Vaccine R&D Slow to Grow

Recent trends suggest there may be little growth globally in the number of anti-infective vaccines entering clinical trials for the rest of this decade, according to a recent analysis from the Tufts Center for the Study of Drug Development.

“Despite widespread agreement that new vaccines are an important public health priority, development remains slow, expensive, and risky,” said Tufts CSDD Director Kenneth I. Kaitin.

According to the study, since 1990 the number of companies initiating development of new vaccines and the number of pathogens targeted—38 companies and 35 targets—have remained essentially unchanged.

Mr. Kaitin said, “The benefit-to-risk profile for vaccines is typically more stringent, liability concerns are often greater, and the return on investment is frequently lower, which partly explains why there aren’t more vaccine development programs in place.” He added that in the near term vaccine R&D is likely to focus on readily transmitted pathogens, such anthrax, dengue, and Ebola.

The Tufts CSDD study also found that of eight new vaccines approved during 2000-2005, only three targeted pathogens that were not associated with childhood diseases or influenza. Also, the five most-studied targets were hepatitis B, hepatitis C, herpes simplex, smallpox, and West Nile viruses and account for 60% of all antiviral vaccines currently in development. According to the study, the success rates for anti-infective vaccines developed in the 1990s ranged from 17% to 25%. Development time for new vaccines averaged 80 months during the past decade and FDA approval averaged 13.9 months.

So far in 2006, the FDA has approved Rotateq, a rotavirus vaccine, and Gardasil, a human papilloma virus vaccine. ACAM2000, a smallpox vaccine currently under review, may be approved later in the year.