What We Know (and Don’t Know) About the Alleged Russian Vaccine Against COVID-19
Since the onset of the COVID-19 pandemic, much of the optimism that “we can handle this” and someday “get back to normal” has been associated with the development and approval of an effective vaccine against the new coronavirus. Major pharmaceutical companies such as Pfizer and Moderna have been conducting clinical trials of several formulations of COVID vaccines in testing sites around the world for several months now. And while some phase 3 trials are underway and we’re getting closer, there is still a lot of work to be done before the COVID vaccine is proven to be safe and effective, let alone make it generally available.
Meanwhile, in Russia, President Vladimir Putin announced yesterday that they have the world’s first approved * COVID-19 vaccine. On a segment of Russian state television that would not look out of place on a traveling medical show of the late 19th century, Putin noted that he was so confident in the vaccine that his own daughter made it. Needless to say, we have a lot of questions about this vaccine and its development. Here’s some of what we know – and don’t know – about it so far.
(* in Russia)
There were serious flaws in the research process.
At the dawn of vaccine development in the 19th century, scientists often first tested the safety and efficacy of a vaccine on themselves and then tested it on others. By the mid-20th century, some medical tests, including tests for vaccines, were routinely conducted using individuals in institutions (including people in prisons, mental health facilities, and orphanages) as dissenting research subjects, many of whom were colored .
Fortunately, we now have a better system. As Rachel Fairbank explained in an article on this site back in April , the United States has standardized a multi- step testing process to ensure that any vaccine that is made available to millions of people actually works and does not cause serious harm.
Potential vaccines are tested in volunteers in three stages :
- Phase 1: Testing different dosages and looking for side effects.
- Phase 2: The optimal dose from Phase 1 is given to a larger group of human volunteers at the therapeutic dose (the dose needed for the average patient) to determine how safe and effective it is.
- Phase 3: Testing is done on a much larger scale to better understand what the range of immune responses will look like in the general population.
It turned out that Russia did not feel the need to conduct phase 3 trials, so the new vaccine was approved without this crucial phase of trials. Scientists report that among the many (many) fears of scientists is the very real possibility that receiving a substandard vaccine could potentially make people even more vulnerable to severe forms of COVID-19 . And the only way to rule out this serious possibility is, you guessed it, to conduct further clinical trials with more participants. What Russia chose not to do.
There is no publicly available data on the results of these studies.
So far, the Russian authorities have not released any data on clinical trials that they actually behave, so we have no evidence that the vaccine is in any way effective, and whether there are any serious side effects. Not only is this bad science; Giving people untested vaccines can do more harm than good.
We know a thing or two about the vaccine itself. As reported by the New York Times , he “uses two strains of adenovirus that commonly causes mild colds in humans. Scientists have genetically modified them to make the infected cells produce proteins from the outbreak of the new coronavirus, officials said. If this sounds familiar, this is because it is similar to the approach to the vaccine being developed by the University of Oxford and AstraZeneca, which is currently in phase 3 trials in the UK, Brazil and South Africa.
But the only information we have so far about the results of preliminary trials of this Russian vaccine comes from the country’s Minister of Health, Mikhail Murashko, who, according to the New York Times, characterized the vaccine as safe and effective, noting that “All the volunteers developed a high [level] of antibodies to COVID-19, and none of them had serious complications of immunization. ” Putin also told how his daughter is doing, noting that after each dose she had a slight fever, but “now she feels good.” That’s all.
Of course it’s political
The “Vaccine Race” is the most recent event in the current member-measuring decathlon between Putin and Donald Trump, who launched his own program to try and get the science to rush to hell called “Operation Warp Speed” – in May. Obviously, we all want a safe and effective vaccine as soon as possible, but Russia’s frank admission that they missed a critical phase of clinical trials does not bode well.
If all this looks like a small Cold War, especially reminiscent of the mid-century space race between the USSR and the United States, then this is not a coincidence. As proof, pay attention to the name that the Russian vaccine will use in foreign markets: “Sputnik V” . Yes, as was the case with the world’s first artificial satellite , which was launched into orbit by the USSR in 1957, ahead of the United States to this scientific milestone. Except for this case, instead of a satellite, they launch a potentially dangerous vaccine that could further exacerbate the global pandemic.