The National Agency for Food and Drug Administration and Control (NAFDAC), has kicked against experts’ idea of conducting a local clinical trial on the proposed N400 billion vaccines before administering them on Nigerians.
A Clinical trial is a type of research that studies new tests and treatments and evaluates their effects on human health outcomes.
While the Nigerian government is hoping to secure the COVID-19 vaccines from international bodies, including the World Health Organisation (WHO), NAFDAC said it will be needless to conduct a clinical trial.
According to the drug and food agency, since the WHO had approved the vaccines, there might not be a need to conduct another clinical trial on the vaccines.
It, however, said it would subject vaccines, which the Federal Government may likely spend N400bn to procure, to proper revalidation before administering them on Nigerians.
NAFDAC’s Media Consultant, Sayo Akintola explained that owing to the exigencies of COVID-19, there may be no reason to conduct a trial before administering the vaccines.
“Once the vaccine arrives, a sample will be taken to the lab for a test. Once its safety and efficacy are certified by NAFDAC, it will be administered to Nigerians. We don’t expect anything to be different though.
“The truth is that once a vaccine is approved by the WHO, it is assumed that it has passed through some preliminary stage of the trial. It is a known fact that for the WHO to sanction a vaccine, it must have gone through a series of trial here and there,” he said.
Although he said NAFDAC’s evaluation of the vaccine would not be rigorous mainly because it’s not a new vaccine, Akintola noted that its efficacy and safety needed to be ratified.
“It is just for ratification. There is nothing on drugs or vaccines you will do without the consent of WHO. It is also expected that the regulatory body in each country would do its work in tandem with the WHO standard,” he stated.