Capital dearth hinders Nigerian Pharma firms from vaccine development

With about one million children dying annually from vaccine preventable diseases such as  tuberculosis, diphtheria, pertussis, tetanus, poliomyelitis, measles and vaccines remaining the most cost-effective public health interventions, dearth in capital has hampered Nigerian pharmaceutical firms from investing into vaccine research and product development.

While it takes years to deliver a licensed vaccine and requires funding commitment throughout the period of the vaccine research, BusinessDay investigations reveal that the cost of developing a vaccine (from research and discovery to testing, gaining regulatory approval, manufacture and product registration)-is estimated to cost between $200 million and $500 million per vaccine.

In an interview with BusinessDay, Ola Ijimakin, General Manager, Marketing, Fidson Healthcare Plc, revealed that the major reason why most Nigerian pharmaceutical firms have not invested in vaccine manufacturing is as a result of the huge capital investment required.

While the requirements for developing vaccines are not so different from the manufacture of other medicines, Ijimakin stated that the technology and investment required is higher, a situation which multinational companies such as GlaxoSmithKline, Novartis, Sanofi Pasteur, Pfizer Inc, etc. have ventured into.

According to Ijimakin “Most of the funds used by government to purchase vaccines are donor funds. There are a lot of rules tied to these funds including WHO pre-qualification of the product.  The process is capital intensive. Exactly how much is required will depend on the scale. If government will buy from local manufacturers, I am sure there are companies that can cope with the capital layout required

Ijimakin pointed out that though the vaccine market is potentially lucrative, the challenge is that vaccine procurement is largely driven by the government.

“Most diseases that vaccines protect against are public health issues therefore government does most of the purchasing and are mostly paid for by donor funds with the attendant conditionalities that do not favour local manufacturers. The private market for vaccines is relatively small,” Ijimakin added.

As the Federal Government is set to introduce Pneumococcal and Rotavirus vaccines for pneumonia and diarrhoea respectively into the routine immunisation programme, this development is set to increase the cost of fully vaccinating a child from $45 to $80 per surviving infant in Nigeria.

Public health experts have called for need to explore internal funding and develop a national sustainability strategy for vaccine financing as Nigeria cannot continue to depend on funds coming from donor agencies such as World Health Organization, (WHO), United Nations’ Children’s Fund (UNICEF as cost of vaccine rises.

“Nigeria must look into the local manufacturing of vaccines as Government has provided sufficient funds to cover procurement of vaccines,” Ado Mohammad, Executive Director, National Primary Health Care Development Agency (NPHCDA) explained.

A peep into vaccine research and product development reveals that global product pipeline requires several early-stage development projects. As a result, to register a single vaccine, a number of independent potential vaccines under development are needed.

To ensure that a vaccine emerges on the market, the pipeline must be composed of a research and product development portfolio of different potential vaccines in different stages of development for each of the targeted diseases and post registration activities that ensure future accelerated introduction and access of vaccines, BusinessDay investigation shows.

Kate Elder, vaccines policy advisor, Médecins Sans Frontières stated that under the current business model, prices for vaccines and medicines are based on recouping both Research and Development (R&D) and manufacturing costs.

Elder noted that some new vaccines are more complicated to produce than older ones, which contributes to their higher cost.

“Vaccine manufacturers do not make their R&D and manufacturing costs public, a practice that makes the vaccine industry one of the most opaque areas of the health sector. One much-discussed effort to reduce costs and spur adaptation of new vaccines for developing countries is the PVC Advance Market Commitment (AMC) designed by the GAVI Alliance, a public-private global health partnership.

“GAVI launched the AMC initiative in 2009 to incentivize R&D aimed at the needs of poor countries and to accelerate introduction of PCV into these settings, by creating a subsidized market for Prevnar 13 (PCV) producers. So far, this pilot program has helped to accelerate the introduction of PCV into developing countries and to distribute 82 million doses but has fallen short of creating formulations adapted to resource-poor settings/of fundamentally influencing the PCV vaccine market,” she concluded.

ALEXANDER CHIEJINA