NAFDAC rules out clinical trial for COVID-19 vaccine

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The National Agency for Food and Drug Administration and Control, NAFDAC has ruled out the possibility of conducting a local clinical trial on the proposed N400bn vaccines before administering them on Nigerians.

The agency said since the World Health Organisation had approved the vaccines there might not be 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 said 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 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,” 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.

He stated, “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.”

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.

A clinical trial, according to the WHO, is a type of research that studies new tests and treatments and evaluates their effects on human health outcomes.

It noted that people volunteer to take part in clinical trials to test medical interventions including drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioural treatments and preventive care. The global health body noted that biomedical clinical trials entail four phases.

A medical virologist at the Adeleke University, Ede, Osun State, Dr Elijah Kolawole, said it would be safer to conduct a mini clinical trial to determine the efficacy of the vaccine before rushing to administer it on a population of over 206 million.

He said, “This is because there is no evidence to show the earlier trial conducted in Europe had African volunteers. There is something we need to understand. In terms of human genetics, African-Americans are different and cannot be used to represent Africans in a trial.

“They could be similar but they cannot be regarded as a proper representation of Africans. That’s why you see a lot of differences in the way we respond to treatments based on our genetic make-up.”

Also, a medical microbiologist at the Lagos State University, Prof Bola Oyefolu, said there was the need to conduct a clinical trial before administering the vaccines on Nigerians.

“Before any vaccine is given, there is a standard procedure for it. Before you can inject people with any vaccine, it must have gone through serious clinical trials, and when you look at the duration for that, it will take an average of three years.

“The clinical trial will prevent mortality; there is the need for more time to do a more open clinical trial to be sure that what we are giving to the people is safe”

Oyefolu also cautioned the Federal Government against procuring COVID-19 vaccines from abroad.

He said, “From the virological point of view, I don’t think Nigeria should go for the vaccines because everything is shrouded; it is not open. I’m just wondering why they are not doing clinical trials with their own people over there? Why must it be Africans? Are we guinea pigs? Unfortunately, most African leaders won’t look into the core of it; they will just go for the vaccines, maybe for the monetary gain.”

He added, “Once this vaccine is administered and it gives us a negative result, it can’t be reversed and that will be an indictment on the scientists in Africa.”

The Director-General, Nigerian Institute of Medical Research, Prof, Babatunde Salako, said although there was a need for a clinical trial, NAFDAC had the responsibility to determine if that was necessary or not.

He said, “The fear of those calling for a clinical trial is understandable. That the vaccines work for Caucasians does not mean it will work the same way for Africans. Therefore, there is a need to determine whether the vaccine is also efficacious here and safe for use on Nigerians.

“Having said that, the owners of the vaccines are the ones who will decide if they want the clinical trial. For us, we have a regulatory body like NAFDAC that may insist that efficacy and safety tests be done before Nigeria accepts to try it. If they don’t have that already, they may have to do it.”

The researcher, however, expressed reservation that the pressure being mounted on manufacturers of the vaccines in other countries may not make them agree to such demand.

“I doubt if they will agree because there are countries who are ready to buy and use them willingly without that kind of conditionality.

“For instance, when we met with the Russian representatives for their COVID-19 vaccine last year, we did ask if we can run a clinical trial on it in Nigeria. They were not willing to agree. According to them, it has been conducted in one or two African countries and they thought that Nigeria is unlikely to be different. They believed that the efficacy of the data they got (from the other African countries) should be extrapolated to the Nigerian situation.

“Again, if the country decides to grant an emergency use of the vaccine, it will only review the data they have for other populations. But under normal circumstances, countries’ regulatory agencies will request a clinical trial on efficacy and safety of the vaccine,” he said.

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