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Guideline Summary
Guideline Title
Prevention and control of seasonal influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices — United States, 2013–2014.
Bibliographic Source(s)
Centers for Disease Control and Prevention (CDC). Prevention and control of seasonal influenza with vaccines. Recommendations of the Advisory Committee on Immunization Practices--United States, 2013-2014. MMWR Recomm Rep. 2013 Sep 20;62(RR-07):1-43. PubMed External Web Site Policy
Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: Centers for Disease Control and Prevention (CDC). Prevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP) - United States, 2012-13 influenza season. MMWR Morb Mortal Wkly Rep. 2012 Aug 17;61(32):613-8.

Scope

Disease/Condition(s)

Seasonal influenza

Guideline Category
Management
Prevention
Clinical Specialty
Allergy and Immunology
Family Practice
Geriatrics
Infectious Diseases
Internal Medicine
Obstetrics and Gynecology
Pediatrics
Pharmacology
Preventive Medicine
Intended Users
Advanced Practice Nurses
Allied Health Personnel
Emergency Medical Technicians/Paramedics
Health Care Providers
Hospitals
Nurses
Physician Assistants
Physicians
Public Health Departments
Guideline Objective(s)
  • To update the 2012 recommendations by Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) regarding the use of influenza vaccines for the prevention and control of seasonal influenza
  • To describe recently approved vaccines, including quadrivalent live attenuated influenza vaccine (LAIV4), egg-based quadrivalent inactivated influenza vaccine (IIV4), trivalent cell culture-based inactivated influenza vaccine (ccIIV3), and trivalent recombinant influenza vaccine (RIV3)
  • To provide updated recommendations and guidance for vaccination providers regarding the use of influenza vaccines for the 2013–14 season
Target Population

All persons aged ≥6 months

Interventions and Practices Considered
  1. Influenza vaccination
    • Live attenuated influenza vaccine (LAIV), available as a quadrivalent formulation (LAIV4) for the 2013–14 season
    • Inactivated influenza vaccine (IIV), including egg-based and cell culture-based trivalent inactivated influenza vaccines (IIV3), and egg-based quadrivalent inactivated influenza vaccine (IIV4)
    • Recombinant hemagglutinin influenza (RIV) vaccine, available as a trivalent formulation (RIV3) for the 2013–14 season
  2. Timing of vaccinations
  3. Vaccination considerations for special groups
    • Vaccination of persons at risk for medical complications attributable to severe influenza
    • Vaccination of persons who live with or care for persons at high risk for influenza-related complications
    • Vaccine dose considerations for children aged 6 months through 8 years
    • Vaccination for pregnant women
    • Vaccination of persons with a history of egg allergy
    • Influenza vaccination in persons receiving influenza antiviral medications
    • Concurrent administration of influenza vaccine with other vaccines
Major Outcomes Considered
  • Influenza-related morbidity and mortality rates
  • Influenza-related hospitalization rates
  • Vaccine efficacy and effectiveness
  • Vaccine coverage levels
  • Side effects and adverse reactions of influenza vaccination

Methodology

Methods Used to Collect/Select the Evidence
Searches of Electronic Databases
Searches of Unpublished Data
Description of Methods Used to Collect/Select the Evidence

To formulate policy recommendations, the Advisory Committee on Immunization Practices (ACIP) reviews many factors, including morbidity and mortality associated with the disease in the general U.S. population and in specific risk groups; available scientific literature (both published and unpublished) on the safety, efficacy, effectiveness, cost-effectiveness, and acceptability of the immunizing agent, with consideration of the relevant quality and quantity of published and unpublished data; clinical trial results and use information provided in the manufacturer's labeling or package insert; recommendations of other professional liaison organizations; and the feasibility of incorporating the vaccine into existing domestic immunization programs.

Source: Smith JC, Snider DE, Pickering LK; Advisory Committee on Immunization Practices. Immunization policy development in the United States: the role of the Advisory Committee on Immunization Practices. Ann Intern Med. 2009 Jan 6;150(1):45-9.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence
Not stated
Rating Scheme for the Strength of the Evidence

Not applicable

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

Using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework, the Advisory Committee on Immunization Practices (ACIP) systematically assesses the type or quality of evidence about a vaccine's expected health impacts and the balance of health benefits and risks, along with the values and preferences of persons affected, and health economic analyses. The evidence is grouped into four categories, with the order reflecting the level of confidence in the estimated effect of vaccination on health outcomes: 1) randomized controlled trials, or overwhelming evidence from observational studies; 2) randomized controlled trials with important limitations, or exceptionally strong evidence from observational studies; 3) observational studies, or randomized controlled trials with notable limitations; and 4) clinical experience and observations, observational studies with important limitations, or randomized controlled trials with several major limitations.

Randomized trials often cannot be used to assess the safety and efficacy of vaccination on rare or long-term outcomes, and such trials might be unethical to conduct for vaccines that are already licensed. Observational studies frequently are conducted for such assessments. The GRADE framework allows evaluation of evidence derived from immunogenicity or other intermediate outcomes as well as evaluation of evidence based on extrapolations from findings with similar vaccines in similar populations or other indirect forms of evidence. The balance of benefits and harms is assessed through review of the baseline risk for disease and the expected relative and absolute effects of vaccination on health outcomes. Health economic analyses include computations of cost per quality-adjusted life year gained. Determination of values includes assessing the relative importance of outcomes related to benefits, harms, and health economic analyses. Evidence tables are used to summarize the type of evidence for a vaccine's health impacts and its expected health benefits and risks.

Source: CDC. New framework (GRADE) for development of evidence-based recommendations by the Advisory Committee on Immunization Practices. MMWR. 2012;61(18):327-327.

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

The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) provides annual recommendations for the prevention and control of influenza. The ACIP Influenza Work Group meets by teleconference every 2–4 weeks throughout the year. Work Group membership includes several voting members of ACIP and representatives of ACIP Liaison Organizations. Discussions include topics such as influenza surveillance, vaccine effectiveness and safety, vaccine coverage, program feasibility, cost-effectiveness, and vaccine supply. Presentations are requested from invited experts, and published and unpublished data are discussed. For newly licensed influenza vaccines, discussion pertaining to new recommendations in this report included presentations of clinical data. For minor modifications to the recommendations for vaccination of persons with egg allergy, discussion included a review of influenza vaccine safety surveillance data from the Vaccine Adverse Event Reporting System (VAERS) for the 2012–13 season.

Information presented in this report reflects recommendations presented during public meetings of the ACIP and approved on February 21, 2013, and on June 20, 2013. Meeting minutes and information on ACIP membership and conflicts of interest are available on the ACIP Web site External Web Site Policy. Modifications were made to the ACIP statement during subsequent review at CDC to update and clarify wording in the document. Further updates, if needed, will be posted at the CDC's influenza Web site External Web Site Policy.

Workgroups

Committee workgroups are formed as a resource for gathering, analyzing, and preparing information for presentation to the Committee. Workgroups must be chaired by an ACIP member and must include at least 2 ACIP members and a CDC subject-matter expert. Other workgroup members include relevant ex officio members, liaison representatives, members of academia, and invited consultants as required. Vaccine manufacturer representatives may not serve as workgroup members. Workgroups meet throughout the year to do in-depth reviews of vaccine-related data and to develop options for policy recommendations for presentation to the Committee. Four ACIP workgroups are permanent (Adult Immunization Schedule, Childhood/Adolescent Immunization Schedule, General Recommendations, Influenza Vaccines), and the remaining workgroups, which typically focus on 1 vaccine or a group of vaccines, are established and then disbanded as appropriate. All workgroup findings and options are presented to the ACIP in an open meeting, and this information is deliberated until members reach a majority decision. A recommendation, when voted on and approved by a majority of voting ACIP members, includes guidance on target groups for immunization, route of administration and dosing intervals, and precautions and contraindications.

