Skepticism gripped the whole world after Russia announced her ‘world’s first’ COVID-19 vaccine, named “Sputnik V,” few days ago.
According to Russia, this announcement was subsequent to the Phases I and II clinical trials of the vaccine, but had yet to conduct the mandatory third phase.
New York Times gathered that the Russian scientific body that developed the vaccine, the Gamaleya Institute, had yet to conduct the compulsory Phase III tests on tens of thousands of volunteers in highly-controlled trials. According to experts and WHO, this phase is seen as the only method of ensuring a vaccine is actually safe and effective for use. In fact, more than 30 vaccines out of a total of over 165 around the world are now in various stages of human trials.
World Health Organization (WHO) maintains a comprehensive list of worldwide vaccine trials and there is no Russian Phase III trial in the report. This indicates that the global health body doesn’t recognize the Russian “Sputnik V” as one that has completed the normal developmental cycle of a COVID-19 vaccine.
Vladimir Putin, the Russian president, while making the declaration claimed a Russian health-care regulator had become the first in the world to approve a vaccine for COVID-19, though the vaccine had yet to complete clinical trials. This has caused uproar from critics all over the world as there are speculations that Russia wants to use their recent development to gain political points.
Medical experts have affirmed that they would not recommend the vaccine for Nigeria as it was fast-tracked and the Russian government did not release any data concerning the development studies around the vaccine.
The final third phase, which is missing from the Russian vaccine, is the only way to know with statistical certainty whether a vaccine prevents an infection. And because it is carried on a much larger group of people, Phase III trial can also pick up more subtle side effects of a vaccine that earlier trials could not.
A professor of virology, Chairman Expert Review Committee on COVID-19 and pioneer Vice-Chancellor of Redeemer’s University, Oyewale Tomori, said: “A safe and efficacious vaccine is, of course, what we need now. It will be a breakthrough of monumental magnitude. However, what we need now is a breakthrough, not a break loose. Russia says, so far, the vaccine is efficacious and we have no way of confirming that. Until we have that confirmation, it will not be safe to touch the vaccine.”
Professor Tomori, who is also a consultant with WHO, said safety concerns were many, especially if clinical trial studies were not complete.
“Questions to be answered are: is the vaccine safe, doing no harm and not having or causing adverse effects, especially irreversible adverse effects? Is it efficacious and offers durable protection against the disease?”
The virologist said these numerous questions could only be answered through clinical trials involving hundreds of people of different age groups and conditions; and this requires appropriate time and adequate number of people.
Source: The Guardian Newspaper