Vaccine Development Stagnates

A recent study on vaccine pipelines found that the number of new products has increased only modestly over the past decade. But industry experts say that bioterrorism--and larger profit margins--could change the scenario.

The study, from the Tufts Center for the Study of Drug Development, covered the years 2000 to 2004. During that period clinical studies were initiated for an average 14 products a year, compared with 12 from 1990 to 1999. Moreover, the number of companies sponsoring trials--and the number of pathogens being targeted--was virtually static.

The Tufts study tracked only "new and innovative products," which would exclude follow-on vaccines like Merck's Zostavax (live zoster), vaccines for many childhood diseases and seasonal influenza, and government and academic research.

"Vaccines have been the underdog for so long," said Janice Reichert, a senior research fellow at Tufts, who called the approval rate of a few vaccines a year "pathetic."

She noted that vaccines currently represent about two percent of the therapeutics market.

Although R&D is likely to remain at its current level in the second half of the decade, the long-term prognosis might be more promising.

New targets are emerging. The Tufts study found that influenza and childhood diseases accounted for five of the last eight vaccines approved between 2000 and 2005.

But those targets too could change. About 60 percent of vaccines now in development target hepatitis B and C, herpes simplex, smallpox, and the West Nile virus, according to Tufts.

"To a large extent, the low-hanging fruit has been achieved," said Dr. John Lebbos, director of infectious diseases at market research firm Decision Resources. "The focus has gotten a lot more intense. That's where there's a lot more excitement."

Companies are also testing new vaccine combinations to improve existing products, he noted.

Big pharma is showing new interest in vaccines. Clement Lewin, vice president of US government affairs and strategy for Acambis, and a veteran of the vaccine divisions of Merck, Bayer, and Chiron, noted that the market is less dismal than Tufts suggests. He said that it is a $10 billion business growing at about 10 percent a year--and should continue growing.

Companies are expanding their investment in vaccines. GlaxoSmithKline in 2005 purchased ID Biomedical, a big player in the Canadian flu vaccine market, and Novartis similarly cited Chiron's flu vaccine capabilities as an impetus for that merger.

Blockbuster vaccines are on the way. Prevnar, Wyeth's pneumoccocal vaccine, reached blockbuster status in 2004, about four years after its launch--the first vaccine to cross the billion-dollar sales mark. And Merck's HPV vaccine, Gardasil, might one day follow suit.

"You're seeing vaccines that are blockbusters in the true sense of the word," said Lewin. "That's what actually changed the perception of vaccines. Vaccines are in vogue because people see they can be profitable."

Concerns about bioterrorism are encouraging development. Government funding for bioterrorism research has opened up opportunities for smaller companies to compete with major players. Acambis is one of those smaller firms developing vaccines for infectious diseases such as smallpox.

"The US government has encouraged companies to develop vaccines they wouldn't ordinarily develop," Lewin said.

But Reichert of Tufts noted that Project Bioshield has encouraged companies to go after exotic targets at the expense of more common ones.

The Critical Path Initiative, FDA's attempt to modernize the drug development process, does not have special provisions for vaccines.

"It's really a matter of putting additional money into vaccine research," Reichert said. "Companies would be well-suited to lobby together for political action."