Factors and Evidence Considered in Immunization Policy Development

When data permit, specific rules of evidence, such as those followed by the U.S. Preventive Services Task Force, are used to judge the quality of data and make decisions regarding the nature and strength of recommendations. In the absence of data or when data are inadequate, expert opinions of voting members and other experts are used to make recommendations. Depending on the relative importance of the issue, either formal (for example, Delphi, nominal group techniques) or informal methods for soliciting expert opinions are used. Published statements of the ACIP explicitly describe the methods used for developing recommendations and provide the evidence used to develop the recommendations (for example, results of controlled trials, case–control studies, case series, expert opinion, meta-analyses, Delphi surveys, focus groups, cost-effectiveness analyses, and other inputs).

Source: Smith JC, Snider DE, Pickering LK; Advisory Committee on Immunization Practices. Immunization policy development in the United States: the role of the Advisory Committee on Immunization Practices. Ann Intern Med. 2009 Jan 6;150(1):45-9.

During the October 2010 ACIP meeting, the ACIP voted to adopt a new framework for developing evidence-based recommendations that is based on the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. Key factors considered in the development of recommendations include the balance of benefits and harms, type of evidence, values and preferences of the people affected, and health economic analyses.

Formulating Recommendations

Category A recommendations will apply to all persons in an age- or risk-factor-based group, with the exception of persons who have a contraindication. Category B recommendations do not apply to all members of an age- or risk-based subgroup of the population, but in the context of a clinician-patient interaction, vaccination may be found to be appropriate for a person. The category B recommendation is similar to what was previously referred to by the ACIP as permissive recommendation. In some instances, the ACIP may decide not to make a recommendation if further information is needed.

The recommendation category depends on the balance between desirable (benefits, savings) and undesirable (harms, costs) effects of vaccination. A category A recommendation is one for which the desirable effects outweigh the undesirable effects (recommendation for) or that the undesirable effects outweigh the desirable effects (recommendation against). Key factors that can lead to a category B recommendation include smaller net benefit (e.g., low baseline risk, small relative or absolute effects); lower confidence in the estimated effect of vaccination on health outcomes (e.g., wide confidence intervals); variability in values attributed to benefits and harms; and lower cost-effectiveness or uncertainty about whether the net benefits are worth the costs (e.g., because of lack of data on input assumptions that substantially affect the results of economic models). Examples of category A recommendations include the ACIP recommendation to vaccinate all U.S. infants with rotavirus vaccine; recommendation to administer pneumococcal polysaccharide vaccine to all children aged 2 years or older with certain underlying medical conditions; and recommendation against use of the 2010–2011 Afluria influenza vaccine among children aged 6 months through 8 years. An example of a category B recommendation is the recommendation that the 2010–2011 Afluria vaccine may be used for a child aged 5–8 years with a medical condition that increases the child's risk for influenza complications if no other age-appropriate, seasonal influenza vaccine is available; providers should discuss with the parents or caregivers the benefits and risks of Afluria vaccination before use of the vaccine.

ACIP members consider all relevant factors for making recommendations. ACIP Work Groups include ACIP members and multiple external experts and stakeholders in the preparation of options for immunization to present to ACIP. ACIP meetings are open to the public, and experts and stakeholders from liaison organizations and other entities provide input during the ACIP decision-making process. Recommendations to the CDC/Department of Health and Human Services (HHS) are passed by majority vote among committee members; recommendations are provisional pending acceptance by the Director of CDC/Secretary of HHS. Existing ACIP recommendations are updated on a periodic basis.

Source: Ahmed F, Temte JL, Campos-Outcalt D, Schünemann HJ; ACIP Evidence Based Recommendations Work Group (EBRWG). Methods for developing evidence-based recommendations by the Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control and Prevention (CDC). Vaccine. 2011 Nov 15;29(49):9171-6.

Rating Scheme for the Strength of the Recommendations

Not applicable

Cost Analysis

Economic analysis is an important factor that informs judgments in formulating recommendations (e.g., cost-benefit, cost-utility, cost-effectiveness). Use of a fixed cut-off threshold such as $50,000 or $100,000 per quality adjusted life year (QALY) for determining cost-effectiveness, however, ignores other determinants of value. The methodology described above for assessing the type or quality of evidence is not intended to be applied to health economic analyses based on modeling. The Advisory Committee on Immunization Practices (ACIP) Work Group on Economic Analysis has published a document titled Guidance for Health Economic Studies Presented to the ACIP that provides a framework for the description and presentation of the methods and results, and that stipulates technical review by anonymous peer reviewers of any economic materials presented to the ACIP. Presentation of health economic data should be undertaken using the guidelines in that document.

Source: Ahmed F, Temte JL, Campos-Outcalt D, Schünemann HJ; ACIP Evidence Based Recommendations Work Group (EBRWG). Methods for developing evidence-based recommendations by the Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control and Prevention (CDC). Vaccine. 2011 Nov 15;29(49):9171-6.

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

After formulation by the relevant workgroup, draft recommendations are subjected to further extensive review by staff of the Centers for Disease Control and Prevention (CDC), U.S. Food and Drug Administration (FDA), other relevant federal agencies, Advisory Committee on Immunization Practices (ACIP) members, liaison members, and external expert consultants. Workgroup members or ACIP members may identify a need for additional data, corrections in data content, and modifications of the interpretation of the data, and members may critique and challenge expert opinions. Public comments also are solicited during each ACIP meeting and are considered in the decision-making process. These inputs are synthesized by the workgroup in an iterative process, and options are presented to the ACIP for final consideration and vote.

Source: Smith JC, Snider DE, Pickering LK; Advisory Committee on Immunization Practices. Immunization policy development in the United States: the role of the Advisory Committee on Immunization Practices. Ann Intern Med. 2009 Jan 6;150(1):45-9.

Recommendations

Major Recommendations
Naming Conventions for Influenza Vaccines
  • The former abbreviation TIV (trivalent inactivated influenza vaccine, previously used for inactivated influenza vaccines) has been replaced with the new abbreviation IIV (inactivated influenza vaccine). For the 2013–14 season, IIVs as a class will include:
    • Egg-based and cell culture-based trivalent inactivated influenza vaccines (IIV3)
    • Egg-based quadrivalent inactivated influenza vaccine (IIV4)
  • RIV refers to recombinant hemagglutinin influenza vaccine, available as a trivalent formulation (RIV3) for the 2013–14 season.
  • LAIV refers to live attenuated influenza vaccine, available as a quadrivalent formulation (LAIV4) for the 2013–14 season.
  • LAIV, IIV, and RIV denote vaccine categories; numeric suffix specifies the number of antigens in the vaccine.
  • When necessary to refer specifically to cell culture-based vaccine, the prefix "cc" is used (e.g., "ccIIV3").

