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Guideline Summary
Guideline Title
Immunization programs for infants, children, adolescents, and adults: clinical practice guidelines by the Infectious Diseases Society of America.
Bibliographic Source(s)
Pickering LK, Baker CJ, Freed GL, Gall SA, Grogg SE, Poland GA, Rodewald LE, Schaffner W, Stinchfield P, Tan L, Zimmerman RK, Orenstein WA, Infectious Diseases Society of America. Immunization programs for infants, children, adolescents, and adults: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Sep 15;49(6):817-40. [123 references] PubMed External Web Site Policy
Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: Gardner P, Pickering LK, Orenstein WA, Gershon AA, Nichol KL. Guidelines for quality standards for immunization. Clin Infect Dis 2002 Sep 1;35(5):503-11. [48 references]

Scope

Disease/Condition(s)

Adult and pediatric diseases that can be prevented through vaccination

Guideline Category
Prevention
Clinical Specialty
Family Practice
Infectious Diseases
Internal Medicine
Obstetrics and Gynecology
Pediatrics
Preventive Medicine
Intended Users
Advanced Practice Nurses
Nurses
Physician Assistants
Physicians
Guideline Objective(s)

To provide immunization program recommendations for health care professionals to ensure appropriate and timely administration of recommended immunizations to infants, children, adolescents, and adults

Target Population

Immunocompetent or immunocompromised people of all ages

Interventions and Practices Considered
  1. Age-appropriate vaccinations (according to the Advisory Committee on Immunizations Practices, American Academy of Family Physicians, and American Academy of Pediatrics)
  2. Timing, spacing, and simultaneous vaccine administration
  3. Health care provider awareness of the National Vaccine Injury Compensation Program (NVICP)
  4. Patient/parent education about the benefits and risks of vaccines
  5. Minimize patient out-of-pocket expenses including the use of vaccine-financing programs
  6. Identify and eliminate barriers to immunizations
  7. Implement reminder/recall systems
  8. Use of community-based settings for immunizations
  9. Immunizations for all health care professionals, immunocompromised patients, and pregnant women as appropriate
  10. Country-specific vaccines for those traveling internationally
  11. Assessment of vaccine status for internationally adopted children and reimmunization when appropriate
Major Outcomes Considered
  • Immunization rates
  • Vaccine adverse event rates

Methodology

Methods Used to Collect/Select the Evidence
Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

For the 2009 update, the Expert Panel reviewed data published since 2000 and literature referenced in the 2002 guidelines. Computerized literature searches of the PubMed database were performed using the terms immunization, vaccination, and vaccines. Only English-language literature was reviewed. The review focused on human studies.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

Quality of Evidence

  1. Evidence from at least 1 properly designed randomized, controlled trial
  2. Evidence from at least 1 well-designed clinical trial, without randomization; from cohort or case-controlled analytic studies (preferably from >1 center); from multiple time series; or from dramatic results from uncontrolled experiments
  3. Evidence from opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees

Note: Adapted from the Canadian Task Force on the Periodic Health Examination.

Methods Used to Analyze the Evidence
Systematic Review
Description of the Methods Used to Analyze the Evidence

In evaluating evidence regarding management of immunizations, the Expert Panel followed a process used in development of other Infectious Diseases Society of America (IDSA) guidelines. The process included a systematic weighting of the quality of evidence and the grade of recommendation.

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

The Infectious Diseases Society of America (IDSA) Standards and Practice Guidelines Committee (SPGC) convened experts in the field of vaccinology from the United States. Panel members had experience in pediatric and adult clinical and laboratory medicine, nursing, public health, and infectious diseases and included representatives from the following collaborating organizations: American Academy of Pediatrics (AAP), American College of Obstetricians and Gynecologists (ACOG), American College of Physicians (ACP), American Medical Association (AMA), American Osteopathic Association, Centers for Disease Control and Prevention (CDC), National Association of Pediatric Nurse Practitioners, National Vaccine Advisory Committee of the Department of Health and Human Services, and the Pediatric Infectious Diseases Society.

