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NAFDAC approves COVID-19 vaccine use without clinical trial

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.

Speaking at the weekend, NAFDAC’s Media Consultant, Sayo Akintola, stated 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.”

Relatedly, the National President, Nigerian Medical Association (NMA), Prof Innocent Ujah, on Friday made a U-turn on the need for clinical trial.

He said since Nigeria is in an emergency situation, the COVID-19 vaccine will no longer need to pass through clinical trial.

Ujah, who had earlier said the COVID-19 vaccine should be subjected to a clinical trial before being administered on Nigerians, said in a telephone interview with one of our correspondents, that the efficacy of the vaccine had been established by scientific process.

He explained that since Nigeria and Africa as a whole were not involved in the clinical trial, “it is good to revalidate so that we can also report some likely untoward effects – side effects.”

He said, “When we have that, we can tell our people that it (the vaccine) cannot kill our people but we can tell the people the likely reactions some people may likely get. That is revalidation. It is not that we are to go through barrage of clinical trials because to do clinical trial particularly in an emergency situation will take some time.”

Ujah, who is also the Vice Chancellor of Federal University of Health Sciences, Otukpo, Benue State, said even though there was yet to be any vaccine for HIV all along, scientists got vaccine for COVID-19 within nine months and was approved by the Food and Drug Administration in the United States because it required an “emergency authorisation.”

Also, a consultant virologist at the University of Ibadan, Oyo State, Prof Olufemi Olaleye, stated that he did not see the need for another clinical trial of the vaccines.

He explained that there may be little difference in response of people to vaccines/antigens, adding that vaccines were supposed to be universal.

He added, “There is no vaccine for Africans that is different from the one for Caucasians or Chinese or any other race for that matter. Even within the same race, people respond to antigens or vaccines differently. I will be surprised if anyone is calling for clinical trial during a threatening pandemic like COVID-19. It is not when a house is on fire that you want to start testing your fire truck.”

The virologist disclosed that clinical trial was a long process, hence the reason for emergency use authorisation in the United States, United Kingdom and the European Union countries.

He also stated that he was unaware of any institution with trained personnel and facilities for a proper clinical trial in Nigeria currently.

“I think what the Minister of Health requires is full information on the vaccines under considerations such as safety, immunogenicity and the logistics of handling to make an informed decision on which brand to procure. Be that as it may, an important question to ask based on the pattern of the disease in Nigeria thus far is whether we require vaccine now or not?” he said.

He, therefore, recommended that the country should seek ways to ensure adherence to the non-pharmaceutical intervention approaches to more prevention and monitor outcomes of the ongoing vaccination in other countries as may be required.

A renowned Professor of virology and former Vice-Chancellor, Redeemer’s University Nigeria, Oyewale Tomori, said the country does not have a site for vaccine clinical trial.

He said, “To the best of my knowledge, I don’t think we have any. What we usually do is to insist that any product, drug or vaccines should obtain WHO approval for full and emergency use as well as NAFDAC authorisation before it is approved for human use in Nigeria.

“I’m not aware of any vaccine that was subjected to local clinical trials after WHO approval and NAFDAC authorisation.”

He explained that what was usually carried out after inoculation with such approved vaccines was to conduct pharmacovigilance and meticulously monitor any adverse events among recipients.

He added, “I’m sure NAFDAC has plans for such studies. The Pfizer/BioNTech Covid-19 vaccine received emergency use validation from the WHO. I assume our NAFDAC will call for and review all the documentation submitted for the WHO approval.

“Again, I do not think it is feasible to do a local Nigerian clinical trial for a vaccine that has received WHO validation. We currently do not have the resources to conduct clinical trials for vaccines.”

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.

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.

The Director, Centre for Human and Zoonotic Virology at the College of Medicine, University of Lagos, Prof Sunday Omilabu, stressed the need for the Federal Government to ensure that the vaccines are safe for Nigerians before administering it on them.

In an interview with one of our correspondents on Saturday, Omilabu warned the Federal Government against rushing to administer the vaccines on Nigerians.

He said, “There are stages vaccines are taken through, which is called vaccine development. It doesn’t come to animals yet until it has been proven that the vaccine is safe for closely-related animals. However, the result of clinical trial will not come out very early; it is not something we can rush into.

“There is a need for proof that the vaccine will be safe. The so-called emergency vaccine is never heard of, save for these ones we see them taking in Europe and America. Of course they have their reasons for that, they have been seriously hit by the virus.

“They have reasons to look for anything that will stop it. But I’m not sure what they are doing now will do the magic. In our own case, the infectivity of the virus is not that much among Africans.

“The vaccine is dangerous now because we don’t know how it is going to behave in the long run. We can see a number of reactions from among those that have taken it. Those are the dangers of rushing into vaccines.”

The World Health Organisation announced on Friday that it had approved the Pfizer/BioNTech vaccine for emergency use, paving the way for lower and middle-income countries to begin immunising their population against COVID-19.

The vaccine was first approved in the United Kingdom on December 8, 2020 for emergency use in the country, with the United States, Canada and the European Union taking same decision afterwards. All have begun their own vaccination drive.

The WHO approval implies that countries without their own regulatory bodies, or the means to rigorously assess the efficacy and safety of vaccines, can now expedite their own approval processes and begin rolling out vaccination programmes.

According to the WHO Assistant-Director General for Access to Medicines and Health Products, Dr Mariângela Simão, the Emergency Use Listing has opened the door for countries to expedite their own regulatory approval processes to import and administer the vaccine.

He added, “This is a very positive step towards ensuring global access to COVID-19 vaccines. But I want to emphasise the need for an even greater global effort to achieve enough vaccine supply to meet the needs of priority populations everywhere.

“WHO and our partners are working night and day to evaluate other vaccines that have reached safety and efficacy standards. We encourage even more developers to come forward for review and assessment. It’s vitally important that we secure the critical supply needed to serve all countries around the world and stem the pandemic.” – Punch.

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