- Russia is the first country in the world to approve a coronavirus vaccine, but the experimental drug has not gone through any of the large-scale testing necessary to ensure safety and effectiveness.
- The Sputnik V vaccine from the Gamaleya Institute in Moscow will be distributed on a “massive scale” in the coming months, even though Phase 3 trials are just now starting.
- If the coronavirus vaccine is unsafe or ineffective, it will do far more harm than good.
Russia made waves on Tuesday when President Vladimir Putin announced that the country had become the first to approve a vaccine for the novel coronavirus that would be used to inoculate millions of Russians. Russia was able to beat every other country to the punch because the experimental vaccine from the Gamaleya Institute in Moscow has yet to go through late-stage trials, and has only been tested in small groups of people.
“I know it has proven efficient and forms a stable immunity,” Putin said without any evidence to support his claim. “We must be grateful to those who made that first step very important for our country and the entire world.” In fact, Putin is so confident in the Sputnik V vaccine that he claims one of his daughters has already “taken part in the experiment,” and after suffering from minor side effects, now has a “high number of antibodies.”
According to the Associated Press, health experts in Russia and around the world have criticized the move. Rushing to distribute a vaccine that has yet to be thoroughly tested could end up doing more harm than good. Not only has the safety of the drug yet to be substantiated, but even if the vaccine doesn’t lead to complications, it might be ineffective and give those who take it a false sense of security, as The Washington Post notes.
The AP reports that Russia’s Sputnik V vaccine uses a modified version of the adenovirus — the virus which causes the common cold — to carry genes for the spike protein found on the new coronavirus to trigger an immune response that will, in theory, protect those who are inoculated from becoming infected in the future. This is the same approach that CanSino in China and AstraZeneca in the UK are taking with their vaccines.
The difference is that Russia plans to start large-scale production of its vaccine in September, and could begin a mass vaccination campaign as early as October, according to Kirill Dmitriev, head of the Russian Direct Investment Fund. In the meantime, Phase 3 clinical trials for Sputnik V are expected to begin on Wednesday.
“We expect tens of thousands of volunteers to be vaccinated within the next months,” he stated. “So people outside of clinical trials will have access to the vaccine in August, and some, already on the massive scale, in October.”
Russia was reported to be behind disinformation campaigns to sow doubts in U.S. about our Covid vaccines; and today’s news that they “approved” a vaccine on the equivalent of phase 1 data may be another effort to stoke doubts or goad U.S. into forcing early action on our vaccines https://t.co/WR6xPkFcfJ
— Scott Gottlieb, MD (@ScottGottliebMD) August 11, 2020
To put into perspective just how reckless this could turn out to be, multiple vaccine candidates have entered Phase 3 trials in recent weeks, and experts say that we’ll be lucky to “have a glimmer of whether the vaccine is working and be able to assess its safety” by January of next year, despite US President Donald Trump’s claim that a vaccine could be rolling out to the public by Election Day. Thousands of participants have already enrolled in those Phase 3 trials, while the World Health Organization lists Gamaleya’s vaccine as being in Phase 1, which consisted of just 76 volunteers. Calling Russia’s decision to approve a vaccine this early “rash” would be an understatement.