Gamaleya Vaccine Approved: In Unprecedented Race to Approved Vaccine, did Russia ‘Win’?

Aug 11, 2020 | COVID-19, Gamaleya Research Institute, News, Popular Posts, Russia, Vaccine

Gamaleya Vaccine Approved: In Unprecedented Race to Approved Vaccine, did Russia ‘Win’?

The Russian Health Ministry has approved the world’s first COVID-19 vaccine after fewer than two months of formal human clinical trials. TrialSite has been following the Gamaleya National Research Institute of Epidemiology and Microbiology (Gamaleya Institute) vaccine effort, and it is suspected that the Russians introduced some form of intensive human challenge trial that started with scientists and perhaps military personnel and then included broader groups, even an elite “VIP” group cohort. Now Russia’s President, Vladimir Putin, proudly declared to all via a televised video conference call with government ministers: “This morning, for the first time in the word, a vaccine against the new coronavirus was registered” in Russia. Putin, in anticipation of the critics, emphatically declared, “I would like to repeat that it has passed all the necessary tests.” As has been the case in Russia, the elite get to line up and get inoculated, and one of President Putin’s daughters was no exception as she was inoculated and apparently feeling well. In what many critics have contended is some form of distorted vaccine nationalism on display, the race to vaccine regulatory approval shouldn’t be at the expense of human safety.

Russian Authorities Skip Phase 3

The Russians, under Putin’s orders, skipped the pivotal, critical Phase 3 clinical trials process. Phase 3 clinical trials are a big deal. This is the sponsors final push to prove safety and efficacy. Phase 3 clinical trials typically involve larger groups of participants (anywhere from 1,000 to 3,000 in a therapy and with vaccines in the tens of thousands) to confirm the product’s efficacy, evaluate its effectiveness, monitor side effects, and compare the drug to commonly used treatments in addition to ongoing data collection for safety. In the case of other vaccine candidates, whether its Moderna’s mRNA-1273 or AstraZeneca/Oxford’s AZD1222, Phase 3 clinical trials in these cases involve up to 30,000 participants.

Many scientists, ethics professionals and regulators have questioned the Russian government’s decision to register this vaccine prior to formal Phase 3 clinical trials. These studies typically can last many months to even years. DW reported that President Putin emphasized that this Gamaleya vaccine product, known as “Gam-COVID-Vac,” underwent the necessary trials. Russian authorities also have expressed that vaccination will be voluntary.

Allegations of Inappropriate Testing

TrialSite reported that one director of the Gamaleya Institute, Alexander Gintsburg, disclosed that the researchers there, prior to even Phase 1 testing, had been testing the vaccine on themselves in a form of experimentation that definitely deviates from the norm in today’s world of science. The cavalier statement placed the spotlight on a research effort that hadn’t much press attention prior. There were other reports of early stage testing on military personnel, even among bank employees. Was this part of some publicity stunt and propaganda apparatus? Or was it rather some kind of human challenge endeavor? If this was in fact the case, how many scientists were testing the experimental vaccine on themselves? And for how long?  How many others were tested? 

Clinical Trials

TrialSite has chronicled the last few months journey of the  Moscow-based “Gamaleya Institute” and its vaccine candidate. Back in June, TrialSite reported that Gamaleya Research Institute vaccine candidate’s Phase 1 clinical trial had commenced. The study, which focuses on safety at this early stage, involved two participant group involving 38 subjects each. These participants were isolated in two separate hospitals in Moscow, according to multiple reports.

By AugustTrialSite reported that there were rumblings out of Russia of imminent “large-scale use.” But was this part of a PR and propaganda campaign or was it real progress? Or somewhere in between. The Phase 1 clinical trial apparently turned out well, and by July, there was purportedly Phase 2 trial activity. 

As the TrialSite reported in August, Russia would likely skip a pivotal Phase 3 trial and rather vaccine the people and treat that like a Phase 4 post-marketing safety study. The TrialSite suspected that the Russians have undertaken considerable human challenge trials, generating significant data along the way. Of course, the ethnics and morals of all of this is another matter.

The ‘Gamaleya’ Vaccine and Ethical Concerns

This didn’t escape attention from research associations in Russia, such as the Association of Clinical Trials Organizations, which condemned the action, stating it was a “crude violation of the very foundations of clinical research, Russian law and universally accepted international regulations,” as reported in ABC News.

