Cost of plasma-derived hepatitis B vaccine production.

ABSTRACT

It is generally accepted that the introduction of hepatitis B vaccine to national programmes of immunization in developing countries is desirable, but it has so far been constrained by the high cost of the vaccine. To determine the potential minimal costs of the vaccine, a study has been carried out of the production of the vaccine in a developing country with a population of approximately 50 million. The study concludes that the manufacture of a plasma-derived hepatitis vaccine in some developing countries may be reasonable. A detailed financial evaluation using the best available information leads to several conclusions. In the hypothetical 50-million population country, a plasma-derived hepatitis B vaccine could be manufactured and made available at a price of approximately US$0.50 per dose packed in 10-dose vials if approximately 4 million doses per year are procured. An important condition of achieving this price level is that approximately 8% of total production is sold in the private sector for a profit. To establish these facilities, an initial capital investment of approximately US$3.7 million would have to be made. The minimal prices for hepatitis B vaccine that could be achieved in very large production facilities manufacturing many tens of millions of doses per year have also been estimated. Extension of the model to such quantities (10 to 20 million doses per year) suggests that the vaccine can be sold for less than US$0.10 per dose, thereby placing it in the same cost range as other EPI vaccines. Thus, hepatitis B vaccine may reach these cost levels when large-scale procurement is undertaken by governments and international donor agencies.