Saturday, May 15, 2021

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Why Nigeria can’t make COVID-19 vaccines now

Many, including the Nigeria Governors’ Forum (NGF) leadership, wished that Nigeria could start manufacturing vaccines and stop relying entirely on imports.

During his last visit to the Presidency, where he vowed that the COVID-19 vaccine would be publicly administered by the governors once it arrived, the Ekiti State Governor, Kayode Fayemi, dismissed the concept of waiting to be served by other countries and wondered why it took the country a long time to perfect vaccine production processes.

However, medical experts have clarified why the country will now not produce vaccines. The situation, in fact, seems to raise more questions than answers, even though everyone is eagerly waiting for arrival of first 100,000 doses of Pfizer’s COVID-19 vaccines.

To encourage local development, what about the recorded partnership Nigeria has with May & Baker? How close is the nation to the achievement of this feat?

Dr. Fidelis Ayebae, Chairman of the Pharmaceutical Manufacturers Group of Manufacturers Association of Nigeria (PMG-MAN), did not mince words when he was engaged on the subject, 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.”

Dr. Everest Okeakpu, managing director of Biovaccines, a company set up to kick-start local vaccine development, acknowledged that it takes a lot of time to produce vaccines. He said: “In contrast to typical small molecule pharmaceuticals, vaccines are complex and challenging to produce.” It is, as such, a painstaking endeavor that takes accuracy and time. The final product could be altered by a subtle shift in the manufacturing process, potentially affecting yield, purity, protection and efficacy.

He is confident that Dr. Osagie Ehanire, Minister of Health, and his team at the Federal Ministry of Health are giving priority to issues related to the development of local vaccines 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 partnership with May & Baker by the Federal Government, which gave rise to the Biovaccines Nigeria Limited (BVNL) Joint Venture (JV) Company, was making tremendous progress.

Okeakpu said the partnership with May & Baker by the Federal Government, which gave rise to the Biovaccines Nigeria Limited (BVNL) Joint Venture (JV) Company, was making tremendous progress.

Okeakpu said, “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.

However, Prof. Oyewale Tomori, Chairman of the Board of Biovaccines, gave a middle-of-the-road description of where the country is developing local COVID-19 vaccines. Via concerted action between the Federal Ministry of Health, the National Agency for Food and Drug Administration and Control (NAFDAC), the National Primary Health Care Development Agency (NPHCDA), the leadership of the National Assembly, the Nigeria Governors’ Forum (NGF) and the Vice President’s Office (VP), efforts are being quickly monitored to get Nigeria involved in future production of not only COVIDD.

“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.”

Olumide Akintayo, a consultant pharmacist and former president of the Nigerian Pharmaceutical Association (PSN), said that the relationship between M&B and FG had little to no effect on the supply of stable vaccines by Pfizer and any other multinational pharmaceutical firm.

“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.”

Dr. Simeon Agwale, African Vaccine Initiative virologist, vaccinilogist and chairman, “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.”

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