The True Story of Pertussis Vaccination: A Sordid Legacy?

During the last half of the twentieth century, pertussis vaccine has been at the center of controversies over the evaluation and marketing of vaccines for children. This controversy has transcended the simple confines of scientific research to redefine relationships among industry, government, law, and consumer advocacy. The dangerous side effects of whole-cell pertussis vaccine have been known for at least the last five decades, and for the last four a safer alternative has been available. But not until the late 1990s has that safer alternative become routine for American children. This paper explains why and how this transformation in care took place. We were part of the transformation, supporting the advocates for the new, acellular vaccine with scientific testimony. Although our appearance in this story takes place in the 1980s, the history of the vaccine began much earlier in the twentieth century.

Even though there was incidental medical evidence as early as the 1930s and clear-cut evidence by the 1950s that whole-cell pertussis vaccine caused neurological sequelae, American pharmaceutical companies by and large persisted in marketing whole-cell vaccines until the end of 2000 because the acellular versions, in their opinion, were too costly to produce, test, and sell. Nevertheless, U.S. manufacturers were granted at least one patent in every decade since the 1920s to produce acellular pertussis vaccines, and several countries either legislated the use of the acellular form only or stopped using pertussis vaccination altogether. Change finally began in the United States in the 1990s and was completed by 2000, largely because of the combined pressures of litigation and political action on the part of groups of parents whose children were damaged by the whole-cell vaccines. These groups pressured the federal government to study and ameliorate the adverse effects of the vaccine, but the federal government was also pressured by vaccine producers for protection from the potentially large numbers of highly expensive civil lawsuits brought by parents. These pressures culminated in the passage of a compensation act and the charging of the U.S. Institute of Medicine (IOM) of the National Academy of Sciences to make recommendations for solving the problem. This ultimately led to the licensing and recommendation of acellular pertussis vaccine for booster shots beginning in 1992 and for all shots given beginning in 1996. By the end of 2000, U.S. manufacturers had stopped making whole-cell pertussis vaccine for use in the United States.

In this detailed history of the topic, we first describe the infectious disease pertussis and the story of the vaccines produced to prevent it. We then consider the history of scientific knowledge about the myriad adverse reactions that have been observed following vaccination—from mild fevers to seizures, encephalopathy, permanent brain damage, and even death. We review the history of the scientific advances that allowed production of a far safer and more effective vaccine. Finally, we explore the history of the industrial, monetary, political, legal, and consumer factors that finally led to the use of the safer vaccine for all U.S. children as well as the work that still needs to be done to provide it to children around the world.

The Scourge of Pertussis

Pertussis, commonly called whooping cough, is a bacterial infection that usually strikes its victims with initially mild symptoms, resulting in an incubation time for the disease that is hard to determine but is usually estimated to be from six to twenty days, with a mean of seven days. As the disease progresses the symptoms become more pronounced, with coughing episodes occurring ten to twenty-five times a day as a means to expel accumulated mucus blocking the airway. After the mucus is expelled, the victim’s breathing is labored due to swollen and irritated air passages, which results in the production of a whooping sound with every inhalation. The...