Why Is Bush Buying 75 Million
Doses Anthrax Vac For Public?
By Meryl Nass, MD

The Washington Post's otherwise excellent article on the US government's plan to contract for 75 million new doses of recombinant anthrax vaccine, published March 11, 2004, leaves out some important background:
1. Apart from the 2001 smallpox vaccine fiasco, no entity has ever before contracted for nearly a billion dollars' worth of untested drug or vaccine. Let's explore the Sept-Nov 2001 smallpox contract first.
* Soon after DHHS contracted with Acambis for a total of 209 million doses of smallpox vaccine, it came to light that the US actually had a stockpile of smallpox vaccine of between 85 and 105 million doses.
* It also turned out that the old vaccine had been tested in college students at various dilutions, and a 20% (1 in 5) dilution yielded as much protection as full strength vaccine. Thus the existing US stockpile was sufficient to vaccinate at least 400 million people before any additional vaccine was purchased. However, that did not stop DHHS from purchasing nearly a billion dollars of new vaccine, which used the identical virus strain that was in the older vaccines.
2. The Acambis smallpox vaccine (209 million doses ordered before this recombinant vaccine had even been created) is unlikely to ever be used, barring a smallpox epidemic, since it employs the same vaccinia virus strain that caused a number of cardiac problems and several deaths in the 38,000 civilian health care workers vaccinated. (It did the same in military troops, who are still receiving it, but those deaths have been covered up--I had a letter published in JAMA [2003;290:2123-4] about this.) A less reactogenic smallpox vaccine was also ordered by DHHS, for people who were not expected to tolerate the original vaccine. However, only 15 million doses of this vaccine, called modified Ankara, were purchased.
3. Acambis's VP Tom Monath was shown by Judith Miller in the August 7, 1998 NYT to have misrepresented himself as a CDC employee, rather than a private vaccine developer, in a meeting with President Clinton in which he pushed hard for production of bioterrorism vaccines. Why did DHHS contract for smallpox vaccine with a small unknown company that had been so tarred?
4. VaxGen (another start-up that is likely to get some or all of the DHHS recombinant anthrax contract) similarly has been investigated by the London Times and The Guardian for improper manipulation of its stock price, has faced several lawsuits by investors, pulled out of a Thai AIDS vaccine trial when close to completion, leaving its partners very unhappy, and to my knowledge has never brought a product to market. Why contract with VaxGen to produce a vaccine created a number of years ago at Fort Detrick? (I am aware that VaxGen has so far only received $80 million from DHHS for 3 million doses, but is anticipated to get a much larger contract for some or all of 75 million doses.)
5. Vaxgen's own head to head trial of its rPA (recombinant protective antigen) anthrax vaccine versus the licensed Biothrax/AVA vaccine showed the recombinant vaccine had over twice the systemic adverse reaction rate (39% vs 18%) as the original. Yet Vaxgen claimed it compared favorably in terms of safety.
6. The WP article is correct in that "many" postal workers refused AVA in 2001-2: 99% to be exact.
7. Effectiveness testing of anthrax vaccine in animals cannot predict human effectiveness. Vaccine effectiveness varies all over the map depending which experimental animals are chosen. And no correlates of protection have been identified yet that permit extrapolation from animals to humans. In fact, in older studies from the 1980s and 1990s performed at Fort Detrick and Porton Down, UK, rPA vaccines were LESS effective in animal models than the currently licensed vaccines.
8. Why rush to order this huge stockpile, which according to DHHS is not expected to be available until two years after the contract is signed, when the vaccine shows no strong evidence of being either safe or effective in humans? There exists no immediate need. Is someone afraid that complete testing will show up its flaws?
9. Is the reason for purchasing now, before testing is complete and licensing assured, to head off development of more promising approaches, such as Human Genome Sciences' privately developed monoclonal antibody ABThrax, which reported very positively on an early clinical trial last week, and derail development of other drugs that are cheaper, more effective than vaccine and only need be given after an actual exposure, not before?
10. Lest anyone be misled that this vaccine is an improvement on the currently licensed anthrax vaccine, it was selected because it had been developed a number of years ago at Fort Detrick but never used, ie it happened to be available when the government decided to replace the existing anthrax vaccine. It is definitely more pure, but unfortunately its purity has not been shown to improve safety or effectiveness. There is no good reason for it to require fewer doses either. In fact, its primary ingredient, PA (protective antigen) has been demonstrated to have significant toxicity. For example, injecting it into the cerebrospinal fluid of monkeys caused complete cessation of brain electrical activity for several minutes, in studies performed at Fort Detrick in the 1960s, but these studies may not have been reviewed by those involved with vaccine contracting.
Meryl Nass, MD
Moount Desert Island Hospital
Bar Harbor, Maine 04609
H 207 276-5092
W 207 288-5082 ext 220 or pager 441



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