BIOSCOPE ‘98

by Dr. Barbara Price

Vaccines

Vaccines stimulate the immune system and elicit immune responses. Ideally the response to the vaccine is the development of antibodies that will attack the antigen and prevent it from infecting the animal or human. Vaccine development is still an art, although the understanding of the science is increasing quickly. In retrospect, Edward Jenner and mankind were fortunate that the cowpox vaccine worked to prevent smallpox infections.

Our understanding is improving and our technology to develop new vaccines is moving forward rapidly, but our understanding is incomplete. The use of adjuvants to enhance vaccine potency is still more in the realm of art, not science. Many adjuvants are oily substances (often hydrocarbons such as paraffin and squalene) that promote protein aggregation, which serves as a slow releasing reserve when mixed with an antigen.

While adjuvants may enhance some vaccines, adjuvants can themselves cause diseases. Human adjuvant disease was first described by women who had injections with silicone, paraffin, and other unknown compounds. It is a multi-symptom disease characterized by rheumatoid arthritis, systemic sclerosis, and other complaints of connective tissues.

Adding experimental adjuvants to existing licensed and approved vaccines for humans is medical experimentation. Recent research submitted to well known professional journals has implicated squalene, which has been used as an adjuvant in animal vaccines, in the blood sera of many patients with Gulf War Syndrome. In this study, antibodies to squalene have been found in almost all of the GWS patients and has been absent in Gulf War veterans who do not have those symptoms. These same squalene antibodies were present in a small group of people who volunteered for vaccine trials in which squalene adjuvant was used as a placebo. Squalene may act in a manner similar to silicone in inducing autoimmune symptoms. And we need to pay attention to this research.

Hopefully we will not find that our Gulf War veterans were an unknowing part of a medical experiment that was not fully thought out and was possibly illegal. Given the risk the US perceived at the time of the Gulf War, whenIraq's BW program was suspected, but not proven, there were reasons to expedite the vaccination program for those who might be exposed. However, if adjuvants were added to licensed and approved vaccines, those given the enhanced vaccines should have been told.

In this context, perhaps the money spent by the government on project management, adherence to federal regulations and integrated management of timely FDA licensure for up to 18 vaccines to be used by U.S. troops faced with biological warfare agents is not frivolous. Perhaps it is money wisely spent and the contractual requirement for this adherence reflects a concern within the US DoD's Biological Acquisition Program that mistakes not be repeated. But if this is true, the JVAP activities (DoD and contractor) need to be closely monitored. The same people, perhaps in different positions, may still be making decisions on our vaccine policies.

Anthrax Vaccination Update

In the continuing unfolding story of the vaccines produced by the Michigan Biological Products Institute, MBPI, there is some disagreement within FDA and DoD as to who is responsible for inspecting the anthrax vaccine line. The FDA has the authority and responsibility for inspecting vaccine production.

However according to the inspection report of the November 1996 FDA inspection at MBPI, the FDA did not cover the anthrax vaccine inspection "since it comes under military inspection." The DoD Health Affairs Office says the FDA inspects the anthrax vaccine line, not the military. But according to Dr. Robert Meyers, COO, the Army does inspect the anthrax vaccine line, but the FDA has not relinquished authority to the DoD.

The FDA inspectors have said that until recently, the anthrax vaccine line was inspected only by the military. The concern has been that if FDA has given an exception to DoD for the anthrax vaccine, is DoD responsible for the safety and efficacy of the vaccine? And if so, the DoD cannot say the FDA has approved the anthrax vaccine. How much distance is the FDA putting between it and the anthrax vaccine? Other reports have said that the DoD owns and maintains the anthrax vaccine line. Who inspects the anthrax vaccines given to veterinarians and meat handlers?

MBPI makes the pertussis vaccine, rabies vaccine and diphtheria, pertussis, tetanus vaccine components, as well as plasma derivatives of albumin and immune globulin. In fact, according to some reports, MBPI is the only source of immune globulin. According to the PRNewswire report announcing the $29 million dollar award to BioPort Corp. for anthrax vaccine production, BioPort expects to earn most of its revenue from the sale of the anthrax vaccines to DoD and from its plasma fractionation services.

Antimicrobial Agent for Anthrax

University of Michigan and Novavax, Inc. of Columbia Maryland have tested a chemical mixture, BCTP, against both anthrax and the flu virus and found it effective. BCTP is an emulsion of water, soybean oil, Triton X 100 and tri-n-butyl phosphate. The BCTP killed most of the anthrax spores (Bacillus anthracis) in a culture dish. BCTP also reduced the mouse death rate to 20%, reduced skin lesions and swelling and helped to heal lesions on mouse skin after it was applied to lesions infected with a relative of anthrax, Bacillus cereus.

In separate experiments, laboratory mice stayed healthy after BCTP, along with influenza A, was inserted into their nasal passages. Between these studies and the development of a vaccine based on protective antigen, it is possible that the "old-fashioned" vaccine produced by BioPort will quickly become obsolete.

Editor’s Note: Assured Capital Return - to the Max!: In September start-up company BioPort Corp. bought the only US manufacturer of anthrax vaccine, the MBPI for a reported $25 million. This included around $3.25M in cash and the rest in IOU’s. Within three weeks, BioPort "won" a Pentagon contract for $29 million to supply anthrax vaccine. Fortune smile$ on the favored few.


For the Professional in Government and Industry with an interest in Nuclear, Biological and Chemical Defense, Disarmament and Verification; Emergency and Disaster Medical Planning; Industrial Health and Safety; and Environmental Protection

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