The U.S. Vaccine Supply
http://www.100md.com
《新英格兰医药杂志》
To the Editor: The National Vaccine Advisory Committee, of which I am a member, agrees with the Institute of Medicine (IOM) vaccine-financing committee1 that legislative measures and additional funding are needed, but we differ with its recommendations for action, as described by Sloan et al. (Dec. 2 issue).2 At the request of the IOM committee, the National Vaccine Advisory Committee convened stakeholder deliberations on vaccine-financing options and concluded that it is not advisable to replace the current system with an insurance mandate and a system of subsidies and vouchers, as the IOM recommends. We are skeptical that such a system would provide attractive incentives to manufacturers or would substantially improve immunization levels among children and adults.3 We are concerned about undertaking a dramatic shift to an unproven, new model for which there is little detail and no estimate of costs. In addition, achieving the multiple simultaneous legislative changes that would be required at the national and state levels seems unlikely.
Instead of abandoning a system that has achieved record levels of immunization coverage, we recommend strengthening and expanding the two programs that currently supply approximately 57 percent of childhood vaccines (established under section 317 of the Public Health Service Act and the Vaccines for Children Program) and providing specific authorization and appropriations for programs to immunize adolescents and adults, including vaccine purchase.4
Harmonizing regulations between the United States and other countries and regions would facilitate the introduction of vaccines licensed in other countries that meet equivalent, although not identical, standards. Finally, since many practitioners currently lose money on immunizations,5,6 we must ensure adequate reimbursement for the administration of vaccines to both children and adults.
Alan R. Hinman, M.D., M.P.H.
Task Force for Child Survival and Development
Decatur, GA 30030
ahinman@taskforce.org
References
Institute of Medicine. Financing vaccines in the 21st century: assuring access and availability. Washington, D.C.: National Academies Press, 2003.
Sloan FA, Berman S, Rosenbaum S, Chalk RA, Giffin RB. The fragility of the U.S. vaccine supply. N Engl J Med 2004;351:2443-2447.
Hinman AR, Gellin BG, National Vaccine Advisory Committee. Institute of Medicine report on financing vaccines in the 21st century: National Vaccine Advisory Committee/National Vaccine Program Office follow-up. October 6, 2004. (Accessed February 17, 2005, at http://www.hhs.gov/nvpo/nvac/NVAC-IOM100604.htm.)
Hinman AR, Orenstein WA, Rodewald L. Financing immunizations in the United States. Clin Infect Dis 2004;38:1440-1447.
Glazner JE, Beaty BL, Pearson KA, Berman S. The cost of giving childhood vaccinations: differences among provider types. Pediatrics 2004;113:1582-1587.
Coleman M, Fontanesi J, Meltzer MI, et al. Estimating medical practice expenses from administering adult influenza vaccinations. Vaccines 2005;23:915-23.
To the Editor: The Sounding Board article on the fragility of the U.S. vaccine supply by Sloan et al. makes a powerful case for a change in the way vaccines are produced and distributed in the United States. Unfortunately, the proposed reform favored by the authors is hampered both by its complexity and by its deference to the private sector.
Given the low profitability of privately manufactured vaccine and the public health imperatives of a reliable and adequate supply, there seems to be little benefit in leaving this responsibility in private hands. A federally operated system to purchase or produce vaccines is required, with provision for adequate compensation to health care providers for storing and administering vaccines.
The concept is not novel. Since 1975, the federal government has bought, stored, and sold oil from the Strategic Petroleum Reserve to protect the nation's oil consumers. If the government can play so critical a role in protecting our oil supplies, why should it do less to protect us from infectious disease?
Harry K. Schwartz, J.D.
7011 MacArthur Blvd.
Bethesda, MD 20816
harrykschwartz@comcast.net
The authors reply: Dr. Hinman and other members of the National Vaccine Advisory Committee believe that the current approach to vaccine financing, which relies on large-scale purchasing and distribution by the government, is sufficient to ensure a stable supply of vaccines and is an effective system for the distribution of vaccines to vulnerable populations and that it should therefore be expanded. Although the current public health model has fostered high rates of childhood immunization, it has also contributed to the fragility of the vaccine supply. Severe shortages of 8 of the 11 recommended childhood vaccines occurred during 2001 and 2002, followed by a shortage of pneumococcal conjugate vaccine in 2004. With only one supplier for each of eight critical vaccines, the potential for disastrous new shortages is a real and immediate concern.
Rather than expanding the current approach to include new populations, the IOM committee suggested that a new strategy was necessary to reshape the financing system for vaccines. A safety-net model originally designed to serve the truly needy cannot be sustained when government purchases account for more than half of the vaccine market. Public-sector purchase prices are simply too low to sustain corporate investments in vaccine products when these are compared with other, more profitable biologic and pharmaceutical products. On the other hand, abandoning the private sector, as suggested by Schwartz, is unnecessary and counterproductive, given the important role that private initiative has historically played in vaccine innovation.
