By Michael Marshall
Vladimir Putin, president of Russia, says that a coronavirus vaccine developed in his country has been registered for use, and one of his daughters has already been inoculated.Alexei Nikolsky/AP/Shutterstock
Russian president Vladimir Putin announced yesterday that the country has approved a vaccine against SARS-CoV-2, the coronavirus that causes covid-19. Putin said that the vaccine is safe and effective. Russia apparently plans to start mass vaccinations in October.
However, the announcement has caused global concern. Immunologists say there is no way to be sure that the vaccine is safe, let alone effective, and that Russia seems to be cutting corners.
What do we know about the vaccine?
The vaccine has been dubbed “Sputnik V”, in reference to the first artificial satellite, Sputnik 1, which was launched by the USSR in 1957 – a sign that the Russian government plans to trumpet it as a matter of national pride. It has been developed by the Gamaleya Research Institute of Epidemiology and Microbiology in Moscow, part of Russia’s Ministry of Health.
The vaccine would be administered in two shots, 21 days apart. Both shots contain modified adenoviruses, which would ordinarily cause a common cold. Both have been given the gene for the spike protein from the coronavirus SARS-CoV-2. This protein allows the virus to enter human cells. In theory, this should prime the immune system for an encounter with the actual coronavirus.
Known as a viral vector, this is a fairly standard approach to a vaccine, and other groups are pursuing similar methods.
What tests has it been through?
New vaccines must normally pass three tests before they can be used widely. A phase I trial involves a small number of volunteers, and is intended to determine a safe dose. Phase II requires more people, because it tests whether the vaccine triggers an immune response, and also looks more carefully for side effects. Then a large phase III trial is used to find out whether the vaccine actually protects against infection. This isn’t just a formality: a vaccine might trigger an immune response in phase II, but this may not be enough to confer real immunity in phase III.
The Russian researchers have preregistered phase I and phase II trials, and according to one website for the vaccine, these trials were completed in early August. It claims that there were no adverse effects, and that the vaccine triggered the desired immune response. But no detailed results have been released. It also claims that a phase III trial will commence today in a number of countries including Brazil, Mexico, Saudi Arabia and the UAE.
In other words, the vaccine hasn’t been through the full gamut of tests. Without the data from phase I and II, we don’t know how safe it is. And without phase III, we don’t know if it works. “We actually have no idea if it is safe and effective at all,” writes epidemiologist Gideon Meyerowitz-Katz in The Guardian.
Is this a good idea?
Public-health experts have identified several ways the Russian move could backfire.
Most obviously, the vaccine may cause dangerous side effects. Adenovirus-based vaccines have been widely used, so the risk is arguably low, but without seeing trial data, there is no way to be sure.
The vaccine also may not provide protection against the coronavirus. If people take it and believe themselves to be immune when they aren’t, the virus could spread more widely and cause many more deaths.
There is also a sociopolitical risk. Many countries already have problems controlling existing diseases through vaccination, because people are reluctant to vaccinate themselves or their children. This is due to the anti-vaccination movement’s false claims that existing vaccines are dangerous. Releasing an untested vaccine could exacerbate the problem.
“This is a reckless and foolish decision,” Francois Balloux at University College London said in a statement. “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.”
Is a working vaccine on the way?
According to the World Health Organization, six vaccines are currently in phase III trials, but none has yet completed them. More than 100 vaccines are in development and many have showed positive results, raising hopes that one will be ready to be rolled out within the next 12 months.
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