The entire Expert Panel met on 4 occasions via teleconference to initiate and complete the guidelines. The purposes of the teleconferences were to discuss and formalize the questions (objectives) to be addressed, designate writing assignments, review draft guidelines, and obtain input about external review. All members of the Expert Panel participated in preparation of the draft guidelines.

Rating Scheme for the Strength of the Recommendations

Strength of Recommendation

  1. Good evidence to support a recommendation for use
  2. Moderate evidence to support a recommendation for use
  3. Poor evidence to support a recommendation

Note: Adapted from the Canadian Task Force on the Periodic Health Examination.

Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation
External Peer Review
Internal Peer Review
Description of Method of Guideline Validation

All members of the Expert Panel participated in preparation of the draft guidelines, which were then disseminated for review by the entire Expert Panel. Feedback from external reviewers also was solicited (see the Acknowledgements in the original guideline document). All collaborating organizations were asked to provide feedback and endorse the guidelines. These guidelines were reviewed and cleared by the Centers for Disease Control and Prevention (CDC), are supported by the American Medical Association (AMA), and have been endorsed by the following organizations: the American Academy of Pediatrics (AAP), the National Association of Pediatric Nurse Practitioners, and the Pediatric Infectious Diseases Society. The content of the guidelines and the manuscript were reviewed and approved by the Infectious Diseases Society of America (IDSA) Standards and Practice Guidelines Committee (SPGC) and by the Board of Directors before dissemination.

Recommendations

Major Recommendations

Quality of evidence (I–III) and strength of recommendation (A–C) ratings are defined at the end of the "Major Recommendations" field.

What Are the Current Immunization Recommendations for Infants, Children, Adolescents, and Adults?

  1. Infants, children, adolescents, and adults should receive all age-appropriate vaccines recommended by the Advisory Committee on Immunization Practices, the American Academy of Family Physicians, and the American Academy of Pediatrics (A-I).
  2. Any vaccine dose not administered at the recommended age should be administered at any subsequent medical encounter when indicated and feasible without reinitiating the series (A-III).
  3. Recommendations for the minimum interval between doses for people who have delayed immunizations or who want to accelerate their schedule should be followed (B-III).
  4. When appropriate, all indicated vaccines should be administered simultaneously (B-III).
  5. Licensed combination vaccines can be administered whenever any components of the combination are indicated, other components are not contraindicated, and if the vaccine is licensed by the U.S. Food and Drug Administration (FDA) for that dose of the series (A-I).
  6. Immunization requirements for childcare, school and college attendance, and nursing homes should be followed (A-II).
  7. Vaccine delivery should be coordinated with other preventive health care services for children, adolescents, and adults (B-III).
  8. All vaccines should be stored and administered as recommended by the manufacturer and as licensed by the Food and Drug Administration (B-II).

What Are the Current Immunization Standards, and How Do They Contribute to Overcoming Barriers to Immunization and Address Vaccine Safety, Misconceptions, Finance, Access, and Strategies to Improve Coverage?

  1. Health care providers should determine and follow valid vaccine contraindications and precautions before administration of any vaccine (B-III).
  2. Health care providers should be aware of the National Vaccine Injury Compensation Program (VICP) and its requirements (B-III).
  3. All patients or parents should receive Vaccine Information Statements (VISs) for each vaccine administered as required by law for vaccines covered by the VICP (C-III).
  4. Providers should educate their patients and parents about the benefits, safety, and risks of vaccines in a culturally appropriate and easy-to-understand language prior to each immunization (C-III).
  5. Clinically significant adverse events following immunization should be reported to the Vaccine Adverse Events Reporting System (VAERS) (B-III).

