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Nigeria’s quest for local vaccines suffers setback

By Chukwuma Muanya
19 July 2018   |   4:24 am
Nigeria’s quest to get its first set of locally manufactured vaccines has suffered a setback. The country was expected to roll out its first locally produced vaccines in July 2019, beginning with the drugs against Yellow fever, Tetanus Toxoid and Hepatitis B.

Nigeria’s Minister of Health Isaac Folorunso Adewole . REUTERS/Afolabi Sotunde – RTX231AG

• FG pledges to meet December 2018 target for refurbishing 10,000 PHC centres nationwide
Nigeria’s quest to get its first set of locally manufactured vaccines has suffered a setback. The country was expected to roll out its first locally produced vaccines in July 2019, beginning with the drugs against Yellow fever, Tetanus Toxoid and Hepatitis B.

But The Guardian investigation revealed that the firm floated to achieve this target, Biovaccines Nigeria Limited, has not began building the state-of-the-art pharmaceutical manufacturing facility needed for the vaccines.

Also, the factory, when completed, would have to be prequalified by the World Health Organisation (WHO) before it starts producing vaccines.What a paradox. Nigeria was not only producing vaccines such as smallpox, yellow fever, and anti-rabies vaccines, between 1940 and 1991, but also exported to Cameroon, Central African Republic and a few other countries.

However, in 1991 the Federal Vaccine Production Laboratory (FVPL) in Yaba, Lagos, stopped production ostensibly because the government wanted to reactivate and upgrade the facility, which did not take place until today.Also, Nigeria spends over N7 billion annually importing vaccines into the country, with about 80 percent cost of vaccines being subsided by Global vaccine innitiative (GAVI).

The Global body had informed the Federal Government of Nigeria (FGN) that it will be stopping this subsidy by 2022.However, The Guardian also reliably gathered that Nigeria has been granted a 10-year extension of vaccines’ facility by GAVI at a very subsidized rate with a credit facility of $1.9 billion. It is feared that this new development would not allow the products from Biovaccines to compete with that from GAVI.

The Guardian investigation also revealed that the company has relegated plans to start with Yellow fever vaccines but with more pressing vaccines needed in the National Immunisation Programme such as: Pentavalent vaccine; the recombinant hepatitis B vaccine; Tetanus with Diphtheria vaccine; Inactivate Polio Vaccine (IPV); the Pneumococcal Conjugate Vaccine (PCV); Human Papilloma Virus Vaccine (HPV) for cervical cancer; and Meningococcal vaccine.

Meanwhile, May and Baker Plc, an indigenous pharmaceutical industry had in June 2017 signed a Memorandum of Understanding (MoU) with the Federal Government, which was vetted by the Federal Executive Council (FEC) to immediately begin local production of vaccines.According to the MoU, the project, which is being handled through Biovaccines, will build local capacity in vaccine production as well as develop a centre of excellence for research and development of vaccine technology and other biologics.It was also gathered that the company would need to invest $50 million (N18.5 billion) to resuscitate a manufacturing line at the defunct NVPL in Yaba, Lagos, which it acquired.

The project when completed is expected to help Nigeria to better respond to emergencies like the recent epidemic of Cerebro Spinal Meningitis (CSM) C that ravaged about 27 states of the federation in 2017, generate increased internal revenue and increase the Gross Domestic Product (GDP) of the country.

Minister of Health, Prof. Isaac Adewole, told The Guardian on Tuesday that the plan is on and the country is not under any stress. “We expect that within two years we will have our first set of local vaccines. We have been granted a 10 year extension till 2028 by GAVI. We want to build capacity to produced vaccines with Biovaccines company. We are getting the vaccines at a discount. For Biovaccines, we want to concentrate on the vaccines that are not covered so that when the GAVI project ends in 10 years we would have been self sufficient and ready to meet our vaccine needs,” he said.

Adewole also reassured that plans by the Federal Government to refurbish 10,000 Primary Health Care (PHC) centres nationwide is on course and will be completed by December 2018. The Minister said: “We have done over 3,000 PHC centres spread across the country. We plan to meet the targeted 10,000 PHC centres with the Basic Health Care Provision Fund (BHCPF) of N55.1 billion appropriated in the 2018 budget. We also have $20 million credit facility and $3 million from Bill and Melinda Gates to achieve this.”

