Content area
Full Text
PERSPECTIVE
Vaccine manufacturing: challenges and solutions
http://www.nature.com/naturebiotechnology
http://www.nature.com/naturebiotechnology
Nature Publishing Group
Nature Publishing Group
Jeffrey B Ulmer1, Ulrich Valley2 & Rino Rappuoli3
The recent influenza vaccine shortages have provided atimely reminder of the tenuous nature of the worlds vaccine supply and the potential for manufacturing issues to severely disrupt vital access to important vaccines. The application of new technologies to the discovery, assessment, development and production of vaccines has the potential to prevent such occurrences and enable the introduction of new vaccines. Gene-based vaccines, virus-like particles, plant-derived vaccines and novel adjuvants and delivery systems represent promising approaches to creating safer, more potent vaccines. As a consequence, more people will have faster access to more effective vaccines against a broader spectrum of infectious diseases. However, the increased cost of producing new vaccines and regulatory uncertainty remain challenges for vaccine manufacturers.
The prevention of diseases by vaccination is without question one of the most significant medical achievements of mankind. Vaccines currently prevent more than 3 million deaths per year, and the positive economic impact is in excess of a billion dollars per year. During the 20th century, the average human life span has increased by approximately 30 years, a significant portion of which has been attributed directly to vaccination1. One infectious disease, smallpox, has been eradicated by vaccination, and another, polio, is expected to be eradicated. However, the stringent regulatory hurdles associated with immunizing healthy people and the perception of modest financial returns on investment have presented a high barrier for entry of pharmaceutical companies into the vaccine business. As a consequence, the number of vaccine manufacturers has decreased in recent years, leading to less competition and little incentive to invest in new technologies2.
The landscape seems to be changing, however. Several new vaccines have recently been licensed for human use, including some that are expected to achieve blockbuster status (>$1 billion in annual sales), such as Prevnar (Wyeth Pharmaceuticals) for pneumococcal disease and Gardasil (Merck) for human papillomavirus (HPV) infection. These scientific and economic successes, and the potential for more, have led to the expectation that the vaccine business will grow at a greater rate than the pharmaceutical drug business over the next decade35. If so, the concomitant development and application of innovative technologies
should...