On Aug. 11, Vladimir Putin announced to the world that Russia has confirmed a successful COVID-19 vaccine. He assured the world it was safe, and that his own daughter had taken it.
“I know that it works quite effectively, it forms a stable immunity,” Putin said. “I repeat: it has passed all the necessary tests.”
That last part, about passing all the necessary tests, was an outrageous fabrication in our opinion.
The Association of Clinical Trials Organizations, a Russia-based industry body, protested via open letter that the vaccine “hasn’t even completed testing with participation of even 100 people.”
To be clear, this whole thing seems crazy — and dangerous.
“I think it’s really scary. It’s really risky,” said Daniel Salmon, director of the Institute for Vaccine Safety at Johns Hopkins.
Virology experts were deeply skeptical, and even alarmed, by Putin’s announcement. This is because Russia has skipped the normal tests and precautionary measures that determine a vaccine is safe.
When Putin says Russia’s vaccine has “passed all the necessary tests,” we believe he is lying, because the “necessary tests” have literally not been conducted.
Vaccines are designed to be administered to tens of millions of people, or even hundreds of millions of people. A COVID-19 vaccine, in theory, could be administered to billions of people.
This means that, when it comes to a vaccine, the stakes for getting it right are incredibly high — and the potential failure costs are catastrophic.
If a vaccine is billed as effective, but is actually non-effective, it can give a population false hope. That, in turn, can lead to greater spread of the disease, and a collapse of public trust in regard to the efficacy of vaccines in general.
Worse still, a faulty vaccine can potentially accelerate the spread of the disease it is supposed to prevent. It could also cause significant adverse reactions — up to and including death — in a significant percentage of the population that gets the vaccine.
Because the stakes of failure are so high, any potential vaccine typically goes through three “phases,” with each one successively harder to pass.
- In Phase 1, the vaccine is tested on animals, typically mice or monkeys, to determine a basic threshold of effectiveness and safety before testing it on humans.
- In Phase 2, hundreds of human volunteers are tested. The vaccine is still highly risky at this phase, which is why participation is voluntary. The data from Phase 2 trials will determine if the vaccine is promising enough to move on to the real test — Phase 3.
- In Phase 3 trials, thousands upon thousands of participants are tested, and then monitored closely, to confirm positive results (and a lack of adverse reactions).
The Phase 3 testing level is critical because, again, a vetted vaccine could roll out to tens of millions, hundreds of millions, or even billions of people. At that scale, it is absolutely critical to confirm that the vaccine actually works as advertised, without causing adverse reactions in a significant percentage of the population.
Russia appears to have skipped Phase 2 and 3. Russia’s vaccine, known as the Gamaleya vaccine, is still listed by the World Health Organization as being in Phase 1.
“Using it in general population before the results of Phase 3 trials are fully studied is a gamble,” says Konstantin Chumakov, a member of the Global Virus Network. “A Russian roulette, if you will.”
Some are skeptical the Gamelaya vaccine is even viable.
“This is all beyond stupid,” said virologist John Moore of Weill Cornell Medical College. “Putin doesn’t have a vaccine; he’s just making a political statement.”
Moore has a point. The vaccine, whose official name is Gam-COVID-Vac, will be marketed under the name “Sputnik V.” The name is a homage to Sputnik 1, the Russian satellite that kicked off the Cold War, and the U.S.-Russia space race, in 1957.
Just as Russia once beat America, and the world, into space with the launch of Sputnik 1, Putin wants to cover his homeland in glory once again by beating the world to a vaccine.
Everything about this screams danger. Like heart surgery or LASIK, there are some things where corners should never be cut, and the process should never be rushed. The space race never put the health of millions at risk.
As of this writing, there are more than 160 COVID-19 vaccine candidates in development around the world. Dozens are in various stages of human trials. Only eight have made it to the Phase 3 stage, where thousands or even tens of thousands of participants are required.
Vaccine development is incredibly challenging because the safety-and-effectiveness bar is so high (which is exactly as it should be). Rule-of-thumb estimates suggest that, even for vaccines that make it all the way to phase 3 — a huge accomplishment in itself — 90% or more will fail at the phase 3 stage.
This is why vaccine development has historically taken years, and why multiple diseases still have no vaccine at all. Coming up with a treatment idea isn’t the hard part. Getting early results that look promising isn’t the hard part, either.
The hard part — the really, really hard part — is passing muster in phase 3.
But again, Russia has decided to skip all that. If Putin is to be taken at his word, mass production of the Russian vaccine will begin within weeks. We’ll just have to wait and see what happens next — while remaining skeptical, and requiring verification, for whatever gets reported.