Protecting the Frontline in Biodefense Research The Special Immunizations Program (2011) / Chapter Skim
Currently Skimming:
7 Conclusions and Recommendations
7 Conclusions and Recommendations
Pages 129-138
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 129... ...
The types of workers for whom SIP vaccination is most relevant include not only laboratory researchers but also animal technicians working to develop next-generation medical countermeasures (MCM) for military and civilian use, personnel engaged in the manufacture of biodefense vaccines and human and veterinary vaccines against zoonotic diseases, and scientists and laboratory technicians engaged in field studies of the ecology and epidemiology of hazardous pathogens.
|
From page 130... ...
However, the clinical protocols under which these vaccines are administered have produced a wealth of data on human safety, immunogenicity, and probable efficacy, including long-term medical monitoring of SIP enrollees. The committee noted that publications analyzing data collected through the SIP have improved the understanding of immune responses to investigational vaccines and have helped to provide guidelines for the safe conduct of pathogen research and the management of laboratory infections.
|
From page 131... ...
, and case fatality rate, so that pathogens that have low infectious doses, high transmissibility, and substantial morbidity and mortality from in fection would receive higher priority. The relevant characteristics of the threat that will influence which pathogens should be included in the SIP include the presence of the pathogen on government priority threat lists (which are largely generated by the intelligence community)
|
From page 132... ...
From the individual laboratory worker's perspective, a vaccine with a good safety profile and strong immunogenicity might well be expected to provide protection despite as yet unproven efficacy in humans. From a societal perspective, use of IND vaccines in laboratory workers permits the collection of safety and immunogenicity data on new vaccines, and these data could someday be of substantial value in a future national biodefense emergency.
|
From page 133... ...
7.4 VACCINE DEVELOPMENT AND SUPPLY WITHIN AND BEYOND THE EXISTING SPECIAL IMMUNIZATIONS PROGRAM Given its emphasis on the importance of shared governance and program flexibility, the committee went on to consider recent developments in vaccine production and in regulatory processes that might affect the SIP. It noted that the modest scale of the current SIP user base means that only a limited number of immunization doses are required for its immediate needs.
|
From page 134... ...
However, the committee observed that the SIP, as currently structured and managed, appears to lack a coordinated civilian and military stakeholder perspective on policy, management, and funding: Indeed, when the full vaccine MCM pathways are considered, there are important synergies but still important differences between the military and civilian programs, as summarized in Table 7.1. With the expansion of the MCM enterprise and the shifting nature of national security and public health threats, the mandate for countermeasures now extends well beyond DOD to include substantial investments by civilian research and public health agencies.
|
From page 135... ...
The IND status of many SIP vaccines also increases the regulatory burden and creates complex logistics for program administration, because continuing medical monitoring is required to document safety and immunogenicity. While the program provides a wealth of information, the IND
|
From page 136... ...
Despite previous reviews of the SIP and a 2004 Homeland Secu rity Council Policy Coordinating Committee decision to expand the program under a fully burdened cost-sharing arrangement, the committee expressed concerns about the continuing financial stability of the SIP and about access to SIP immunizations for all at-risk personnel who handle hazardous pathogens. The committee offers the following suggestions to address aspects of those concerns, although it recognizes that these may present additional costs: • The committee encourages agencies awarding contracts and grants (by HHS, BARDA, and others)
|
From page 137... ...
As a result, the committee offers a final recommendation: Recommendation 8: All biodefense contracting and granting agencies should consider covering the cost of immunizing at-risk research work ers so that this cost is not borne solely by the institutions working on government-supported programs. The committee supports the idea of central SIP administration but recommends that the SIP explore options for having a small number of satellite clinic locations around the country to reduce travel and inconvenience for other participating institutions (provided that they are able to adhere to the IND protocols)
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.