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Regulation of Vaccines: Strengthening the Science Base

Journal of Public Health Policy, 2004 by Milstien, Julie B

INTRODUCTION

OFTEN heard today is the complaint that the standard of regulation of vaccines in the industrialized world serves as a barrier to entry of manufacturers into the market, especially for vaccines designed for the developing world, adding significantly to the costs of production. Vaccines play a critical role in international public health. Their development has been based on universal scientific principles; however, their regulation is centered in national regulatory authorities. The United States Food and Drug Administration (USFDA) has perhaps the longest history in vaccine regulatory activities, and has played a leading role in vaccine regulation. That role is in part traced here, with examples from activities of other regulatory authorities and the World Health Organization (WHO), as relevant.

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The aim of this paper is to look at how these regulatory practices developed, the justification for their continued use, and a review of new approaches that are being put into play. Part IIA presents examples of old vaccines still in use. Part IIB traces the development of regulatory systems in the US and elsewhere. Part IIC looks at the concept of biological standardization in the regulation of biologicals. Part IID explores the evolving role of laboratories, and Part IIE presents some of the changes in regulation that are being introduced, and the implications for the older vaccines. Section III considers some of the larger issues resulting from these changes, while Section IV discusses the future. From this review, it is apparent that in the future we need vaccine regulation guided by a strong science base for vaccine regulatory decisions; a risk-based approach to define processes and evaluations; an integrated quality management system underlying the whole procedures; and international collaboration throughout.

HISTORY OF VACCINE REGULATION

Vaccines of the past

Many vaccines still in use today are very old, having been developed 50-80 years ago, with little change in technology since then. Table 1 gives an example of some of these.

Although newer vaccines may be moving away from the older constructs that were based on extracts of bacterial or viral suspensions, some of the vaccines on the market today still use this older technology-for example, diphtheria and tetanus toxoids, whole cell pertussis vaccines, and BCG. The latter two are no longer in use in the US but remain widely used in much of the rest of the world, including some parts of Europe. Production and testing methods remain essentially unchanged from when they were first licensed. Live viral vaccines like oral polio vaccine (OPV) (still in use in much of the world, although not in the US), measles, and yellow fever vaccines have not undergone much change since the 1960s. Even a relatively "new" vaccine, recombinant hepatitis B vaccine, is almost 20 years old.

History of vaccine regulation (1)

The United States FDA, the agency responsible for regulatory oversight of vaccines in the US, recently celebrated its 100th anniversary, commemorating the passage of the Biologies Control Act by Congress on 1 July 1902. Like other major changes in vaccine regulation that would follow, this first step was in response to a tragic event: the death of 13 children in St. Louis in 1901 who had received diphtheria antitoxin that had been accidentally contaminated with tetanus. The horse from which the antitoxin had been prepared had contracted tetanus and had been killed, but the serum was not destroyed. This was followed by a similar contamination of smallpox vaccine, also in 1901, when nine children in Camden, NJ, died of tetanus after receiving this vaccine.

Prior to the 1902 law, biologics testing had been done by the Laboratory of Hygiene of the Marine Health Service, established on Staten Island, NY, in 1887, and moved to Washington, DC, in 1891. This laboratory, under the Biologics Control Act, was charged with the regulation of biologicals and the research necessary to support such regulation, under its new name, the Hygienic Laboratory of the Public Health and Marine Hospital Service.

The Act authorized the laboratory to issue regulations to ensure safety, purity, and potency, which was done in 1903, 1909, and thereafter. The Laboratory established standards and licensed smallpox and rabies vaccines (and later other biological products). In 1934, the Laboratory, called the National Institute of Health since 1930, issued a regulation stating that licenses would depend on evidence of efficacy as well. All these provisions were codified in the Public Health Service Act of 1944 (2).

The FDA put into place a parallel regulatory structure for oversight of drugs (which before 1972. implicitly, but not explicitly, covered biologicals). In 1938 Congress enacted the Federal Food, Drug and Cosmetic Act following deaths caused by the diethylene glycol used in an elixir of sulfanilamide. This act required sponsors of Investigational New Drugs (INDs) to submit safety data about the candidate product prior to receiving approval to market it (3). In 1941, 300 people were injured and some died as a result of contamination of sulfathiazole tablets with phenobarbital, which led to the definition of Good Manufacturing Practice (GMP) (4).

Health Care Industry

Regulation of Vaccines: Strengthening the Science Base

Journal of Public Health Policy, 2004 by Milstien, Julie B

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