Tomori, NMA, PSN Give Conditions for Local Production of COVID-19 Vaccines

•Virologist insists on release of N10bn fund
•Locally-made vaccines feasible in next 18 months, says PSN

Onyebuchi Ezigbo in Abuja

A professor of Virology, Professor Oyewale Tomori; the Nigerian Medical Association (NMA), and the Pharmaceutical Society of Nigeria (PSN) have given conditions for Nigeria to start the local production of COVID-19 vaccines.
Despite the country’s impressive rating in its response to the pandemic, it appears not to be making progress on the issue of the production of vaccines.

In their separate interviews with THISDAY, Tomori, NMA, and PSN explained the challenges hindering Nigeria’s efforts to manufacture the vaccines locally.

While the PSN said the local production of the vaccines is feasible in the next 18 months, the Director-General of the National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Mojisola Adeyeye, said the agency was working to attain WHO’s Level 3 maturity, which will qualify it to supervise local manufacturers.

She, however, promised that safe and efficacious vaccines would be manufactured in Nigeria in no distant future.
But Tomori, who is the Chairman of the board of the Bio-Vaccine Nigerian Limited, said the country’s efforts to manufacture the vaccines were being hindered by conflicting decisions and pronouncements by government officials.

Tomori told THISDAY that the Executive Arm and the National Assembly appeared not to be on the same page as far as plans for the actualisation of the noble initiative are concerned.
Tomori said that the N10 billion budget approved since 2020 to secure the take-off of the vaccine manufacturing company has not been released.

“The problem is that we have not been serious as a nation regarding the issue of vaccine manufacturing. We have had a budget of N10 billion since last year but nothing has been released. So, when you said that Nigeria is at the forefront of countries bidding for the deal to manufacture COVID-19 vaccines, that is not true; we are not in the forefront, we are on the back burner.

“You can’t compare Nigeria with those countries which are acting, we are mere talkers,” he said.
The virologist lamented that Nigeria is not where it should be on the issue of vaccine production considering the enormous human and material resources the country possesses.
According to Tomori, many of the factors that are delaying the local manufacturing of vaccines in the country are man-made.
“We are reaping the benefits of our lack of seriousness and neglect. That is why we are still talking about vaccine donation; that is why we have not been able to secure a deal to manufacture vaccines locally”, he added.
Tomori argued that country’s inability to focus on long-term goals and work genuinely towards achieving such goals without attaching personal or parochial interests has robbed the country of the opportunity to secure a deal to manufacture COVID-19 vaccines ahead of other African countries.

“The challenges are many and multifaceted. They include inconsistent government policies that make it impossible to set and meet long-term goals and objectives, overriding national interest by personal interests that ensure that Nigeria continues to import vaccines through translucent (semi-transparent) procurement processes.

“Others are time-bomb obstacles placed in the way of doing business where getting approvals becomes difficult and forever obstacles/steeplechase race, dealing with pretenders, who loudly proclaim and carry the banner and flag of accountability and transparency, but gunning to milk the country dry using you as the conduit pipe to drain the national resources into their filthy and leaking pockets”.

Tomori also bemoaned what he described as the government’s prolonged dependence on donations as a major source of acquiring COVID-19 vaccines to tackle the ravaging health emergency.
He said that such dependence has not enabled Nigeria to meet up with COVID-19 vaccine requirements for her teeming population in need of protection from the deadly virus.
“There was a budget of N296 billion set aside since last year for the purchase of COVID-19 vaccine. Since then, how many doses have been bought except for the recent purchase of 177,600 doses of the Johnson and Johnson vaccine from the United States?

Some serious countries had even before the production of the vaccines started paying for it.
“It is not by word of the mouth that I am going to buy the vaccine, the question is did you pay for the vaccine?” he added.
Tomori however said that as individuals who love the country, patriotic Nigerians must never relent in their efforts but continue to fight for the development of the country.

