Bioscope ‘04

by Dr. Barbara Price

Vaccines

Today’s headlines highlight the expanding gap in vaccine manufacturing capabilities in the US. The US is doing a very good job researching and making advances in vaccines (whether genetically modified vaccines based on avirulent viruses and bacteria or selected portions of them expressed in different systems or vaccines based on different forms of immune system enhancements).

The current disconnect is in the vaccine manufacturing. The business of vaccines is based on small profit margins and a limited population – if the vaccine is effective, we only need 1, 2 or 3 vaccinations over our lifetime. This is a very different business base that a large pharmaceutical company making either an over-the -counter pain reliever used by a very large population or a prescription hormone replacement taken by many every day. In the case of influenza A, the virus has an antigenic drift, so that each year the previous year’s vaccine may not work well on strains of viruses spreading in the current year. Making new vaccines for these new variations is the closest to a normal pharmaceutical business, except that each change requires the FDA to re-license the manufacturing facility. If the FDA licenses a facility to produce a vaccine according to its rules, who should carry the liability? If indeed the profit margin is small, why doesn’t the government relieve the liability and thus take away some of the dis-incentive for manufacturing the vaccine?

A list of recent vaccine recalls is at http://www.cdc.gov/nip/vacsafe/concerns/recalls/default.htm#recalls. This list includes rabies vaccine (Aventis Pasteur), hepatitis A and B vaccines, rotavirus, Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine, and Meningococcal Polysaccharide Vaccine. Most vaccine manufacturers are to be represented in this list.

The number of manufacturers in the US has decreased considerably in the last 30 years, but it is not a problem unique to the US. The WHO lists only 24 pre-qualified vaccine manufacturers. http://www.who.int/vaccines-access/. The Developing Country Vaccine Manufacturers Network (DCVMN) was formed by the vaccine manufacturers from developing countries “to provide a continuing and sustainable supply of quality vaccines at affordable prices.” From 1986 to 2001, the number of vaccine suppliers for the UN increased from 7 to 12, but the number of suppliers from developing countries increased from 0 to 58%. In the US the price of some of the individual vaccines doubled during that same period. The challenges noted in Economics of Vaccine Production include Trade-Related Aspects of Intellectual Property Rights (TRIPS) and patents, changes in production lines from large in developed countries to smaller in developing countries working to provide their local and regional populations, and increased regulation costs with uncertain gains. However increased competition and outsourcing may work to decrease costs, if they do not require a further increase in regulations.