Russian coronavirus vaccine – tested by showing it a photo of the word “test”

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A new Soviet Russian coronavirus vaccine, called “Sputnik V” was approved by the Soviet Union Russia. The “first” vaccine to be approved was announced by Soviet General Secretary Russian President Vladimir Putin, otherwise known as Donald Trump’s best friend forever.

Amusingly, the “Sputnik V” name harkens back to the Space Race, a Cold War competition between the USA and the Soviet Union in the 50s and 60s to see which country could build the best space program. Sputnik was the name of the first orbital satellite launched by the Soviets beating the USA to space by two months. It didn’t really do much but beep every few seconds while orbiting the earth – we’ll take that as an excellent metaphor.

Not to be totally cynical, the name is an obvious propaganda statement by Putin that the Soviets Russians won the coronavirus vaccine war. 

Of course, the scientist in me says “not so fast there Comrade.” Let’s take a look at the science, or better still the lack of science, of this new Russian coronavirus vaccine. Considering how skeptical I am of the US coronavirus vaccine effort, you can imagine what I’m going to write about Putin’s effort.

By © Milan Nykodym, Czech Republic, CC BY-SA 2.0, 

The Russian coronavirus vaccine

Well, I would like to write a whole bunch about this vaccine, but I can’t. Why? Because there is not a whole bunch of published information about the Russian coronavirus vaccine. 

Early in the race to a new coronavirus vaccine, the Russia-based Gamaleya Research Institute announced the development of a recombinant adenovirus vector-based vaccine. Adenoviruses are highly immunogenic in humans, so there has been a lot of research in using an adenovirus vector in vaccines. 

Johnson and Johnson, China’s CanSino Biologics, and the University of Oxford are using the adenovirus vector in their vaccine candidates. So, that is not an issue.

In this case, Gamaleya was able to add the SARS-CoV-2 S-protein gene into the adenovirus vector to develop the vaccine. They actually registered two clinical trials, NCT04437875 and NCT04436471, that were open-label, phase I clinical trials that started on June 20. These trials included a grand total of 38 healthy volunteers, which is typical for a phase I trial. 

We have no data from those phase I trials, so I can’t tell you if they determined if the vaccine was safe or if it worked. There are no peer-reviewed published articles from these trials, so we have nothing.

Despite what a lot of people say, including many scientists, science is pretty black and white. You either have evidence to support or reject a hypothesis or you don’t. Sure, you might argue that the evidence is weak or improperly analyzed, but that’s why science relies upon not only quality but also quantity. That’s why the safety and effectiveness of most vaccines are settled science

The story gets even stranger. The phase I trial only included the researchers who developed the vaccine, which is highly unusual if not downright unethical. This may be something done 100 years ago, but it would never happen now in most clinical research.

Why? Because it’s the epitome of bias is having the researchers research themselves. They, of course, want the vaccine to work and to be safe, so they’ll overlook anything to make that happen. And that, my friends, is why it’s no longer ethical to use oneself as an experimental subject. Well, except in movies

Despite the lack of data, over 500 million doses of the Russian coronavirus vaccine will be manufactured. I’m not concerned about the financial risk, although I find it kind of troubling when that capacity could be used for a vaccine that works, it’s the fact that it’s being used for a vaccine that has not been shown to either be safe or to work.

Phase 3 trials

To get valid data on a new vaccine’s safety and effectiveness, large phase III clinical trials are necessary. And they are required by the vast majority of pharmaceutical and medical regulatory agencies worldwide.

Usually, phase III vaccine clinical trials are placebo-controlled (that is, there are at least two groups, one of which receives a placebo or the antecedent vaccine, not what the anti-vaxxers claim), double-blinded (neither the patient nor the physician knows who gets the vaccine or placebo), and randomized (no one gets to choose which person gets into which arm of the study). These studies should be large, should represent a wide part of the population, and should be carefully watched over time.

Furthermore, because it’s difficult to determine if a vaccine confers immunity (using seroconversion as a parameter is important, but does not guarantee immunity) unless the person is exposed to COVID-19, usually a study needs to be very large (Moderna is including over 30,000 patients in its phase III study) and patients need to be observed for a long enough period of time to be sure that they might be exposed to the coronavirus.

