Russia has announced that a domestically developed COVID-19 vaccine has been approved by its health authorities, the first such approval globally. However, with large-scale Phase III trials having not yet been completed, critics both from within Russia and internationally have raised concerns as to the vaccine’s safety and efficacy.
The vaccine, developed by the Gamaleya Institute in Moscow in collaboration with Russia’s Defense Ministry, is given in two doses and is made of two adenoviruses that express the coronavirus “spike” protein. This technology is similar to that being developed by China’s CanSino Biologics and in the collaboration between Oxford University and AstraZeneca in the UK.
I know it has proven efficient and forms a stable immunity. We must be grateful to those who made that first very important step for our country and the entire world
President Vladimir Putin
Although large-scale production of the vaccine is not scheduled to begin until September, Russian Deputy Prime Minister Tatyana Golikova has said that vaccination of doctors could start as early as this month, with mass vaccination potentially beginning as early as October.
In announcing the Health Ministry’s approval President Vladimir Putin said that one of his two adult daughters had already been inoculated. “I know it has proven efficient and forms a stable immunity,” he said. “We must be grateful to those who made that first very important step for our country and the entire world.”
Kirill Dmitriev, chief executive of the Russian Direct Investment Fund that bankrolled research into the vaccine, told reporters that “We expect tens of thousands of volunteers to be vaccinated within the next months.”
Advanced trials involving several thousand volunteers and spanning several countries, including the UAE, Saudi Arabia, the Philippines and possibly Brazil, are set to begin shortly, although the details are still unclear.
Purchase requests for one billion doses of the vaccine have been received from 20 countries across Latin America, the Middle East, Asia and elsewhere, and manufacturing has been put in place to produce 500 million doses, with more capacity in the works, according to official sources.
However, by approving the vaccine prior to Phase III clinical trials involving tens of thousands of participants, Russian authorities have attracted criticism from scientists at home and abroad.
Russia’s Association of Clinical Trials Organizations stated that “Fast-tracked approval will not make Russia the leader in the race, it will just expose consumers of the vaccine to unnecessary danger,” and urged government officials to postpone approving the vaccine without completed advanced trials.
Francois Balloux, a geneticist at University College London was even more forthcoming in a statement distributed by the UK Science Media Centre. “This is a reckless and foolish decision,” he noted. “Mass vaccination with an improperly tested vaccine is unethical. Any problem with the Russian vaccination campaign would be disastrous both through its negative effects on health, but also because it would further set back the acceptance of vaccines in the population.”
This is a reckless and foolish decision. Mass vaccination with an improperly tested vaccine is unethical
Francois Balloux, University College London
Vaccine scientist Peter Hotez of Baylor College of Medicine in Houston, Texas, added, “That the Russians may be skipping such measures and steps is what worries our community of vaccine scientists. If they get it wrong, it could undermine the entire global enterprise.”
Writing in the Guardian, epidemiologist Gideon Meyerowitz-Katz summed up the uncertainty around the approval. “No one really knows if this vaccine actually works. Phase I and II trials can inform this question, but because they only measure antibody titers or another surrogate outcome they can’t tell us whether the vaccine prevents the disease it’s meant to stop. By all accounts, people inoculated with the Russian vaccine do have antibodies, but these may not last, may not provide enough protection, or may fail for another reason because the immune system is fiendishly complex. We just don’t know.”
Winning the Vaccines Arms Race?
Some critics have attributed the vaccine’s rapid approval to an attempt to gain national prestige and reinforce Russia’s image as a global power, noting that the drug’s name, ‘Sputnik V’, is a reference to the world’s first satellite launched in 1957 during the Cold War space race.
With the US, UK, and Canada last month accusing Russia of using hackers to steal vaccine research from Western labs, Russia has denied involvement and its officials are painting international criticism, especially from the US, as biased and unfounded.
Our point to the world is that we have this technology, it can be available in your country in November/December if that works with your regulator
Kirill Dmitriev, Russian Direct Investment Fund
Dmitriev told CNBC’s “Squawk Box Europe” on 12th August that “It (the announcement) really divided the world into those countries that think it’s great news … and some of the US media and some US people who actually wage major information warfare on the Russian vaccine.”
He added, “We were not expecting anything else, we are not trying to convince the US. Our point to the world is that we have this technology, it can be available in your country in November/December if that works with your regulator … (while) people who are very sceptical will not have this vaccine and we wish them good luck in developing theirs.”
Russia has so far registered 897,599 coronavirus cases, including 15,131 deaths.