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Little Growth Seen in Vaccine R&D for Rest of Decade

PharmaManufacturing.com
07/11/2006

Although the number of anti-infective vaccines entering clinical study each year since 2000 has been higher on average than it was in the 1990s, recent trends suggest there may be little growth globally in this product area for the rest of this decade, according to a recently completed 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.

Each year from 2000 through 2004, clinical studies were initiated for 14 products, compared with an average of 12 each year from 1990 to 1999, according to findings reported in the July/August Tufts CSDD Impact Report, released today.

Since 1990, the study noted, the number of companies initiating study of new vaccines and the number of pathogens targeted — 38 companies and 35 targets — have remained essentially unchanged.

Kaitin said that while success rates and development times for new vaccines are similar to new biopharmaceuticals, “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.

So far in 2006, the U.S. Food and Drug Administration (FDA) has approved Rotateq, a rotavirus vaccine, and Gardasil, a human papilloma virus vaccine. ACAM2000, a smallpox vaccine currently undergoing FDA review, may be approved later in the year.

The Tufts CSDD study also found that:

• Of eight new vaccines approved in the U.S. during 2000-05, only three targeted pathogens that were not associated with childhood diseases or influenza.



• Hepatitis B, hepatitis C, herpes simplex, smallpox, and West Nile viruses have been the five most-studied targets so far in the 2000s, accounting for 60% of all antiviral vaccines currently in development.



• Overall approval success rates for anti-infective vaccines developed in the 1990s ranged from 17 percent to 25 percent.



• Clinical development and FDA approval phases for innovative vaccines approved in the U.S. during the past decade averaged 80.0 and 13.9 months, respectively.

For more information about the Tufts Center for the Study of Drug Development, visit csdd.tufts.edu.