Russia has extended a hand to the Philippines, offering to work closely with that southeast Asian country to supply Russian COVID-19 vaccine candidates. Reports are that Igor Khovaev, Ambassador to the Philippines, introduced during a virtual presser the vaccine developed at Gamaleya National Research Institute of Epidemiology and Microbiology, part of the Ministry of Health of the Russian Federation; he suggested that Russia would make the experimental product available to the Philippines. Apparently, a proposal is on the table. TrialSite urges the Philippines to proceed with caution.
Russian Vaccine Update
TrialSite and others have questions the speed by which the Gamaleya vaccine candidate has gone through clinical trials, including what appears to be aggressive human challenge trials. Recently, the Russian Direct Investment Fund (RDIF), again the sovereign wealth fund that has contributed financing and deal-making, most recently joined an alliance with R-Pharm Group “to combat coronavirus infection and produce the first Russian vaccine with high export potential.” According to rumblings in the Philippines press, Russia invested 4 billion Rubles, or $54 million US.
Now that RDIF forged a partnership with R-Pharm Group, the latter will produce the vaccine at a new plant in Yaroslavl, reported Alexey Repik, chairman of the board of the R-Pharm Group. On the topic of production, Kirill Dmitriev, a high-powered player leading RDIF—and who joined the human challenge taking the vaccine before approvals were in place—reports the country is in the works to make 30 million doses in Russia and 200 million to be made globally should tests conclude successfully in 2020.
Seeking Distribution Partners for the Gamaleya Vaccine
Now the Russians are sending signals that they want to do deals with third parties, e.g., other nations. Although Ambassador Khovaev suggests they are “ready to share” this vaccine and this can be triggered in one of three ways including 1) initiate clinical trials in the Philippines if it is deemed necessary, 2) directly supply the vaccine to the Philippines, or 3) license the vaccine to the Philippines for production locally.
According to local Philippines press Sunstar, the Russians have already submitted a proposal to the Philippines, which is now under consideration.
Vaccine Approval Imminent?
More press now is covering the rapidly compressed Russian vaccine timelines. TrialSite has expressed concerns given SARS-CoV-2 just emerged on the world scene, and the most advanced Western life science companies (the most advanced in the world) can’t even more at the speed Russia now operates. But there are political and nationalistic aspirations as Russia harkens back to a Soviet-era momentum in Sputnik and an associated propaganda victory: the Soviet Union did launch the first satellite in 1957. Now, the Gamaleya vaccine commenced formal human trials just a couple of months ago. However, as TrialSite has uncovered through the various press in Russia and beyond early state and what many would consider highly unethical early state testing started a couple of months before that—possibly as early as March or April.
Recently, Lawrence Gostin, Georgetown University global public health expert, suggested, “I’m worried that Russia is cutting corners so that the vaccine that will come out maybe not just ineffective, but also unsafe. Perhaps Russia can change the rules of the clinical trials order, but it’s playing a risky game.
Who is R-Pharm Group?
R-Pharm Group was founded in 2001 by Alexey Repik. By 2017, 10% of JSC R-Pharm’s shares were acquired by Japanese Corporation Mitsui & Co., Ltd. R-Pharm’s mission: increase the accessibility of the most modern medicines for patients in Russia and all over the world.
Based in Moscow with over 3,000 employees, the Group operates throughout the Russian Federation, CIS member states, USA, Germany, Japan, and elsewhere. The company positions on its website that it specializes in research and development, manufacturing of high-tech medicines, as well as the distribution of laboratory supplies and medical equipment. The company generates over $1 billion in revenue.
Russia appears to have undertaken extensive human testing before or in parallel while they ramped up their Phase 1 clinical trial. From the first scientists at Gamaleya to military personnel to a “VIP” program for the rich and famous, the culture is different from that of the West. A different history, heritage, and sense of connection to the State. Will that translate to a superior or inferior COVID-19 vaccine? It can’t be certain. But if corners from the established global clinical trials ICH, GcP standards, the risks for trouble certainly could rise.