Finance

  1. Patient out-of-pocket immunization expenses should be minimized (A-I).
  2. Vaccine-financing programs, including the Vaccines for Children (VFC) program, Section 317 of the Public Health Service Act federal grant program, state programs, and private insurance, should be optimized for each patient, as appropriate (B-II).
  3. Providers who serve infants, children, and adolescents aged <19 years should be enrolled in the VFC program (B-II).
  4. Providers should be aware of other government-supported and other funded programs that cover the cost of vaccines and their administration for people who do not have adequate resources (C-III).

Access to Immunizations

  1. Barriers to immunizations should be identified and eliminated or as minimized as possible (B-II).
  2. Immunization services should be easy to access, including express immunization services (e.g., influenza immunization clinics) and expanded hours of immunization services (A-II).
  3. Immunization should be integrated into routine health care services offered in offices and clinics (C-III).
  4. Private providers should consider participating in programs that provide financially vulnerable adults with access to immunizations at no cost (C-III).

Strategies to Improve Immunization Coverage

  1. Reminder/recall systems should be used to enhance immunization rates (A-I).
  2. Information regarding administration of vaccines should be entered into immunization information systems (i.e., immunization registries) (B-III).
  3. Standing orders for immunizations should be established in clinics, hospitals, and nursing homes (A-I).
  4. The immunization status of patients should be reviewed at each patient visit (B-II), and patients and parents should be provided with accurate immunization records at office or clinic visits (B-III).
  5. All health care providers who administer vaccines should be properly educated and should receive ongoing education (A-III).
  6. Regular assessments of immunization coverage rates should be conducted in provider practices (A-I).
  7. Demand for adolescent and adult immunization should be increased by improving public and provider awareness of immunizations recommended for adolescents and adults (B-III).

How Is Immunization Implemented in Complementary (Nontraditional) Immunization Settings?

  1. Providers should support use of community-based settings to immunize target populations that have difficulty accessing usual immunization providers (B-III).
  2. Providers should support establishment of school-based, childcare-based, and hospital-based immunization programs to deliver influenza immunization to school-aged children, adolescents, and adults (B-III).
  3. Immunization providers in complementary settings should adhere to quality standards, including ability to appropriately manage vaccine-related adverse events, proper storage and handling of vaccines, appropriate record keeping, regulatory issues, and provision of education regarding both risks and benefits of immunizations, as well as other preventive care measures, including adherence to hand hygiene (B-III).
  4. Providers of immunizations in nontraditional settings should ensure that records of immunizations administered in these settings are sent to primary care providers and to immunization information systems (registries) and should encourage vaccinees in such settings to see their primary care providers for other preventive and therapeutic services (B-III).

What Are the Current Immunization Recommendations for Special Groups, Including Health Care Providers, Immunocompromised People, Pregnant Women, International Travelers, and Internationally Adopted Children?

Health Care Professionals

  1. All health care professionals should be immunized appropriately (B-II). Specifically, annual immunization with influenza vaccine and receipt of a booster dose of the tetanus, diphtheria, and pertussis (Tdap) vaccine should be ensured, as well as adequate immunization against measles, mumps, rubella, and varicella. People whose work anticipates they may be exposed to blood or body fluids should be immunized against hepatitis B.
  2. Hospitals, clinics, and offices should implement programs to ensure that health care professionals are immunized appropriately and that annual immunization coverage assessments are performed (B-II).

Immunocompromised Persons

  1. All immunocompromised infants, children, adolescents, and adults should be appropriately immunized (B-II).
  2. Providers should be aware of contraindications and precautions for vaccines in people with primary and secondary immunodeficiencies (B-III).
  3. Providers should educate immunocompromised patients that, depending on the vaccine and their degree of immune dysfunction, the vaccines that are administered may not be fully effective (C-III).
  4. Providers who care for immunocompromised patients should ensure that household contacts are immunized appropriately to reduce the risk of exposure of immunocompromised patients to vaccine-preventable diseases (B-III).

