MOSCOW -- Russia has become the first country to issue regulatory approval for a vaccine against COVID-19 and plans to launch a mass immunization program in October. Announcing the news in a teleconference with his cabinet on August 11, President Vladimir Putin said one of his daughters was inoculated with no serious side effects. “The main thing now is for us to ensure the safety of this vaccine's use and its effectiveness,” he said.
But international health officials point to Russia’s lack of late-stage clinical trials, which are considered crucial to determining a vaccine’s safety and effectiveness, and criticize its expedited development amid a global race for a coronavirus shot -- a battle for prestige and soft power that could tempt governments to play geopolitics and cut corners in a bid to come first.
Here’s a look at how Russia’s vaccine was developed, why it’s controversial -- and whether it’s premature for Russia’s medical researchers to seek a Nobel Prize.
Who Developed It?
The vaccine project is a government-backed endeavor, overseen by the Gamaleya Institute, a scientific body which developed Russia’s Ebola vaccine, and financed by the state-run Russian Direct Investment Fund (RDIF). The RDIF says it has invested 4 billion rubles ($550,000) in the project.
The vaccine underwent human trials in two phases spanning June and July. The first involved 38 civilians and 38 members of the military, and the second involved 100 people. Trials will also be carried out in Saudi Arabia, the United Arab Emirates, and the Philippines, the RDIF says.
The vaccine is being marketed with the name Sputnik-V, a symbolism-laden nod to the world’s first satellite. RDIF chief Kirill Dmitriyev has called the unveiling of Russia’s vaccine "a Sputnik moment,” in reference to the successful launch of the Sputnik satellite in 1957 -- the opening salvo of the Cold War-era Space Race between the Soviet Union and the United States.
Why The Doubts?
Russian officials have persistently touted an aggressive schedule for a vaccine against the pathogen that has infected at least 849,000 people in Russia and killed more than 14,000 -- the fourth- and 11th-highest numbers in the world, respectively.
Human testing of vaccines typically includes three stages prior to approval for mass production and use. The first two involve trials on a small group of people to determine whether the vaccine causes harmful side effects and whether it’s capable of stimulating the immune system. The final phase, known as Phase III, extends the trial to thousands of people by administering some with the vaccine candidate and others with a placebo.
What is publicly known of the Russian vaccine suggests that it is scientifically plausible, as it uses two adapted strains of the adenovirus recognized as capable of triggering an immune response. But it is the final phase of the trial, Phase III, that Russia is yet to complete, a fact that has prompted the strongest skepticism.
“I certainly would not take a vaccine that hasn't been tested in Phase III. Nobody knows if [it’s] safe or if it works,” Florian Krammer, professor at the Department of Microbiology at Icahn School of Medicine in New York City, wrote on Twitter. “They are putting [health-care workers] and their population at risk.”
“What is important is not to be first with a COVID-19 vaccine but to be the best, which means it must be proven safe and effective,” Lawrence Gostin of Georgetown University’s O’Neill Institute for National and Global Health Law in Washington, D.C., wrote in a column for the English-language Moscow Times. “The international community will not recognize Russia’s claims until rigorous scientific and ethical standards have been met.”
Dmitriyev, the RDIF chief, defended Russia’s approach. He said the vaccine developed by the Gamaleya Institute relies on tried and tested technologies that he claimed are superior to experimental methods being used in vaccine trials funded and endorsed by the United States.
“Western corporations are worried that they’ll look bad compared to Russia’s [vaccine] developers, that Russians have overtaken them,” he asserted in comments to the Russian newspaper Vedomosti.
The World Health Organization (WHO) has urged Russia to stick to international guidelines in its vaccine research. “Between finding or having a clue of maybe having a vaccine that works, and having gone through all the stages, [there] is a big difference,” WHO spokesman Christian Lindmeier said last week. “Any vaccine...[or medicine] for this purpose should be, of course, going through all the various trials and tests before being licensed for rollout," he said.
Why Is This Such A Big Deal?
The world’s major powers have for months been vying to take the lead in the global race for a vaccine, which would give its victor prestige and the opportunity to prioritize its population before making the successful vaccine available to other countries stricken by an illness that has sickened more than 20 million people worldwide, according to official figures, and killed almost 750,000.
According to the WHO, 25 vaccines are currently in clinical trials and more than 100 more in development around the world. In the United States, the Massachusetts-based laboratory Moderna is conducting a Phase III trial involving 30,000 adults at 89 research sites nationwide.
Moscow says at least 20 countries have expressed an interest in its vaccine. Philippine President Rodrigo Duterte said on television on August 10 that he had accepted Putin’s offer to ship the vaccine from Russia when it’s ready, and that he is willing personally to participate in trials.
"I will tell President [Vladimir] Putin that I have huge trust in your studies in combating COVID and I believe that the vaccine that you have produced is really good for humanity," said Duterte, an authoritarian leader and a frequent critic of the United States.
If, as expected, major participants in the quest for a vaccine, like China and the United States, forge ahead with their own programs and shun Russia’s claimed vaccine, countries outside the West may turn to Moscow.
And if Russia allays the doubts and its vaccine proves safe and effective, it will prove a major achievement. But that may take months, and some researchers suggest the odds are against it.
The timing of Russia’s announcement means it is “very unlikely that they have sufficient data about the efficacy of the product,” Natalie Dean, a biostatistician and infectious disease expert at the University of Florida, told The New York Times. She said vaccines that have produced promising data from early trials in humans have failed at later stages.
Many of the most optimistic researchers around the world have suggested the development of a vaccine against the virus will take until the end of 2020 at least -- still a remarkable pace compared to the years and even decades needed for most vaccines in circulation today.