In September 2019 RDIF announced a cooperation agreement with the National Investment Promotion Agency of the Republic of India (Invest India). The agreement was signed in the presence of the President of the Russian Federation, Vladimir Putin and the Prime-Minister of the Republic of India, Narendra Modi. RDIF and the National Investment Promotion Agency of the Republic of India intend to jointly search for attractive investment projects that help strengthen bilateral economic ties and increase the volume of mutual investments between Russia and India and enable their implementation.