Nigerian virologist, Dr Solomon Chollom, on Thursday warned against the use of Russian Coronavirus (COVID-19) vaccine, Sputnik V, stating that it has not gone through entire clinical trials protocols.
Effiezy notes that the Federal Government recently got delivery of COVID-19 vaccine developed by Russian scientists for assessment.
Chollom told the News Agency of Nigeria (NAN) in Abuja, that this should be a cause for concern for all health care practitioners and the Nigerian public.
According to him, it is only the full clinical trials that will guarantee evidence-based approval from regulatory bodies and confident use by professionals.
He said that for the purpose of clarity, vaccine development was a combination of intensive laboratory-based work and extensive field or clinical trials to generate evidence around safety, efficacy and potency.
”We are expressing our interest for the COVID-19 vaccine so that we will have the opportunity to work elaborately,” he said.
Chollom said that clinical trials for vaccines are in four phases.
“Phase one has to do with administration of the candidate vaccine to a very small group of healthy volunteers to assess safety parameters.
”At this stage, the bioavailability and tenure of the vaccine in the target area is also assessed.
“Phase two is usually carried out subsequent to the success of phase one trials.
”A larger group of healthy volunteers is usually mobilised and administered the vaccine and then exposed to the disease-causing agent to assess if they will come down with the disease or stay protected by the administered vaccine.
”This phase is out to generate evidence around the effectiveness (efficacy) and dosage of the product,” he explained.
Chollom said that the success and proven evidence from Phase two would guarantee the Phase three trials.
“Here, the trial is done in a very large population, usually a multi-national study involving volunteers in thousands.
”This stage is peculiar because it brings on board different races, demographics and other possible human and environmental factors under scrutiny.
”Safety, efficacy and most importantly, potency are assessed on a larger scale across many parameters; some are host-specific and others environment-specific.
“Phase III trials usually take a long time. After successful and proven evidence from this phase, regulatory bodies are at liberty to approve the drug for clinical use,” he said.