Priorities for the National Vaccine Plan (2010) / Chapter Skim
Currently Skimming:
2 The Safety of Vaccines and Vaccination Practices
2 The Safety of Vaccines and Vaccination Practices
Pages 51-78
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 51... ...
The fact that the founding of the National Vaccine Program (and by extension its executive entity, the National Vaccine Program Office [NVPO]
|
From page 52... ...
the National Vaccine Program and Plan. The second part of the chapter is organized around four recommendations about priority actions for vaccine safety in the National Vaccine Plan.
|
From page 53... ...
Vaccine safety researchers both at FDA and outside government have emphasized the equal importance of adequate pre-licensure study and post-licensure surveillance for "signals" of adverse events. It is challenging to detect a true "signal" of a vaccine safety problem amidst the considerable "noise" of coincidental, only temporally related events.
|
From page 54... ...
. A CASE STUDY OF VACCINE SAFETY SYSTEM FUNCTIONING The federal vaccine safety system's response to evaluate reported adverse events following immunization with RRV-TV entailed an extensive effort.
|
From page 55... ...
55 THE SAFETY OF VACCINES AND VACCINATION PRACTICES TABLE 2-1 Rotashield Vaccine Timeline (1999-2001) Date Event Before licensure In the absence of rotavirus vaccines, there are 3 million cases of rotavirus infection per year (in children under age 5)
|
From page 56... ...
. CDC investigators review medical records of all VAERS reports of intussusception following rotavirus vaccine (Zanardi et al., 2001)
|
From page 57... ...
that provide "expert consultative services for vaccine adverse events case management and reporting; research in vaccine safety and quality assurance; and healthcare provider/patient education and training programs." Before the 1986 NCVIA was enacted, reports of adverse events following immunization were captured through two different systems. One was a system administered by FDA and intended to gather spontaneous vaccine adverse event reports from manufacturers, pharmacists, health care providers, and the military.
|
From page 58... ...
. Acronyms: CISA: Clinical Immunization Safety Assessment; MCOs: Managed Care Organizations; NIH: National Institutes of Health.
|
From page 59... ...
network that is a collaborative effort between CDC, AHIP, five academic medical institutions, and one managed care organization. CISA investigators conduct intensive clinical study of cases of adverse events following immunization, in an effort to better understand the complex relationship to vaccines and inform the development of guidance for clinicians on the management of serious adverse events (Halsey et al., 2009)
|
From page 60... ...
A national discussion among both federal partners and non-government stakeholders about vaccine safety research priorities could also inform investigations based on the sentinel system. This will require greater coordination between CDC, FDA, and other federal agencies, and the committee hopes, strong coordination with national health information technology efforts.
|
From page 61... ...
CDC is able to deploy epidemiologists and other experts to conduct case-control interviews, conduct laboratory research, work with state public health personnel and health care providers, and carry out other activities needed to intensively investigate a potential serious adverse event following immunization. The experience with the first rotavirus vaccine, RRV-TV, described above, is an example of the federal and state public health capabilities in quickly responding to and elucidating the meaning of a vaccine safety "signal" captured through VAERS or by other means (e.g., active surveillance through VSD)
|
From page 62... ...
Escalating litigation costs related primarily to claims of vaccine-related injuries inadvertently caused by properly manufactured and administered live oral polio virus vaccine and whole cell pertussis vaccines threatened the vaccine industry's economic viability and thereby the supply of vaccine required to continue public health immunization programs. Congress established VICP "[b]
|
From page 63... ...
Delays also have resulted in the large proportion of off-table awards based only on a preponderance of the often scant evidence available, perhaps heightening public worry about vaccine safety. NVPO and the Plan The Introduction to this report provides a history of NVPO and the National Vaccine Plan.
|
From page 64... ...
Development of a coordinated, structured process to address vaccine safety signals promptly on detection and track them through until resolution (including a way to consider and address safety concerns raised through the Vaccine Injury Compensation Program)
|
From page 65... ...
