Soon after COVID-19 started showing its harsh and devastating effects, scientists across the globe realized the need for a protective vaccine. This global pursuit for a worldwide antidote fast-tracked the scientific efforts of many. Now, and nearly nine months into the rise of the pandemic, twenty-nine candidate vaccine trials remain underway across the world, with eight already in Phase 3 of testing. Two more were recently approved for extensive trials.
Unlike therapeutic drugs — which are a frontline solution for people already afflicted with diseases — vaccines are primarily offered to healthy people. Vaccine pre-approvals require in-depth testing on large groups of volunteers to clear a high-standard safety bar. A safety threshold of three phases was set in place to protect the public. As such, we now know that the preparation and ultimate release of vaccines to the public requires a protracted route, mainly to evaluate all possible risks and acquire administrative approvals. It took 25 years for instance, to secure an effective vaccine against the rotavirus.
To assess potential risks, a stringent, controlled, and transparent trial system is required before regulatory bodies can authorize the release of vaccines for general public use. Only months after the first case of COVID-19 was reported in the city of Wuhan in China, Russian President Vladimir Putin now announced in a world-first, the successful adoption and implementation of a COVID-19 vaccine. The announcement, which took place on August 11, 2020, has since generated well-warranted debate.
Dubbed a “Sputnik moment”, the announcement saw Moscow name the vaccine Sputnik-V — a direct reference to the very first satellite launched into space by humans. This clearly was meant to resonate with people as a reminder of the successes Russia had in the USA-USSR race into space.
Reports from Russian news channels have since suggested that many countries, including India, Saudi Arabia, and Brazil, along with a dozen others, are showing interest in Sputnik-V. International experts however, question whether Russia may have rushed this announcement, some have denounced the move as inadequate, risky, and even inappropriate.
As of now, Russia has indeed not yet provided the scientific community with adequate data on the efficacy and safety of the vaccine, raising real questions on its value. Sputnik-V was corroborated and eventually formalized by the Ministry of Health in Russia, as an endorsement of the Gamaleya Research Institute of Epidemiology and Microbiology’s efforts. But the report also revealed that the vaccine has been tested on only 76 people with 38 participants producing antibodies against a COVID-19 viral spike protein.
Although the Gamaleya Research Institute has prior experience in vaccine development, Russia’s scientists by default still need to conduct a trial with a randomized group of ethnically different people and placebo settings for the world to acknowledge the validity of Sputnik-V. The trials, which typically constitute large groups of people, often fail an estimated 90 percent of the time. They are also less likely to recapitulate the findings of small-scale studies, as ethnically diverse people tend to reveal side effects that are specific to their own populations. Sputnik-V’s official website suggests that the Gamaleya Research Institute is now beginning trials on 2000 people across Russia, the UAE, Saudi Arabia, and Mexico.
Russia has taken an unprecedented step by skipping the necessary measures and rushing the Phase 3 requirement. Phase 3 trials are critical in determining whether vaccines are any more effective than placebos. They also are imperative towards assessing potential side effects. If Sputnik-V ultimately proves wrong, the global vaccine enterprise and trust of people in this – and other – vaccines may be irrevocably undermined.