Russian Approval of Unproven “Sputnik V” Coronavirus Vaccine Raises Safety and Effectiveness Concerns

Health officials in both Russia and around the world are raising concerns over Moscow’s approval of a vaccine to be used against the SARS-CoV-2 coronavirus, despite not having finished critical Phase 3 clinical trials for the new treatment necessary to determine both the effectiveness and safety of the new inoculation. The vaccine has only been tested on a handful of individuals, according to Russia’s clinical trials authority, and no scientific papers having been released regarding the scant testing that has been conducted so far, leading many health experts to question the new vaccine’s safety and effectiveness.

Developed by the Gamaleya Research Institute of Epidemiology and Microbiology, the state-funded vaccine, labeled “Gam-COVID-Vac” by the institute but given the public nickname “Sputnik V”, has reportedly already received bids from roughly 20 countries, according to Russian officials, including the Philippines, a country suffering from a surge in coronavirus infections.

Although the vaccine has only been in development since March of this year, numerous individuals amongst Russia’s business and political elite have had access to the vaccine since April, including President Vladimir Putin’s daughter, and military volunteers were used to complete Phase 2 trials in July. Phase 3 trials began in the first week of August, but the Russian Health Ministry expects Sputnik V to be available for mass vaccinations by October, well ahead of the one to four years that would typically be required to conduct a Phase 3 trial.

“I know that it works quite effectively, forms strong immunity, and I repeat, it has passed all the needed checks,” asserted Putin.

“We have nothing to be proud of in Russia, it’s more of a shame that the country demonstrates it’s willing to violate common rules and cut corners just to demand rewards,” according to an Association of Clinical Trials Organizations (ACTO) spokesperson. ACTO is a Russian-based association of multinational pharmaceutical companies. The government denies this accusation, but rather insists that they’ve fast-tracked regulations of the new vaccine because it is ready and it is worthwhile given the scale of the pandemic.

“This is a political decision by Putin so he can claim that Russia was the first in the race to develop a Covid-19 vaccine,” according to Svetlana Zavidova, ACTO’s executive director. “I can’t understand why Russia needs to build this Potemkin village.”

ACTO says that Sputnik V has only been tested on 76 subjects, a far cry from the tens of thousands of people required for a full series of clinical trials. Typically, a Phase 1 trial is conducted on 20–100 healthy volunteers to test for immediate safety; Phase 2 will involve 100–300 individuals to test for efficacy (in this case an appropriate immune response) and potential side effects; Phase 3 involves thousands of volunteers in tests to confirm its efficacy (how effective the drug is under ideal conditions) and evaluate its effectiveness (how well it works under real-world circumstances), monitor side effects, and gather further data that will be used in the drug’s medical use, if approved.

But roughly half of all candidate drugs wash out during their Phase 3 trials—typically even more in the case of vaccine candidates—and without wide-scale testing, it is impossible to know if the vaccine is indeed safe, let alone effective against the coronavirus itself: an immune response being observed in test subjects does not necessarily mean that the vaccine will be effective against the actual coronavirus, a factor that won’t be realized until inoculated individuals are exposed to the actual virus.

Drug candidates that produce side effects in only a small number of people require testing in thousands of individuals to reveal the true rate of complications: for instance, if a given drug produces an adverse reaction in one in every one thousand people (0.1%), statistically speaking it would require a minimum of a thousand test subjects to reveal the flaw; regardless, researchers would want even more data to nail down the true rate.

If this same drug was tested on only 76 people—the number of Sputnik V test subjects as claimed by ACTO—a real-world reaction rate of 0.1% would be unlikely to occur in the test group; indeed, with such a small number of test subjects, a failure rate as high as 1 in 4 (25%) could potentially go unnoticed.

“It’s very dangerous to scale this up to an entire population without doing those trials,” according to Dr. Zain Chagla, an infectious disease specialist at St. Josephs’ Health Centre in Hamilton, Ontario.