The coronavirus pandemic has been a struggle across the globe since the beginning of 2020, and, as a result, many countries have been trying to create a vaccine that will protect the world’s population from the sweeping disease.
One country that claims it has a vaccine ready to be used as early as October is Russia, though this has been met with the skepticism of many Western scientists, who claim it is simply too soon for a safe and effective vaccine to have been developed and used.
Is it safe?
Last month, Russian scientists announced that the early-stage trials of an adenovirus-based vaccine developed by the Gamaleya Institute had been completed, and that the results they had logged were a success.
However, many Western countries have concerns about the safety of the vaccine, with Ashish Jha, Dean of Brown University of Public Health, saying: “We have no idea whether this vaccine is safe or whether it works.”
Although she admits that Russia could hold off on vaccinating the general population until it has received ‘favourable’ results from its Phase 3 trial, she still agrees that it is “[w]orrying when people bypass the standard process we have for vaccine development.”
Some critics of the vaccine have said that while the vaccine itself may be safe, it could have a counterproductive effect if it offers minimal or brief immune responses, which may lower confidence in vaccines more generally.
The Ministry of Health and Gamaleya says that the vaccine has ‘proved its safety and efficiency’; in fact it is so confident about this that it isn’t seeking full indemnity from purchasers, meaning that if major side-effects are later discovered, the state will be left open to huge compensation claims.
Is the country cutting corners?
On 11th August, Putin announced that the Gamaleya Scientific Research Institute of Epidemiology and Microbiology in Moscow has been developing a Covid-19 vaccine that has been approved by Russia’s health regulator for widespread use, even though Phase 3 trials are yet to be completed.
This would involve giving thousands of people either a vaccine, or a placebo injection (as a control), and monitoring them to see if the vaccine does prevent infection. This also gives researchers the opportunity to confirm the safety of the vaccine and look out for any side effects that were missed in earlier trial stages, but should this be done before being trialled on the volunteering public? The vaccine uses two human adenoviruses engineered with a coronavirus gene and would be given in two shots taken three weeks apart.
In the development of any vaccination, the Phase 3 trials are where toxicity, immunogenicity and any serious adverse effects are monitored on a much larger scale than Phase 2. Typically, the vaccine must be proven as safe and effective in natural disease conditions before it can be submitted for approval and general production. Thus, Russia has not completed large trials to test the vaccine’s safety.
Peter Hotez, vaccination scientist as the Baylor College of Medicine in Houston, Texas, says: “that the Russians may be skipping such measures and steps is what worries our community of vaccine scientists.”
Russia’s failure to complete these Phase 3 trials is the main cause for concern among other countries’ scientists. This is especially the case because administering an inadequately vetted vaccine could endanger those people who receive it so early on, and there is a severe lack of published findings surrounding Russia’s research.
Danny Altmann, Professor of Immunology at Imperial College London, highlighted that: “Everyone else in the world is publishing details of their vaccines and clinical trial protocols but it has been hard to find out much about the Russian vaccine.”
Is it ethical?
This is a question very much debated by professionals. Some, like Francis Balloux, a geneticist at University College London, argue that: “Mass vaccination without an improperly tested vaccine is unethical.”
Indeed over the summer, Britain accused Russian state-sponsored hackers of targeting research labs in the United Kingdom, the United States and Canada involved in developing a coronavirus vaccine.
They claim that this was with the apparent intention of stealing research, though this has been denied by Russia. This unethical approach to researching and developing the vaccine is another concern of many scientists, as they worry that Russia is seeking to destabilise other countries by using propaganda tactics that reflect political warfare.
General Sir Nick Carter, Chief of Defence staff, said: “Their goal is to win without going to war: to achieve their objectives by breaking our willpower, using attacks below the threshold that would prompt a war-fighting response.”
Intelligence officials say the cyber-attacks were from a group called APT29, who are linked to the country’s FSB or SVR intelligence agencies. Foreign secretary Dominic Raab described the attacks as ‘completely unacceptable.’
There are also signs that not everyone is participating in these vaccine trials voluntarily. One employee of a Moscow government department described pressure at work to sign up: “It was made clear that we had to sign up online for the trial. When they called to tell me to come for an appointment, I had to make up an excuse as to why I couldn’t.”
Indeed, a journalist for Meduza, a Russian outlet, said that when she arrived for her vaccination, a man was complaining that he had been forced to attend.
What are the possible repercussions?
There are many possible large repercussions to an improperly tested and premature vaccination. Not only could it affect the public perception of the vaccine process in Russia if it does not work, but it could also worsen the pandemic if people who receive the jab stop taking the proper precautions to help reduce the spread of the virus, for instance if they stop wearing masks or washing their hands as thoroughly and regularly. Some scientists also worry that it could impede global efforts to produce Covid-19 vaccines that are safe and effective.
Amelia Cutting
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