May 12, 1996|By Mark Guidera | Mark Guidera,SUN STAFF
Maryland, the state that gave the world Babe Ruth, the Star Spangled Banner and hot crabs, appears poised to offer another lasting contribution: revolutionary vaccines targeting some of the world's most vexing diseases.
Quietly, but surely, the Baltimore-Washington region has emerged as a hotbed of vaccine research and development.
That trend is the result of larger phenomena, say experts like Dr. James B. Kaper, chief of the bacterial genetics division at the University of Maryland's Center for Vaccine Development. Vaccine research, he notes, is undergoing a renaissance largely because stunning advances in biotechnology have made it possible to create vaccines for diseases once thought unpreventable, or vaccines to replace old standbys.
Many of today's vaccines were created by using either killed or weakened microbes to stimulate the body's immune response.
But many of the new vaccines are made using a completely different methodology, thanks to advances in molecular biology.
For example, some vaccines are created by employing molecules called purified proteins. These proteins make the vaccine "smarter" by attaching themselves directly to a protective capsule that bacteria have, rendering them harmless.
Also at work in the vaccine industry today: managed care's push toward preventive care and a growing resistance to antibiotics by some bacteria.
A handful of biotechnology companies in the Baltimore-Washington region, including MedImmune in Gaithersburg and North American Vaccine in Beltsville, are in the thick of this renaissance.
Public research institutions like the National Cancer Institute in Bethesda and the University of Maryland's Center for Vaccine Development in Baltimore, which license their vaccine discoveries and conduct clinical tests for private industry, also are a part of this emerging vaccine industry.
There are about two dozen vaccines under development at these companies and institutions; they aim at both traditional targets like typhoid, cholera and whooping cough as well as new ones like Lyme disease, cancers and a hardy bacteria considered a leading cause of diarrhea.
Most are in the early stages of development, but a few are in clinical trials to assess their safety or effectiveness so marketing approval can be sought from the Food and Drug Administration and the Public Health Service.
Several have been approved, either in the United States or overseas, for sale. These include an infant pneumonia vaccine developed by MedImmune, a new cholera vaccine developed by the University of Maryland's vaccine center, and a whooping cough vaccine developed by North American Vaccine.
Bright future
It remains to be seen how many of these Maryland-bred vaccines ever make it to market; some surely are destined to never even make it out of the lab.
But company executives have high hopes that at least a few will be blockbusters that generate millions -- if not billions -- of dollars in revenues. In the process, these companies could earn the state a reputation as one of the leading vaccine producers.
"Outside of the industry, few people realize what an important role Maryland is beginning to play in vaccine development," said Dr. Steven Keith, a pediatrician and former Merck & Co. executive who heads the sales and marketing division of North American Vaccine.
The roots for this emerging vaccine industry in the region, the University of Maryland's Kaper said, can be traced to scientists who have left top research institutions in the area, including the National Institutes for Health, the Walter Reed Army Institute of Research and the Bethesda Naval Research Hospital, to either form their own firms or join others.
"There's a lot of very good brainpower in this region for vaccine development," he said.
Fierce competition
Meanwhile, biotechnology companies like MedImmune find themselves in a niche of the drug industry where competition is very fierce, say experts.
According to the Pharmaceuticals Research and Manufacturers of America (PHARMA), a trade group, vaccine development is the second largest focus of research and development activity in the biotechnology industry.
A 1995 survey by Washington-based PHARMA found 43 new vaccines in clinical trials. Well-healed pharmaceutical industry firms like Merck & Co., Bristol-Myers-Squibb and Schering-Plough are among the competitors.
Furthermore, dozens of other U.S. companies are trying to develop vaccines for the same diseases.
For example, MedImmune has in its pipeline two new types of vaccines for Lyme disease, a potentially debilitating illness caused by a bacteria passed on to humans by deer ticks. The disease has a potentially large market today as deer populations grow on the East Coast.
But pharmaceutical powerhouses Connaught Laboratories of Swiftwater, Pa., and SmithKline Beecham of Philadelphia also are working on Lyme disease vaccines. Both are in late-stage clinical trials, while MedImmune's vaccine is in early clinical testing.
