An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program

An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309086264
Category : Medical
Languages : en
Pages : 179

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Book Description
In 1998, the Department of Defense (DoD) began a program of mandatory immunization against anthrax for all military personnel. As the program proceeded, however, some military personnel and their families raised concerns about the safety and efficacy of the anthrax vaccine. Acknowledging both the need to protect military personnel and the concerns about the anthrax vaccine, congress directed the Centers for Disease Control and Prevention (CDC) to carry out a research program on its safety and efficacy. To assist in the development of this program, CDC requested the Institute of Medicine (IOM) to convene a committee to review the completeness and appropriateness of the research program. In An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program, the committee makes an overall assessment of the CDD research plan and reviews the specific studies proposed by CDC in the three areas of efficacy, safety and acceptability. The committee also notes additional research needs that became evident following the bioterrorist events of 2001 and makes recommendations about the leadership of the research program.

An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program

An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309086264
Category : Medical
Languages : en
Pages : 179

Get Book Here

Book Description
In 1998, the Department of Defense (DoD) began a program of mandatory immunization against anthrax for all military personnel. As the program proceeded, however, some military personnel and their families raised concerns about the safety and efficacy of the anthrax vaccine. Acknowledging both the need to protect military personnel and the concerns about the anthrax vaccine, congress directed the Centers for Disease Control and Prevention (CDC) to carry out a research program on its safety and efficacy. To assist in the development of this program, CDC requested the Institute of Medicine (IOM) to convene a committee to review the completeness and appropriateness of the research program. In An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program, the committee makes an overall assessment of the CDD research plan and reviews the specific studies proposed by CDC in the three areas of efficacy, safety and acceptability. The committee also notes additional research needs that became evident following the bioterrorist events of 2001 and makes recommendations about the leadership of the research program.

The Anthrax Vaccine

The Anthrax Vaccine PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309182743
Category : Medical
Languages : en
Pages : 288

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Book Description
The vaccine used to protect humans against the anthrax disease, called Anthrax Vaccine Adsorbed (AVA), was licensed in 1970. It was initially used to protect people who might be exposed to anthrax where they worked, such as veterinarians and textile plant workers who process animal hair. When the U. S. military began to administer the vaccine, then extended a plan for the mandatory vaccination of all U. S. service members, some raised concerns about the safety and efficacy of AVA and the manufacture of the vaccine. In response to these and other concerns, Congress directed the Department of Defense to support an independent examination of AVA. The Anthrax Vaccine: Is It Safe? Does It Work? reports the study's conclusion that the vaccine is acceptably safe and effective in protecting humans against anthrax. The book also includes a description of advances needed in main areas: improving the way the vaccine is now used, expanding surveillance efforts to detect side effects from its use, and developing a better vaccine.

An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program

An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program PDF Author: Committee to Review the CDC Anthrax Vaccine Safety and Efficacy Research Program
Publisher: National Academies Press
ISBN: 0309168953
Category : Medical
Languages : en
Pages : 179

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Book Description
In 1998, the Department of Defense (DoD) began a program of mandatory immunization against anthrax for all military personnel. As the program proceeded, however, some military personnel and their families raised concerns about the safety and efficacy of the anthrax vaccine. Acknowledging both the need to protect military personnel and the concerns about the anthrax vaccine, congress directed the Centers for Disease Control and Prevention (CDC) to carry out a research program on its safety and efficacy. To assist in the development of this program, CDC requested the Institute of Medicine (IOM) to convene a committee to review the completeness and appropriateness of the research program. In An Assessment of the CDC Anthrax Vaccine Safety and Efficacy Research Program, the committee makes an overall assessment of the CDD research plan and reviews the specific studies proposed by CDC in the three areas of efficacy, safety and acceptability. The committee also notes additional research needs that became evident following the bioterrorist events of 2001 and makes recommendations about the leadership of the research program.

Vaccine Safety Research, Data Access, and Public Trust

Vaccine Safety Research, Data Access, and Public Trust PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309165245
Category : Medical
Languages : en
Pages : 152

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Book Description
The Vaccine Safety Datalink (VSD) is a large, linked database of patient information that was developed jointly by CDC and several private managed care organizations in 1991. It includes data on vaccination histories, health outcomes, and characteristics of more than 7 million patients of eight participating health organizations. Researchers from CDC and the managed care groups have used VSD information to study whether health problems are associated with vaccinations. The subsequent VSD data sharing program was launched in 2002 to allow independent, external researchers access to information in the database. In this report, the committee that was asked to review aspects of this program recommends that two new oversight groups are needed to ensure that the policies and procedures of the VSD and its data sharing program are implemented as fairly and openly as possible.

Twenty-first Century Biological Threats

Twenty-first Century Biological Threats PDF Author: United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions. Subcommittee on Bioterrorism and Public Health Preparedness
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 64

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Book Description


General Recommendations on Immunization

General Recommendations on Immunization PDF Author:
Publisher:
ISBN:
Category : Immunization
Languages : en
Pages : 12

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Book Description


The Childhood Immunization Schedule and Safety

The Childhood Immunization Schedule and Safety PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309267021
Category : Medical
Languages : en
Pages : 237

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Book Description
Vaccines are among the most safe and effective public health interventions to prevent serious disease and death. Because of the success of vaccines, most Americans today have no firsthand experience with such devastating illnesses as polio or diphtheria. Health care providers who vaccinate young children follow a schedule prepared by the U.S. Advisory Committee on Immunization Practices. Under the current schedule, children younger than six may receive as many as 24 immunizations by their second birthday. New vaccines undergo rigorous testing prior to receiving FDA approval; however, like all medicines and medical interventions, vaccines carry some risk. Driven largely by concerns about potential side effects, there has been a shift in some parents' attitudes toward the child immunization schedule. The Childhood Immunization Schedule and Safety identifies research approaches, methodologies, and study designs that could address questions about the safety of the current schedule. This report is the most comprehensive examination of the immunization schedule to date. The IOM authoring committee uncovered no evidence of major safety concerns associated with adherence to the childhood immunization schedule. Should signals arise that there may be need for investigation, however, the report offers a framework for conducting safety research using existing or new data collection systems.

