A tale of two new anthrax vaccines

[Guest guest]

WIRED has the most complete version I've seen of the AP story on

anthrax vaccines, below.

http://www.wired.com/news/wireservice/0,71887-0.html

First, there is a thorough trouncing of VaxGen. VaxGen (amazingly)

got a huge contract to manufacture vaccine when its only expertise

was in vaccine development, not manufacture.

Neither the executive branch, which designed Project Bioshield

initially as a slush fund to be doled out by the President, without

Congressional oversight, nor the Congress, which required more normal

funding arrangements for the 5.6 billion dollars, seemed to have much

insight as to what it takes to go through the complex process of

assuring the effectiveness and safety of new drugs and vaccines for

humans.

Arbitrary goals were established for the new anthrax vaccine: it

needed to be given in 3 or fewer shots (but no one mentioned that

this might not confer adequate protection from this already-developed

vaccine, nor how long the protection would actually last) and it

needed to be just as effective as Bioport/EmergentBiosolutions'

vaccine. (No one mentioned that the effectiveness of Bioport's

vaccine was questionable, and a function of the anthrax strain used

and the number of spores inhaled, among other things. So there was

no gold standard with which to assure effectiveness.)

The VaxGen contract was, therefore, primarily designed to immunize

the government against criticism that it had not " prepared " for an

anthrax attack.

Not surprisingly, it turned out the VaxGen vaccine was not as

effective as Bioport's. So now experimental adjuvants (not used in

any US vaccines and of questionable safety) are being tested to

improve the vaccine. One, apparently, yielded test results

demonstrating even less efficacy than before. Don't worry--the

testing will continue. Eventually there will be a recombinant rPA102

anthrax vaccine that tests show is as effective as Bioport's. (But

since all the tests use surrogate endpoints, none of which have been

proven to reflect human effectiveness, this too is a shell game.) And

you can bet the surveillance for adverse effects of the vaccine will

be carefully managed so that no serious side effects are found. With

$877 million and government prestige at stake, how could it be

otherwise?

On page 2, we again hear that we need to attract big pharma to

Bioshield, and perhaps our only hope of doing this is to protect the

pharmaceutical companies from liability lawsuits. How do you think

that would affect their safety testing?

http://www.onelocalnews.com/duntonsprings/ViewArticle.aspx?

id=10245 & source=2

This article talks about an Avecia anthrax vaccine. Avecia was given

a contract initially to do what VaxGen did: manufacture a Fort

Detrick-designed recombinant Protective Antigen-based vaccine in

small quantities. For some reason, Avecia never bid on the contract

VaxGen later got to manufacture 75 million more doses of the

identical vaccine.

Now Avecia is back in the picture. Making the same thing as VaxGen,

and Avecia's vaccine was also not as effective as Bioport's

vaccine. But Arthur Friedlander, an old anthrax hand at Fort

Detrick, says it's safe. He said that about Bioport's vaccine too.

Take home message: we are no closer to a safe and effective anthrax

vaccine. We need a new paradigm to get there. Either using multiple

antigens in a killed vaccine, or developing a live attenuated vaccine

will give us greater effectiveness. We still don't know what will

give us a safe vaccine, or even if a safe and effective vaccine is

possible.

Meryl Nass, MD

Mount Desert Island Hospital

Bar Harbor, Maine 04609

207 288-5081 ext. 220