A chasm was exposed in Russia, between politics and science: morals and ethics on the one side, and power and expediency on the other. Between a Russia working tirelessly to evolve and progress into a new era and a Russia that harkens back to totalitarian authority. An unbelievably high, untenable bar was set by the political class in Russia and the scientific class, unlike America where there is a far more open and free debate on matters such as these. The good scientists that transformed themselves into human subjects were praised by the Kremlin. At the time TrialSite, perhaps naively, suggested there was a large delta between Russian political aspirations and the realities of science.

The VIP Testing Cohort

TrialSite picked up on a story generated from Bloomberg Russian correspondents, reporting that along with the start of Phase 1 trial, an elite group of executives, billionaire tycoons, and government officials lined up early to get vaccine shots loaded with the Gamaleya vaccine. The confidence was high, and this information was undoubtedly surfaced to evidence the high degree of confidence in this vaccine product. TrialSite asked the question: “Is that because they have accumulated more real-world evidence thanks to stealthy early access programs or was it a multi-faceted propaganda campaign evidencing national pride in the age of vaccine nationalism? Either way, from the point of view of a Western bias, the goings on in Russia were not simple, straight forward or rational for that matter. Or were they?

The Vaccine

With the onset of COVID-19, the Kremlin, like other central governments, sought to move fast to investigate vaccine candidates. Organized and financed by the Russian Health Ministry as well as sovereign wealth fund known as the Russian Direct Investment Fund (RDIF), the pressure was on the Gamaleya National Research Institute of Epidemiology and Microbiology to develop what became known as Gam-COVID-Vac, an adenoviral-based vaccine targeting the novel coronavirus known as SARS-COV-2. This now approved vaccine product utilizes a diluted pathogen, which delivers smaller amounts in a bid to stimulate the human immune response. As Precision Vaccines explains, the “Gamaleya” vaccine is also a vector vaccine derived of adenovirus DNA, integrated with the SARS-CoV-2 coronavirus gene. Hence the Gamaleya team engineered the delivery container (made of the adenovirus) to delivery the coronavirus gene to the cells triggering synthesis of the spike proteins, hence introducing the immune system to the enemy pathogen.

Putin gets Personal

Vladimir Putin reported that he had one of his daughters vaccinated with the now approved Gamaleya vaccine. Germany’s DW reported that Putin told the press, “One of my daughters got vaccinated, so in this sense, she took part in the testing.” This of course refers back to the “VIP testing cohort” that TrialSite reported on. Putin went on that his daughter did experience a “slight fever, 38 degrees Celsius (100.4F),” reported DW. But the fever went down back to normal the day after. Putin continued that after the second shot, his daughter developed another fever but then “everything was fine. She is feeling well and has a high antibody count.” Putin has two daughters and didn’t share with the world whether it was Maria or Katerina. Clearly, President Putin has confidence in the vaccine; otherwise, would he have let his daughter get inoculated?

First Wave of Vaccinations

The first set of vaccinations will involve what are considered “at-risk” groups such as medical/health care workers, teachers, first responders and others that might encounter those infected more frequently.

Philippines Lines Up, or Do they?

The Philippines, under another “strongman” type of leader, President Rodrigo Duterte, praised the Russian vaccine, declaring that he personally would “be the first they can experiment on.” Duterte continued, “I will tell President Putin that I have huge trust in your studies in combating COVID-19 and I believe that the vaccine that you have produced is really good for humanity.” Is Duterte credible here? Does he have the expertise to make such claims? President Duterte might have “faith” in the vaccine but that doesn’t mean a majority of the people of the Philippines do. Regardless, Duterte has shared with the media that the vaccine will be arriving in the Philippines by December. Will it be voluntary?

Conclusion

Russia will commence large-scale production starting in September. They will purportedly start mass vaccination in October and through the rest of the year. Perhaps this vaccine is truly safe and effective; that would be a good thing for humanity. If Russia is able to contain and control COVID-19 then that is one less place on the planet that has worry of human suffering and economic catastrophe. If the Russian Gamaleya vaccine works then certainly the top biotechnology companies of the West will nail their vaccines as well. But what if this vaccine isn’t 100% effective or even 50%? What if large numbers of people get inoculated and think they can go back to normal but it turns out that the pathogen still infects these “vaccinated” individuals? All sorts of implications surface from this.

