Why Nigeria cannot meet its vaccine needs

Depends 100 Per Cent On Imported Vaccines, 75 Per Cent On Donor Funds

Today marks the end of the World Immunisation Week. The main goal of the campaign is to raise awareness about the critical importance of full immunisation throughout life, and its role in achieving the 2030 Sustainable Development Goals (SDGs).

Several studies, including the World Health Organisation (WHO), United Nations Children Fund (UNICEF) and Global Vaccine Alliance (GAVI) indicate that immunisation saves millions of lives and is widely recognised as one of the world’s most successful and cost-effective health interventions.

Vaccines have been one of the biggest success stories of modern medicine. WHO estimates that at least 10 million deaths were prevented between 2010 and 2015 due to vaccinations delivered around the world. Many millions more lives were protected from the suffering and disability associated with diseases such as pneumonia, diarrhea, whooping cough, measles, and polio. Successful immunisation programmes also enable national priorities, like education and economic development to take hold.

Such success builds on a long history of research and innovation, with discovery science producing new product breakthroughs and delivery science carving out ways to reach universal vaccine coverage.

However, despite these facts, today, there are still 19.4 million unvaccinated and under-vaccinated children in the world.2017 marks the halfway point in the Global Vaccine Action Plan (GVAP), endorsed by 194 Member States of the World Health Assembly in May 2012, which aims to prevent millions of deaths from vaccine-preventable diseases by 2020, through universal access to immunisation.

The Expanded Programme on Immunisation was born out of success at a time of tremendous optimism about the game-changing potential of vaccines. The Programme was established in 1974 as the world moved closer to smallpox eradication.

Confidence was high, that with international commitment and cooperation, other vaccine-preventable diseases could be conquered. The 1979 certification of smallpox eradication was taken as proof of the power of vaccines to permanently improve the world.

Despite improvements in individual countries and a strong global rate of new vaccine introduction, all of the targets for disease elimination, including measles, rubella, and maternal and neonatal tetanus, are behind schedule.

The ambitious GVAP to reach everyone with vaccines by 2020 started strong, but is falling behind. WHO challenges all health leaders to make immunisation one of the biggest success stories of modern medicine.

Unfortunately, countries like Nigeria depend 100 per cent on imported vaccines and 75 per cent of donor funds to meet its vaccine needs. The Guardian investigation revealed that Nigeria pays only 25 per cent of the cost, the rest of it is sourced from international partners and donors.

The existing Federal Vaccine Production Laboratory (FVPL), Yaba, Lagos, is moribund, while the National Veterinary Research Institute Vom (NVRIV), Plateau State, is barely meeting its mandate to produce vaccines against animal diseases.

The FVPL, Yaba, Lagos, started the production of human vaccines with the introduction of smallpox and yellow fever (YF) vaccines in 1974. When smallpox was declared eradicated in 1980 by the WHO, the production of smallpox vaccine was stopped, but FVPL continued to produce YF vaccines until 1986.

The first batch of YF vaccine employed to control the 1986 yellow fever outbreak in Nigeria was locally produced in Yaba. However, when the epidemic escalated, spreading through many states, the local production of about five million doses annually and the poor thermo-stability of the vaccine, prompted Nigeria to seek assistance, collaboration and funding for increased production from five to 20 million doses.

An international advisory team led by WHO provided guidelines for upgrading the Yaba facility and building a new one to meet the projected annual production of 20 million YF doses.

The Canadian agency IDRC provided funding, while staff of the FVPL were sent to the Oswaldo Cruz Foundation Laboratories in Brazil for training.
But lack of funds and political will scuttled the plans. The operations were shut down in 1991, and since then Nigeria has not produced a single vaccine.

However, the recent outbreak of Cerebro Spinal Meningitis (CSM) serotype C that has killed over 839 persons and affected over 9,646 in 43 Local Government Areas (LGAs) in 23 States of the country, and the scarcity of the needed vaccines, have further exposed Nigeria’s failings.

The country is stranded and at the mercy of the world. It can only procure vaccines through the WHO and UNICEF. At the cost of $50 (N18, 000) per dose, Nigeria needs about N396b to vaccinate 22 million people, aged two years and 29 years with the required CSM serotype C vaccines. But the country does not have the resources or back up from local production. Nigeria even borrows to vaccinate its citizens.

