On 11 August, Russia became the first country to approve a vaccine for COVID-19. The Russian vaccine, named “Sputnik V”, has been hailed by President Vladimir Putin as “quite effective” and claimed to offer “sustainable immunity” against the virus.
According to officials, mass vaccination is planned to start as early as October this year. Doctors and teachers are set to receive the vaccines first.
With the approval of this vaccine, Russia has declared victory over almost 170 teams worldwide in the vaccine race. That’s right, despite the US’, China’s, and even Singapore’s best efforts, Russia’s got them all beat. So, how did they do it?
They just… didn’t do a Phase III clinical trial*.
Yes, you read that right. Sputnik V was granted regulatory approval after just two months of human testing.
According to the Executive Director of the Association of Clinical Trials Organizations (Acto), which represents the top international drug companies in Russia, the vaccine was approved after a combined first and second phase clinical trial, involving 76 participants.
Even then, data on this trial has not been released, leaving the methodology and results of the study up in the air.
Unsurprisingly, scientists across the world have collectively furrowed their eyebrows at this. Health officials in the US and across Europe have also expressed concern over the safety and efficacy of the vaccine.
As Germany’s Health Minister said, “It can be dangerous to start vaccinating millions… of people too early because it could pretty much kill the acceptance of vaccination if it goes wrong.”
Acto has also called for a delay in the mass vaccination plan until a Phase III trial has been completed.
Still, some have more faith in the vaccine than others. Chinese researchers told the Global Times that the “technology of developing and producing adenovirus vector (the technology used in the Russian vaccine) is mature,” and that “it is very likely Russia will succeed.”
Rodrigo Duterte has expressed interest in the vaccine as well. “When the vaccine arrives, I will have myself injected in public. Experiment on me first, that’s fine with me,” the Philippine President said.
The Philippines has since announced plans to hold clinical trials for the Russian vaccine in October. Duterte may receive the vaccine himself as early as May next year.
According to the official site for Sputnik V, a Phase III clinical trial started on 12 August. The trial is claimed to involve over 2000 people in various countries, including Russia, Saudi Arabia, UAE, Brazil, India and the Philippines.
However, a senior official in the Indian Council of Medical Research (ICMR) has stated that “as far as our information is concerned, there is no movement on that front yet.”
* For the stats-savvy people out there, a phase III clinical trial is a (usually multi-centre) double-blinded randomised controlled trial with up to 3000 participants. It is widely considered to be the gold standard of evidence proving the efficacy and safety of a drug before it is rolled out.