Primary Changes and Updates in the Recommendations

Routine annual influenza vaccination of all persons aged ≥6 months continues to be recommended. No preferential recommendation is made for one influenza vaccine product over another for persons for whom more than one product is otherwise appropriate. Updated information and guidance in this document include the following:

  • 2013–14 U.S. trivalent influenza vaccines will contain an A/California/7/2009 (H1N1)-like virus, an H3N2 virus antigenically like the cell-propagated prototype virus A/Victoria/361/2011, and a B/Massachusetts/2/2012-like virus. Quadrivalent vaccines will include an additional vaccine virus strain, a B/Brisbane/60/2008-like virus.
  • Several new, recently licensed vaccines will be available for the 2013–14 season and are acceptable alternatives to other licensed vaccines indicated for their respective age groups. These vaccines include the following:
    • A quadrivalent live attenuated influenza vaccine (LAIV4; FluMist Quadrivalent [MedImmune, Gaithersburg, Maryland]) is expected to replace the trivalent (LAIV3) formulation. FluMist Quadrivalent is indicated for healthy, nonpregnant persons aged 2 through 49 years.
    • A quadrivalent inactivated influenza vaccine (IIV4; Fluarix Quadrivalent [GlaxoSmithKline, Research Triangle Park, North Carolina]) will be available, in addition to the previous trivalent formulation. Fluarix Quadrivalent is indicated for persons aged ≥3 years.
    • An IIV4 (Fluzone Quadrivalent [Sanofi Pasteur, Swiftwater, Pennsylvania]) will be available, in addition to the previous trivalent formulation. Fluzone Quadrivalent is indicated for persons aged ≥6 months.
    • An IIV4 (FluLaval Quadrivalent [ID Biomedical Corporation/GlaxoSmithKline]) will be available, in addition to the previous trivalent formulation. FluLaval Quadrivalent is indicated for persons aged ≥3 years.
    • A trivalent cell culture-based inactivated influenza vaccine (ccIIV3; Flucelvax [Novartis Vaccines and Diagnostics, Cambridge, Massachusetts]) is indicated for persons aged ≥18 years.
    • A recombinant hemagglutinin (HA) vaccine (RIV3; Flublok [Protein Sciences, Meriden, Connecticut]) is indicated for persons aged 18 through 49 years.
  • RIV3, an egg-free vaccine, is now an option for vaccination of persons aged 18 through 49 years with egg allergy of any severity.
  • For persons with egg allergy who have no known history of egg exposure but for whom results suggestive of egg allergy have been obtained on previous allergy testing, consultation with a physician with expertise in the management of allergic conditions is recommended before vaccination.

Influenza Vaccine Composition for the 2013–14 Season

All influenza vaccines licensed in the United States will contain HA derived from influenza viruses antigenically identical to those recommended by the U.S. Food and Drug Administration (FDA). This season, for the first time, both trivalent and quadrivalent influenza vaccines will be available in the United States. Trivalent influenza vaccines will contain HA derived from three vaccine virus strains: one A(H1N1), one A(H3N2), and one B vaccine virus strain. Quadrivalent vaccines will contain the same the HA antigens as trivalent vaccines, but will also contain HA from a second B virus strain (one B virus strain from each lineage will be represented) (see "Quadrivalent Influenza Vaccines" in the original guideline document).

TIVs will contain HA derived from the following:

  • An A/California/7/2009 (H1N1)-like virus
  • An (H3N2) virus antigenically like the cell-propagated prototype virus A/Victoria/361/2011 (A/Texas/50/2012 is recommended to replace the A/Victoria/361/2011-like virus used in the 2012–13 vaccine because egg-adaptation of the A/Victoria/361/2011-like virus resulted in mutations that altered antigenicity)
  • A B/Massachusetts/2/2012-like (Yamagata lineage) virus. Quadrivalent influenza vaccines will contain these 3 antigens.
  • A B/Brisbane/60/2008–like (Victoria lineage) virus

Recommendations for the Use of Influenza Vaccines, 2013–14 Influenza Season

Groups Recommended for Vaccination

Routine annual influenza vaccination is recommended for all persons aged ≥6 months who do not have contraindications. Recommendations pertaining to the use of specific vaccines and populations are summarized below.

Timing of Vaccination

In general, health-care providers should begin offering vaccination soon after vaccine becomes available and, if possible, by October. All children aged 6 months through 8 years who are recommended for 2 doses should receive their first dose as soon as possible after vaccine becomes available; these children should receive the second dose ≥4 weeks later. This practice increases the opportunity for both doses to be administered before or shortly after the onset of influenza activity. To avoid missed opportunities for vaccination, providers should offer vaccination during routine health-care visits or during hospitalizations whenever vaccine is available.

Vaccination efforts should be structured to ensure the vaccination of as many persons as possible before influenza activity in the community begins. In any given year, the optimal time to vaccinate cannot be determined precisely because influenza seasons vary in their timing and duration, and more than 1 outbreak might occur in a single community in a single year. In the United States, localized outbreaks that indicate the start of seasonal influenza activity can occur as early as October. However, in >80% of influenza seasons since 1976, peak influenza activity (which often is close to the midpoint of influenza activity for the season) has not occurred until January or later, and in >60% of seasons, the peak was in February or later.

In recent seasons, initial shipments of influenza vaccine have arrived to some vaccine providers as early as July. Very early availability of vaccine as compared with typical onset and peak of influenza activity raises questions related to the ideal time to begin vaccination. Antibody levels induced by vaccine decline over the months after vaccination. Although a 2008 literature review found no clear evidence of more rapid decline among the elderly, a 2010 study noted significant decline in titers 6 months postvaccination among persons aged ≥65 years (though titers still met European Medicines Agency levels considered adequate for protection). More recently, some investigators have estimated vaccine effectiveness over the course of a season, as a function of time since vaccination.

A case-control study conducted in Navarre, Spain, during the 2011–12 season revealed a decline in vaccine effectiveness from 61% (95% confidence interval [CI] = 5–84) in the first 100 days postvaccination to 42% (95% CI = -39–75) for 100–119 days postvaccination and to -35% (95% CI = -211–41) thereafter. This decline primarily affected persons aged ≥65 years, among whom vaccine effectiveness declined from 85% (95% CI = -8–98) to 24% (95% CI = -224–82) to -208 (95% CI = -1,563–43) over these intervals. Most viruses isolated among those infected which were characterized did not match the vaccine strains. A case-control study conducted in the United Kingdom during the same season estimated an overall vaccine effectiveness against A(H3N2) of 53% (95% CI = 0–78) among those vaccinated <3 months, and 12% (95% CI = -31–41) for those vaccinated 3 months or more. The proportion of persons aged ≥65 years was too small to detect a substantial difference in vaccine effectiveness among this age group. Further evaluation of this effect in larger studies and in different seasons is needed. The Advisory Committee on Immunization Practices (ACIP) will continue to evaluate further data as they become available.

While delaying vaccination until later in the season might permit greater immunity later in the season, such deferral might result in missed opportunities to vaccinate, as well as difficulties in vaccinating a population within a more constrained time period. Community vaccination programs should balance maximizing likelihood of persistence of vaccine-induced protection through the season with avoiding missed opportunities to vaccinate or vaccinating after influenza circulation occurs.

Vaccination efforts should continue throughout the season, because the duration of the influenza season varies and influenza activity might not occur in certain communities until February or March. Providers should offer influenza vaccine routinely, and organized vaccination campaigns should continue throughout the influenza season, including after influenza activity has begun in the community. Vaccine administered in December or later, even if influenza activity has already begun, is likely to be beneficial in the majority of influenza seasons. The majority of adults have antibody protection against influenza virus infection within 2 weeks after vaccination.

Available Vaccine Products and Indications

No preferential recommendation is made for one influenza vaccine product over another for persons for whom more than one product is otherwise appropriate. A variety of influenza vaccine products are available (see Table 1 in the original guideline document), including (as of August 2013) six newly approved vaccines (see "New and Recently Approved Influenza Vaccine Products" in the original guideline document). For many vaccine recipients, more than one type or brand of vaccine may be appropriate within indications and ACIP recommendations. Considerations for selection of a given vaccine when several appropriate options are available are discussed below. However, not all products are likely to be uniformly available in any practice setting or locality. For newer vaccines, supplies might be limited during the 2013–14 season; moreover, postmarketing safety and effectiveness data are as yet unavailable, prohibiting a full risk-benefit analysis of newer versus previously available products. Therefore, within these guidelines and approved indications, where more than one type of vaccine is appropriate and available, no preferential recommendation is made for use of any influenza vaccine product over another.

