Mr. Sharma. Just, I want to make a few points here. First of all, in the product inserts, the adverse reaction rates that we see are from a different vaccine which has different contents and ingredients. And I think there is an issue that we had raised in our previous testimony; however, an assumption was made that the two vaccines are identical and, therefore, the adverse reaction rates would also be very similar. But this is an assumption which hasn't been tested. Second, following the licensing of this vaccine, we really have very little information about its use. So we have no post- licensing experience with this vaccine. The only time we had was during the Gulf, when records were not maintained, and we don't know. This is the first time you are using this vaccine, and if you compare the adverse reaction rates that DOD has presented based on VAERS, which is 0.007, and they are true, by that token, it is the safest vaccine. But when you look at the active surveillance systems, you see a range of reaction rates that, for some of these specific symptoms as many as 80 percent or 90 percent close to people are reporting some adverse reactions. Now, I agree that a majority of them are temporary and would disappear, but it is striking the upper range. And second, something that we didn't know before, because during the licensing phase, the clinic that the field trial that was done had some problem in the sense that individuals who were in that study had received both the vaccine, and a determination could not be made which of the reactions were attributable to the mark vaccine versus the current vaccine. And second, and more importantly, the reaction-rate data could not be differentiated with regard to the gender. So they really didn't know how women were going to--what experiences women had. This is the first time we have learned from the active surveys that women are responding differently, reporting twice the rate, and I think this is a great revelation. And I think we would not have learned if we did not have such active surveillance systems. And this is the point that I just wanted to make it clear.

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Mr. Sharma. I think one of the problems with this vaccine is that, you know, as Mr. Chan mentioned about the lack of correlates, and when this vaccine was licensed antibody levels were considered to be a marker, but subsequently we have found that there is no relationship between antibodies level and protection. And that raises this whole issue about the number of the shots itself. I mean, the whole premise of number of shots is that if you reach certain level of antibodies your body has, then it will protect you. So for that reason, if you can attain, you know, a certain antibodies level with two shots, you as much protected as with six shots. And I think I have to really recognize Dr. Engler, who is in my view an excellent clinician and researcher and from whom I have learned quite a bit about the relationship between antibodies and their implications. With the recombinant vaccine, in addition to developing surrogate markers for protection for which whereby we could certainly know for sure that the vaccine will work or not, it would also require fewer doses which certainly has, in the current vaccine, a clear indication that the more shots you give, and logically you would expect more reactions. So if you have fewer shots, and the researcher that we have spoken to at USAMRIID and in Camar in England, they certainly seem to believe that you could easily reduce the dosage to two, or at the most three. And that is quite a bit of improvement over the current vaccine.

Sushil K. Sharma
Assistant Director, Special Studies and Evaluation Group
National Security and International Affairs Division
U.S. General Accounting Office

ANTHRAX VACCINE ADVERSE REACTIONS Hearing Transcript in Adobe Acrobat

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Last revised: June 2003