http://www.insightmag.com/cgi-bin/ViewNews.cfm?Item=334

 

Vaccine Bailout

DOD to bail out anthrax vaccine maker

10/20/01 - WASHINGTON -- The Pentagon is going to make one final attempt to bail out Lansing, Mich.-based BioPort, the only source of the anthrax vaccine but one that has not yet been certified by the FDA, Defense Secretary Donald Rumsfeld said Thursday.

"We're going to try and save it. ... We are going to give one more crack at getting the job done with that outfit," he said. "What we're trying to do is figure out a way where we might get some help so that they might improve their performance."

BioPort bought the laboratory from the state of Michigan three years ago and entered into a contract with the Defense Department to produce millions of doses of anthrax vaccine. Using DOD funds, BioPort built a new laboratory but thus far has failed to get Food and Drug Administration approval for the facility.

The vaccine manufacturing facility repeatedly failed to pass FDA inspections both before and after being purchased by BioPort. In 1996, the facility faced having its license revoked, Mark Elengold told the House Committee on Government Reform Oct. 3 of last year. Elengold, then deputy director of FDA's Operations Center for Biologics Evaluation and research, explained that the facility at that time failed to meet provisions of the Food, Drug and Cosmetic Act, FDA regulations and "current good manufacturing processes."

Progress had been made on addressing deficiencies prior to the sale to BioPort said Elengold. The new owners undertook a renovation and sought the necessary FDA approval. But a pre-approval inspection in November 1999 found a number of problems including issues with sterilization, standard operating procedures and environmental monitoring.

The Pentagon originally intended to vaccinate every active duty and reserve member of the armed forces but has repeatedly scaled back the program to the point that just those deploying to "high-risk" areas -- Iraq and North Korea -- may receive the six-shot inoculation.

Pentagon officials met Thursday on the matter and will work with Health and Human Services to fashion a last-chance agreement with BioPort to produce the vaccine.

"Well, I shouldn't be characterizing a private entity that way, but things have not been going swimmingly for them," Rumsfeld said.

Former Chairman of the Joint Chiefs of Staff Adm. William Crowe is one of the main investors in the company.

By: PAMELA HESS, UPI Pentagon correspondent

ALL INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR LEGAL ADVICE.  THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.