Inactivated Influenza Vaccines

IIVs comprise a large group of products. For the 2013–14 season, most IIVs will be trivalent (IIV3), with some quadrivalent (IIV4) also available. Among IIV3 preparations, ccIIV3 will be available. As a class, IIVs include products which might be administered to all persons aged ≥6 months. However, approved age indications for the various IIV products differ (see Table 1 in the original guideline document). Only age-appropriate products should be administered. Providers should consult package inserts and updated CDC/ACIP guidance for current information. Of particular note, although Afluria (CSL Limited) is FDA-approved for children aged >5 years, CDC and ACIP recommend against use of Afluria in persons aged <9 years because of increased risk for febrile reactions noted in this age group with CSL's 2010 Southern Hemisphere IIV3. If no other age-appropriate, licensed inactivated seasonal influenza vaccine is available for a child aged 5 through 8 years who has a medical condition that increases the child's risk for influenza complications, Afluria can be used; however, providers should discuss with the parents or caregivers the potential benefits and risks of influenza vaccination with Afluria in this age group before administering this vaccine.

All IIV preparations contain the same quantity of HA (15 μg per vaccine virus strain per 0.5 mL dose; 45 μg total), except Fluzone Intradermal and Fluzone High-Dose (Sanofi Pasteur). Fluzone Intradermal is approved for persons aged 18 through 64 years, and contains 9 μg of each HA per vaccine virus strain (27 μg total). Fluzone High-Dose is approved for persons aged ≥65 years and contains 60 μg of each HA per vaccine virus strain (180 μg total). Within specified age indications, ACIP expresses no preference for any given IIV over another.

The one IIV product licensed by the FDA for children aged 6 through 36 months contains 0.25 mL/dose. The 0.25 mL dose may be administered from a prefilled single-dose syringe, single-use vial, or multi-dose vial of this age-appropriate formulation. Children aged 36 months through 18 years, and adults receiving intramuscular (IM) preparations of IIV, should receive a 0.5 mL dose. If a pediatric vaccine dose (0.25 mL) is administered inadvertently to an adult, an additional pediatric dose (0.25 mL) should be administered to provide a full adult dose (0.5 mL). If the error is discovered later (after the patient has left the vaccination setting), an adult dose should be administered as soon as the patient can return. Vaccination with a formulation approved for adult use should be counted as a dose if inadvertently administered to a child.

With the exception of Fluzone Intradermal (Sanofi Pasteur), IIVs should be administered intramuscularly. For adults and older children, the deltoid is the preferred site. Infants and younger children should be vaccinated in the anterolateral thigh. Additional specific guidance regarding site selection and needle length for intramuscular administration are provided in ACIP's General Recommendations on Immunization. Fluzone Intradermal is administered intradermally, preferably over the deltoid muscle, using the included delivery system.

Trivalent versus Quadrivalent IIVs

For the first time, during the 2013–14 influenza season, both trivalent (IIV3) and quadrivalent (IIV4) IIVs will be available. The relative quantity of doses of IIV4 that will be available is not certain; however, it is expected that the supply of IIV4 might be limited. Quadrivalent vaccines are designed to provide broader protection against circulating influenza B viruses in seasons during which the B virus contained in trivalent vaccines is not an optimal match to the predominant circulating B viruses. However, vaccination should not be delayed if only IIV3 is available. No preference is expressed for IIV4 over IIV3.

IIVs and Persons Aged ≥65 Years

For persons aged ≥65 years, either an age-appropriate standard-dose IIV (IIV3 or IIV4) or high-dose IIV3 are acceptable options. High-dose IIV3 (available as Fluzone High-Dose) is approved for persons aged ≥65 years. Immunogenicity data from 3 prelicensure studies among persons aged ≥65 years indicated that, compared with standard dose Fluzone, Fluzone High-Dose elicited higher hemagglutination-inhibition (HAI) titers against all three influenza virus strains included in seasonal influenza vaccines recommended during the study period. Whether the higher postvaccination immune responses observed among Fluzone High-Dose vaccine recipients will result in greater protection against influenza illness is under study. Some solicited injection site and systemic adverse events were more frequent after vaccination with Fluzone High-Dose compared with standard Fluzone, but typically were mild and transient. No preferential recommendation is made for high-dose IIV over standard dose IIV for persons aged ≥65 years.

IIVs and Egg Allergy

With the exception of Flucelvax, IIVs are manufactured via propagation of virus in eggs and therefore might contain residual egg protein. Egg protein content (usually described as ovalbumin content as a surrogate measure) is not disclosed on all package inserts (see Table 1 in the original guideline document); where not listed, this information generally can be obtained by contacting the manufacturer. Flucelvax is manufactured from virus propagated in Madin Darby Canine Kidney (MDCK) cells rather than embryonated eggs; however, before production seed virus is created using reference virus strains supplied by the World Health Organization (WHO), which have been passaged in eggs. Flucelvax can therefore not be considered egg-free. The total egg protein is estimated to be <50 femtograms (5x10-14 grams) total egg protein (of which a fraction is ovalbumin) per 0.5 mL dose of Flucelvax (Novartis, unpublished data, 2013). Flucelvax can be administered to persons with a history of mild egg allergy (specifically, those who have experienced only hives following egg exposure; see "Influenza Vaccination of Persons with Egg Allergy" in the original guideline document) who are aged ≥18 years and have no other contraindications. Because no data are available regarding the use of ccIIV among egg-allergic persons, and there is no established safe threshold for ovalbumin content in vaccines, ccIIV should be administered according to the guidance for other IIVs (see "Influenza Vaccination of Persons with Egg Allergy" in the original guideline document).

Contraindications and Precautions for Use of IIVs

Manufacturer package inserts and updated CDC/ACIP guidance should be consulted for current information on contraindications and precautions for individual vaccine products. In general, IIV is contraindicated for, and should not be administered to, persons known to have anaphylactic hypersensitivity to eggs or to any vaccine components (see Table 2 in the original guideline document). Prophylactic use of antiviral agents is an option for preventing influenza among such persons. Information about vaccine components is located in package inserts from each manufacturer.

Moderate or severe acute illness with or without fever is a general precaution for vaccination. Guillain-Barré syndrome (GBS) within 6 weeks following a previous dose of influenza vaccine is considered a precaution for use of influenza vaccines (see Table 2 in the original guideline document).

Recombinant Influenza Vaccine

One RIV product, Flublok, a trivalent recombinant HA vaccine, is expected to be available for the 2013–14 influenza season. This RIV3 is administered by intramuscular injection, and is indicated for persons aged 18 through 49 years. RIV3 is manufactured without the use of influenza viruses; therefore, similarly to IIVs, no shedding of vaccine virus will occur. No preference is expressed for RIV versus IIV within specified indications.

RIV and Egg Allergy

The currently available RIV, Flublok, is manufactured without the use of eggs, and does not carry a contraindication for egg allergy. Therefore, Flublok can be administered to persons with egg allergy of any severity who are aged 18 through 49 years and do not have other contraindications. Since 2011, ACIP has recommended that persons with a history of mild egg allergy (specifically, those who experience only hives following egg exposure) can receive IIV, with additional safety precautions. For such persons, vaccination should not be delayed if RIV is not available; IIV should be used in these settings, following the recommendations outlined (see "Influenza Vaccination of Persons with Egg Allergy" in the original guideline document).

