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Advancing Regional Vaccine Manufacturing and Access in Africa



Nigeria’s population is estimated to be around 225.7 million as of November 10, 2023, as per the worldometer.6  A significant public health issue in Nigeria continues to be communicable diseases. The burden of HIV/AIDS is projected to be 3.2%, the TB prevalence is 323 per 100,000 residents, and malaria accounts for 27% of the global burden (World Health Organization, 2010). In 2021, the vaccination coverage for the third dose of the DTP-containing vaccine, Hepatitis B, Haemophilus influenzae type B, was 56%. BCG had a vaccination coverage rate of 75% in 2021 (World Health Organization, 2022b).

Pharmaceutical Market

The National Agency for Food and Drug Administration and Control (NAFDAC) is the medicines regulatory agency of Nigeria. It was established by Decree No. 15 of 1993, as amended by Decree No. 19 of 1999, and is now the National Agency for Food and Drug Administration and Control Act, Cap N1, Laws of the Federation of Nigeria (LFN) 2004. The mandate of the NAFDAC is to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale, and use of food, drugs, cosmetics, medical devices, packaged water, chemicals, and detergents (collectively known as regulated products), and the agency was officially established in October 1992. NAFDAC is currently at WHO ML3 as per the assessment done by the WHO experts in March 2022. Nigeria has not ratified the AMA treaty, but it has adapted the AU model law and is part of the West Africa medicines regulatory harmonization program. 

It has listed 180 inspected local pharmaceutical manufacturers in Nigeria (NAFDAC, 2021). These manufacturers mostly manufacture drugs for oral use, like syrups, tablets, and capsules. The Nigerian pharmaceutical market is a large and growing market with significant potential for growth. Nigeria spends about $10 billion annually on healthcare, with about $4 billion going toward medicines. More than 70 percent of medicines in Nigeria are imported. When people do not have access to health insurance, they must pay as much as 62% of their healthcare costs out of pocket. The market is projected to grow from its current estimated 220 million to 262 million by 2030 and to 400 million by 2050, making it the fifth largest population in the world.7 Furthermore, 70% of the drugs imported into Nigeria are mainly from China and India (Labaran and Hamma-Adama, 2021).

Vaccination Manufacturing Capacity

In 2022, Nigeria had two vaccine manufacturers, Innovative Biotech Ltd. and Biovaccines Nigeria Limited (Saied et al., 2022). Innovative Biotech LTD was established in 2005 and is the first privately held biotechnology company in Nigeria (Inovative Biotech LTD, no date). Its manufacturing stage mainly focuses on the research and development of several vaccines like COVID-19, Ebola, Yellow Fever, HIV, and HPV (Saied et al., 2022; BCG and Biovac, 2023). Biovaccines Nigeria Limited is a partnership between the Federal Government of Nigeria and MAY & BAKER NIGSERIA PLC and was established in 2005. Biovaccines aims to distribute and produce human vaccines for Nigeria and to reverse the situation of high mortality from immunizable diseases. Furthermore, it plans to create a regional center for vaccine production in West Africa (May & Baker Nigeria PLC, no date). Nevertheless, Biovaccines is not manufacturing vaccines at the moment, but it is included as a recipient of the mRNA technology transfer hub from the WHO (World Health Organization, no date; BCG and Biovac, 2023).