National vaccine advisory committee issues recommendations to strengthen supply of routine vaccines

December 16, 2003

In an effort to enhance the supply of necessary childhood vaccines without the shortages seen in recent years, the National Vaccine Advisory Committee (NVAC) has issued a list of recommendations that are published in a special communication in the December 17 issue of The Journal of the American Medical Association (JAMA).

The NVAC was chartered in 1988 to advise and make recommendations to the Director of the National Vaccine Program and the Assistant Secretary for Health at the Department of Health and Human Services on matters related to the prevention of infectious diseases through immunization and the prevention of adverse reactions to vaccines. The NVAC is composed of 15 members from public and private organizations representing vaccine manufacturers, physicians, parents, and state and local health agencies.

"Beginning in late 2000, significant unprecedented and unanticipated shortages of routinely administered vaccines against 8 of 11 vaccine-preventable childhood infectious diseases occurred in the United States," according to background information provided by the Committee's report. "Affected vaccines included diphtheria and tetanus toxoids and acellular pertussis [whooping cough] (DtaP), measles, mumps, and rubella (MMR), varicella [chicken pox], and pneumococcal conjugate [pneumonia] vaccines; combined tetanus and diphtheria toxoids (Td) was also in short supply. Vaccine supply disruptions affected private practices and public clinics because both sectors purchase vaccines from the same manufacturers."

The Committee's report states that some of the problems that contributed to the shortage of vaccine supplies between 2000 and 2003 included a relatively low value given to preventive measures such as vaccines compared with that of therapeutic medicines, reflected in what individuals and public and private payers are willing to pay for vaccines; the high cost and complexity of development, approval, manufacturing and distribution of vaccines; the lack of continued investment in some vaccine manufacturing facilities; the relatively small number of vaccine manufacturers; and communication barriers between stakeholder groups, including proprietary information and confidentiality requirements that inhibit the recognition of evolving problems and development of effective responses.

The Committee concludes that: "Disruptions to the supply of routinely administered vaccines are likely to continue to occur. Action to implement short- and long-term solutions should be considered and implemented now."

The Committee recommends several solutions that may be implemented in the immediate future, including: increase funds for vaccine stockpiles; increase support for regulatory agencies; maintain and strengthen liability protections; require manufacturers to provide advance notice regarding intent to withdraw from marketplace; improve communications among leaders and consumers - provide accurate information about vaccine supply; initiate a national campaign to emphasize the safety and benefits of recommended vaccines for the public good.

Several strategies that require further study are: evaluation of appropriate financial incentives to manufacturers to sustain supply of existing vaccines and stimulate development of new vaccines; and streamline regulatory process without compromising safety or efficacy (JAMA. 2003;290:3122-3128. Available post-embargo at JAMA.com)
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Editor's Note: The source of funding for the stakeholder meeting was the Department of Health and Human Services (DHHS), which paid for travel and accommodations for all attendees as well as the meeting facility and transcription fees. The DHHS had no role in the protocol, development, data collection, and management. The DHHS assisted in manuscript preparation.

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