Successful implementation of the IOM committee's recommendations requires further public discussion, as well as refinements in the proposal to address both technical and political concerns. But in order to have a meaningful discussion of the merits of the IOM proposal and the strategies for its implementation, the stakeholders must first agree that there is a serious and urgent problem that requires us to move beyond status-quo solutions.
Frank A. Sloan, Ph.D.
Duke University
Durham, NC 27708
Rosemary A. Chalk, B.A.
Robert B. Giffin, Ph.D.
National Academies
Washington, DC 20001
Instead of abandoning a system that has achieved record levels of immunization coverage, we recommend strengthening and expanding the two programs that currently supply approximately 57 percent of childhood vaccines (established under section 317 of the Public Health Service Act and the Vaccines for Children Program) and providing specific authorization and appropriations for programs to immunize adolescents and adults, including vaccine purchase.4
Harmonizing regulations between the United States and other countries and regions would facilitate the introduction of vaccines licensed in other countries that meet equivalent, although not identical, standards. Finally, since many practitioners currently lose money on immunizations,5,6 we must ensure adequate reimbursement for the administration of vaccines to both children and adults.
Alan R. Hinman, M.D., M.P.H.
Task Force for Child Survival and Development
Decatur, GA 30030
ahinman@taskforce.org
References
Institute of Medicine. Financing vaccines in the 21st century: assuring access and availability. Washington, D.C.: National Academies Press, 2003.
Sloan FA, Berman S, Rosenbaum S, Chalk RA, Giffin RB. The fragility of the U.S. vaccine supply. N Engl J Med 2004;351:2443-2447.
Hinman AR, Gellin BG, National Vaccine Advisory Committee. Institute of Medicine report on financing vaccines in the 21st century: National Vaccine Advisory Committee/National Vaccine Program Office follow-up. October 6, 2004. (Accessed February 17, 2005, at http://www.hhs.gov/nvpo/nvac/NVAC-IOM100604.htm.)
Hinman AR, Orenstein WA, Rodewald L. Financing immunizations in the United States. Clin Infect Dis 2004;38:1440-1447.
Glazner JE, Beaty BL, Pearson KA, Berman S. The cost of giving childhood vaccinations: differences among provider types. Pediatrics 2004;113:1582-1587.
Coleman M, Fontanesi J, Meltzer MI, et al. Estimating medical practice expenses from administering adult influenza vaccinations. Vaccines 2005;23:915-23.
To the Editor: The Sounding Board article on the fragility of the U.S. vaccine supply by Sloan et al. makes a powerful case for a change in the way vaccines are produced and distributed in the United States. Unfortunately, the proposed reform favored by the authors is hampered both by its complexity and by its deference to the private sector.
Given the low profitability of privately manufactured vaccine and the public health imperatives of a reliable and adequate supply, there seems to be little benefit in leaving this responsibility in private hands. A federally operated system to purchase or produce vaccines is required, with provision for adequate compensation to health care providers for storing and administering vaccines.
The concept is not novel. Since 1975, the federal government has bought, stored, and sold oil from the Strategic Petroleum Reserve to protect the nation's oil consumers. If the government can play so critical a role in protecting our oil supplies, why should it do less to protect us from infectious disease?
Harry K. Schwartz, J.D.
7011 MacArthur Blvd.
Bethesda, MD 20816
harrykschwartz@comcast.net
The authors reply: Dr. Hinman and other members of the National Vaccine Advisory Committee believe that the current approach to vaccine financing, which relies on large-scale purchasing and distribution by the government, is sufficient to ensure a stable supply of vaccines and is an effective system for the distribution of vaccines to vulnerable populations and that it should therefore be expanded. Although the current public health model has fostered high rates of childhood immunization, it has also contributed to the fragility of the vaccine supply. Severe shortages of 8 of the 11 recommended childhood vaccines occurred during 2001 and 2002, followed by a shortage of pneumococcal conjugate vaccine in 2004. With only one supplier for each of eight critical vaccines, the potential for disastrous new shortages is a real and immediate concern.
Rather than expanding the current approach to include new populations, the IOM committee suggested that a new strategy was necessary to reshape the financing system for vaccines. A safety-net model originally designed to serve the truly needy cannot be sustained when government purchases account for more than half of the vaccine market. Public-sector purchase prices are simply too low to sustain corporate investments in vaccine products when these are compared with other, more profitable biologic and pharmaceutical products. On the other hand, abandoning the private sector, as suggested by Schwartz, is unnecessary and counterproductive, given the important role that private initiative has historically played in vaccine innovation.
Successful implementation of the IOM committee's recommendations requires further public discussion, as well as refinements in the proposal to address both technical and political concerns. But in order to have a meaningful discussion of the merits of the IOM proposal and the strategies for its implementation, the stakeholders must first agree that there is a serious and urgent problem that requires us to move beyond status-quo solutions.
Frank A. Sloan, Ph.D.
Duke University
Durham, NC 27708
Rosemary A. Chalk, B.A.
Robert B. Giffin, Ph.D.
National Academies
Washington, DC 20001