Source: DW

4 Comments

  1. Walt

    The Russians are intelligent people. They would not mass inoculate their people or another population without knowing that it is effective. They did human challenge tests and know it has some good level of efficacy. Think about it, if they went ahead with inoculations and the vaccine failed or was not effective, they would become a world laughing stock and scientific pariah. Putin would not risk that. Does anyone really think that Putin and his billionaire buddies and family would have taken this vaccine without knowing it works. Fat chance. Since the Russians have developed a vaccine using well understood and well used vaccine technology, I have faith some western vaccines based on the same accepted platform will work. As far as these novel mRNA platforms, who knows if they will really work and what will be the long term effects. I know when I have the choice between a vaccine based on the tried and true platform(Oxford, J&J), or new mRNA platform (Moderna),I will go tried and true, as I know the long term safety and side effects with some certainty.

  2. Peter Mann BE AO3

    I am dismayed to see trialsitenews publishing sanctimonious nonsense like this propaganda from a nameless author.
    To propose that safety is more important than timeliness is idiotic : beyond criminal and into ghoulish parasite.
    Risk enginering is about managing risk ; only the armchair expert would assert that safety is about eliminating risk entirely. Many professions require balacing risks, but this apparatchik cares nothing for professional standards ; the benchmark here is religious : Russia = Bad.
    Russia is going ahead knowing full well that their reputation rides on the success of this vaccine, so only a cynic of monumental ignorance would presume Russia has been careless in this crucial piece of medical engineering.
    Stupidity is mankind’s most destructive enemy, and this filthy piece of bad thinking should never have got past the editor.
    Disgracefully unprofessional and intellectually dishonest.

    • TrialSite

      Peter we are sorry you feel this way. We believe in supporting a diversity of perspectives and points of view and we are not anti-Russia at all. In fact we are one of the few research focused media that track the Gamaleya vaccine. We try to maintain an objective stance but we are not always objective—we are human after all. As mentioned, we have been following Gamaleya as closely as we can and we have observed some challenges in apparently skipping Phase 3 trials. We have questioned some of their tactics as well involving preclincial human testing.

      Rarely are Phase 3 studies skipped—hence why none of the major vaccine makers in China, Germany nor the UK or the United States for that matter are skipping this critical and pivotal phase. It isn’t just a mindless slavery to “safety” at all. It follows tried and true methods and best practices associated with clinical research.

      Today, probably much to your disgust, we published another piece, this time on an Israeli medical center professor declaring that they have been working on the Gamaleya vaccine and that the studies are not over. In fact this Israeli source declared that they are still monitoring the safety data from the vaccine. We believe that there is some nationalism going on now which we don’t think is necessarily healthy in time of a pandemic and we have been on the record about this: that is if national pride supersedes that precious risk threshold so embraced by some people, for example. However true to TrialSite form, we do question the source and wonder if there is an alternative agenda–that is an anti-Russian agenda.

      We are an independent media source—no pharma money; no government money; no Russia money, just our own money and our own effort to try to get closer to the truth. We are not perfect and we certainly have made mistakes—and will continue to do so. We have a lot of experience with clinical trials–ins and outs codified in software, every rule and audit trail we have lived in software development powering thousands of clinical trials around the world. In the process our feedback is 90% positive because a great majority of visitors appreciate what we do undertake—on our own time and dime—and never have they espoused the anger and outrage toward us that you have done so in these remarks.

      Your assumption: How dare you question Russia AND Russia = Bad.

      We don’t agree. We will absolutely question Russia as we will our own government and any other government. We do question when a major government-sponsored trial skips a pivotal Phase 3 stage; the Chinese haven’t; the Americans haven’t; the Germans haven’t and Brits haven’t. That doesn’t mean Russia’s Gamaleya vaccine doesn’t work. In fact we are on the record that we hope that it does—we happen to have dear friends in Russia and consider it an incredible place.

      So we choose not to agree with your critique that we are a bunch of dumb miscreants peddling in poop just because we challenge some underlying assumptions of a major government and their decision to skip the so critical Phase 3 stage. We aren’t alone. A lot of top scientists do as well.

      However–and this is important for you to know Peter: we created this site for you.

      This is a trusted site, for people to express what they think and feel about research and investigational drugs. We continue to invest to develop an inclusive major media that is very different; that is free of commercial crap and open to a divergence of opinion. So we are grateful for your critique.

      We respect that you disagree and despite your anger we absolutely love your visits and the fact that you provide feedback in the first place. We certainly hope that you keep it coming.

      Publisher

  3. john blonski

    This article presents development of vaccine which purpose is to stop pandemic with which the whole world is wrestling with, as a race of Russia against the “free world”.
    It is understandable that competing entities will be questioning effectiveness of vaccine developed by their competition, after all there is a lot of money to be made, but for rest of humanity is less important who, but when and would it be made available with no restriction at the affordable price.

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