CHAPTER 13

• Jurisdiction: United States

CHAPTER 13 WHAT CAUSED THE SUCCESSES AND THE FAILURES OF PREVIOUS VACCINES?

Why did some vaccines "succeed" and receive general adoption, while others failed to gain acceptance and wide distribution? Successful vaccines that were received well by the population ensured safety, efficacy, established trust through effective communications, established reliable screening and selection of vaccine candidates, and, most importantly, had effective vaccine management and planning for the future. Successful vaccines have been developed for infections including polio, tetanus, flu, hepatitis B, rubella, hepatitis A, measles, and whooping cough. As of 2021, failures have included vaccines proposed for HIV and Lyme disease. Both have been tried extensively with grant funding but have not yet succeeded.

Validation of success in multiple sub-populations is important to achieving broad acceptance of the vaccine. The economic savings that result from the Centers for Disease Control's childhood routine vaccination schedule are remarkable.¹ A 2005 study evaluated the savings as a direct result of childhood vaccination for seven routine vaccines (diphtheria and tetanus toxoids and acellular pertussis; tetanus and diphtheria toxoids; Haemophilus influenzae type b conjugate; inactivated poliovirus; measles, mumps, and rubella; hepatitis B; and varicella vaccines). The results indicated $5.3 billion in direct savings, and up to $16.5 billion in indirect savings.²

Access to vaccines in diverse populations is important. The FDA released a recommendation in November 2020 in an effort to enhance diversity in clinical trial populations, both demographically (race, ethnicity, age, socioeconomic status, etc.) and non-demographically (comorbid conditions, weight range extremes, patients with organ dysfunction, etc.).³ Critical in evaluation of the efficacy of vaccines and other drug treatments in multiple sub-populations...