Nigerian scientists say that immunising Nigerians with COVID-19 vaccine when clinical trials have not been done in the country is very risky and should be reconsidered.
They also expressed worries over its likely long-term effects.
Nigeria expects its batch of vaccines by first quarter of 2021, with the Director-General of the National Centre for Disease Control, Dr. Chikwe Ihekweazu, saying that 20 percent of the population would have access to the vaccine.
Speaking on the issue, a virologist at the Lagos University Teaching Hospital, Prof. Sunday Omilabu; and a Pharmaceutical Research Scientist with the National Institute for Pharmaceutical Research and Development, Abuja, Prof. Martin Emeje, are of the view that immunising Nigerians with COVID-19 vaccine when clinical trials were not done in the country is very risky and should be reconsidered.
According to the World Health Organisation, while three COVID-19 vaccines have received ‘emergency use approval’ of some national regulatory authorities, none of them has received the pre-qualification by the World Health Organisation.
The WHO, however, disclosed that an assessment of the Pfizer-BioNTech vaccine is expected by the end of December, adding that assessment of other vaccine candidates will follow thereafter.
Online journal, Nature, reports that the fastest any vaccine had previously been developed, from viral sampling to approval, was four years, and that was for mumps in the 1960s.
Nature, in its article, The lightning-fast quest for COVID vaccines — and what it means for other diseases, noted that Pfizer and BioNTech got their vaccines approved less than eight months after the trial started, noting that the rapid turnaround was achieved by overlapping trials and because they did not encounter safety concerns.
The quest for COVID-19 vaccine, which started in early 2020 has, therefore, resulted in vaccines being used for immunisation by December – a period of less than a year.
Recall that vaccine developer, Pfizer-BioNTech and Moderna applied for emergency use approvals for their vaccines in the United States and from the European Union drug regulator after some positive results from their clinical trials.
While the United States Food and Drug Administration has already granted emergency use approval for COVID-19 vaccines from Pfizer-BioNTech and Moderna, the European Medicines Agency has also approved COVID-19 vaccine developed by Pfizer-BioNTech.
Speaking with PUNCH HealthWise, Prof. Omilabu said Nigeria should exercise caution before accepting to immunise citizens with vaccines that were granted emergency use approval in Europe and the United States.
Omilabu, who is also the director, Centre for Human and Zoonotic Virology at the College of Medicine, University of Lagos, said it might be very risky to start immunising Nigerians and Africans with the COVID-19 vaccines as they have not gone through the regular scientific process before the emergency approval.
He said, “Immunising Nigerians with the vaccine is a serious risk. The reason is that it is a new vaccine and we don’t know how it would react in patients, especially in the long term.
“The minimum period it normally takes to develop a vaccine and ensure it is safe is 10 years. The test starts in animals and the process is followed until science can ascertain it is safe.
“Europe and America are granting emergency approval because they urgently needed something to curb the situation they are in as regards COVID-19. Their people do not seem to have the natural immunity that is making the infection mild in us here.
“As for Africans, we have to be cautious because our situation is different,” he said.
The virologist warned that the COVID-19 vaccine might impact negatively on the natural immunity of Nigerians and Africans to the viral disease.
“We need to look into this vaccine critically and not jeopardise our natural immunity.
“We don’t know what impact the vaccine will have on our natural immunity that has so far prevented us from being in the situation they are in Europe and America.
“There is something in our body that is preventing COVID-19 from having the kind of effects it is having in Europe and America.
“We have lots of COVID-19 cases in circulation, but something is preventing the disease from having a devastating effect.
“If we derail that balance with the vaccine, it may spell doom for us. My take is that we should be managing our situation as we have done so far.
“We should continue to adhere to the preventive measures by using face masks, avoiding crowd and washing hands regularly.
“We should also encourage preventive measures, especially for the vulnerable group and not jump on the vaccine,” Omilabu said.
Also speaking with our correspondent, Prof. Emeje, a molecular pharmaceutical researcher and immediate past national chairman of the Nigerian Association of Pharmacists in
Academia, said not doing a clinical trial in Nigeria with the COVID-19 vaccines is a big minus.
When asked if the vaccine would be effective in Nigerians as clinical trials published so far has indicated, Emeje said, “Who told us these vaccines we are running to beg for will be efficacious in Nigerians? Was Nigeria a centre for the clinical trials?”
Continuing, he said, “In Africa, only South Africa was reported to have participated in the clinical trial.
“I don’t know why Nigeria wants to go and import these vaccines; maybe we want to start a clinical trial of that vaccine here. I don’t know why we are like this.”
Emeje reiterated that it is potentially dangerous to immunise Nigerians with the vaccines without local clinical trials, stressing that it is difficult to predict its likely long-term health effects and side effects.
He said, “All vaccines are drugs, even though not all drugs are vaccines.
“It is absolutely unwise and potentially dangerous to mass immunise a huge population of people of a particular race like Nigeria without carrying out clinical trials.
“The danger in that is that, since the vaccination will not be done under a controlled system like clinical trials, any adverse events may not be under control.”
Emeje also pointed out that it should be noted that COVID-19 may not be affecting Nigerians the way it was affecting American and most Europeans used for the clinical trials.
“Is COVID-19 affecting us exactly the way it is affecting other people in other parts of the world?
So, who told us that the vaccine will be efficacious in our people the same way it is with the people over there?
“Even South Africa cannot in all sincerity be taken to represent the African population. Why was the trial not conducted in Nigeria.”
Prof. Emeje insisted that before any company can sell drugs in Nigeria, it ought to apply to the National Health Research Ethics Committee of Nigeria, Federal Ministry of Health and the National Agency for FOOD and Drug Administration and Control for approvals to conduct clinical trials, noting that jumping this important process is dangerous.
“Even chloroquine and hydroxychloroquine, which have been used extensively in Nigeria, is still undergoing clinical trials for use in COVID-19 in Nigeria, how much more a new vaccine. We had better be careful,” he said.
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