http://www.newsmax.com/archives/articles/2001/10/28/210212.shtml

Anthrax Vaccine? No, Not Yet

Dave Eberhart, NewsMax.com
Monday October 29,2001

With the U.S. Army and the Institutes of Health (NIH) racing to perfect a minimal side-effects anthrax vaccine, and BioPort, the sole Department of Defense (DoD) supplier benched by the Federal Pure Food and Drug Agency (FDA) for violations, less than 25,000 doses of the controversial vaccine remain available for military use – and none for the civilian population.

Unlike Cipro and other antibiotics that are prescribed for those who have been exposed to anthrax, the vaccine is administered as a preventive measure.

The count of remaining doses is according to Dr. Meryl Nass of Freeport, Maine, an internist and author of vaccine studies who has treated military members suffering reactions. DoD spokesman Jim Turner said his agency would not disclose the particulars of anthrax vaccine stockpiles. "Current events have led us to a state of war,” he said.

"We’ve gotten a tremendous amount of calls” asking about the vaccine, said Bernie Adams, a spokesman for BioPort Corp. of Lansing, Mich., which has about 6 million unusable doses still under federal quarantine. Presently BioPort is awaiting FDA approval on renovations it has made to its labs to sell its vaccine to the DoD. The FDA revoked BioPort’s license to make the vaccine in 1998.

BioPort received $126 million from the Pentagon as part of its efforts to eliminate problems in quality control.

However, according to the Office of the Special Assistant Secretary of Defense for Gulf War Illnesses (OSAGWI), even if BioPort were up and running "vaccination against anthrax is not recommended for the general public.”

Perhaps behind the recent OSAGWI recommendation: tough Hill testimony last Tuesday regarding BioPort by the General Accounting Office’s (GAO) Managing Director, Nancy Kingsbury. According to Kingsbury, the BioPort vaccine insert claims that only about 34% of the vaccine’s recipients would suffer mild reactions.

"By comparison, in a study we conducted in calendar year 2000, 85% of National Guard and reserve forces in our survey who were given the [BioPort] anthrax vaccine reported some reactions,” said Kingsbury, "with local reactions experienced by 76.2% of recipients and systemic reactions experienced by 23.8%...”

At another Hill session, BioPort President Robert Kramer testified, "We have the right people doing the right things to get this job done. We will get approval for the renovated facility.”

The U.S. Army vaccine program is utilizing modern genetic-engineering techniques, Carl McNair of Dynport Vaccine Company of Maryland (under Army contract) told the Wall Street Journal last week. Human trials are expected to begin this fall, he added.

Mr. McNair said that the great challenge was to manufacture a vaccine that will be effective against as many as possible of the more than 1,000 known anthrax strains. Comparing the problem to the flu, he said, "The minute you have a vaccine that takes care of one type of flu, then boom, someone gets another type of flu.”

Both the Army program and the NIH program are working on creating a vaccine that will not have the side-effects track record of the BioPort product.

NIH researcher John Robbins told the Journal that the new vaccine will be more pure than the existing vaccine. Robbins added that the NIH vaccine in the works, features an ingredient to thoroughly mobilize the body’s immune system against any future anthrax infection.

Despite BioPort’s problems of the past, Health and Human Services Secretary Tommy Thompson told the House Government Reform subcommittee this week that if BioPort facilities win FDA approval, "they should be operational” by Nov. 22.

Defense Secretary Donald H. Rumsfeld has given the beleaguered BioPort a vote of confidence of sorts. "What we’re trying to do is figure out a way where we might get some help so that they might improve their performance,” he told reporters at a recent Pentagon briefing.

Rumsfeld said Pentagon officials were meeting with representatives of the Department of Health and Human Services "to try to fashion some sort of an arrangement whereby we give one more crack at getting the job done with that outfit.”

In the meantime, BioPort faces more than just the FDA hurdles.

·  Air Force Reserve Maj. Tom Rempfer has co-authored a citizens’ petition, filed recently, asking the FDA to declare the vaccine "unsafe, ineffective or misbranded.”

Among other points the petition alleges the military’s mandatory anthrax inoculation policy "is leaving an indelible stain on the integrity of the U.S. military.”

·  A private multimillion-dollar lawsuit alleging negligence against BioPort Corp. was filed in federal District on behalf of soldiers allegedly harmed by vaccine shots they were required to take.

The named plaintiffs are the survivors of deceased Army Specialist Sandra Larson of Spokane, Wash., and Ronda Wilson, of Savannah, Ga., a former soldier whose chronic ill health allegedly resulted from the vaccine.

The lawsuit alleges that the efficacy of the vaccine in the mass immunization program for the military was not sufficiently tested and adverse reactions by soldiers were not accurately assessed.

BioPort spokeswoman Kim Brennen Root, who was unable to comment until company attorneys studied the complaint, conceded that the FDA had noted deficiencies, but the company expected a good report on its revised procedures and new plant from federal regulators.

Also see : Sole Source of Anthrax Vaccine Isn't Source at All

and Army Not Immune to Anthrax Vaccine Threats

Read more on this subject in related Hot Topics:

Bioterrorism

War on Terrorism

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