After drawing criticism for officially registering a fast-tracked vaccine nearly a month ago, Russian scientists published their first report about the vaccine’s clinical trials. Researchers for the registered vaccine, developed by the Gamaleya Institute for Epidemiology and Microbiology, published results for a combined Phase 1 and Phase 2 trial, in the Lancet, a British medical journal, on Sept. 4.

The trial took place in two Russian hospitals with 76 adults between the ages of 18 and 60, split into two groups to test different forms of the vaccine—frozen, and freeze-dried. The two groups were then further divided into “phase 1” and “phase 2” groups, referring to the standard stages of vaccine development. Participants in both phases were each given one shot of the vaccine, with Phase 2 participants receiving an additional shot 21 days after the initial one. The study also included a follow-up period of 42 days, in which researchers continued to monitor the effects of the vaccine. 

The initial results of the study were quite optimistic: 61% of the Phase 1 participants and all of the Phase 2 participants produced antibodies in response to the vaccine, and had antibody levels 1.4 to 1.5 times those of the plasma taken from 4817 people who had recovered from mild or moderate cases of COVID-19. Additionally, researchers found that the vaccine also triggered responses from T-cells, which help the immune system fight off infection. While 58% of the participants felt pain at the injection site, and 50% of them had a higher body temperature after being injected, the vaccine produced no major side effects.

Despite the positive results of the trial, many scientists still have their reservations about the efficacy and safety of the vaccine, especially considering the breakneck speed of the vaccine’s development. Typically, when conducting clinical trials for vaccine development, Phase 1 includes a small number of healthy volunteers to test for safety, Phase 2 widens the scope into hundreds of people to determine the vaccine’s protection and dosage, and Phase 3 uses thousands of volunteers to test for long-term effectiveness and any side effects, with results from each trial being published along the way. 

However, the Gamaleya study only included 76 individuals, most of which were fairly young and healthy. Furthermore, for both Phase 1 and Phase 2, these participants were only monitored for a period of less than two months, raising a multitude of concerns from the scientific community. With an unrepresentative, small sample size and shortened trial time, it’s still uncertain what long-term effects the vaccine could have, especially for patients with pre-existing or chronic conditions. Additionally, all participants in the trial were given some form of the vaccine, without any placebo or control group to act as a baseline for the results. Due to the lack of extensive clinical trials, it’s also unknown how vaccinated individuals would react to the actual virus. 

“Safety outcomes up to now are reassuring, but studies to date are too small to address less common or rare serious adverse events,” wrote Naor Bar-Zeev, associate professor at the Johns Hopkins Bloomberg School of Public Health, describing the results of the trial as “encouraging but small.” 

Nonetheless, the vaccine has generally received a frosty international reception. One of the biggest concerns scientists have brought up is that the hastiness of the vaccine’s development could set a dangerous precedent for other countries about ignoring ethics and international legal standards in the search for a vaccine. It doesn’t help that Russia already isn’t very popular in the vaccine race, as they’ve already been accused by the U.K., the U.S., and Canada of hacking into international institutions for vaccine information. Additionally, the U.S.’s leading infectious-disease expert Anthony Fauci has stated that the U.S. is unlikely to use Russian or Chinese-developed vaccines over concerns about testing.

Despite the amount of criticism Russia is receiving for fast-tracking vaccine development, it isn’t difficult to see their motives for doing so. For starters, being the first country to conduct mass vaccinations would give Russia a head start in reopening and rebuilding its economy. It would also have the potential to improve the country’s world standing. So far, 20 countries have reached out to Russia, requesting a billion units of the vaccine. In addition to generating a huge revenue from the vaccine, Russia would also be able to improve its international relations and expand its sphere of influence. Conversely, though, a mishap could leave a permanent stain on Russia’s image.

Moreover, many critics are also worried that the political nature of the vaccine’s development is being prioritized over public health. Since the beginning of the race to develop a vaccine ahead of Western and Asian competitors, Russian President Vladimir Putin has made it clear that he wants Russia to be first, despite the risks of fast-tracking the vaccine’s development. The vaccine’s name itself, Sputnik V, a reference to Russia beating the U.S. in launching a satellite into orbit in the Cold War, makes this apparent.

This much is clear to Konstantin Chumakov, a member of the international coalition Global Virus Network and a U.S.-based Russian virulogist.“Even the name tells you that the whole point of this is to get geopolitical advantage, to be the first,” he remarked. “It might be a great vaccine. But we just don’t know. It’s a gamble with people’s lives, a Russian roulette.” 

Photo courtesy of CNEWS.FR