October 12, 2001

Smallpox vaccine tests now a ‘highest priority’

By KAREN BUCKELEW Daily Record Business Writer

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The University of Maryland School of Medicine is studying the effectiveness of existing smallpox vaccine as part of the federal government’s intensified efforts to deal with the threat of bioterrorism.

“The study is now our highest priority,” said Dr. Carol Tacket, University of Maryland professor of medicine and leader of the local portion of the study, in a statement.

In the wake of the Sept. 11 terrorist attacks, the government already has enlisted the help of Massachusetts company Acambis and Rockville’s BioReliance Corp. in the development of a new vaccine for the long obsolete disease. But the National Institutes of Health is examining the use of the older vaccine — despite its shortcomings — in the event of an emergency situation.

The existing vaccine, while highly effective, was developed decades ago using outdated methods, and most likely would not pass today’s higher regulatory standards, said experts. However, Acambis’ updated vaccine is not expected to be ready until 2003, at the earliest.

The University of Maryland is one of four research centers nationwide testing the vaccine on adults to measure its effectiveness, and determine whether it could be diluted to make more doses with less material.

“The advantage is that we would have a greater supply of the vaccine now ...” - Dr. Ellen Gursky

The current vaccine, unused since the early 1980s, “wouldn’t pass regulatory muster right now,” said Dr. Robert Edelman, University of Maryland professor of medicine and associate director of the school’s Center for Vaccine Development.

“Up until recently, we were so concerned about any side effects, [the existing vaccine] wouldn’t have passed” the regulatory process, Edelman said. “But right now, that becomes moot, because it’s a crisis situation.”

The center is testing the vaccine on 680 adults for the next 10 weeks, trying different dilutions to measure their efficacy.

If the vaccine could be diluted, it would be a boon in an emergency situation, said Dr. Ellen Gursky, a senior fellow with the Johns Hopkins University Center for Civilian Biodefense Studies.

Diluting a vaccine “makes it go further without compromising its efficacy,” Gursky said. “The advantage is that we would have a greater supply of the vaccine now … in case we needed it quickly.”

Though the last documented case of smallpox occurred in Somalia in 1977, and mass immunization stopped decades ago, there are fears the disease could be given new life in an act of biological warfare.

The National Institute of Allergy and Infectious Disease is funding the study at Maryland, the St. Louis University School of Medicine, the University of Rochester School of Medicine and Baylor College of Medicine.

http://www.mddailyrecord.com/current_issues/2_87_friday/businessnews/57998-1.html

-- Martin Thompson (mthom1927@aol.com), October 14, 2001