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NBSB Pandemic Influenza Working Group Detailed Report important to distinguish adverse events from conditions that would have occurred without immunization given the normal background rates. To illustrate his point, Dr. Salmon referred to spontaneous abortions. Given the current background rate of approximately 15% of clinically recognized pregnancies resulting in a spontaneous abortion (miscarriage), it is likely that with 50% vaccine coverage of all pregnant women, there would be about 1,200 spontaneous abortions within 24 hours of vaccination due entirely to chance. In the event of mass vaccination, an otherwise random event will not be seen as random, especially if and when adverse events occur in clusters. The following infrastructure are in place to support vaccine safety monitoring: VAERS is a passive surveillance system operated by the CDC and FDA that accepts reports from any source. Its limitations include likely underreporting and incomplete data. VAERS can be helpful in detecting signals or generating hypotheses but can not assess causality. It’s a national database that can look at vaccine-specific events and subpopulations. VSD is a large database of information from eight managed care organizations, operated by CDC, that includes exposure data (including vaccine histories), lot numbers, and complete patient medical records. It is useful for testing hypotheses but is limited by the small numbers of patients represented (3% of the U.S. population). CDC’s Clinical Immunization Safety Assessment (CISA) Network is used to investigate pathophysiological mechanisms and biological risks for adverse reactions. It incorporates VAERS data and can be used to develop clinical guidance. The DoD uses a number of systems, including VAERS, that involve both passive and active surveillance. The Military Vaccine Reporting System provides an option that allows a health care provider to follow up on the report. The Department of Veterans Affairs (VA) monitors events through its Adverse Events Reporting System and conducts active surveillance of influenza and pneumococcal vaccines in collaboration with FDA. It is developing rapid-cycle analysis techniques. The NVPO’s summary document, Comprehensive Review of Federal Vaccine Safety Programs and Public Health Activities, is available online at http://www.hhs.gov/nvpo/nvac/documents/ vaccine-safety-review.pdf. The challenges of safety monitoring for <strong>H1N1</strong> include the number of uncertainties about the formula, dosages, use of adjuvant, distribution, and prioritization. Will those vaccinated first be captured under current surveillance systems? What other mechanisms are available for surveillance? Dr. Salmon said the key challenges of evaluating the data include linking exposure and outcomes data, particularly if the vaccine is not delivered through the health care system. The database of the Centers for Medicare and Medicaid Services (CMS) could be useful if it can identify who was vaccinated. When pregnant women are vaccinated, it may be 32
NBSB Pandemic Influenza Working Group Detailed Report difficult to link the woman’s exposure with the child’s outcome. It’s likely there will be more than one vaccine. Background rates of other conditions are difficult to pin down. Finally, there must be a mechanism or planning to link State plans and data with Federal monitoring efforts. A subcommittee of the National Vaccine Advisory Committee (NVAC) has been charged to review current Federal plans for safety monitoring for a novel (<strong>H1N1</strong>) vaccine and provide feedback on the adequacy, strengths, weaknesses, and considerations for enhancement. Dr. Salmon stressed the need to get feedback quickly. Vaccine Safety: Basic Research—Charles Hackett, Ph.D., NIAID Dr. Hackett informed the NBSB Panel that a high priority for NIAID is conducting basic research relevant to vaccine safety, and it is increasing its research portfolio to that effect. The objectives of the immunological group on vaccine safety and efficacy research are as follows: Maximize efficacy and minimize side effects o Determine the immunological basis for adjuvant activity • Mechanisms of toxicity vs. immunogenicity • Extrapolation from animal models • Role of formulation and delivery systems o T & B cell memory induction and maintenance (an important part of efficacy) o Immunogen design and production • Critical epitopes—T and B cells; NIAID is awarding grant funding to map both T- and B-cell epitopes and send them to the NIAID Immune Epitope Database • Potential mechanisms for cross-protection • Innate immune stimulae in live attenuated vs. inactivated vaccines • Potential for adjuvants to expand vaccine supply and make vaccines more efficient Diversity of response across human populations o Immunologically interesting groups, such as those who do not respond to antigen-only vaccine Ongoing research programs include the following: Immune Function and Biodefense in Children, Elderly, and Immunocompromised (This program includes pregnant women; it is in the early stages, and enrollment has been slow.) Population Genetics Analysis Program (This program includes several studies on adverse events with smallpox vaccine.) Atopic Dermatitis and Vaccinia Network Adjuvant Discovery Adjuvant Development (The discovery and development programs have been asked to identify potential adjuvant safety issues.) 33
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