Utilization of a licensed vaccine depends on the willingness of a pharmaceutical company or other entity to undertake its manufacture and on the company’s ability to produce the vaccine in sufficient quantities to meet the demand. Factors influencing a pharmaceutical company’s willingness to manufacture a vaccine include:
profitability in public or private sale, which is affected by market size and composition, public health initiatives, patentability or status as sole supplier, and provider and lay acceptance
legal concerns, particularly costs associated with vaccine injury compensation liability
technical difficulty of production
humanitarian/public relations issues.
The committee felt that it did not have sufficient information to include these factors in calculations of the expected benefits of new vaccines,* so it was decided to assume that any licensed vaccine would be available in quantities sufficient to meet the demand.
The high levels of immunization achieved in the U.S. for the seven major pediatric vaccines currently available (measles, mumps, rubella, diphtheria, pertussis, tetanus, and polio) are due in large part to the existence of state laws requiring evidence of immunization for school entry.
The process of predicting possible changes in such laws and the effects such changes might have on utilization of new vaccines is complicated because:
many different legislative bodies are involved
it is not possible to predict how state legislatures will respond (with or without federal pressure) to encouragement to incorporate requirements for new vaccines into existing legislation
requirements for new vaccines probably will not gain acceptance until a medical consensus has developed on the desirability of such action
the speed with which such a consensus could develop might be affected by federal promotional campaigns, the likelihood of which would depend on characteristics of the licensed vaccine and on unpredictable political and funding considerations