But Russia’s hard charge toward a potential vaccine has raised alarm among global health experts that the country is jumping dangerously ahead of critical, large-scale testing that is essential to determine if a possible protection against the coronavirus is safe and effective. Few details of the Gamaleya research have been made public or have undergone peer review.
Russia’s Health Ministry did not respond to requests for comment, and the Gamaleya Institute referred an interview request to the ministry.
Konstantin Chumakov, a member of the Global Virus Network, an international coalition working on viral threats, said “it is scientifically impossible to prove efficacy” without widespread trials, known as Phase 3.
“Using it in general population before the results of Phase 3 trials are fully studied is a gamble,” he said. “A Russian roulette, if you will.”
Cold War namesake
The vaccine is named Sputnik V, a reference to the first orbital satellite, which was launched by the Soviet Union in 1957 and set off the global space race. The name also evokes how Putin’s government has seen the vaccine race as a point of national pride and competition on a global scale, with labs in the United States, Europe, China and elsewhere also in the hunt for a potential vaccine.
“Of course, what counts most is for us to be able to ensure the unconditional safety of the use of this vaccine and its efficiency in the future. I hope that this will be accomplished,” Putin said at a meeting with government members Tuesday, adding that one of his two daughters had received the potential Gamaleya vaccine. He didn’t identify which daughter.
The aggressive strategy from a country eager to declare a victory amid one of the worst outbreaks in the world has been criticized by outside scientists who worry that shots could be harmful or give people a false sense of security about their immunity. China has already authorized one vaccine for use in its military, ahead of definitive data that it is safe and effective.
“This is changing the rules. This is cutting corners,” said J. Stephen Morrison, senior vice president at the Center for Strategic and International Studies. “It’s a major development, and it starts with Putin. He needs a win.
“It’s hearkening [back to] the Sputnik moment,” he added. “It’s harking back to the glory days of Russian science; it’s putting the Russian propaganda machine into full gear. I think this could backfire.”
Race to be first
The international jockeying to find a vaccine has sharpened concerns about vaccine nationalism, in which countries’ need to declare victory over the pandemic could bypass long-standing safeguards to protect people from unproven medical products by ensuring that their benefits outweigh the risks.
For Russia, leading the vaccine race is an avenue for greater geopolitical clout. But the country is also looking to avoid appearing dependent on Western powers, with whom relations are historically poor, analysts said.
Last month, security officials from the United States, Britain and Canada accused hackers linked to a Russian intelligence service of trying to steal information from researchers working to produce coronavirus vaccines in those countries.
Russian officials denied that, and Kirill Dmitriev, head of the Russian Direct Investment Fund that bankrolled the country’s vaccination effort, dismissed international scrutiny of Russia’s own vaccine efforts as political.
“For countries, it’s difficult to acknowledge that, ‘How is it possible that Russia, which has been always shown as this backward, authoritarian country, can do this?’ ” Dmitriev said last week.
Dmitriev said Russia has received preliminary applications for more than 1 billion doses of the vaccine from 20 countries and is prepared to manufacture more than 500 million doses of the vaccine per year in five countries.
Russia’s move could potentially increase political pressure on other countries to take a similar bet on an unproven vaccine.
That’s a huge concern because any adverse effects from the vaccine are far less likely to be transparently reported if it is given outside of a rigorous trial. There’s also concern, Morrison said, that people will be coerced to take an unproven and potentially dangerous vaccine to keep their jobs.
“We’re seeing, in all countries, the tension between the political need to demonstrate to the public you’re doing something useful and the scientific hesitancy to only act when a vaccine is shown to be safe and effective,” said Mark Poznansky, director of the Vaccine and Immunotherapy Center at Massachusetts General Hospital.
At a congressional hearing this month, Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, testified that it would be problematic if countries made a vaccine available before extensive testing.
“I do hope that the Chinese and the Russians are actually testing the vaccine before they are administering the vaccine to anyone, because claims of having a vaccine ready to distribute before you do testing, I think, is problematic at best,” Fauci said.
Driven by the urgency of the pandemic, countries around the world are placing massive advance orders for vaccines and spending billions of dollars to help companies scale up production before they are proven safe and effective.
The risk is mainly a financial one — if the vaccines do not succeed in large-scale clinical trials, they will not be used.
The leading Russian vaccine candidate has so far been tested in small, early clinical trials designed to find the right dose and assess any safety concerns. It was given to scientists who developed it, in self-experimentation that is unusual in modern science, as well as to 50 members of the Russian military and a handful of other volunteers.
Dmitriev said Russia will go ahead with Phase 3, a larger trial involving thousands of participants normally considered an essential precursor to receive regulatory approval. Parallel trials are planned in Saudi Arabia, the United Arab Emirates and possibly Brazil and the Philippines, he said.
The southern Brazilian state of Paraná announced that it will begin producing the possible Russian vaccine in November.
Russia also intends to start using the potential vaccine on willing front-line medical workers and teachers, who will be asked to document how they’re feeling. But while Russian officials have repeatedly assured that the vaccine is safe, Dmitriev was unable to say if it was tested on someone already infected with the coronavirus. Some vaccines, like one developed for dengue fever and used in the Philippines, can make the disease more severe.
“We will have tens of thousands of people already vaccinated like this in August,” Dmitriev said.
The World Health Organization still lists the Gamaleya vaccine as being in Phase 1.
“We are in close contact with Russian health authorities and discussions are ongoing with respect to possible WHO prequalification of the vaccine,” WHO spokesman Tarik Jasarevic said at a briefing in Geneva.
“But again,” he continued, “prequalification of any vaccine includes the rigorous review and assessment of all required safety and efficacy data.”
Lack of transparency
Most of what outside scientists know about the experimental vaccine is from secondhand sources and not from published medical studies. Dmitriev acknowledged that while that may be unusual elsewhere, Russia is traditionally secretive in its scientific endeavors.
The results from Phases 1 and 2 will be published by the end of this month, he said, adding that the delay came from waiting for formal registration.
“You have to think a little bit about the Russian system; after Sputnik was flying for five days, only on Day 5 did Russia acknowledge that there is a satellite flying,” he said.
Russia’s vaccine uses two doses to deliver different harmless cold viruses, or adenoviruses, that have been engineered to carry into cells the gene for the spiky protein that studs the outside of the coronavirus.
The approach was inspired by the Ebola vaccines Gamaleya developed in 2015 and 2018. But while Putin boasted earlier this year that Russia’s Ebola vaccine “proved to be the most effective in the world,” the WHO still lists it as a “candidate vaccine” on its website.
Adenoviruses are also being used by scientists at the pharmaceutical giant Johnson & Johnson, the Chinese company CanSino Biologics and the University of Oxford in their vaccine candidates.
But those other efforts have published data on how vaccines perform in animals ranging from mice to monkeys, and also presented data from early human trials showing the severity of any reactions, ranging from soreness at the injection site to fevers.
The CanSino vaccine uses one of the same harmless viruses the Russians are using in its vaccine, and its results have been disappointing to some scientists.
Dmitriev said his personal confidence in Russia’s vaccine was so high that he, his wife and his parents, both over the age of 70, were test subjects. He said just his wife reported a mild fever the first night of the injection.
“It’s not some crazy Russians using some crazy not proven stuff,” Dmitriev said. “Adenovirus existed with humans for thousands of years, and we made a bet on this proven platform because we understand that it takes very little time to develop, given the challenges.”
Johnson reported from Washington. Terrence McCoy in Rio de Janeiro contributed to this report.