Meanwhile, the Biovaccines Project Coordinator, Everest Okeakpu, told The Guardian: “The plan to locally produce vaccines suffered set back because of GAVI’s 10-year plan for vaccines which are subsidized. We are looking at details of those numbers. The Yaba facility has been given a facelift as a pharmaceutical facility where you can conduct pharmaceutical transactions.

“Vaccines manufacturing is a big business. A lot is happening. Nigeria had the capacity to produce Yellow fever vaccine using egg-based technology. What that means is that you can only manufacture it in one facility. People are moving up with higher technology. There is no need working with what will be lost with time. Also, from the business perspective, it is not exactly profitable, there are more pressing vaccines needed to make the National Immunisation programme more sustainable.”

Okeakpu, however, said Biovaccines have made some progress. “Already we have issued Request For Proposal (RFP). One for would be partner for technology acquisition. We have selected a partner. The second RFP is for building the factory for contemporary manufacturing facility in Ota, Ogun State.”

When will Nigeria produce its first set of vaccines? “We are looking at the next three years and then getting WHO prequalification. We have to begin a stop-gap. We have to select a new set of people and train them gradually. This means we can only have our vaccines by 2022/2023.”

Managing Director and Chief Executive Officer of May & Baker, Mr. Nnamdi Nathan Okafor, told The Guardian that the Biovaccines company has started and the Board has met twice, and is set to meet again on Thursday next week. Okafor said the Business plan for Biovaccines has been approved but the new development from GAVI has affected the situation. “GAVI’s new guideline has distorted our plans. We have to tweak the plan. There are two things- we have to do the construction of the factory as well as running the company. We are trying to get a Chief Executive Officer (CEO). We have interview for that yesterday but the Board will meet next week to take a decision.”

Okafor, said to ensure the rapid production of the vaccine, the Biovac Institute South Africa and Biovaccine Nigeria have agreed to collaborate to build capacity for vaccines and biologicals in Africa, and to hold hands through mutual exchanges in technology, processes and expertise.However, the Board of Biovaccines Nigeria Limited (BVNL) has said strategies have been put in place to ensure vaccines are produced within the quickest timeframe.

The board said it is also working, not only to meet the stipulated time fame, but to also ensure it produces vaccines of highest quality in a sustainable manner, which will be of no harm to Nigerians.Chairman, Biovaccine Board, Prof. Oyewale Tomori, had told journalists at a press conference following the board’s second meeting in Lagos that the board has reviewed and approved business plans needed for the company to begin it activities, adding that the vaccine production requires highly technical and complex technology, which needs time to perfect.

He said, though, the required time for implementation of the vaccine production in the market would take a long period of time, expatriate and relevant government agencies have been engaged to shorten the process without making quality compromise.Tomori said the board is mindful of the fact that many Nigerians and stakeholders in the health sector are in a hurry to see the country produce her own vaccines to ameliorate the huge burden posed by diseases, particularly on children and mothers, noting that board is putting strategies in place to deliver their expectations.“We shall take calculated steps to ensure we get everything right. We are already addressing the challenges from all angles so we don’t fall to where the old vaccine production company fell. We won’t follow the old system, we want to provide quality vaccines that will cause no harm to Nigerians,” he said.

Tomori said in order to ensure quality production for the first time, the team is working with foreign technical team, comprising of international expert vaccines and biologicals technology to develop and implement a robust business plan.The Virologist noted that the team has undertaken a robust feasibility studies, as it evaluated all strategic options and recommendations that underpinned their strategic direction.

On the delay in production, the Director, Food and Drug Services, Federal Ministry of Health, Moshood Lawal, said it is to ensure the proper production without any for of compromise, adding that the project is a national project, which would be implemented in due time.Okafor said though, sustainability and governance remains the major challenges in Nigeria, the company in a Public Private Partnership with the government will drive implementation of the vaccines production forward, with a view to providing sound health of the nation.