The Guardian investigation revealed that the country in 2014, obtained $120m loan from the World Bank for vaccine importation to take care of the country’s vaccine needs from 2015 till the end of 2016. It was also reliably gathered that Nigeria uses up to 169 million doses of vaccines annually, a figure, which is expected to increase to 210 million doses by 2020.

More worrisome is the report that international donors have reduced funding support for vaccines to Nigeria and will eventually halt funds by 2022.

According to the WHO, vaccine preventable diseases account for 40 percent of all childhood deaths in Nigeria. UNICEF regards the provision of immunisation as a basic child right and a significant cost effective survival intervention.

The Nigerian government, however, recognises this fact and as at 2015 spent approximately N12b to purchase 130 million doses of vaccines for preventable childhood diseases.

Since 2001, GAVI, Bill and Melinda Gates Foundation and other donors have been providing funding support towards vaccines procurement and strengthening of Nigeria’s health systems for effective delivery of immunisation services.

The GAVI funding is for countries whose Gross National Income per capita is below the eligibility benchmark of $1, 580; with the rebasing of its economy in 2014, Nigeria’s economy pushed gross national income from to $2950, surpassing the $1, 580 eligibility threshold for GAVI support. Consequently, the country has begun a five-year accelerated exit transition phase of GAVI funding beginning from this year (2017).

Nigeria’s immunisation funding gap was expected to rise from N1b in 2016 to N40b by 2020, when arrangement with GAVI runs out.According to the National Immunisation Comprehensive Multi-Year Plan (cMYP 2016-2020), GAVI funding shall witness annual progressive decrease from $199m in 2017 to $74m in 2021, while funding from the Federal Government is expected to rise annually and progressively from $123m in 2017 to $279m in 2021.

Experts recommend Sustainable Immunization Financing (SIF) as key to securing immunisation services and good health for the over seven million children that are born yearly in Nigeria.

Experts are worried that the loss of GAVI support has placed Nigeria’s immunisation at a “critical stage, where urgent action is needed to ensure sustainable financing for vaccines, devices, and cold chain infrastructure.”

They, however, advise that as donor partners warm up to halting funding by 2022, Nigeria must look at ways of concretising local vaccine production, which was the country’s mainstay during the yellow fever outbreak in the 80’s.

It is believed if Nigeria succeeds in her quest for local vaccine production, chances are that employment will be created, neighbouring African countries, will now have to buy vaccines from Nigeria and above all there will be vaccine security for all Nigerians.

The Federal Government had in 2005 incorporated Biovaccines Nigeria Limited. The company is owned 51 per cent by May & Baker Nigeria Plc. and 49 per cent by the Federal Government. It is a vaccine production and distribution company.

The company is currently located at two facilities in Yaba, Lagos. The objective of Biovaccines Nigeria Limited is to produce safe and affordable human vaccines for Nigeria and reverse the situation of high mortality from immunisable diseases. It also plans to create a regional centre for vaccine production in West Africa and position Nigeria as a global player in vaccine business.

The project was meant to resuscitated Yaba facilities for renewal of production of yellow fever and measles vaccines, with plans for an ultra modern vaccine plant in Ota, Ogun State, expected to produce the following vaccines: HPV, Diphtheria, Toxoid and Pertussis (DTP) and Tetanus Toxoid (TT).The Guardian investigation revealed that the project has not made any progress because of government bureaucracy and change of leadership.

Also, another company, Innovative Biotech Nigeria Limited, incorporated in 2005, and operating from Nassarawa State, Abuja and the United States of America, promised to produce clinical grade lots of vaccines for testing in human trials as a first contract vaccine manufacturer based in Africa.

To ensure vaccine security and catalyse a broad-based action, the National Primary Health Care Development Agency (NPHCDA) inaugurated the National Immunisation Financing Task Team (NIFT) on March 25, 2015, to coordinate the development of a sustainable vaccine financing strategy and roll out plan. NIFT has developed evidence and conducted various advocacy activities, including the recent legislative engagement that sensitised legislators on the values of vaccines, the need for increased funding, and to prevent cuts on proposed 2017 federal budget on immunization.

