Prevnar broke into the quiet world of vaccines last year with the amps cranked up. Introduced in February, American Home Products Corp.'s vaccine against pneumococcal bacteria, which can cause brain damage or death in young children in its most severe form, pulled in $461 million in sales in 2000, the best opening for a vaccine.

In the process, Prevnar not only blew past its established brethren but also topped the sales charts for all pharmaceuticals brought on the market last year, as tracked by the research firm IMS Health.

Moreover, analysts expect Prevnar to be on the leading edge of a new wave of vaccines that become instant hits. New design and production techniques learned from bio-technology combined with the perception that vaccines may be the best weapon against germs' growing resistance to antibiotics have prompted drugmakers to start about 200 new vaccines through the Food and Drug Administration approval process.

The growth curve for these products will slow more quickly than ... something like Lipitor (Pfizer's best-selling drug for lowering cholesterol), but they will still be strong. This would mark a major transformation for a niche of the pharmaceutical business long perceived as ho-hum, with slow growth and built on laboratory methods now three or four decades old.

Being an early entrant in the new generation of vaccines allowed American Home, based in Madison, not only to build volume quickly by selling more than 10 million doses to date, but also to command a premium price. The four-dose regimen re-commended for children 2 years old and younger costs $232 before any physician fees, at least double the cost of many other vaccines.

Pricing is critical from a business standpoint because many vaccines are purchased by government bodies as part of mandatory immunization programs, effectively allowing agencies to set prices. About half of Prevnar sales has been through private physicians.

To ensure that Prevnar sold well from the outset, American Home started a marketing campaign a year before sales started. "We did a lot of work to build awareness of pneumococcal (bacteria) among parents and professional groups," said Kevin Reilly, president of the Wyeth Vaccines and Nutrition division of American Home.

Perhaps more importantly, Prevnar also landed a coveted spot on the highly influential recommended childhood immunization schedule, published jointly each year by the American Academy of Pediatrics, the Advisory Committee on Immunization Practices of the Centers for Disease Control, and the American Academy of Family Physicians. The list generally goes through only about a half-dozen changes a year, many of them as technical as rewriting dosage footnotes, and in some years does not add any new vaccines.

Dr. Elizabeth Baorto, director of pediatric and infectious diseases at Atlantic Health Systems in Morristown and a strong proponent of Prevnar, said the list of recommendations is almost a commandment in pediatrics. "If you don't follow it, you are flying by the seat of your pants, and that means legal liability," she said.

Reservations Persist

Still, there are reservations about its use. Dr. Dennis Murray, a professor of pediatrics and human development at Michigan State University and a member of the American Academy of Pediatrics committee that recommended Prevnar, expressed concern that some doctors and parents expect it to prevent childhood ear infections.

He noted that about half of all ear problems are caused by viruses and American Home does not have FDA approval to make the claim that it prevents ear infections.

Dawn Richardson, president of Parents Requesting Open Vaccine Education in Austin, Texas, said, "We are now overusing vaccines to cover for the overuse of antibiotics."

Since 1983, the recommended vaccinations have grown from five to 19, with five coming in the first few months of life.

Richardson also objects to Prevnar as an expensive solution to a relatively small problem.

Last year, pneumococcal bacteria caused meningitis, which can result in brain damage, deafness or even death, in about 1,400 children nationwide. Another 17,000 children contracted bacteremia, a blood disease that can cause bone and soft tissue damage but often is cured by the body's immune system.

Tim O'Reiley can be reached at toreiley@morristo.gannett.com or (973) 428-6651.

Daily Record March 5, 2001