A vial containing a trial vaccine against COVID-19 at Moscow’s N62 Outpatient Clinic in a post-registration phase of testing. (Photo by Sergei BobylevTASS via Getty Images)
Despite the protests of many critics, Donald Trump has been touting the possible arrival of an American coronavirus vaccine by Election Day. While some say that’s impossible, others hold out hope for an imminent end to the pandemic’s terror.
But is it possible that COVID-19 has already found a vanquisher in Russia? When it comes to vaccine trials, America seems to be many steps behind the Russians. U.S. COVID-19 vaccines entered a Phase III human trial on July 27, but Russia recently announced the end of their vaccine’s trial period and plans to expand into a nationwide inoculation in early October.
Even so, lots of people are worried, and they should be. The Russian trials’ methodology and safety have many terrifying cracks in them, yet Russia has announced plans to start inoculating its most vulnerable people as early as September. The reliability of any test results will be shaky at best.
In short, the Russian government, in its haste to win the global vaccine race, could very well inoculate its citizens with a non-working placebo shot.
According to the World Health Organization (WHO), 34 candidate vaccines from around the world are in clinical evaluation as of September 8. Only eight of them have entered Phase III mass human trials, which is the most reliable way to determine the effectiveness of a vaccine. According to WHO, there’s only one Russian vaccine on the list. It was developed by the Gamaleya National Research Center of Epidemiology and Microbiology. Even though it has just entered Phase III, the Russians have announced the world’s first approved coronavirus vaccine for public use in August, which was before Phase III trials had been completed.
All of this hassle is less about the safety of the Russian population and more about winning the global race for a coronavirus vaccine. For several months now, Russian state-owned media outlets and television channels have been actively transmitting the idea of Russian leadership in the competition. It’s the same type of propaganda that flourished during the ’60s-era space race. “It’s like the moment of satellite launch. The Americans were surprised when they heard the satellite signal. The same is true for this vaccine. Russia will be first in this,” said Kirill Dmitriev, general director of the Russian Direct Investment Fund (RDIF).
In June, Vladimir Putin criticized the United States for its failure to provide an adequate response to the COVID-19 crisis, juxtaposing U.S. incompetence with Russia’s alleged success in curbing the spread of the virus in its territory. Pioneership in vaccine production is a logical continuation of Russia’s leadership narrative.
But the lack of reliable data on the safety and efficacy of the Russian vaccine is troubling. “Of course, you can create a prototype vaccine during such a brief period of time,” said Vitaly Zverev, head of the molecular technology department at the Mechnikov Research Institute of Vaccines in Moscow. “But it is impossible to have it properly tested. …Some things simply cannot be sped up.”
Russia’s Ministry of Health allowed two clinical trials of two forms of the Gamaleya vaccine. The first was carried out at the Burdenko Military Hospital on June 19. The other was given to volunteers at the Sechenov First Moscow State Medical University.
The testing sample for both trials was extremely small: 76 volunteer soldiers received the vaccine (38 in each study). After getting the shot, the patients were asked to quarantine in the hospital for 28 days, about the same length of time trial volunteers in the U.S. will be tested. All patients emerged from the hospital with immunity and no side effects. But that doesn’t prove much. Only randomized double-blind testing can eliminate biases leading to an incorrect estimation of treatment effect.
In the U.S., out of 30,000 volunteers, half will get a saline placebo and the other half will receive the real vaccine. Ashish Jha, dean of the Brown University School of Public Health, has voiced his concerns over the safety of Russia’s vaccine. “It is really worrying when people start to bypass the standard process we have for vaccine development,” he said.
Most clinical trials of humans and vaccines worldwide require hundreds–if not thousands–of test patients and take months and even years to be approved. Russia’s Ministry of Health’s vaccination guideline also explicitly says that for a vaccine to get a green light, thousands of people must participate in human trials.
Even if the Gamaleya vaccine is not harmful per se, it still poses a threat to the Russian people. If the Russian government inoculates its population with an unreliable “placebo” while making its people believe they’re safe, the consequences of such a “win” could be disastrous.
Anastasiia Rusanova is a communications associate at the International Center for Law & Economics. Prior to ICLE, Anastasiia worked at the Cato Institute as an intern in the Center for Global Liberty and Prosperity, and as a research assistant at the Kennan Institute of the Woodrow Wilson International Center for Scholars.