It made the clarification following reports that about 20 countries had ordered billions of the controversial Russian vaccine, which were approved by the Russian authority.
Also yesterday, the Nigerian Medical Association (NMA) and other medical experts commended Russia and her scientists for approving their COVID-19 vaccine.
Russian President Vladimir Putin announced approval of the coronavirus vaccine, Sputnik V, for use on Tuesday, claiming it was “world’s first,” amid continued concern and unanswered questions over its safety and effectiveness.
Developed by Moscow-based Gamaleya Institute, the vaccine has yet to go through the crucial Phase 3 trials needed before approval.
Reacting to the question on whether Nigeria had ordered for the vaccine, the Executive Director (ED)/Chief Executive Officer (CEO) of the National Primary Health Care Development Agency (NPHCDA), who is also, a public health specialist and epidemiologist, Dr. Faisal Shuaib, told The Guardian: “No! Nigeria has not ordered any vaccines from Russia. Nigeria is working with the World Health Organisation (WHO), Global Alliance for Vaccines (GAVI), Coalition of Epidemic Preparedness and Innovations (CEPI) and many critical stakeholders to access vaccines that have gone through the required clinical trials and approval processes. So in the end, whatever vaccines come to Nigeria, they would be of globally-acceptable standards.”
NMA President, Prof. Innocent Ujah, told The Guardian: “We need to congratulate Russia and her scientists for this feat. It is excellent! This is a clear advancement in science in response to the global health pandemic, even if it is not as perfect.”
Asked if he would recommend the vaccine for use in Nigeria considering reports that the clinical trial was not conclusive, Ujah, who is a former Director General of the Nigerian Institute for Medical Research (NIMR) Yaba, Lagos, and Vice Chancellor of the Federal University of Health Sciences, Otukpo, Benue State, said: “First, I will not subscribe to the notion that the trial was rushed. We are not in the know when the whole process started and it will, therefore, be purely presumptuous. However, in this global health emergency, any safe and effective options could be accepted. I suggest that before it can be used in Nigeria, it should be subjected to further studies and evaluation on the behaviour of the vaccine on Nigerians. It is only after the evaluation, that it can be licensed by the National Agency for Food and Drug Administration and Control (NAFDAC) for use in Nigeria.”
He said safety concerns should inspire extended study in other parts of the world to determine its reproducibility and safety.
A pharmaceutical chemist and Project Lead of Bloom Public Health, Prof. Chimezie Anyakora, told The Guardian the Russian COVID-19 vaccine came from a government-owned laboratory that also produced fantastic Ebola vaccine.
Anyakora, who was the Chief of Party, Promoting the Quality of Medicines Programme (PQM) of the United States Pharmacopeia Convention (USP) in Nigeria, however, said: “A breakthrough in COVID-19 vaccine will be a big victory for the world. However, the extraordinary pace with which the Russian vaccine was approved for use by the Russian government is a cause for concern.
“I won’t recommend the vaccine to Nigeria as it was fast-tracked and also because Russia has not shared or released safety and immunity data concerning the development and studies around this vaccine. This notwithstanding, it shows that there is hope in the near future that COVID-19 vaccine will be available to Nigerians.”
HOWEVER, a virologist and vaccinologist and Chief Executive Officer (CEO) of Innovative Biotech, Keffi, Nasarawa State and Innovative Biotech, United States of America (USA), Dr. Simon Agwale, told The Guardian that the approach by Russia could cause harm in several ways such as negative impact on health, creating a false sense of security and undermining trust in vaccinations.
Agwale said: “Vaccine development is a process and it usually takes an average of 10 years to develop and license a vaccine. However, this process has been shortened to just about 12 months without compromise to the scientific integrity of the process due to multiple factors, including but not limited to advance purchase commitments by governments, utilisation of well-tested vaccine platforms, political will, impact of the virus on global economies etc. There are about three candidate vaccines that have entered the last phase of clinical trials (Phase III), which will require enrollment of thousands of volunteers for a minimm period of about six months before we will know whether the vaccines are safe and efficacious.
“The Russian vaccine fell short of this process because only about 76 volunteers participated in the early stage of the clinical trials. The vaccine should undergo the last phase (Phase III) before licensing and there is no record that this was done. The World Health Organisation said all vaccine candidates should go through full stages of testing before being rolled out, but what Russia is doing is deploying the vaccine before we know whether it works or not. There is a clear difference between a large vaccine trial, with careful and frequent follow-up of all vaccinated individuals, and rolling out of a vaccine to the general public.”
CHAIRMAN, Pharmaceutical Manufacturers Group of the Manufacturers Association of Nigeria (PMG-MAN), Dr. Fidelis Ayebae, told The Guardian: “Russia just wants to be seen as the first to market and actually short-circuited a typical development process and phases. Unfortunately the information around the Russian vaccine is opaque and insufficient.
“Secondly I will not use or recommend it for usage for now until after wide usage by Russians themselves. The medium-term results of this ‘herd clinical use’ will be helpful for health authorities in Nigeria to gather more evidence of its efficacy and safety.
“Lastly the aforementioned throws up a lot of safe questions. These must be answered before the authorities in Nigeria should permit usage. We should not be joined in the global politics surrounding COVID-19 but be led by validated science.”
A public health physician and Director General and Chief Executive Officer (CEO) of the Delta State Contributory Health Commission (DSCHC), Dr. Ben Nkechika, told The Guardian it was a welcome development that there was great effort toward finding solution to contain the virus but the effort must follow all medical ethics, safety and regulatory compliance protocols, which he said, the Russian COVID-19 vaccine did not seem to follow.
“Obviously not recommended for use in Nigeria. Clinical efficacy and safety trials have not been done within the Nigeria population.
“There are obvious consequences of deploying a vaccine that has not met standardised protocols for wide spread vaccination. Most important danger is failure to generate a proper antibody response to the vaccine that could create new problems instead of a solution.”
Another public health physician and Executive Director of Enugu State Agency for the Control of AIDS (ENSACA), Dr. Chinedu Idoko, told The Guardian: “The breakthrough is of course a good step in the right direction. It is a welcome development. The vaccine probably has gone through a number of technical protocols culminating to this point of its announcement. I believe it would have reached a certain limit/ level of safety to be declared publicly. I believe going forward as the vaccine is being applied on a wider scale the necessary trials would continue in the process. Sometimes, uncertain times/ situations call for uncommon approaches.
“The Nigerian regulatory authorities and health establishments would of course apply their independent assessment to authentication before widespread application to the public so I think it won’t be a bad idea for Nigeria to tap into this.”
MEANWHILE, the Federal Executive Council (FEC) presided over by President Muhammadu Buhari on Wednesday approved N8.49 billion to facilitate procurement of 12 items in various quantities to aid officials of the Nigeria Centre for Disease Control (NCDC) in conducting COVID-19 test in the country’s 774 local government councils.
The memo was presented by the Minister of Health, Osagie Ehanire, on behalf of the center at the Council chambers of the Presidential Villa, Abuja.
Briefing State House correspondents after the meeting, Ehanire said the procurement was to guard against against community transmission of the disease which has already affected over 586 local government.
The minister explained that the items were needed to expand testing and diagnostic capabilities.
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