Contraindications and Precautions for Use of RIV

Flublok is contraindicated in persons who have had a severe allergic reaction to any component of the vaccine. Moderate or severe acute illness with or without fever is a general precaution for vaccination. GBS within 6 weeks following a previous dose of influenza vaccine is considered a precaution for use of influenza vaccines (see Table 2 in the original guideline document). Flublok is not licensed for use in children aged <18 years or adults aged >49 years.

Live Attenuated Influenza Vaccine

One LAIV4 product, FluMist Quadrivalent (MedImmune), is expected to be available during the 2013–14 influenza season. FluMist is indicated for nonpregnant persons aged 2 through 49 years who do not have a medical condition that predisposes them to medical complications from influenza. No preference is indicated for LAIV versus other vaccines appropriate for this group.

LAIV is administered intranasally using the supplied 0.2 mL intranasal sprayer (0.1 mL in each nostril). If the vaccine recipient sneezes immediately after administration, the dose should not be repeated. However, if nasal congestion is present that might impede delivery of the vaccine to the nasopharyngeal mucosa, deferral of administration should be considered until resolution of the illness, or IIV should be administered instead.

LAIV versus IIV

Several randomized studies have evaluated the relative effectiveness of LAIV3 as compared with IIV3. Most studies conducted among adults have noted superior relative efficacy of IIV3. A significantly greater relative efficacy of LAIV3 as compared with IIV3 has been noted in several studies conducted among younger children, including a randomized, open label study among children aged 6 through 71 months, a randomized blinded trial of children aged 6 through 59 months, and a randomized blinded trial of children with asthma aged 6 through 17 years. However, no postmarketing safety data are yet available for the new quadrivalent formulation, LAIV4, which will be available for the first time during the 2013–14 season and is expected to replace LAIV3. Therefore, no preferential recommendation is made for LAIV4 over IIV for any age group at this time. This information will be updated as more data become available. Vaccination should not be delayed if LAIV is not available.

LAIV and Egg Allergy

Because of relative lack of data demonstrating safety of LAIV for persons with egg allergy, egg-allergic persons should receive IIV rather than LAIV (see "Influenza Vaccination of Persons with Egg Allergy" in the original guideline document).

Contraindications and Precautions to the Use of LAIV

LAIV is contraindicated for persons with a history of severe hypersensitivity reaction to any component of the vaccine or to a previous dose of any influenza vaccine, and in children and adolescents receiving concomitant aspirin therapy (see Table 2 in the original guideline document). In addition, LAIV should not be administered to the following groups:

  • Children aged <2 years
  • Adults aged ≥50 years
  • Children aged 2 through 4 years whose parents or caregivers report that a health-care provider has told them during the preceding 12 months that their child had wheezing or asthma or whose medical record indicates a wheezing episode has occurred during the preceding 12 months (see Table 1 in the original guideline document)
  • Persons with asthma
  • Children and adults who have chronic pulmonary, cardiovascular (except isolated hypertension), renal, hepatic, neurologic/neuromuscular, hematologic, or metabolic disorders
  • Children and adults who have immunosuppression (including immunosuppression caused by medications or by human immunodeficiency virus [HIV])
  • Pregnant women

Moderate or severe acute illness with or without fever is a general precaution for vaccination. GBS within 6 weeks following a previous dose of influenza vaccine is considered a precaution for use of influenza vaccines.

Persons at Risk for Medical Complications Attributable to Severe Influenza

Vaccination to prevent influenza is particularly important for persons who are at increased risk for severe complications from influenza, or at higher risk for influenza-related outpatient, emergency department (ED), or hospital visits. When vaccine supply is limited, vaccination efforts should focus on delivering vaccination to the following persons (no hierarchy is implied by order of listing):

  • All children aged 6 through 59 months
  • All persons aged ≥50 years
  • Adults and children who have chronic pulmonary (including asthma) or cardiovascular (except isolated hypertension), renal, hepatic, neurologic, hematologic, or metabolic disorders (including diabetes mellitus)
  • Persons who have immunosuppression (including immunosuppression caused by medications or by HIV infection)
  • Women who are or will be pregnant during the influenza season
  • Children and adolescents (aged 6 months through 18 years) who are receiving long-term aspirin therapy and who might be at risk for experiencing Reye's syndrome after influenza virus infection
  • Residents of nursing homes and other long-term care facilities
  • American Indians/Alaska Natives
  • Persons who are morbidly obese (body mass index [BMI] ≥40)

Persons Who Live with or Care for Persons at High Risk for Influenza-Related Complications

All persons aged ≥6 months should be vaccinated annually. Continued emphasis should be placed on vaccination of persons who live with or care for persons at higher risk for influenza-related complications. When vaccine supply is limited, vaccination efforts should focus on delivering vaccination to persons at higher risk for influenza-related complications listed above, as well as these persons:

  • Health-care personnel
  • Household contacts (including children) and caregivers of children aged ≤59 months (i.e., aged <5 years) and adults aged ≥50 years, with particular emphasis on vaccinating contacts of children aged <6 months
  • Household contacts (including children) and caregivers of persons with medical conditions that put them at high risk for severe complications from influenza

Annual influenza vaccination is recommended for all health-care personnel and persons in training for health-care professions. Personnel in health-care settings who should be vaccinated include physicians, nurses, and other workers in inpatient and outpatient-care settings, medical emergency-response workers (e.g., paramedics and emergency medical technicians), employees of nursing home and long-term care facilities who have contact with patients or residents, and students in these professions who will have contact with patients. ACIP guidance for immunization of health-care personnel has been published previously.

Health-care personnel and persons who are contacts of persons in these groups and who are not contacts of severely immunocompromised persons (those living in a protective environment; see "Close Contacts of Immunocompromised Persons" in the original guideline document) may receive any influenza vaccine that is otherwise indicated. Persons who care for the severely immunocompromised should receive either IIV or RIV3. The rationale for avoiding use of LAIV among health-care personnel or close contacts of severely immunocompromised patients is the theoretical risk that a live attenuated vaccine virus could be transmitted to the severely immunosuppressed person. In addition, to further reduce the theoretical risk of vaccine virus transmission, ACIP/Healthcare Infection Control Practices Advisory Committee (HICPAC) has recommended that health-care personnel who receive LAIV should avoid providing care for severely immunosuppressed patients requiring a protected environment for 7 days after vaccination, and that hospital visitors who have received LAIV should avoid contact with severely immunosuppressed persons (i.e., persons requiring a protected environment) for 7 days after vaccination. However, such visitors should not be restricted from visiting less severely immunosuppressed patients. Healthy nonpregnant persons aged 2 through 49 years, including health-care personnel, who have close contact with persons with lesser degrees of immunosuppression (e.g., persons with chronic immunocompromising conditions such as HIV infection, corticosteroid or chemotherapeutic medication use, or who are cared for in other hospital areas such as neonatal intensive care units) can receive LAIV.

Vaccine Dose Considerations for Children Aged 6 Months through 8 Years

Evidence from several studies indicates that children aged 6 months through 8 years require 2 doses of influenza vaccine (administered a minimum of 4 weeks apart) during their first season of vaccination to optimize immune response. In a study of children aged 5 through 8 years receiving IIV3 for the first time, the proportion of children with protective antibody responses was significantly higher (p<0.001 for influenza A[H1N1], p = 0.01 for influenza A[H3N2], and p<0.001 for influenza B) after 2 doses as compared with a single dose. Several studies have indicated that the time interval between 2 initial doses (from 4 weeks up to 1 year) of the same antigen may not be critical. However, because of the antigenic novelty of the 2009 influenza A(H1N1) pandemic virus, which is anticipated to continue circulating during the 2013–14 influenza season, exposure history to this vaccine virus antigen also must be considered. Children who last received seasonal (trivalent) influenza vaccine before the 2010–11 season but did not receive a vaccine containing 2009 (H1N1) antigen (i.e., either in seasonal vaccine since July 2010 or monovalent 2009 [H1N1] vaccine) will not have received this antigen. These children are recommended to receive 2 doses this season, even if 2 doses of seasonal influenza vaccine were received before the 2010–11 season. This recommendation is illustrated in the approaches outlined below. These recommendations are consistent with those of the American Academy of Pediatrics. Two approaches are recommended, both of which are acceptable.

