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BACKWATER NO MORE:
Expected growth of vaccine industry through 2012: 10.5% // Merck’s vaccine sales in 2007: $4.3 billion // Sales from Wyeth’s Prevnar: $2.4 billion // Interest in vaccines: restored.

Prevention’s New Profits

By Deborah Kelly and Charles Slack // Spring 2008
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Vaccine vials

Roman Luba for Proto

Until the late 1960s, for millions of children, coming down with mumps meant a week or two away from school with fever, sore throat and painful swollen glands. But in a fraction of cases, the consequences were dire, with complications that could include meningitis, paralysis and sterility. Carried on droplets of saliva, the virus was so infectious that a child could get it just by standing near someone who laughed. With time as the only cure, it seemed to be an affliction that might be with us forever. Then one day mumps messed with the wrong little girl.

When five-year-old Jeryl Lynn Hilleman awoke with a sore throat and swollen glands, her father, virologist Maurice Hilleman of Merck Research Laboratories, swabbed a sample of the virus from the back of her throat and went to work. By growing and regrowing the virus in fertilized chicken eggs, Hilleman developed a strain that resembled the original but had been weakened so that it was harmless to humans. The modified virus—dubbed the Jeryl Lynn strain—spurred the development of antibodies capable of fighting off the virus. Launched in 1967, it has prevented millions of cases of mumps and hundreds of thousands of serious complications.

But this remarkable success story was only one of many during the 1950s and 1960s, the golden age of vaccines. That was a time of big diseases and even bigger breakthroughs. To a nation living in fear of polio, Jonas Salk’s announcement in 1953 of trials for a vaccine made him a hero—and the news two years later that his vaccine had been deemed ready for mass distribution only increased his stature. Measles, rubella and several dangerous flu strains fell in quick succession, and it began to seem as if anything were possible. In 1967, U.S. Surgeon General William H. Stewart announced that it was time to “close the book on infectious diseases.”

Gradually, though, that unbridled optimism gave way to financial and medical realities. As it turned out, vaccines weren’t that great a business proposition for private pharmaceutical companies. Vaccines are hugely labor-intensive to develop, and because most combat a single virus, the process must be repeated from scratch for each new strain. Worse, from a profit perspective, is that the better a vaccine performs, the fewer times it’s needed. Most provide protection for life; others require a booster shot every few years.

None of this posed much of a problem when drug companies were small and pharmacology’s accomplishments modest. But in the 1970s, rapid medical and technological advances led to drugs for treating an array of diseases, including high blood pressure and heart arrhythmias. Patricia Danzon, a professor of health care management at the University of Pennsylvania’s Wharton School, says the golden age of vaccines gave way to the era of the blockbuster drug, in which a relative handful of large pharmaceutical companies was always on the lookout for the next big thing.

By the 1980s existing vaccines, while still effective, were an old story, and the field’s one big chance to return to the heroic days of yore—by developing an effective vaccine against AIDS—fell short. Indeed, some vaccines came to be considered villains, not heroes. Since the 1990s many parents have become convinced that rising rates of autism are linked to the proliferation of Hilleman’s combined measles, mumps and rubella (MMR) vaccine. Though no credible connection between the two has been found, that furor, along with declining profits and the threat of litigation, has made the vaccine business increasingly unappealing, says Paul A. Offit, Hilleman’s biographer, who is chief of infectious diseases at the Children’s Hospital of Philadelphia. By 2000 there were just five major vaccine manufacturers worldwide, compared with 26 in 1957.

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From Cows to Cures

Edward Jenner

The story of vaccines—coined from the Latin word for cow—begins in 1796.

The Making of a Vaccine

Vaccine manufacturing remains a slow, painstaking process, as Merck’s Gardasil facility shows.

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hed-dossier

1. Vaccinated: One Man’s Quest to Defeat the World’s Deadliest Diseases, by Paul A. Offit (Smithsonian Books, 2007). The author, a renowned virologist, recounts the fascinating story of Maurice Hilleman, the developer of eight of the 14 vaccines that are routinely recommended.

2. “Bridging the Knowledge Gaps in Vaccine Design,” by Rino Rappuoli, Nature Biotechnology, December 2007. The head of vaccine research at Novartis Vaccines & Diagnostics details the possibilities and challenges of new approaches to vaccine development.

3. “One Step Forward, Two Steps Back—Will There Ever Be an AIDS Vaccine?” by Robert Steinbrook, New England Journal of Medicine, Dec. 27, 2007. A physician examines the frustrating search for an AIDS vaccine.

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