Anthrax Vaccine: Why You Can't Get It
Oct. 10, 2001 -- Only one American company is licensed to produce an Anthrax vaccine right now. And yet, at this time of national concern over the deadly bacteria, the company has not passed FDA inspections, and the vaccine is only authorized and intended for government use.
ABCNEWS' Barbara Walters talks to Robert Kramer, President and COO of BioPort Corporation, to find out why.
For Government — Not Civilians
ABCNEWS' BARBARA WALTERS: You make the vaccine only for the government … Why not also make it for civilians?
KRAMER: It will be made available for civilian use at the appropriate time, when we have met all the obligations that we have to the Department of Defense … We have for the last several years maintained and built a stockpile of vaccine, which is available for an emergency use basis if fully supported by FDA … We have enough vaccine to support the anthrax vaccination immunization program that is currently sponsored by the Department of Defense, and at some point in the future, we will have additional vaccine available for civilian use.
WALTERS: At what point in the future?
KRAMER: It'll be several years, but you need to understand that the Department of the Defense and the Department of Health and Human Services are in close cooperation with one another to make sure that if there is an emergency need for the vaccine and by civilians, that they are coordinating and cooperating to do so.
WALTERS: Citizens have been following you and saying: "We want this vaccine." And I understand your phone has been ringing off the hook. What do you say?
KRAMER: We say that for right now, our inventory and production is committed to satisfying the needs of the Department of Defense. However, as Secretary of Health and Human Services Tommy Thompson has commented upon, he is working, in a cooperative way, with the Department of Defense and the other appropriate health agencies to make sure that, if the need arises, that vaccine will be made available.
WALTERS: How long would it take to have enough vaccine for the military needs and for any number of civilians?
KRAMER: It may be a matter of a half a year to a year before we have sufficient inventory out of the renovated facility approved, by the FDA.
WALTERS: Tommy Thompson, who is the head of Health and Human Services, has said that "We are prepared for biological warfare." If that "biological warfare" is Anthrax, are we prepared?
KRAMER: We have a significant amount of vaccine that is in stockpile, which can be used on an emergency basis with the support of the FDA. So I think we are adequately prepared to respond to a bio-warfare attack that would involve Anthrax.
WALTERS: Should the public be scared?
KRAMER: The public should be at a heightened sense of awareness and they could clearly report any unusual matters to their respective public health officials, but they should not be scared. We don't need to create a frenzy over this issue. People need to understand that there is a vaccine that can be made available and it will be made available on an emergency use. But they should not be scared.
FDA Violations
WALTERS: BioPort has failed the Food and Drug Administration's inspections in 1999 and 2000. The inspectors cited contamination problems and lack of consistency in your production standards. You have had 18 FDA violations. How do you answer this?
KRAMER: I answer it by saying that we have again met with the FDA. We took a long time following the November 1999 inspection to lay out a plan to address all of their concerns. We've worked with them very closely for the last 18 months and I'm confident that when we submit this package to them on October the 15th, that will completely satisfy all the requirements for them to approve our facility … We went through an extensive process for the last 18 months to ensure that every product, every batch of product in, out of our facility is manufactured consistently and in control.
WALTERS: In your opinion, what were the problems?
KRAMER: Well, the FDA has significantly heightened their regulatory requirements for approval of renovated manufacturing facilities, particularly in the vaccine industry … They said we needed to perform some additional studies and work required to meet their heightened regulatory requirements. And that has taken 20 months to respond adequately to their requirements … We've responded to what the FDA has clearly said they want done in order to approve the facility and I'm confident that on October the 15th they will be satisfied with that package.
WALTERS: Is the vaccine safe?
KRAMER: It is absolutely safe. There have been over 13 independent studies performed on the vaccine to prove its safety. I'm confident.
WALTERS: What you were saying is all of the concerns of the FDA have to do with your facility, but not with the actual product, not with the vaccine. The vaccine has been determined to be safe?
KRAMER: The vaccine has been determined to be safe and effective, and has been licensed by the FDA since 1970.