At his last visit to the Presidency, where he pledged that governors would be publicly administered the COVID-19 vaccine whenever it arrived, the Ekiti State Governor, Kayode Fayemi, rued the idea of waiting to be served by other countries and wondered why it was taking the country long to perfect processes regarding vaccine production.
Medical experts have, however, explained why the country cannot manufacture vaccines now. In fact, the situation seems to pose more questions than answers even as everyone waits eagerly for arrival of first 100,000 doses of Pfizer’s COVID-19 vaccines.
What about the reported partnership Nigeria has with May & Baker, to facilitate local production? How close is the country to achieving this feat?
Chairman, Pharmaceutical Manufacturers Group of Manufacturers Association of Nigeria (PMG-MAN), Dr. Fidelis Ayebae, did not mince words when The Guardian engaged him on the matter. He said: “Overall, we are very far from vaccine production because we have not yet made the investment needed as a country. Firstly, the facility is not available. Secondly, the partnerships with those with the technology are yet to be cultivated. Thirdly, our in-licensing/patent laws need to be worked on such that Nigeria, in collaboration with owners of a patent, can roll out products under licence when there are national emergencies. Still a lot to accomplish in this direction but no one is working on it because of inconsistency in our policy implementation. No one will invest in something which gestation will be short-lived because someone in government made tragic pronouncements without consulting with the organised private sector as they often do.”
Managing Director of Biovaccines, a company set up to kick-start local vaccines production, Dr. Everest Okeakpu, admitted that making vaccines requires a lot of effort. He said: “Vaccines, unlike the typical small molecule pharmaceuticals are complex and challenging to manufacture. As such, it is a painstaking effort that requires precision and time. A subtle change in the production process may alter the final product, possibly affecting yield, purity, safety and efficacy.”
He is optimistic that the Minister of Health, Dr. Osagie Ehanire, and his team at the Federal Ministry of Health are prioritising issues related to local vaccines manufacturing, to ensure that Nigeria not only succeeds with this venture but do so as fast as possible.
He said: “With regards to the COVID-19 vaccine, BVNL is contemplating importing modular facilities to shorten the time to be ready for locally filling and finishing of the vaccine.
“Yes, we are all excited about the news of Nigeria receiving the first batch of 100,000 doses of Pfizer-BioNTech COVID-19 vaccines, AKA BNT162b2 or Tozinameran (International Non-proprietary Name – INN). However, as you’re aware Nigeria will need much more. Apart from the Pfizer-BioNTech, other companies with ready or almost ready COVID-19 vaccine include Moderna-National Institute of Health; University of Oxford-AstraZeneca; Johnson & Johnson (Janssen); Novavax; CanSino Biologics; Institute Gamaleya; SinoPharm and Sinovac Biotech.”
Okeakpu said the Federal Government’s partnership with May & Baker, which gave rise to the Joint Venture (JV) Company, Biovaccines Nigeria Limited (BVNL), was making tremendous progress.
“We are on track for a groundbreaking ceremony to begin the construction of the vaccine manufacturing facility by Q1, having advanced discussions with our technology transfer partners. This has largely been made possible by the support we have been enjoying from the Federal Government,” Okeakpu said.
Chairman of Biovaccines Board, Prof. Oyewale Tomori, however, gave a middle-of the-road explanation of where the country is on local COVID-19 vaccines production. According to him: “Efforts are being fast-tracked with concerted action among the Federal Ministry of Health, National Agency for Food and Drug Administration and Control (NAFDAC), National Primary Health Care Development Agency (NPHCDA), National Assembly leadership, the Nigeria Governors’ Forum (NGF) and office of Vice President (VP) to get Nigeria involved in future production of not only COVID-1919 vaccine but others.
“I cannot give you more as these are preliminary discussions. We know what is needed and until we all agree on the what, the how and the when, I cannot provide more. Very soon we will gave concrete details. I believe by March when the Board meets, we will talk with more confidence and, maybe, hold a joint press conference with all stakeholders.”
A consultant pharmacist and former President, Pharmaceutical Association of Nigeria (PSN), Olumide Akintayo, said the partnership between M & B and the FG had little or no bearing with availability of vaccines from the stables of Pfizer and any other multinational pharmaceutical company.
“Typically, it is the company that owns a patent that manufactures a drug product or vaccine. In pandemics or emergencies, there may be exemptions to allow production of generic equivalent of the patent rights before the expiration of the mandatory and exclusive 10-year window for post marketing surveillance.
“This is usually brokered by global bodies like World Health Organisation (WHO).
Except such procedures are approved, it will be a mirage to expect local production of COVID19 vaccines in Nigeria.”
A virologist, vaccinilogist and lead, African Vaccine Initiative, Dr. Simeon Agwale, told The Guardian: “Our company Innovative Biotech LTD Nigeria is working on our COVID-19 vaccine here in the United States (US) in collaboration with two major partners and we hope to do the clinical trials in Nigeria this year if we secure the funding we’re looking for. We are also bringing international vaccine manufacturing to Nigeria, but first starting with the downstream formulation, fill/finish and we hope to have this process completed sometime next year. It’s been a very long journey for us, but it will be done.”