Pregnancy

  1. Providers should be aware of immunizations routinely recommended for women during pregnancy, including inactivated trivalent influenza vaccine (A-II).
  2. Providers should administer appropriate vaccines to pregnant women with medical or exposure indications that put them at risk of certain vaccine-preventable diseases (A-I).
  3. Following delivery, women should receive all recommended vaccines that could not be or were not administered during pregnancy (A-II).
  4. Providers should be aware of and follow valid contraindications and precautions for immunizing pregnant women (A-III).

International Travel

  1. Providers who care for people who travel should ensure that all country-specific vaccines are administered in a time frame that ensures optimal development of protection (A-I).
  2. Health care professionals should be aware of key sources of information regarding immunization of travelers at every age (B-III).

Internationally Adopted Children

  1. Providers should accept only written documentation as evidence of previous immunization (B-III).
  2. Providers should be aware of the various approaches that can be followed if there is concern about whether vaccines administered to an international adoptee were immunogenic (B-III).

Definitions:

Quality of Evidence*

  1. Evidence from at least 1 properly designed randomized, controlled trial
  2. Evidence from at least 1 well-designed clinical trial, without randomization; from cohort or case-controlled analytic studies (preferably from >1 center); from multiple time series; or from dramatic results from uncontrolled experiments
  3. Evidence from opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees

Strength of Recommendation*

  1. Good evidence to support a recommendation for use
  2. Moderate evidence to support a recommendation for use
  3. Poor evidence to support a recommendation

*Adapted from the Canadian Task Force on the Periodic Health Examination.

Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is identified and graded for each recommendation (see the "Major Recommendations" field).

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Appropriate and timely administration of recommended immunizations to infants, children, adolescents, and adults

Potential Harms

Anaphylaxis has been demonstrated to occur on rare occasions to certain vaccines, and immunoglobulin E–mediated immune responses to some vaccine components have been demonstrated, including gelatin contained in some vaccines. If a person with a history of anaphylaxis to a vaccine or component of the vaccine is given the vaccine inappropriately, then anaphylaxis may recur. On some occasions, disseminated infection with vaccine virus has occurred, with serious consequences, in persons who are severely immunocompromised and who receive a live viral vaccine. Such outcomes have included vaccine-associated paralytic poliomyelitis following administration of oral polio virus vaccine and measles-associated encephalitis in patients with congenital immunodeficiencies who have received a measles virus–containing vaccine.

Contraindications

Contraindications
  • A generic contraindication for all vaccines is prior anaphylactic reaction to a vaccine or a vaccine constituent. A precaution does not preclude vaccine administration, but the events or conditions listed as a precaution should be reviewed carefully before vaccine administration (http://www.cdc.gov/vaccines/recs/vac-admin/contraindications.htm External Web Site Policy).
  • Health care providers should determine and follow valid vaccine contraindications and precautions before administration of any vaccine.
  • For information about vaccine contraindications in children and adolescents with primary and secondary immune deficiencies, see Table 5 in the original guideline document External Web Site Policy.

Qualifying Statements

Qualifying Statements

These guidelines were developed and issued on behalf of the Infectious Diseases Society of America (IDSA). It is important to realize that guidelines cannot always account for individual variation among patients. They are not intended to supplant physician judgment with respect to particular patients or special clinical situations. The IDSA considers adherence to these guidelines to be voluntary, with the ultimate determination regarding their application to be made by the physician in the light of each patient’s individual circumstances.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Implementation Tools
Audit Criteria/Indicators
Pocket Guide/Reference Cards
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Staying Healthy
IOM Domain
Effectiveness
Patient-centeredness
Safety
Timeliness

Identifying Information and Availability

Bibliographic Source(s)
Pickering LK, Baker CJ, Freed GL, Gall SA, Grogg SE, Poland GA, Rodewald LE, Schaffner W, Stinchfield P, Tan L, Zimmerman RK, Orenstein WA, Infectious Diseases Society of America. Immunization programs for infants, children, adolescents, and adults: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Sep 15;49(6):817-40. [123 references] PubMed External Web Site Policy
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2002 Sep 1 (updated 2009 Sep 15)
Guideline Developer(s)
Infectious Diseases Society of America - Medical Specialty Society
Source(s) of Funding

