The ACIP working group was charged with (1) evaluating data on vaccine safety, and the vaccine safety monitoring and treatment system, of the civilian National Smallpox Vaccination Program and DoD’s Smallpox Vaccination program, and (2) monitoring safety data for use of VIG and cidofovir (both of which are under an investigational new drug protocol).

There are two competing concerns that surround the disclosure of the data that are reviewed by the ACIP working group: (1) the need for confidentiality of vaccinees’ medical data and for private deliberations of the working group to analyze those data, and (2) the need for public disclosure of the ACIP working group’s findings based on analysis of these adverse event data. Both of these concerns are extremely important, and one must not be jeopardized for the sake of the other.

Private deliberations of the ACIP working group are necessary for ensuring that adverse events that are coincidental illnesses rather than reactions to vaccination do not alarm the public needlessly about the safety of the vaccine or the safe use of the vaccine. These private deliberations also are necessary for ensuring confidentiality of vaccinees’ medical data. Even if vaccinees’ personally identifiable information is not discussed during the working group meetings, a vaccinee’s particular circumstances could lead to identification if disclosed to the public (e.g., living in a state that only vaccinated a small number of response team members, unique characteristics of the adverse event that would be evident to the vaccinee’s personal or professional contacts, unique job description).

The committee notes that reports of adverse events often appear in the media very early and may be unverified. Conducting case investigations of adverse events and designating them as suspected or probable are vitally important activities for all reported adverse events, whether or not they appear in the media before being formally described by CDC. The ACIP working group plays a valuable role in this process by conducting the final assessment of the putative adverse events.

Although recognizing that protection of the confidentiality of vaccinees’ medical data and private deliberations of the ACIP working group are paramount to ensuring free discussion of data surrounding each reported adverse event, the committee also strongly believes that the working group should be able to freely issue findings or recommendations once they have reached a conclusion. Should the American public come to believe that relevant vaccine and program safety data are not being completely disclosed, the committee fears that lack of public trust in the implementation of the pre-event smallpox vaccination program could become an impediment to continued successful operation of the program. The committee recommends that whenever the ACIP working group issues findings/recommendations to the ACIP and through it to the director of CDC, it carefully consider concurrent release to the public, and do so if it would be in the interest of transparency and maintaining the public’s trust in the program.



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