Russia’s Gamaleya Vaccine Nears Readiness for Large-Scale Use: How Can this be Possible?

Russia’s Gamaleya Vaccine Nears Readiness for Large-Scale Use How Can this be Possible TrialsiteN

Russia continues to make assertive claims about its national adenovirus-based vaccine developed out of the Gamaleya Research Institute, the state research facility based in Moscow. Reuters reports that the Russian health minister will prepare, “a mass vaccination campaign against the novel coronavirus for October,” once clinical trials are completed. As August has just commenced, it takes some “chutzpa” to forecast a fully safe and effective vaccine product so soon. Based on TrialSite’s understanding of the timeline, the Gamaleya vaccine should only be in the Phase 2 clinical trial stage. Russian health minister Mikhail Murashko reported clinical trials were completed, and paperwork is now underway for authorization according to the Interfax news agency. First on the vaccination list: doctors and teachers. Murashko was quoted saying that wider vaccinations would occur by October. In the meantime, a Reuters source informed the news agency that the vaccine would make it through the regulatory process in August and be administered to health workers soon after. How can insiders be so sure, unless the conclusion has already been made? Typically, only a few vaccines out of dozens, if not hundreds, become approved.  And of course the vaccine development vaccine is usually managed in years rather than quarters. 

Background

Early-stage clinical trials (Phase 1)  involving the Gamaleya vaccine started in June and ran just over a month. However, it has been disclosed that scientists involved with the research program have tested the experimental vaccine on themselves.  This made the way for the next wave of early-stage human testers, although this time it was the rich, powerful, and influential as was uncovered by Bloomberg correspondents in Russia. Military personnel, businessmen, and other prominent people secured access to the vaccine to protect themselves from COVID-19, well before the Phase 1 study was complete. Either the Russians had a lot more information about the safety and efficacy of this vaccine candidate then we know, or it is complete R&D chaos, or perhaps some other complex reality too mystifying and to comprehend for this author. 

Vaccine Nationalism

Growing calls to curtail so-called “vaccine nationalism” emphasize the dangers a COVID-19 life sciences arms race could mean for normal citizens. This is true for both the larger, most influential countries around the world and the poorer countries where people could be volunteered into research programs as human guinea pigs for money. TrialSite News has been quite critical of reports out of Russia, as they seem unrealistic. After all, their clinical trials only started in June; here in the United States, many fret that Operation Warp Speed is too aggressive, and this involves the most sophisticated life sciences operations in the world with durations of several months to over a year in vaccine clinical timelines. But in Russia, the Gamaleya vaccine appears to have been put through the entire clinical research process in three months or so. Russian life science research is definitely not on the same level as the Western biopharmaceutical apparatus. So how could this be?   

Kirill Dmitriev was recently profiled by the TrialSite. He is a powerful man in Russia who leads the Russian Direct Investment Fund that was involved with financing the vaccine. He suggests this crusade is similar to the Soviet Union’s launch of Sputnik 1, the world’s first satellite; harkening back national pride and an indirect declaration to its adversary. But that was a long time ago, and under the Soviet Union science and technological prowess was probably more sophisticated than it is today in relative terms. But Russia isn’t alone. Nationalism has been a growing trend around the world, as the Post World War 2 neoliberal order succumbs to the pressures of change and transformation. Due to a confluence of forces and factors, calls are heard for “the local” and “national” over “regional” or “international” foci. Often driven by underlying populism, whether it’s the UK “Brexit” or the Trump “Wall,” the trend toward nationalistic politics gained speed prior to COVID-19. But with the response to the COVID-19 unfolding, its clear international coordination and collaboration is as important now as ever. Pathogens such as SARS-CoV-2 know no boundaries.  

Ethics Questioned

But with what could be considered a hyper-accelerated vaccine development timeline, even a number of Western media sources fret that Moscow could be placing national pride over science and citizen safety. In June allegations, albeit from a source hostile to Russia, the Latvian Meduza, reported on purported ethical violations in Russia’s research associated with the Gamaleya vaccine. They reported that, “researchers had become test subjects of a coronavirus vaccine that had yet to undergo any other human trials.” Moreover, they reported that the Russian military declared they were testing the early-stage vaccine on “military personnel volunteers,” and cited the soldiers as “administratively vulnerable.”

The ‘VIP’ Program

In what to the West would seem like a strange alternate reality, a program was created to allow wealthy, powerful, and influential Russians to sign up early to essentially serve the State as human guinea pigs. This news surfaced  from a Bloomberg report that Russia’s business, political, and military elite secured early access to an investigational vaccine targeting COVID-19. Kirill Dmitriev, the head of the Russian sovereign investment fund, even acknowledged he was administered the vaccine. To a naïve Westerner, if this is all true it would mean that both ethical and research norms were ignored over the last several months. That prior to approval for humans, they were being administered the vaccine, nonetheless. 

Western Skepticism

Many in the West, including TrialSite, are quite skeptical as to the timeline of the Gamaleya Institute. Most recently, Dr. Anthony Fauci shared this same sentiment, telling a panel of U.S. lawmakers that, “I do hope the Chinese and the Russians are actually testing the vaccines before they are administering the vaccine to anyone. Because claims of having a vaccine ready to distribute before you do testing is problematic in the very least.” Definitely “problematic.”

TrialSite Speculation

Given that Phase 1 was completed not much more than a month ago, and Phase 2 is probably ongoing, it would appear that the Russians could be fast-tracking their primary national vaccine so that it will be approved without completing a pivotal Phase 3 clinical trial. 

Remember, Phase 3 clinical trials evaluate the safety and efficacy of an intervention in large-scale populations. As an example, companies such as Moderna, Pfizer/BioNTech, and AstraZeneca (Oxford) are conducting large Phase 3 trials with up to 30,000 volunteers per study. These trials can take months, if not years, to complete. 

Perhaps one part of the explanation for the rapid move toward approval: Russia is skipping that pivotal stage and rather will treat Phase 3 like a Phase 4 post-marketing safety study. The TrialSite truly hopes for the sake of the Russian people that this isn’t the case. One could speculate that Russia has done so much ethically-questionable early-stage clinical testing on humans that they have sufficient data to assure regulators there that the Gamaleya vaccine is safe and efficacious. Because the TrialSite doesn’t have direct validation of these facts we certainly can’t know the truth with any certainty.

Anglo Intelligence Services Chime in

In the meantime, according to certain Western media intelligence agencies from the UK, US, and Canada reported recently that  Russian hackers were on the prowl, working to penetrate Western research groups working on COVID-19 vaccines. The TrialSite cannot verify if this is true, but the implication would be that Russian agents  are seeking to steal proprietary vaccine information.  According to CNN, The UK’s National Cyber Security Centre (NCSC) explained it was 95% certain the operation originated from APT29 (aka “The Dukes” or “Cozy Bear”), Russian hacking gangs that could be part of Russian intelligence operations. 

Andrei Kelin, Russia’s Ambassador to the UK, outright rejects these claims, calling it nonsense. However, NCSC is a pretty serious operation. Why, during the height of a pandemic would they make such allegations? Why would Americans and Canadian intelligence agencies support such allegations unless there was some truth? Some conspiracy theorists could suggest they are making trouble to deflect attention for nefarious “deep state” purposes, but that seems a bit preposterous at this point. 

A more likely explanation is urgency on the part of China and Russia to make progress combined with a totalitarian-leaning government and research institutions. This urgency could stem from a sense that they need to “catch up” with the West. But a simple test may show the under-developed  nature of the Russian product: how many wealthy and middle-income markets are committing millions or billions of dollars to buy the Gamaleya product? Not many.