Although the rapid reduction in GAVI funding support begins this year, the NIFT said the rollover of excess vaccine stock and existing loans will cushion the impact of the transition on the 2017 budget, as only 21 per cent of need was budgeted for. NIFT, however, said the situation in 2018 would be very different. Without additional loans or carry over vaccines, Nigeria must come up with $141m (N43b) to meet its co-financing obligations. Given the prevalent tight fiscal space and poor macroeconomic indices, the feasibility of raising a single budget line item by four and half times (from $25m to $I41m) is still an open question.

To address this, NIFT Advocacy Subcommittee in conjunction with the John Hopkins International Vaccine Access Centre (IVAC) and other partners, in February 2017, held a one-day workshop to sensitise advocates on the current immunisation financing outlook, develop an advocacy strategy for the development of Sustainable Immunization Financing (SIF) transition plan and also finalise NIFT Advocacy subcommittee harmonized January-June, 2017 work plan.

NIFT recommends an “Immunisation Trust Fund” to bridge the funding gap between funding from the Basic Health Care Provision Fund, built into the National Health Act and traditional appropriation for routine immunisation.The trust fund is to pool funding from private sector, willing Nigerians, captains of industry, any willing donor—at the same time being a rallying point for evidence, advocacy and support for domestically funded immunisation.

NIFT is also seeking policy on local vaccine production through Ministry of Science and Technology. NIFT after a stakeholders’ meeting on LVP, which involved foreign investors, and players in the research industry, adopted two critical actions points for Nigeria. First, stakeholders agreed on the need for a LVP policy document that would act as the driving tool for vaccine production. Second, private sector participants spoke on the need for a ‘bankable business plan’ to enable them navigate the market arena in Nigeria.

The NIFT team included delegates from International Vaccine Access Center (IVAC), Health Reform Foundation of Nigeria (HERFON), Community Health and Research Initiative (CHR), National Biotechnology Development Agency (NABDA), Vaccine Network for Disease Control (VNDC) and the Federal Ministry of Health (FMOH).

Chairman of NIFT, Dr. Ben Anyene told the Minister of Science and Technology, Dr. Ogbonnaya Onu, in Abuja October, last year, that when fully in production, vaccines from Nigeria will cater for seven million children. They could also yield $280m in export.

Former Executive Director, NPHCDA, Dr. Ado Gana Muhammad, told The Guardian last year: “Government plan is still very much on the table. With the coming of this new administration and on the need to be self-sufficient in local vaccine manufacturing, another round of meeting chaired by the Minister of Health (HMH) and attended by the Minister of State for Health (HMSH), Permanent Secretary (PS), NPHCDA and May and Baker (M&B) pharmaceuticals took place in March 2016, in Abuja in order to explore avenues to move this project forward. The FMOH is providing leadership to make it happen.”

On the planned resuscitation of Yellow Fever (YF) vaccine plant in Yaba, Lagos, the NPHCDA boss said: “The Government of Nigeria plan and in line with the global best practices is to resuscitate Yaba YF vaccine plant using a Public-Private Partnership arrangement. Since 2005, a Memorandum of Understanding (MoU) was signed between the FMoH and a local pharmaceutical company, May & Baker that was followed by the signing of a Joint Venture Agreement (JVA) in 2007.

This shows how serious the country is committed to in the production of YF both for our domestic use and subsequently for export.”Also, the former Director General of the National Agency for Food and Drug Administration and Control, NAFDAC, Dr. Paul Orhii, in 2015, said the country was set to begin local production of routine immunization vaccines for tuberculosis, hepatitis B, diphtheria, tetanus and pertussis/whooping cough (DPT), polio, measles and yellow fever.

The CSM outbreak, however, caught government napping and forced a return to the drawing board.To achieve the local content growth, the NMA President, Mike Ogirima, called for an expansion of local vaccines production at NVRI.

Ogirima said that revival of local vaccines production would afford the country opportunity to administer vaccination on its populace as and when due. This, he said, would help reduce the impact of outbreak of any epidemic.

The NMA President said: “Nigeria was able to produce her vaccines in 1947 to fight the small pox epidemics. What has gone wrong with this Yaba vaccines production laboratory since 1991 is embarrassing. We demand immediate resuscitation of local vaccine production (LVP) at Yaba and expansion of the scope of LVP at National Veterinary Research Institute, Vom. Researches as far back as 1975 showed the various epidemics of CSM as to the type of strains involved. It is embarrassing again to note that this epidemic has taken us unawares.”

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