“Although groups initially considered for preexposure vaccination for bioterrorism preparedness included emergency first responders, federal responders, medical practitioners, and private citizens, vaccination of these groups is not recommended. Recommendations regarding preexposure vaccination should be based on a calculable risk assessment. At present, the target population for a bioterrorist release of B. anthracis cannot be predetermined, and the risk of exposure cannot be calculated. In addition, studies suggest an extremely low risk for exposure related to secondary aerosolization of previously settled B. anthracis spores (28,83). Because of these factors, preexposure vaccination for the above groups is not recommended. For the military and other select populations or for groups for which a calculable risk can be assessed, preexposure vaccination may be indicated.”
- a federal advisory committee voted in favor of testing the vaccine in children,
- an additional $1.25 billion worth of anthrax vaccine was purchased for the civilian stockpile 3 weeks ago (44.75 million doses),
- the decision to approve use of the vaccine in civilian first responders were all made without these data.
All 3 decisions were made by DHHS agencies or their advisory committee, while a DHHS agency withheld the most important scientific evidence about vaccine safety and serologic efficacy. Is there any rational, scientific or ethical justification anyone can make for how DHHS can behave like this? How can anyone claim the Department of Health and Human Services is acting in the public good?
Do the data so challenge government policy that they have to be hidden? How could any policymaker, knowing this cache of data exists, not demand it before buying $1.25 B worth of vaccine, or proposing vaccine for first responders, and then children?
“Some researchers question whether the results should have been published before all the data were available; full results are expected in 2014. Interim trial data are usually reported only to regulatory authorities, and clinical trials published only once all the data are in, noted Nicholas White, a malaria expert at Mahidol University in Bangkok, in an editorial3 accompanying the interim results. “There does not seem to be a clear scientific reason why this trial has been reported with less than half the efficacy results available,” he wrote.”