Previously, TrialSite has covered the Russian Direct Investment Fund (RDIF) and their involvement with that country’s COVID-19 therapy and vaccine development programs. Now, the organization’s chief, Kirill Dmitriev, has emerged as an international drug development deal maker, crisscrossing the world to secure buy-in and commitment by various countries to test Sputnik V, the Russian COVID-19 vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology. Although as TrialSite has reported, the Russian health authorities appeared to have cut corners in developing Sputnik V, bypassing an industry-standard Phase 2 trial. Instead they registered the product as approved by health authorities, before even starting Phase 3 trials. Moreover, a questionable and highly unorthodox set of human-challenge trials evidences stark difference in culture from the West, for example. That all being said, the Sputnik V vaccine is being embraced by several countries as a Phase 3 investigational candidate. To date, TrialSIte cannot find any evidence of any serious safety issues associated with what the West still considers an investigational candidate. Evidence is mounting that the world, or at least a number of nations, are buying in. In the latest such “buy in,” the United Arab Emirates (UAE) and its Abu Dhabi Health Services Company now serves as trial site for the Phase 3 Sputnik V study in that Gulf nation.
First, Russia has also embarked on Phase 3 clinical trials for its “approved” Sputnik V. For those new to the industry, in most developed nations drugs are not approved by regulatory authorities until they successfully complete pivotal Phase 3 clinical trials. In the case of the Sputnik V vaccine, the Russian authorities approved the product before the Phase 3 clinical trials. Then they commenced with the Phase 3 trials. Why did they do this? Well this is TrialSite speculation, but first and foremost it was deemed urgent to get a vaccine out due to the pandemic, and also because Russia had embarked on a highly questionable human challenge endeavor it could very well be the case that they accumulated more safety and efficacy data than just from clinical trials. Perhaps the scientists, medical professionals, and health regulators in that country identified enough safety and efficacy signals to proceed?
Secondly a healthy dose of “Vaccine Nationalism” was undoubtedly present. To be fair, the nationalist theme has been popular around the world since the last few election cycles. Nonetheless, incidents with China (think CanSino Biologics and Canada) raise serious questions of nation states using vaccines for good and not so good purposes. Additionally, Russia is working desperately to expand and diversify its economy, and it considers life sciences (e.g. development of drugs and devices) as a critical piece of that strategy.
Administration of the Phase 3 Trial in UAE
The UAE Ministry of Health and Prevention has approved Phase 3 clinical trials involving the Sputnik V vaccine in the UAE, as reported by RDIF. UAE’s leading laboratory provider, PureHealth, will partner with Abu Dhabi Department of Health and the UAE Ministry of Health and Prevention to oversee the study. Medical protocols will be handled by Abu Dhabi’s public health provider, the Abu Dhabi Health Services Company (SEHA). RDIF issued this statement about the trials, “Conducted in line with the highest international standards (e.g. FDA/GxP & ICH) volunteers for the UAE trial will be medically supervised for 90 days after taking the Sputnik V vaccine.”
Deal Maker Extraordinaire
TrialSite is highly suspect of the way the Gamaleya National Research Institute of Epidemiology and Microbiology, part of the Ministry of Health of the Russian Federation, conducted the Sputnik V research based on observations to date. Too many short cuts, and what could be considered highly unorthodox approaches, deviating from international standards, were taken. There is a reason that RDIF announced that the UAE study would be “Conducted in line with international standards,” as the international drug development community has looked at the Sputnik development effort with great suspicion and concern. But what will ultimately judge this effort is the results. Thus far TrialSIte hasn’t been able to pick up on any data points indicating material trouble. Moreover the Harvard and Stanford educated Kirill Dmitriev has proven himself a shrewd and successful drug development deal maker. A relentless sense of purpose, astute and drive—and undoubtedly reporting directly to the Putin himself–the way that Mr. Dmitriev has secured strategic discussions and deals has certainly appeared to produce results.
About the Abu Dhabi Health Services Company (SEHA)
Established by Emiri Decree No. 10 of 2007, SEHA is the largest and most comprehensive healthcare network in the UAE. This network includes 13 hospitals, 2644 medical beds, 36 primary healthcare clinics, and 10 disease prevention and screening centers. SEHA employs over 17,000 people and is considered an “integrated and patient-centric company.” SEHA will serve as the trial site locations for the Phase 3 Sputnik V clinical trial in the UAE.