Heading off a Crisis in Vaccine Development

Article excerpt

An R&D partnership between industry and government is the best way to develop urgently needed new vaccines.

Vaccination is the single most cost-effective health intervention known to modern science - and public policy. Effective use of vaccines results in low childhood mortality, freedom from epidemics of devastating diseases, and protection against widespread illnesses such as influenza and pneumonia. These facts are viewed as axiomatic by the medical and public health communities.

However, the United States, with its vast scientific resources and great expenditures on health care, is doing a poor job of fulfilling this basic responsibility. Between 1989 and 1991, a measles epidemic shocked the country. More than 55,000 children contracted the disease and 136 died from it. The epidemic never should have begun because there has been an effective vaccine for decades.

More disasters are waiting to happen. Polio, whooping cough, rubella, and mumps could follow. According to the Centers for Disease Control and Prevention (CDC), one-third of U.S. children have not received all the recommended doses of diptheria-pertussis-tetanus (DPT), measles-mumps-rubella, and poliomyelitis by the time they are 2 years old. In addition, only 55 percent had received the three recommended Hemophilus influenzae type B (HIB) shots, and only 16 percent had been properly vaccinated against hepatitis B. Vaccination rates in low-income communities are believed to be far lower. Indeed, many children do not receive all recommended shots until they are required to do so when entering school at age 5, and some - perhaps 10 percent of the population - slip through the cracks because of lax enforcement of the vaccination rules.

Clearly, nationwide immunization is well below the levels needed for full protection of the population. Furthermore, unless there is a change in public policy, the nation will be unable to take full advantage of scientific advances in biotechnology and immunology. New "combination" vaccines have already been formulated that would reduce the required number of childhood shots. One example is a vaccine that combines protection against hepatitis B and HIB with the existing combination vaccines for DPT. In addition, formulations that would reduce the number of required booster doses, and therefore visits to the doctor or a clinic, are in the research stage. Currently, for example, DPT requires a primary dose and three booster doses, resulting in four trips to a doctor or clinic. Research is also underway to provide better vaccines against influenza, hepatitis B, and pneumococcal pneumonia, which kill more than 500,000 adults annually, as well as new products to ward off dangerous illnesses for which there is no current defense, such as Lyme disease. And improvements are being pursued in existing products such as the measles vaccine, which does not work in infants younger than 9 months.

Unfortunately, high development costs and the long approval process are major obstacles to bringing new vaccines to the market. In addition, federal and state government purchases of well over 50 percent of child vaccines at highly discounted prices discourage private-company R&D.

Indeed, the current "system" in the United States for vaccine research, development, manufacturing, purchase, and delivery is not capable of bringing the best possible vaccines or combinations of vaccines into use or of reducing development costs. The reasons for this unhappy conclusion He in the structure of the system and the lack of effective coordination among its many constituents.

The nonintegrated system worked reasonably well until now because the scientific options for vaccines were limited. With the biotechnology revolution, however, the system's limitations are becoming more apparent and more serious. An expanding menu of options, the potential for greatly improved combination vaccines and greatly simplified delivery systems and schedules, and an efficient immunization program require a much-improved and coordinated R&D strategy. …