COVID-19 Vaccine: NAFDAC Rules Out Clinical Trial
National Agency for Food and Drug Administration and Control has ruled out the possibility of conducting a local clinical trial on the proposed N400bn vaccines before administering them on Nigerians.
A clinical trial, according to WHO, is a type of research that studies new tests and treatments and evaluates their effects on human health outcomes.
According to ThePunch, NAFDAC stated that since the World Health Organisation approved vaccines like Pfizer, Moderna, there might not be need to conduct another clinical trial on the vaccines.
It, however, said it would subject vaccines, which Federal Government may likely spend N400bn to procure, to proper revalidation before administering them on Nigerians.
Speaking in an interview with the publication on Friday, NAFDAC’s Media Consultant, Sayo Akintola, noted that owing to the urgent demand for COVID-19 vaccine, there may be no reason to conduct a trial before administering the jabs.
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 on 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.
Although Akintola said NAFDAC’s evaluation of the vaccine would not be rigorous mainly because it’s not a new vaccine, he noted that its efficacy and safety needed to be ratified.
The media consultant added;
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.
However, some virologists and infectious disease experts have disagreed with NAFDAC, insisting that there is a need to conduct a clinical trial on the vaccines in the country before administering it on Nigerians.
Many of them opined that the clinical trial is necessary as there is no evidence to show the earlier trial conducted in Europe had African volunteers.
They added that in terms of human genetics, African-Americans are different and cannot be used to represent Africans in a trial.