The first approach (see Figure 1 in the original guideline document), takes into consideration only doses of seasonal influenza vaccine received since July 1, 2010. This approach has the advantage of simplicity, particularly in settings in which it is difficult to ascertain vaccination history before the 2010–11 season. Using this approach, children aged 6 months through 8 years need only 1 dose of vaccine in the 2013–14 influenza season if they received a total of 2 or more doses of seasonal vaccine since July 1, 2010. Children who did not receive a total of 2 or more doses of seasonal vaccine since July 1, 2010, require 2 doses in the 2013–14 season.

In settings where adequate vaccination history from before the 2010–11 season is available, the second approach may be used. By this approach, if a child aged 6 months through 8 years is known to have received at least 2 doses of seasonal influenza vaccine during any prior season, and at least 1 dose of a 2009 (H1N1)-containing vaccine (i.e., 2010–11, 2011–12, or 2012–13 seasonal vaccine or the monovalent 2009 [H1N1] vaccine) then the child needs only 1 dose for the 2013–14 season. Using this approach, children aged 6 months through 8 years need only 1 dose of vaccine in the 2013–14 season if they have received any of the following:

  • 2 or more doses of seasonal influenza vaccine since July 1, 2010
  • 2 or more doses of seasonal influenza vaccine before July 1, 2010 and 1 or more doses of monovalent 2009 (H1N1) vaccine
  • 1 or more doses of seasonal influenza vaccine before July 1, 2010, and 1 or more doses of seasonal influenza vaccine since July 1, 2010.

Children aged 6 months through 8 years for whom one of these conditions is not met require 2 doses in the 2013–14 season.

Influenza Vaccination for Pregnant Women

Pregnant and postpartum women are at higher risk for severe illness and complications from influenza than women who are not pregnant because of changes in the immune system, heart, and lungs during pregnancy. Vaccination during pregnancy has been shown to protect infants from influenza, including infants aged <6 months, for whom no influenza vaccines are currently licensed. The ACIP and American College of Obstetricians and Gynecologists (ACOG) recommends that all women who are pregnant or who might be pregnant in the upcoming influenza season receive IIV because of this increased risk for serious illness and complications from influenza. Influenza vaccination can be administered at any time during pregnancy, before and during the influenza season.

Women who are or will be pregnant during influenza season should receive IIV. LAIV is not recommended for use during pregnancy. Postpartum women can receive either LAIV or IIV. Pregnant and postpartum women do not need to avoid contact with persons recently vaccinated with LAIV.

Influenza Vaccination of Persons with a History of Egg Allergy

Severe allergic and anaphylactic reactions can occur in response to a number of influenza vaccine components, but such reactions are rare. With the exceptions of RIV and ccIIV3, currently available influenza vaccines are prepared by propagation of virus in embryonated eggs. A recent review of published data (including 4,172 patients, 513 of whom were reported to have a history of severe allergic reaction to egg) noted that no occurrences of anaphylaxis were reported, though some milder reactions did occur, suggesting that severe allergic reactions to egg-based influenza vaccines are unlikely. Vaccines containing as much as 0.7 μg/0.5 mL have been tolerated; however, a threshold below which no reactions would be expected is not known. Although ovalbumin content is not required to be disclosed on package inserts for vaccines used in the United States, manufacturers either report maximum albumin content in the package inserts or will provide this information on request. Among IIVs for which ovalbumin content was disclosed during the 2011–12 and 2012–13 seasons, reported maximum amounts were ≤1 μg/0.5 mL dose. Ovalbumin is not directly measured for Flucelvax, but it is estimated by calculation from the initial content in the reference virus strains to contain a maximum of 5x10-8 μg/0.5 mL dose of total egg protein (Novartis, unpublished data, 2013). Flublok is egg-free. It should be noted, however, that neither Flucelvax nor Flublok are licensed for children aged <18 years.

Surveillance for Anaphylaxis Following Influenza Vaccination

Following review of available data, since the 2011–12 influenza season, ACIP has recommended that persons with egg allergy who report only hives after egg exposure should receive IIV, with several additional safety measures; current FDA-approved packaging for influenza vaccines lists only severe hypersensitivity to egg protein as a contraindication to vaccination. Review of Vaccine Adverse Event Reporting System (VAERS) data for the 2011–12 and 2012–13 seasons indicated no disproportionate reporting of allergic reaction or anaphylaxis after influenza vaccination during the first 2 seasons the new recommendation was in place. However, during the 2012–13 influenza season, VAERS received one report containing a documented medical history of anaphylaxis following receipt of a first-ever split dose IIV in a child aged 12 months with atopy but no known prior egg ingestion in the past, who had a previous positive allergy skin prick test to ovalbumin. This child had previously received allergy testing attributed to a strong personal and family history of food allergies and other allergies. For the 2013–14 season, the recommendations which follow include guidance concerning persons who have no history of exposure to egg, but who have documented results potentially suggestive of egg allergy on previously performed allergy testing.

For the 2013–14 influenza season, ACIP recommends the following:

  • Persons with a history of egg allergy who have experienced only hives after exposure to egg should receive influenza vaccine. Because relatively few data are available for use of LAIV in this setting, IIV or RIV should be used. RIV is egg-free and may be used for persons aged 18 through 49 years who have no other contraindications. However, IIV (egg- or cell-culture based) also may be used, with the following additional safety measures (see Figure 2 in the original guideline document):
    • Vaccine should be administered by a health-care provider who is familiar with the potential manifestations of egg allergy.
    • Vaccine recipients should be observed for at least 30 minutes for signs of a reaction after administration of each vaccine dose.
  • Other measures, such as dividing and administering the vaccine by a 2-step approach and skin testing with vaccine, are not necessary.
  • Persons who report having had reactions to egg involving such symptoms as angioedema, respiratory distress, lightheadedness, or recurrent emesis; or who required epinephrine or another emergency medical intervention, particularly those that occurred immediately or within a short time (minutes to hours) after egg exposure, are more likely to have a serious systemic or anaphylactic reaction upon reexposure to egg proteins. These persons may receive RIV3, if aged 18 through 49 years and there are no other contraindications. If RIV3 is not available or the recipient is not within the indicated age range, such persons should be referred to a physician with expertise in the management of allergic conditions for further risk assessment before receipt of vaccine (see Figure 2 in the original guideline document).
  • All vaccines should be administered in settings in which personnel and equipment for rapid recognition and treatment of anaphylaxis are available. ACIP recommends that all vaccination providers should be familiar with the office emergency plan.
  • Some persons who report allergy to egg might not be egg-allergic. Those who are able to eat lightly cooked egg (e.g., scrambled egg) without reaction are unlikely to be allergic. Egg-allergic persons might tolerate egg in baked products (e.g., bread or cake). Tolerance to egg-containing foods does not exclude the possibility of egg allergy. Egg allergy can be confirmed by a consistent medical history of adverse reactions to eggs and egg-containing foods, plus skin and/or blood testing for immunoglobulin E antibodies to egg proteins.
  • For persons who have no known history of exposure to egg, but who are suspected of being egg-allergic on the basis of previously performed allergy testing, consultation with a physician with expertise in the management of allergic conditions should be obtained before vaccination (see Figure 2 in the original guideline document). Alternatively, RIV3 may be administered if the recipient is aged 18 through 49 years.
  • A previous severe allergic reaction to influenza vaccine, regardless of the component suspected to be responsible for the reaction, is a contraindication to future receipt of any influenza vaccine.

