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?
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 August, TrialSite 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?
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?
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.