Vaccine development in the twenty-first century: changing paradigms for elusive viruses

Abstract

Vaccine development and licensure for new viral diseases is a complex enterprise. In the past, pathogenic viruses might have been simply attenuated or inactivated to generate an effective vaccine. Such vaccines had an enormous impact on the spread of common viral diseases and have resulted in extraordinary improvements in personal and public health. However, as the frequency of epidemic disease has receded, public tolerance for adverse effects has diminished. Today, the perceived risk‐to‐benefit ratio for an individual must be lower than ever if a new vaccine is to be acceptable to the public. Even when objective data indicate that adverse events are rare and efficacy is nearly 100%, some vaccines have been anecdotally linked to prevalent disease conditions in popular opinion, creating a perception of harm and evading scientific rebuttal.

Clinical Pharmacology & Therapeutics (2009); 86 3, 234–236. doi:10.1038/clpt.2009.128

Conflict of interest statement

The authors declared no conflict of interest.

Figures

Figure 1

Investment during vaccine development increases substantially when a decision is made to advance into efficacy trials and scale up manufacturing. In the past, industry has had the dominant role in preparing products for advanced testing and licensure. The graph depicts the concept that, to develop vaccines for difficult viral pathogens and emerging virus diseases in the future, the balance of investment may need to shift more to government and public–private partnerships. The y‐axis indicates the relative level of investment required for successive stages of vaccine development.