Mr Mark A. Elengold, United States of America

The number of licensed vaccine manufacturers in the USA fell from 26 in 1967 to 17 in 1980, and down to 12 in 2002. There are currently shortages of a number of vaccines, including DT, TT, MMR, varicella, pneumococcal polysaccharide conjugates and influenza.

The three major causes for the current vaccine shortages in the USA are the limited production capacity, vaccine use and the economic situation.

The production capacity of vaccines is limited by the following factors:

• aging and inflexible plants;

• differences in regulatory requirements in different countries;

• scientific challenges, e.g. use of different adventitious agents and additives in different countries; and

• costly GMP requirements.

Vaccine use changes as a result of changes in recommendations, and in response to changes in public acceptance. Such changes can make it difficult for manufacturers to plan their manufacturing.

The difficult economic situation is related to:

• the uncertainty of the market;
• the complexity of the product; and
• the low price generally paid for preventative measures.

The USA currently faces a number of challenges including:

• ensuring the supply of vaccines;
• developing new vaccines;
• combination vaccines; and
• supplying vaccines at an affordable price to developing countries.

In order to increase vaccine availability, the USA should:

• improve early and frequent communication among the relevant parties;
• develop research that facilitates product development, improvement and safety;
• allow fast track and accelerated approval;
• increase the price of vaccines;
• limit liability by, e.g. offering indemnities to manufacturers; and
• seeking a balance between the risks and benefits of vaccines.