The fragility of the U.S. vaccine supply

Abstract

The availability of vaccines in the United States is now threatened by systemic problems in the development, purchase, and distribution of vaccines. The number of companies that produce vaccines for the United States has declined markedly since the 1960s, and today, only five companies produce all routine vaccines for this market. There is only one supplier for measles, mumps, and rubella (MMR), diphtheria, pertussis, and tetanus (DPT), and polio, and if this supplier ceases production, it could take years to have a replacement vaccine licensed and publicly available. The dearth of suppliers has also decreased the availability of vaccines, with recent shortages of 8 of 11 recommended childhood vaccines, as well as the pneumococcal conjugate vaccine. The shortage of suppliers may be related to (1) the high cost of vaccine licensure requirements and development, (2) increasingly stringent regulations of production, (3) high vulnerability to product-liability lawsuits, and (4) low risk-adjusted returns on investment. While incremental reforms may improve the current system, structural changes are needed to ensure a stable vaccine supply for the long term. Among many proposals that have been advanced in response to the recurrent shortage of vaccines in the United States, is an alternative proposed in the 2003 Institute of Medicine (IOM) report, Financing Vaccines in the 21st Century. The IOM proposed a government subsidy mechanism for vaccine development and health insurance coverage coupled with a requirement that all public and private insurers cover the vaccines eligible for the subsidy. This subsidization program has a clear economic rationale in that by preventing disease, the use of vaccines can achieve reductions in the cost of treating disease that far exceed the costs of immunization. It may take repeated disruptions in the supply of vaccines to create political momentum for change of this magnitude.—Michael D. Wagoner