The availability of an expanding range of safe and efficacious vaccines against important infectious diseases has created unprecedented opportunities to improve public health and to save lives. With the widespread implementation of many of these vaccines in the United States, impressive reductions in rates of morbidity and death attributable to vaccine-preventable diseases have been achieved and substantial cost savings realized.1,2 Building on the tremendous public health benefits of today's vaccines, advances in technology are enabling the development of vaccines for diseases once considered out of reach of biomedical prevention efforts. These vaccines include new or improved vaccines for the prevention of human papillomavirus-associated diseases, meningococcal meningitis, invasive pneumococcal disease, and rotavirus gastroenteritis. Despite these exciting biomedical and public health advances, significant proportions of children, adolescents, and adults in the United States encounter financial barriers to full access to recommended vaccines and vaccination services. The fact that funding for immunization programs has not kept up with the range and number of important new vaccines that recently have been licensed and recommended for use for children, adolescents, and adults is an issue of significant contemporary concern.3 As a result, and within the context of broader challenges and inequities in the US health care system, many individuals in the United States do not receive all of the vaccines recommended for them by organizations such as the Advisory Committee on Immunization Practices and the American Academy of Pediatrics.
Having served as industry representatives to the National Vaccine Advisory Committee (NVAC) Vaccine Financing Working Group, we are writing to share our perspectives concerning current vaccine financing challenges in the United States.3 The vaccine industry thinks that both public and private sectors must play roles in addressing financial barriers, to ensure that our vaccines are accessible to all who can benefit from them.
On the public side, we support the measures outlined in the NVAC report that are intended to enhance the public safety net, including extending the Vaccines for Children (VFC) program to allow underinsured children and adolescents to receive immunizations in public health clinics, rather than only at federally qualified health centers and rural health clinics, and expanding the VFC program to cover administration fees for all VFC-eligible children and adolescents. The vaccine industry also has actively supported expansion of the Federal Section 317 program, which would enable states to broaden vaccine access for underserved children and adults by supporting vaccine purchase and infrastructure development.
On the private side, the vaccine industry recognizes the significant challenges faced by private health care providers, including inadequate reimbursement from payers and the financial burden of carrying large inventories. Many manufacturers have been taking steps to address these challenges. For example, some manufacturers are extending payment terms for vaccine purchases, allowing up to 90 or 120 days. Manufacturers also are developing programs that assist providers with management of product inventory, provide replacement vaccine doses for patients who receive vaccines but subsequently are determined to lack coverage, and create reimbursement support service centers that assist providers with reimbursement questions and information. For adults, one manufacturer makes free vaccines available to uninsured, low-income populations through patient assistance programs. Recognizing the financial burdens of underinsured families and of vaccine providers, the vaccine industry supports the NVAC recommendation that the insurance industry move toward first-dollar coverage for all vaccines recommended by the Advisory Committee on Immunization Practices. This approach would be consistent with an appreciation of the fundamental value of disease prevention and the unique role that vaccines play in protecting the health of individuals and their communities.
We think that efforts to enable broad equitable access to all recommended vaccines should be approached in a manner that does not compromise the vaccine industry's ability to introduce new and improved vaccines and to provide a sustainable supply of existing vaccines. The ability of the vaccine industry to meet these needs depends on pricing that provides an adequate return on the substantial investments made in the development of new vaccines, as well as sufficient operating profits from sales of long-established vaccines to ensure their continued supply. Indeed, the recognition that the pricing of vaccines should be commensurate with their individual and public health value has helped transform the US vaccine industry from one characterized over a decade ago by companies exiting the vaccine business to one that is now vibrant and attracting new companies to join the vaccine enterprise. However, the vaccine industry continues to face several significant challenges, including the increasingly risky, lengthy, and expensive research and development processes to develop novel vaccines and the increasing size, complexity, and expense of studies necessary to ensure the safety and efficacy of novel vaccines and to achieve product licensure within a complex regulatory environment. In addition, substantial capital investments are needed to construct vaccine-manufacturing facilities, at risk, before licensure. After licensure, ongoing investments in these facilities are necessary to maintain compliance with rigorous and evolving regulatory standards. Significant costs are also incurred as a result of the need to support increasingly large, long-term, postlicensure studies of vaccine safety and effectiveness. The vaccine industry's ability to optimize existing vaccines and to develop new vaccines for vexing disease targets for which preventative interventions are not now available will require that significant investments be made in the development and application of sophisticated new enabling technologies. To support these continued investments, a healthy balance between public and private markets will continue to be necessary.
As the administration of President Barack Obama and the 111th Congress take on the challenges of health care reform, the opportunities to improve public health with vaccines have never been greater. We think that all partners in the public health enterprise, including the vaccine industry, must work together to develop and to implement solutions that address the barriers to full implementation of vaccine programs for children, adolescents, and adults.
- Accepted August 25, 2009.
- Address correspondence to Mark Feinberg, MD, PhD, FACP, Merck Vaccines and Infectious Diseases, Merck, Medical Affairs and Policy, 770 Sumneytown Pike, PO Box 4, West Point, PA 19486. E-mail:
Financial Disclosure: Dr Feinberg is an employee of Merck, a company that develops, manufactures, and markets a number of vaccines currently included in recommended child and adolescent vaccine schedules in the United States; Dr Gordon is employed by ImmunoBiologics, a company that focuses on the development of novel vaccines; and Drs Feinberg and Gordon are members of the National Vaccine Advisory Committee but receive no compensation for their service.
- ↵Lindley C, Orenstein WA, Shen A, Rodewald L, Birkhead GS. Assuring Vaccination of Children and Adolescents Without Financial Barriers: Recommendations From the National Vaccine Advisory Committee (NVAC), U.S. Department of Health and Human Services. Washington, DC: National Vaccine Advisory Committee Vaccine Financing Working Group; 2009
- Copyright © 2009 by the American Academy of Pediatrics