By Ehichioya Ezomon
eartwarming as government’s revelation of production of two candidate vaccines is, Nigeria, with even availability of the needed funds, cannot conduct clinical trials, much less produce COVID-19 vaccines or any vaccines, in the country.
The “why” isn’t far-fetched: Absence of or inadequate infrastructure and equipment for such ventures. This might be the reason, and not lack of funds, as Health Minister Osagie Ehanire adduced, for halting the clinical trials of the candidate vaccines.
It’s a given that with no capability to conduct clinical trials, the competency to develop and produce vaccines would be lacking, and hinders even the production of vaccines for clinical trials.
South Africa, Nigeria’s African economic competitor, participated in the global clinical trials prior to the rolling out of COVID-19 vaccines in Europe, America, China and Russia in late 2020, with Britain to administer the world’s first jab on December 8, 2020.
Experts as Profs. Oyewale Tomori and Simon Agwale speak about Nigeria’s incapability to carry out the large-scale clinical trials of COVID-19 vaccines. Both fielded questions from media sources, but below are some quotes from The Guardian’s version, prior to Nigeria receiving its first of AstraZeneca vaccines on March 2, 2021.
Prof. Tomori, a consultant virologist, former Vice Chancellor of Redeemer’s University, Ede, Osun State, and Chairman of Expert Review Committee on COVID-19, says Nigeria has “neither the capability nor the facility” to conduct clinical trials, “to ascertain the potency of a vaccine before administering.”
He lists the requirements for clinical trial procedure as “appropriate facilities and capabilities to recruit participants, administer, follow up and monitor the vaccines, and superb coordination and adherence to approved guidelines and protocols,” which “do not exist here.”
Recall that because of its capability, South Africa was able to determine that the AstraZeneca vaccine was ineffective against the local virus variant of COVID-19, known as 501Y.V2, discovered on December 18, 2020, and described as more infectious than the COVID-19 virus identified at the start of the pandemic.
South Africa acquired 1.5 million doses of the AstraZeneca vaccine from the Serum Institute of India, but “results from a small local study with only mild and moderate infections showed that the vaccine was not effective against the 501Y.V2 variant.”
As South Africa has sold the vaccines to 14 African countries through the African Union (AU) vaccines acquisition teams, some experts, including the country’s ministerial advisory committee on vaccines, say the move to reject AstraZeneca vaccine “is in line with South Africa’s evidence-based approach to COVID-19 decisions.”
It’s uncertain if Nigeria is among the “needy African countries” that bought the South African “rejected” doses of AstraZeneca vaccine, but the resale, said to be completed in March, became a matter of reversing the hackneyed axiom, “One man’s meat is another man’s poison,” to “One man’s poison is another man’s meat.”
Nigeria fits into the latter jacket, as it didn’t participate, for reason of incapacity, in the clinical trials of vaccines across the globe. So, for failure to participate in the trials, the country is hamstrung in picking a particular vaccine suitable for its population, and when to expect the doses it acquired or received from donors.
Hence, to Prof. Tomori, Nigeria had… “to wait, watch and monitor the unfolding story of AstraZeneca vaccine, to decide what to do with the expected and unknown arrival date of the 16 million doses” from the COVID-19 Vaccines Global Access (COVAX).
Dr Faisal Shuaib, executive director, National Primary Health Care Development Agency, stated in February 2021 that the AU Commission, via the African Acquisition Task team, had approved 41 million doses of Pfizer, AstraZeneca and Johnson and Johnson COVID-19 vaccines, to be delivered between March and April.
“Furthermore, the COVAX facility has informed us that they will be supplying Nigeria with approximately 16 million doses of the AstraZeneca vaccine this month (February),” Dr Shuaib said.
Prof. Tomori also talks about the timeframe it takes to conduct clinical trials, explaining it depends on protocol, but long enough for antibodies to develop after “completion of dosage protocols.”
Perhaps, due to the exigency of the pandemic, Prof. Tomori said: “You are looking at between one and three months. Ideally and certainly, it should be done prior to vaccination exercise.
“Definitely, NAFDAC (National Agency for Food and Drug Administration and Control) has to be involved but not necessarily carry out the exercise. Research and clinical trial centres in our health institutions are the ones set up to carry out the trials… but again with active involvement of NAFDAC,” he said.
However, Prof. Tomori’s claim that NAFDAC can only “test for safety and not efficacy of food and drugs” is disputed by a consultant pharmacist and Medical Director of Merit Healthcare, Dr. Lolu Ojo.
He says every new product in Nigeria goes through “the rigours of clinical trials,” and stresses that NAFDAC “has an established process for conducting clinical trials to ensure that they are fit for purpose, safe and efficacious.”
Dr Ojo states that NAFDAC would take COVID-19 vaccines through the efficacy and safety testing, “even if it had to be accelerated procedures,” as the clinical trial on the vaccines in Nigeria “belongs to the phase 4 variant… that does not take much time because there is enough documentation to guarantee FDA approval.”
“It (clinical trials) may or may not be prior to the arrival of the vaccines,” Dr Ojo said. “If it were to be a commercial engagement, the samples will come first, which will be used for clinical trials before NAFDAC will grant registration approval.
“But in this particular case, the trial and deployment can go on simultaneously. It is an emergency situation and Nigeria will not be alone in rapid adoption of vaccines for human use,” he added.
Still, Prof. Agwale confirms that Nigeria lacks the wherewithal to conduct clinical trials, and urges the government to “invest in strengthening clinical trial capacities, focusing on the available two research institutes and selected universities.”
Dr Agwale, a virologist and vaccinologist, who’s Chair of Africa COVID-19 Vaccine Manufacturing Initiative and Chief Executive Officer of Innovative Biotech USA and Nigeria, suggests a head-start for Nigeria on the road to developing vaccine capability.
He wants Nigeria’s participation in all phases of clinical trials of new COVID-19 vaccines,” and to conduct a placebo-controlled phases I/II of existing COVID-19 vaccines “to assess safety, immunogenicity and efficacy before introducing them in the country.”
Dr Agwale salutes South Africa’s smartness “to have subjected COVID-19 vaccines to clinical trials and noticed the efficacy wasn’t that strong and thereby, halting the rollout,” noting that the trials helped South Africa’s vaccines rollout “evidence-based” that would rub-off on Nigeria and other African countries.
LAST LINE: Next on the serial: Dr Simon Agwale on “Why Nigeria, Africa’s largest economy, “cannot develop and produce COVID-19 vaccines, and any other vaccines,” and the solutions to the embarrassing situation for a country of 208 million inhabitants.
* Mr. Ezomon, Journalist and Media Consultant, writes from Lagos, Nigeria.