Influenza Vaccines and Use of Influenza Antiviral Medications

Administration of IIV to persons receiving influenza antiviral drugs for treatment or chemoprophylaxis is acceptable. The effect on safety and effectiveness of LAIV co-administration with influenza antiviral medications has not been studied. However, because antiviral drugs reduce replication of influenza viruses, LAIV should not be administered until 48 hours after cessation of influenza antiviral therapy. If influenza antiviral medications are administered within 2 weeks after receipt of LAIV, the LAIV dose should be repeated 48 or more hours after the last dose of antiviral medication. Alternatively, persons receiving antiviral drugs within the period 2 days before to 14 days after vaccination with LAIV may be revaccinated another approved vaccine formulation (e.g., IIV or RIV).

Concurrent Administration of Influenza Vaccine with Other Vaccines

Limited data are available on the concurrent administration of influenza vaccines with other live vaccines. Use of LAIV3 concurrently with measles, mumps, rubella (MMR) and varicella vaccine among children aged 12 through 15 months has been studied, and no interference with the immunogenicity to antigens in any of the vaccines was observed. Among adults aged ≥50 years, the safety and immunogenicity of zoster vaccine and IIV3 were similar whether administered simultaneously or sequentially spaced 4 weeks apart.

In the absence of specific data indicating interference, following ACIP's general recommendations for vaccination is prudent. Inactivated vaccines do not interfere with the immune response to other inactivated vaccines or to live vaccines. Inactivated or live vaccines can be administered simultaneously with LAIV. However, after administration of a live vaccine (such as LAIV), at least 4 weeks should pass before another live vaccine is administered.

Sources of Information Regarding Influenza and Surveillance

Updated information regarding influenza surveillance, prevention, detection, and control is available at http://www.cdc.gov/flu External Web Site Policy. U.S surveillance data are updated weekly during October–May on FluView External Web Site Policy. In addition, periodic updates regarding influenza are published in the Morbidity and Mortality Weekly Report (MMWR) External Web Site Policy. Additional information regarding influenza vaccine can be obtained from CDC by calling 1-800-232-4636. State and local health departments should be consulted about availability of influenza vaccine, access to vaccination programs, information related to state or local influenza activity, reporting of influenza outbreaks and influenza-related pediatric deaths, and advice concerning outbreak control.

VAERS

The National Childhood Vaccine Injury Act of 1986 requires health-care providers to report any adverse event listed by the vaccine manufacturer as a contraindication to further doses of the vaccine, or any adverse event listed in the VAERS Table of Reportable Events Following Vaccination External Web Site Policy that occurs within the specified time period after vaccination. In addition to mandated reporting, health-care providers are encouraged to report any clinically significant adverse event following vaccination to VAERS. Information on how to report a vaccine adverse event is available at http://vaers.hhs.gov/esub/index External Web Site Policy. Reports can be filed securely online, by mail, or by fax. A VAERS form can be downloaded from the VAERS Web site or requested by sending an e-mail message to info@vaers.org, by calling 1-800-822-7967, or by sending a request by facsimile to 1-877-721-0366. Additional information on VAERS or vaccine safety is available at http://vaers.hhs.gov/about/index External Web Site Policy or by calling 1-800-822-7967.

National Vaccine Injury Compensation Program

The National Vaccine Injury Compensation Program (VICP), established by the National Childhood Vaccine Injury Act of 1986, as amended, provides a mechanism through which compensation can be paid on behalf of a person determined to have been injured or to have died as a result of receiving a vaccine covered by VICP. The Vaccine Injury Table External Web Site Policy lists the vaccines covered by VICP and the associated injuries and conditions (including death) that may receive a legal presumption of causation. If the injury or condition is not on the Table, or does not occur within the specified time period on the Table, persons must prove that the vaccine caused the injury or condition. Eligibility for compensation is not affected by whether a covered vaccine is used off-label or inconsistently with recommendations.

For a claim to be eligible for compensation under the VICP, it must be filed within 3 years after the first symptom of the vaccine injury. Death claims must be filed within 2 years of the vaccine-related death and not more than 4 years after the start of the first symptom of the vaccine-related injury from which the death occurred. When a new vaccine is covered by VICP or when a new injury/condition is added to the Table, claims can be filed within 2 years from the date the vaccine or injury/condition is added to the Table for injuries or deaths that occurred up to 8 years before the Table change. Persons of all ages who receive a VICP-covered vaccine may be eligible to file a claim. Additional information is available at http://www.hrsa.gov/vaccinecompensation External Web Site Policy or by calling 1-800-338-2382.

Clinical Algorithm(s)

The following clinical algorithms are provided in the original guideline document:

  • Influenza vaccine dosing algorithm for aged children 6 months through 8 years — Advisory Committee on Immunization Practices, United States, 2013–14 influenza season
  • Recommendations regarding influenza vaccination of persons who report allergy to eggs — Advisory Committee on Immunization Practices, United States, 2013–14 influenza season

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is not specifically stated for each recommendation.

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Improved vaccination coverage levels

Potential Harms

Safety of Influenza Vaccines

Refer to the "Safety of Influenza Vaccines" section in the original guideline document for a detailed review of studies on the safety of inactivated influenza vaccines, live attenuated influenza vaccines, and recombinant influenza vaccine, including safety in special populations, such as children, pregnant women, neonates, and immunocompromised persons. See also the "New and Recently Approved Influenza Vaccine Products" section in the original guideline document for specific adverse effects of vaccines.

Precautions to the Use of Influenza Vaccines — United States, 2013–14 Influenza Season

  • Moderate to severe illness with or without fever
  • History of Guillain-Barré syndrome within 6 weeks of receipt of influenza vaccine

Immunization providers should check Food and Drug Administration-approved prescribing information for 2013–14 influenza vaccines for the most complete and updated information, including (but not limited to) indications, contraindications, and precautions. Package inserts for U.S.-licensed vaccines are available at http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm093833.htm External Web Site Policy.

Contraindications

Contraindications

Contraindications to the Use of Influenza Vaccines — United States, 2013–14 Influenza Season

Inactivated Influenza Vaccine (IIV) (Includes Trivalent Inactivated Influenza Vaccine [IIV3], Quadrivalent Inactivated Influenza Vaccine [IIV4], and Trivalent Cell Culture-based Inactivated Influenza Vaccine [ccIIV])

History of severe allergic reaction to any component of the vaccine, including egg protein, or after previous dose of any influenza vaccine

Recombinant Influenza Vaccine (RIV)

History of severe allergic reaction to any component of the vaccine

Live attenuated Influenza Vaccine (LAIV)

  • History of severe allergic reaction to any component of the vaccine, including egg protein, gentamicin, gelatin, and arginine, or after a previous dose of any influenza vaccine
  • Concomitant aspirin therapy in children and adolescents
  • In addition, the Advisory Committee on Immunization Practices (ACIP) recommends against use in the following:
    • Children aged <2 years
    • Adults aged ≥50 years
    • Children aged 2 through 4 years whose parents or caregivers report that a health-care provider has told them during the preceding 12 months that their child had wheezing or asthma or whose medical record indicates a wheezing episode has occurred during the preceding 12 months (see screening guidance, footnote in Table 1 in the original guideline document)
    • Persons with asthma
    • Children and adults who have chronic pulmonary, cardiovascular (except isolated hypertension), renal, hepatic, neurologic/neuromuscular, hematologic, or metabolic disorders
    • Children and adults who have immunosuppression (including immunosuppression caused by medications or by human immunodeficiency virus [HIV])
    • Persons with egg allergy
    • Close contacts and caregivers of severely immunosuppressed persons who require a protected environment
    • Pregnant women

Immunization providers should check Food and Drug Administration–approved prescribing information for 2013–14 influenza vaccines for the most complete and updated information, including (but not limited to) indications, contraindications, and precautions. Package inserts for U.S.-licensed vaccines are available at http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm093833.htm External Web Site Policy.

