Remedies to vaccine shortages

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With the flu season nearly spent, few people are still thinking about vaccinations. Yet, shortages of common vaccines have plagued states over the last few years, and they pose a significant threat to the public health.

Vaccines are not in short supply at the moment. That is a welcome change from the period between late 2000 and the spring of 2003, when vaccines for eight of 11 preventable diseases in children (including measles, mumps and rubella) were in short supply. As a consequence of those shortages, 49 state immunization programs rationed some of their vaccines, and 35 state programs permitted children to attend classes without the requisite number of vaccinations.

There are many reasons for those shortages. A special communication by the members of the National Vaccine Advisory Committee (NVAC) on the matter published in December's Journal of the American Medical Association (JAMA) cited several factors, including the relatively small number of vaccine makers; the costly, complicated regulatory process vaccines must go through to get to the market, and the relatively low value of vaccines compared to other therapeutics once they arrive.

The material consequences of vaccine shortages are difficult to quantify, but there is little doubt that they increase societal vulnerabilities. As a September 2002 General Accounting Office (GAO) report on the subject noted, "Underimmunization destabilizes population immunity and may lead to outbreaks." With the billions of dollars properly being spent against bioterrorism, it behooves policy-makers to ensure that sufficient resources are available to protect children from common, potentially life-threatening diseases.

Members of the vaccine committee made several recommendations toward that end, such as increasing funds for vaccine stockpiles, strengthening the National Vaccine Injury Compensation Program (VICP), examining and possibly changing incentives offered to vaccine makers, and streamlining regulatory processes at the Food and Drug Administration (FDA). The GAO report echoed many of those recommendations, but it pointed out that "stockpiling vaccines is not a panacea and, if poorly implemented, may provide little in the way of value."

As a remedy to vaccine shortages, Senate Majority Leader Bill Frist introduced the Improved Vaccine Affordability and Availability Act (S. 754) in April. The bill dovetails with many of the recommendations of the VICP and GAO, including increasing the distribution of vaccines and allowing the FDA to fast-track vaccine products that strengthen the overall supply. However, no action on the bill has been taken since its markup in the Health Education Labor and Pensions Committee was abruptly cancelled in the spring.

Notwithstanding that apparent failure, this season's shortage of flu vaccine proved that some measures must be taken to address the problem. The vaccine supply situation is so volatile that it will be surprising if additional shortages do not occur. Those shortfalls could cause great harm to unvaccinated children and the communities they live in. Legislators must make time to consider potential legislative remedies.