By Tim Martin
Lansing State Journal
BioPort Corp. is a late entry in the race to develop a next-generation anthrax vaccine.
Lansing's BioPort Corp. is the sole U.S. producer of the anthrax vaccine. But several groups - including BioPort - want to make a faster, potentially safer version.
An estimated 20 companies, federal agencies and universities are working on several projects.
BioPort's current vaccine is given by injection. It requires six doses over 18 months, with annual boosters.
BioPort is developing a new version that could be administered by nasal spray. It could be given in three doses during a two- to three-month period.
BioPort has been working on the new version for about a year. Other efforts began as early as 1997.
An estimated 20 companies, federal organizations and universities are working toward a possible replacement for the drug now made exclusively in the United States by the Lansing company.
One of the potential competitors might be ready for human safety trials this summer, but all are likely years away from approval for use.
BioPort's long-term viability might depend on developing a faster and potentially safer version of its vaccine - before someone else does. A new drug could render BioPort's current product obsolete.
The 220-employee company also is researching or developing drugs that could protect against other biological weapons, but officials won't say which ones. They might represent the long-term future of the Lansing company that spent the past three years getting approval for renovated labs that make a relatively old, slow-acting vaccine against anthrax.
That Food and Drug Administration approval came earlier this year.
"Based on the experience of the past three years, we're in a unique position,'' BioPort spokeswoman Kim Brennen Root said. "We have every intention of moving forward with a next-generation vaccine candidate.''
BioPort has worked on a new anthrax vaccine for the past year, company officials disclosed last week. Other researchers began as early as 1997.
BioPort's research into a new vaccine came as a "natural progression" of trying to better understand its current vaccine, Brennen Root said. And its status as the only U.S. license-holder of the current drug - approved in 1970 - could give the company some advantages in the race to catch up with competitors.
BioPort's current vaccine is considered effective and relatively safe compared with other vaccines for adults, according to a report issued last week by the National Academy of Sciences. But it requires six doses over an 18-month period and annual boosters - too slow to be practical for mass vaccinations of large groups of people, especially civilians, who may need protection in a hurry, experts say.
"It's only logical to pursue something that would work more quickly,'' said Brian Strom, a University of Pennsylvania scientist who chaired the National Academy of Sciences committee.
BioPort's drug has been used primarily by the U.S. military. The Pentagon had to suspend its mandatory vaccination plan because of BioPort's production problems and hasn't decided how it will resume the program.
But a new vaccine could have broader use in the wake of last fall's anthrax mailings in the United States, which left five dead. Some civilian groups - including mail carriers, emergency rescue personnel and police - could eventually want a protection against anthrax.
Here's a look at BioPort's main competition:
The National Institutes of Health plans to start clinical trials this summer or fall on a new vaccine. The first human tests will focus on safety, such as side effects of the drug. The federal government project - which includes help from the military - began at least five years ago.
"We are on a fast track for this,'' said Carole Heilman of the National Institute of Allergy and Infectious Diseases, an NIH affiliate. "We are pushing for something that would be applicable for civilian use.''
Eventually, the agency will hook up with a yet-to-be selected manufacturer for the vaccine.
The military also has hired Dynport Vaccine Co. of Frederick, Md., to develop several biochemical vaccines, including one to fight anthrax. That work began in 1997.
BioPort's new vaccine is nearing the end of what is called the "discovery" phase, a first step that includes some pre-clinical animal testing. The vaccine could be administered through a nasal spray. And it could take effect after three doses given during a two- to three-month period - much faster than the current drug.
Several other companies and universities have begun research on vaccines - including future generation drugs that could be administered by nasal sprays or taken orally. Several companies are developing antibiotics that could be given to treat anthrax exposure.
Even Ross Perot, the Texas billionaire and former Reform Party presidential candidate, has offered to put up his own money into research for a better vaccine.
BioPort - while in the race to develop a new technology - continues to say its existing product could prove more effective.
The Centers for Disease Control and Prevention is studying whether the current vaccine could provide protection in fewer doses, in part by changing the way it is administered. The drug is administered under the skin - not in the muscle like most vaccines.
And there's no guarantee that a new drug would be any quicker or more effective than the current version.
"Anything that is done will need to be tested thoroughly before we know for sure,'' Strom said.
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