So, the Russian coronavirus vaccine is being rushed without this phase III study. In fact, it appears that Russia plans to use its population as a phase III trial – that is the most egregious violation of medical ethics in many years. Of course, there are a lot of pro-vaccine people in the USA who are pushing for the same thing. 

Clearly, based on the “Sputnik V” name is just a propaganda coup for Putin. J. Stephen Morrison, a senior VP at the Center for Strategic and International Studies, said:

This is changing the rules. This is cutting corners. It’s a major development, and it starts with Putin. He needs a win.

It’s hearkening [back to] the Sputnik moment. 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.

Putin wants to declare a victory for his country against COVID-19. And the safety of his citizens be damned. Russia does not want to appear to be dependent on western countries, so they want to similarly appear to be the leader in the race for this vaccine.

In case this isn’t clear enough that it’s about propaganda rather than public health, the KGB Russian hackers tried to steal data about the coronavirus vaccine. Geez, this feels like the 1970s, except no disco music.

To be honest, Putin isn’t alone in this matter. China, the USA, the UK, and many other countries are pushing ahead with a coronavirus vaccine seemingly without consideration of good clinical science. Many of these countries want to declare “victory” in this race, and it is not inconceivable that the leaders of these countries bypass the regulations and science to become “Number One” with a coronavirus vaccine.

Furthermore, this Russian coronavirus vaccine could conceivably increase political pressure on other governments to take a similar bet on an unproven vaccine and rush it to market. That will lead to either a lot of people harmed from the vaccine or that the pandemic will continue. 

Moreover, the Russian government pushing the vaccine probably means that the any adverse effects will not be transparently reported in such an atmosphere. The government, whether Russia or in other countries, may coerce people from reporting any dangers through financial incentives or job threats. This is why we do large, randomized, placebo-controlled, double-blinded clinical trials!

Which leads me to Donald Trump.

Russian coronavirus vaccine

Donald Trump and the Russian coronavirus vaccine

No, there is no conspiracy here, though if one later showed up, I wouldn’t be shocked.

Since Donald Trump has a longstanding love affair with Vladimir Putin, he is undoubtedly thinking that if Russia can do this, why can’t he Make America Great Again by copying his Soviet Russian handlers.

I have been worried that Trump, just to claim victory against COVID-19, will push out a vaccine that has not been properly tested for safety or effectiveness. He’s already started the process by claiming that a vaccine will be out for an “October Surprise” just in time for the November 2020 election. 

Because most Americans are not scientists, maybe enough will believe him that he wins the election. That worries me because he’ll be re-elected and then we still don’t a vaccine in a country where he has shown no leadership in managing this pandemic.

Summary

I do not know if this Russian coronavirus vaccine is either safe or effective. Like I always say, I don’t get interested in any vaccine, drug, or treatment until phase III clinical trials are completed and published in a highly respected peer-reviewed journal. This is because I want to see whether the study was well-designed, whether there was any bias, and whether it was statistically significant. And I can’t do that based on the word of Vladimir Putin. Or his best buddy, Donald Trump.

As I have stated, I am troubled about how science is slowly being eroded in a blind rush to get a new coronavirus vaccine. Our world of outstanding vaccines against measles, mumps, polio, HPV, and many other dangerous diseases is based on an immense amount of high-quality science that is transparent and available to everyone. 

I understand the need to rush a vaccine because every single day of delay will lead to a tragic loss of life. But should we shortcut long-established clinical research just to give us a vaccine that may not be safe and/or effective? I say no, but apparently the Russians aren’t listening to me.

But don’t listen just to me about the Russian coronavirus vaccine. Let’s see what Dr. Anthony Fauci, who knows more about this vaccine in his right pinky finger than Trump or Putin, says about it:

I hope that the Russians have actually, definitively proven that the vaccine is safe and effective. I seriously doubt that they’ve done that.

Citations


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The Original Skeptical Raptor
Chief Executive Officer at SkepticalRaptor
Lifetime lover of science, especially biomedical research. Spent years in academics, business development, research, and traveling the world shilling for Big Pharma. I love sports, mostly college basketball and football, hockey, and baseball. I enjoy great food and intelligent conversation. And a delicious morning coffee!