Is Russia’s COVID-19 vaccine going to work?

Russia is prematurely declaring victory in the race for a vaccine against covid-19, with potentially dangerous consequences for the Russian population.

President Vladimir Putin says his government has approved a vaccine and will start inoculating teachers and medical workers this month, before embarking on a mass vaccination effort in the fall.

Yet the shot is not backed by evidence from a complete phase 3 trial, the gold standard for confirming safety and efficacy. Deciding to move ahead without this proof stands to hamper rather than help Russia’s Covid-19 response.

“It works effectively enough, forms a stable immunity and, I repeat, it has gone through all necessary tests,” Putin said at a cabinet meeting Tuesday.

Russia is taking an enormous chance on whether the vaccine works safely. A significant amount of data from thousands of people in a real-world setting is needed to prove that a shot is protective or broadly tolerable

- Max Nisen

What little we know about Russia’s vaccine effort suggests he has limited ground for these claims; the vaccine has reportedly completed only early-stage trials, and data hasn’t been made available for independent scientific review.

According to Russia’s Association of Clinical Trials Organizations, fewer than 100 people had received the vaccine as of early August.

The human immune system is enormously complicated and varies significantly from person to person, based on age and many other factors. As a result, people experience a range of reactions to a vaccine.

Some shots may work well in certain parts of a population yet be harmful or ineffective in others. Safety signals aren’t always obvious or immediately apparent in trials; in rare cases, a vaccine can cause someone’s immune system to overreact, leading to a severe form of the illness the drug is meant to prevent.

Beyond missing these essential nuances, Russia is taking an enormous chance on whether the vaccine works safely. A significant amount of data from thousands of people in a real-world setting is needed to prove that a shot is protective or broadly tolerable.

Not enough details

Perhaps Russian scientists have great animal models or lab data from early participants. They haven’t been forthcoming with details. But such data would not appreciably improve the picture. Scientists have had less than a year of experience with the novel coronavirus itself and even less with immunity to covid-19.

Putin noted that one of his daughters took the vaccine and then registered high antibody levels. At this point in the scientific process, however, secondary measures such as antibody levels do not confirm that a vaccine is effective.

It’s not hard to see why Russia might be willing to gamble on an inadequately tested vaccine. If it works, the country could get back to normal more rapidly. And a win in the vaccine race could burnish Putin’s reputation at home and abroad. But the potential to lose this bet is enormous, and the cost may come in lives.

If the vaccine turns out to offer minimal, transient or variable protection, then it may give the Russian people a false sense of security. They may interpret getting a shot as a license to behave as if the virus has gone away, allowing the germ to spread more widely than it otherwise would.

If that happens, or if people suffer significant side effects, it will undermine confidence in the government and in vaccination generally. Like the rest of the world, Russia will remain in Covid uncertainty for a long time.

Max Nisen is a columnist covering biotech, pharma and health care. He previously wrote about management and corporate strategy for Quartz and Business Insider.

Bloomberg