Infectious Diseases Society of America (IDSA)

Guideline Committee

Expert Panel of the Infectious Diseases Society of America (IDSA)

Composition of Group That Authored the Guideline

Expert Panel Members: Carol Baker (Baylor College of Medicine), Gary Freed (University of Michigan Health System), Stanley Gall (University of Louisville), Stanley Grogg (Oklahoma State University), Walter Orenstein (Bill and Melinda Gates Foundation), Larry Pickering (Centers for Disease Control and Prevention), Gregory Poland (Mayo Clinic College of Medicine), Lance Rodewald (Centers for Disease Control and Prevention), William Schaffner (Vanderbilt University School of Medicine), Patricia Stinchfield (Children's Hospitals and Clinics of Minnesota), L. J. Tan (American Medical Association), and Richard Zimmerman (University of Pittsburgh School of Medicine)

Financial Disclosures/Conflicts of Interest

All members of the Expert Panel complied with the Infectious Diseases Society of America (IDSA) policy on conflicts of interest, which requires disclosure of any financial or other interest that might be construed as constituting an actual, potential, or apparent conflict. Members of the Expert Panel were provided the IDSA conflict of interest disclosure statement and were asked to identify links to companies developing products that might be affected by promulgation of the guidelines. Information was requested regarding employment, consultancies, stock ownership, honoraria, research funding, expert testimony, and membership on company advisory committees. The Expert Panel made decisions on a case-by-case basis as to whether an individual’s role should be limited as a result of a conflict. No limiting conflicts were identified.

S.A.G. serves as a consultant to the advisory boards and has received research grants from Merck and GlaxoSmithKline and serves on the speaker’s bureaus of Merck, GlaxoSmithKline, Sanofi Pasteur, and the Advisory Committee on Immunization Practices working group for Influenza and HPV.

S.E.G. has received research funding from Astellas, GlaxoSmithKline, Merck, Sanofi Pasteur, MedImmune, and Wyeth; is a member of Merck’s Male Population Advisory Board for the HPV (Gardasil) vaccine; and serves on the speaker’s bureau for and has received honoraria from Merck and AstraZeneca Pharmaceuticals.

W.S. serves on the Merck Data Safety Monitoring Board for Experimental Vaccines and has received honoraria from Sanofi Pasteur and MedImmune.

G.A.P. has received research grants from and serves as a consultant to the National Institutes of Health, the Centers for Disease Control and Prevention, Novavax, Merck, Protein Sciences, GlaxoSmithKline, Novartis, CSL Limited, PowderMed, and Avianax.

R.Z. serves on the Data Safety Monitoring Board, has received educational and research grants from Merck, and is in contract negotiations with MedImmune.

L.K.P., C.J.B., G.L.F, L.R., P.S., L.T., and W.A.O.: no conflicts.

Guideline Endorser(s)
American Academy of Pediatrics - Medical Specialty Society
National Association of Pediatric Nurse Practitioners - Professional Association
Pediatric Infectious Diseases Society - Medical Specialty Society
Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: Gardner P, Pickering LK, Orenstein WA, Gershon AA, Nichol KL. Guidelines for quality standards for immunization. Clin Infect Dis 2002 Sep 1;35(5):503-11. [48 references]

Guideline Availability

Electronic copies: Available from the Infectious Diseases Society of America (IDSA) Web site External Web Site Policy.

Availability of Companion Documents

The following is available:

Measures for internal performance improvement are available in the original guideline document External Web Site Policy.

Patient Resources

None available

NGC Status

This NGC summary was completed by ECRI Institute on March 16, 2010. The information was verified by the guideline developer on May 3, 2010. This summary was updated by ECRI Institute on November 12, 2010 following the U.S. Food and Drug Administration (FDA) advisory on Afluria (influenza virus vaccine).

Copyright Statement

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

Disclaimer

NGC Disclaimer

The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

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