On his part, the President of the NMA and a former Director-General of Nigerian Institute of Medical Research, Prof. Innocent Ujah, said that for the country to manufacture the COVID-19 vaccines locally, the federal government should establish a partnership with a foreign company to facilitate the manufacture of these vaccines locally.

“This requires a partnership between government and the private sector entities to sign Memorandum of Understanding. What they need is to get this MoU done because it is going to be driven by the private sector but the government has to create the enabling environment; they have to make it conducive for the company to start production,” he said.
Ujah, however, said that the country presently lacks such a conducive environment to quicken the establishment of a vaccine manufacturing facility.

For instance, he disclosed that there is no hospital or health facility with the equipment that can conduct clinical trials in the country.
Ujah said that although the National Institute for Medical Research (NIMR) in Lagos has started building hospital wards for clinical trials, the government needs to activate the national centre for research and innovation to drive the process.

According to the NMA president, what was lacking is the right commitment to getting things done.
“I know Nigerians are very resilient and resourceful people; all that is needed is a firm commitment by the government and the private sector and we will achieve results,” he added.
On his part, the President of PSN, Mazi Sam Ohuabunwa told THISDAY that two critical stakeholders in the vaccine manufacturing venture – NAFDAC and private sector firms were still in the process of setting up the needed facilities for the project.

He said: “At the moment, one or two companies are trying to set up plants for the manufacture of vaccines in the country but they are just at the preliminary stages.
“Some of them just got some facility from the Central Bank of Nigeria (CBN) and they are trying to acquire equipment because vaccine manufacturing requires the highest level of GNP compliance.

“Even the regulatory agency, NAFDAC is currently struggling to get qualified to be able to regulate and inspect vaccine manufacturing process. So, while the regulator is trying to get itself ready to be able to regulate, the companies are still in the process of setting up plant”.

Ohuabunwa said that there is presently a high appetite for local manufacturing, adding, however, that getting to the stage of actual manufacturing in the country won’t be possible until at least, the next 18 months.
He, however, said that the delay in actualising the dream was due to a lack of requisite facilities and qualified regulators.

He said: “At the moment, it is important that NAFDAC secures the certification it needs to be able to regulate the vaccine sector because if companies set up their plants first, they may be required to make further adjustments that may condemn the equipment due to poor standards”.
Ohuabunwa said that some international vaccine manufacturing firms have shown interest in licensing vaccine manufacturing in Nigeria so long as the required facilities are ready.

NAFDAC Working to Attain WHO’s Level 3 Maturity, Says Agency

On her part, the Director General of NAFDAC, Adeyeye, who spoke through the Resident Consultant of the agency, Sayo Akintola, said NAFDAC was working to attain WHO’s Level 3 maturity to be able to regulate the local manufacturers.
Adeyeye said Nigeria was assessed in July 2019 with a couple of follow-up assessments in a bid to ensure that the country attains the WHO maturity level 3.

The WHO Global Benchmarking exercise is a regulatory system strengthening effort used to assess the national regulatory systems of medicine regulatory authorities in the world.
Adeyeye said that the assessment would position the country, especially NAFDAC, to be better equipped to regulate the prospective vaccine manufacturers.
According to her, it would also give the local manufacturers the opportunity of being WHO pre-qualified, which means potentials to participate in international bids.

“There has been a global challenge in the supply of COVID 19 vaccines. Countries, where these vaccines are manufactured, are ensuring that their populace gets access to this scarce essential health commodity before they are allowed for exports. This has necessitated the need for Nigeria to sustain efforts in supporting the local capacity for COVID-19 vaccine production. NAFDAC being the national medicine regulatory authority in Nigeria is poised to give the required guidance in terms of capacity building. There have been several stakeholder engagements with prospective applicants in this regard. It is hoped that in no distant future, quality, safe and efficacious vaccines would be manufactured in Nigeria,” she explained.