Prepositioning Antibiotics for Anthrax

Prepositioning Antibiotics for Anthrax PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 030921808X
Category : Medical
Languages : en
Pages : 358

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Book Description
If terrorists released Bacillus anthracis over a large city, hundreds of thousands of people could be at risk of the deadly disease anthrax-caused by the B. anthracis spores-unless they had rapid access to antibiotic medical countermeasures (MCM). Although plans for rapidly delivering MCM to a large number of people following an anthrax attack have been greatly enhanced during the last decade, many public health authorities and policy experts fear that the nation's current systems and plans are insufficient to respond to the most challenging scenarios, such as a very large-scale anthrax attack. The U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response commissioned the Institute of Medicine to examine the potential uses, benefits, and disadvantages of strategies for repositioning antibiotics. This involves storing antibiotics close to or in the possession of the people who would need rapid access to them should an attack occur. Prepositioning Antibiotics for Anthrax reviews the scientific evidence on the time window in which antibiotics successfully prevent anthrax and the implications for decision making about prepositioning, describes potential prepositioning strategies, and develops a framework to assist state, local, and tribal public health authorities in determining whether prepositioning strategies would be beneficial for their communities. However, based on an analysis of the likely health benefits, health risks, and relative costs of the different prepositioning strategies, the book also develops findings and recommendations to provide jurisdictions with some practical insights as to the circumstances in which different prepositioning strategies may be beneficial. Finally, the book identifies federal- and national-level actions that would facilitate the evaluation and development of prepositioning strategies. Recognizing that communities across the nation have differing needs and capabilities, the findings presented in this report are intended to assist public health officials in considering the benefits, costs, and trade-offs involved in developing alternative prepositioning strategies appropriate to their particular communities.

Vaccines

Vaccines PDF Author: Stanley A. Plotkin
Publisher: Elsevier Health Sciences
ISBN: 1437721583
Category : Medical
Languages : en
Pages : 1748

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Book Description
Completely revised and updated, this respected reference offers comprehensive and current coverage of every aspect of vaccination-from development to use in reducing disease. It provides authoritative information on vaccine production, available preparations, efficacy, and safety...recommendations for vaccine use, with rationales...data on the impact of vaccination programs on morbidity and mortality...and more. And now, as an Expert Consult title, it includes a companion web site offering this unparalleled guidance where and when you need it most! Provides a complete understanding of each disease, including clinical characteristics, microbiology, pathogenesis, diagnosis, and treatment, as well an epidemiology and public health issues. Offers comprehensive coverage of both existing vaccines and vaccines currently in the research and development stage. Examines vaccine stability, immunogenicity, efficacy, duration of immunity, adverse events, indications, contraindications, precautions, administration with other vaccines, and disease control strategies. Analyses the cost-benefit and cost-effectiveness of vaccines. Discusses the proper use of immune globulins and antitoxins. Illustrates concepts and objective data with approximately 600 tables and figures. Includes access to a companion web site offering the complete contents of the book - fully searchable - for rapid consultation from anyplace with an Internet connection.

Adverse Effects of Vaccines

Adverse Effects of Vaccines PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309214351
Category : Medical
Languages : en
Pages : 894

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Book Description
In 1900, for every 1,000 babies born in the United States, 100 would die before their first birthday, often due to infectious diseases. Today, vaccines exist for many viral and bacterial diseases. The National Childhood Vaccine Injury Act, passed in 1986, was intended to bolster vaccine research and development through the federal coordination of vaccine initiatives and to provide relief to vaccine manufacturers facing financial burdens. The legislation also intended to address concerns about the safety of vaccines by instituting a compensation program, setting up a passive surveillance system for vaccine adverse events, and by providing information to consumers. A key component of the legislation required the U.S. Department of Health and Human Services to collaborate with the Institute of Medicine to assess concerns about the safety of vaccines and potential adverse events, especially in children. Adverse Effects of Vaccines reviews the epidemiological, clinical, and biological evidence regarding adverse health events associated with specific vaccines covered by the National Vaccine Injury Compensation Program (VICP), including the varicella zoster vaccine, influenza vaccines, the hepatitis B vaccine, and the human papillomavirus vaccine, among others. For each possible adverse event, the report reviews peer-reviewed primary studies, summarizes their findings, and evaluates the epidemiological, clinical, and biological evidence. It finds that while no vaccine is 100 percent safe, very few adverse events are shown to be caused by vaccines. In addition, the evidence shows that vaccines do not cause several conditions. For example, the MMR vaccine is not associated with autism or childhood diabetes. Also, the DTaP vaccine is not associated with diabetes and the influenza vaccine given as a shot does not exacerbate asthma. Adverse Effects of Vaccines will be of special interest to the National Vaccine Program Office, the VICP, the Centers for Disease Control and Prevention, vaccine safety researchers and manufacturers, parents, caregivers, and health professionals in the private and public sectors.