Although Goal 1 of the draft National Vaccine Plan is not titled “vaccine development and regulation,” the two processes are profoundly intertwined; the outcome of successful vaccine development is licensure by the Food and Drug Administration (FDA) of safe and effective vaccines that will improve the public’s health. Infectious disease vaccine development and regulation occur in a dynamic environment shaped by public health considerations and policies, scientific and technologic barriers, news media commentary, judicial decisions, and the multiple public avenues available for information exchange. A major challenge to the field is meeting the necessarily very high standard of safety for preventive vaccines used in healthy populations. Also, vaccines are generally used for large proportions of the population, for example, childhood vaccines for an entire birth cohort (e.g., 4 million newborns annually in the United States alone), and in hundreds of millions of people worldwide.

The pharmaceutical companies that produce vaccines “experienced a period of great contraction in the 1980s and 1990s”1 (reasons that have been described include fear of liability, low profit margins, and low likelihood of recouping investment), but the first decade of the 21st century appears increasingly promising for the industry, as demonstrated by expansion in the number of manufacturers, a promising pipeline of potential new vaccines, and a changing view of the profitability of vaccines (Werble, 2009a,b). The industry conducts most of the applied and clinical research necessary for the further development and production of a vaccine.

The federal government supports vaccine research through several agencies including the National Institutes of Health (NIH) in the Department of Health and Human Services (HHS) and the more recently established Biomedical Advanced Research and Development Authority (BARDA), located in the office of the Assistant Secretary for Preparedness and Response (ASPR) also in HHS.2 NIH funds basic and clinical vaccine research totaling an estimated $1.675 billion in 2009. The majority of vaccine-related research at NIH takes place in the National Institute of Allergies and Infectious Diseases (NIAID).

NIH and BARDA also represent two different and complementary approaches to vaccine development. NIH has long supported primarily an


In 1967, 26 vaccine manufacturers were licensed by FDA, while in 2002, only 12 FDA-licensed vaccine manufacturers remained (Plotkin et al., 2008). According to the 2004 IOM report Financing Vaccines in the 21st Century, five companies made all vaccines routinely recommended for children and adults, and two were based in the United States—Merck and Wyeth (recently purchased by Pfizer, a U.S. pharmaceutical company), and the others were Europe-based multinationals.


ASPR was created in 2006 by the Pandemic and All-Hazards Preparedness Act.

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