The committee believes that scientific hypotheses raised by the compensation program could inform the safety research agenda, help to spur additional research, and potentially 8 The Global Advisory Committee on Vaccine Safety of the World Health Organization has described a set of widely accepted criteria for assessment of causality with regard to adverse events following immunization (Folb et al., 2004)
|
From page 66... ...
Although the ISO agenda represents the future work of a considerable proportion of the federal vaccine safety system, a national vaccine safety research agenda is needed to help guide and coordinate the efforts of all federal agencies and non-government and industry stakeholders that are responsible for one or more aspects of vaccine safety research. Furthermore, the ISO agenda is largely focused on
|
From page 67... ...
There has been a high level of public interest in and speculation about potential links between vaccines and certain diseases of the immune and nervous systems, such as Guillain-Barré syndrome, autism, ADHD,9 and asthma, and the institutes listed above support a variety of studies that might shed some light on biological mechanisms, genetic factors, and other characteristics that may have relevance to vaccine safety. Recommendation 2-2: The National Vaccine Plan should emphasize the development and publication of a framework for prioritizing a national vaccine safety research agenda that spans all federal agen cies and includes all stakeholders, including the public.
|
From page 68... ...
Coordination and Vaccine Safety One of the five dimensions of the vaccine safety system outlined by the 1986 act refers to the overarching National Vaccine Program, and by extension, to its operating arm, NVPO. The HHS Comprehensie Reiew of Federal Vaccine Safety Programs and Public Health Actiities (2008a)
|
From page 69... ...
The committee recognized that the task force was seeking to fill a major gap in the coordination necessary to ensure an effective vaccine safety program. The task force discussed the Interagency Vaccine Group, an internal government entity that is still in operation, and described a potential role for it in strengthening coordination of vaccine safety activities, from communication, to monitoring and surveillance, to safety research.
|
From page 70... ...
National Vaccine Plan in 1994.a a The task force report added: "Vaccine safety oversight resides among a broad group of advisory committees and government groups. Most notable are the DHHS immunization related advisory committees including the Advisory Commission on Childhood Vaccines, the Immunization Practices Advisory Committee, the Microbiology and Infectious Diseases Review Advisory Committee (MIDRAC)
|
From page 71... ...
, and that such a role would ideally be performed in a setting that permits meetings that are open to the public. 10 The IAVG has continued to operate, and the committee has found several references to it in NVAC minutes between 2004 and 2009 (for example, a reference to the group's role in shaping the charge to the former IOM Immunization Safety Review Committee, a reference to a 2008 meeting with the ISO on its draft agenda, and a reference to its role in developing the National Vaccine Plan)
|
From page 72... ...
. Funding for Vaccine Safety Research A major theme in the stakeholder comments about Goal 2 of the draft National Vaccine Plan was the inadequacy of funding for vaccine safety research (IOM, 2009)
|
From page 73... ...
, especially in the absence of a strong coordinating entity within the National Vaccine Program that can help align program-wide needs (such as vaccine safety research) with solutions.
|
From page 74... ...
With regard to academia and its contributions to the safety research agenda, stakeholder comments identified a need to comprehensively integrate education about vaccines and immunization in professional education, and also to train the next generation of vaccine safety researchers in relevant disciplines. Recommendation 2-4: The National Vaccine Plan should incor porate concrete steps to expand and strengthen vaccine safety research, including: • enhanced funding for CDC's Immunization Safety Office activities, including support of extramural research; • enhanced funding for FDA's safety monitoring activities; and • expansion of NIH vaccine safety activities to include re search portfolios, funding through requests for proposals, program announcements, and creation of a study section dedicated to vac cine safety research.
|
From page 75... ...
The links between Goals 2 and 3 in the National Vaccine Plan were also very evident at the committee's information-gathering meetings with national stakeholders. Communication, or "informed vaccine decision making," as the topic is framed in the draft plan, is discussed in detail in Chapter 3.
|
From page 76... ...
. Transcript, Fourth National Stakeholder Meeting of the IOM Commit tee on Reiew of Priorities in the National Vaccine Plan.
|
From page 77... ...
. The National Vaccine Program 00 State of the Program Report.
|
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.