Qualifying Statements

Qualifying Statements
  • Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of Health and Human Services.
  • References to non-Centers for Disease Control and Prevention (CDC) sites on the Internet are provided as a service to Morbidity and Mortality Weekly Report (MMWR) readers and do not constitute or imply endorsement of these organizations or their programs by CDC or the U.S. Department of Health and Human Services. CDC is not responsible for the content of these sites. URL addresses listed in MMWR were current as of the date of publication.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Implementation Tools
Chart Documentation/Checklists/Forms
Clinical Algorithm
Foreign Language Translations
Mobile Device Resources
Patient Resources
Resources
Tool Kits
Wall Poster
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

Identifying Information and Availability

Bibliographic Source(s)
Centers for Disease Control and Prevention (CDC). Prevention and control of seasonal influenza with vaccines. Recommendations of the Advisory Committee on Immunization Practices--United States, 2013-2014. MMWR Recomm Rep. 2013 Sep 20;62(RR-07):1-43. PubMed External Web Site Policy
Adaptation

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

Date Released
1984 Apr (revised 2013 Sep 20)
Guideline Developer(s)
Centers for Disease Control and Prevention - Federal Government Agency [U.S.]
Source(s) of Funding

United States Government

Guideline Committee

Advisory Committee on Immunization Practices (ACIP) Influenza Vaccine Work Group

Composition of Group That Authored the Guideline

Prepared by: Lisa A. Grohskopf, MD, Influenza Division, National Center for Immunization and Respiratory Diseases, CDC; David K. Shay, MD, Influenza Division, National Center for Immunization and Respiratory Diseases, CDC; Tom T. Shimabukuro, MD, Immunization Safety Office, National Center for Emerging and Zoonotic Diseases, CDC; Leslie Z. Sokolow, MSc, MPH, Influenza Division, National Center for Immunization and Respiratory Diseases, CDC, Battelle Memorial Institute, Atlanta, Georgia; Wendy A. Keitel, MD, Baylor College of Medicine, Houston, Texas; Joseph S. Bresee, MD, Influenza Division, National Center for Immunization and Respiratory Diseases, CDC; Nancy J. Cox, PhD, Influenza Division, National Center for Immunization and Respiratory Diseases, CDC

Advisory Committee on Immunization Practices (ACIP)

Membership List, as of June 2013

Chair: Jonathan L. Temte, MD, PhD, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin

Executive Secretary: Larry K. Pickering, MD, National Center for Immunization and Respiratory Diseases, CDC, Atlanta, Georgia

Members: Nancy Bennett, MD, Rochester, New York; Joseph A. Bocchini, Jr, MD, Louisiana State University Health Sciences Center, Shreveport, Louisiana; Douglas Campos-Outcalt, MD, University of Arizona College of Medicine-Phoenix, Phoenix, Arizona; Tamera Coyne-Beasley, MD, University of North Carolina School of Medicine Chapel Hill, North Carolina; Jeffrey Duchin, MD, Public Health–Seattle and King County and University of Washington School of Medicine Seattle, Washington; Kathleen Harriman, PhD, California Department of Public Health, Richmond, California; Lee H. Harrison, MD, University of Pittsburgh, Pittsburgh, Pennsylvania; Renée R. Jenkins, MD, Howard University College of Medicine, Washington, District of Columbia; Ruth A. Karron, MD, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; Wendy A. Keitel, MD, Baylor College of Medicine, Houston, Texas; Sara Rosenbaum, JD, George Washington University, Washington, District of Columbia; Lorry Rubin, MD, Hofstra–North Shore LIJ School of Medicine, Hempstead, New York; Mark H. Sawyer, MD, University of California, San Diego School of Medicine San Diego, California; Marietta Vázquez, MD, Yale University School of Medicine, New Haven, Connecticut

Ex Officio Members: Centers for Medicare and Medicaid Services, Mary Beth Hance, Baltimore, Maryland; US Department of Defense, Jesse Geibe, MD, Atlanta, Georgia; Department of Veterans Affairs, Linda S. Kinsinger, MD, Durham, North Carolina; Food and Drug Administration, Wellington Sun, MD, Rockville, Maryland; Health Resources and Services Administration, Vito Caserta, MD, Rockville, Maryland; Indian Health Service, Amy Groom, MPH, Albuquerque, NM; National Vaccine Program Office, Bruce Gellin, MD, Washington, District of Columbia; National Institutes of Health, Richard L. Gorman, MD, Bethesda, Maryland

Liaison Representatives: American Academy of Family Physicians, Jamie Loehr, MD, Ithaca, New York; American Academy of Pediatrics, Chair, Committee on Infectious Diseases, Michael T. Brady, MD, Columbus, Ohio; American Academy of Pediatrics, Red Book Editor, David Kimberlin, MD, Birmingham, Alabama; American Academy of Physician Assistants, Marie-Michèle Léger, MPH, Alexandria, Virginia; American College Health Association, James C. Turner, MD, Charlottesville, Virginia; American College of Obstetricians and Gynecologists, Laura E. Riley, MD, Boston, Massachusetts; American College of Physicians, Gregory A. Poland, MD, Rochester, Minnesota; American College of Physicians (alternate), Sandra Adamson Fryhofer, MD, Atlanta, Georgia; American Geriatrics Society, Kenneth Schmader, MD, Durham, North Carolina; America's Health Insurance Plans, Mark J. Netoskie, MD, Houston, Texas; American Medical Association, Sandra Adamson Fryhofer, MD, Atlanta, Georgia; American Nurses Association, Katie Brewer, MSN, Silver Spring, Maryland; American Osteopathic Association, Stanley E. Grogg, DO, Tulsa, Oklahoma; American Pharmacists Association, Stephan L. Foster, PharmD, Memphis, Tennessee; Association of Immunization Managers, Kelly Moore, MD, Nashville Tennessee; Association for Prevention Teaching and Research, W. Paul McKinney, MD, Louisville, Kentucky; Association of State and Territorial Health Officials, José Montero, MD, Concord, New Hampshire; Biotechnology Industry Organization, Clement Lewin, PhD, Cambridge, Massachusetts; Council of State and Territorial Epidemiologists, Christine Hahn, MD, State Epidemiologist, Office of Epidemiology, Food Protection and Immunization, Boise, Idaho; Canadian National Advisory Committee on Immunization, Bryna Warshawsky, MDCM, London, Ontario, Canada; Department of Health, United Kingdom, David M. Salisbury, MB BS, London, England, United Kingdom; Healthcare Infection Control Practices Advisory Committee, Alexis Marie Elward, MD, St. Louis, Missouri; Infectious Diseases Society of America, Kathleen M. Neuzil, MD, Seattle, Washington; Infectious Diseases Society of America (alternate), Carol J. Baker, Houston, Texas; National Association of County and City Health Officials, Matthew Zahn, MD, Santa Ana, California; National Association of Pediatric Nurse Practitioners, Patricia A. Stinchfield, MS, St. Paul, Minnesota; National Foundation for Infectious Diseases, William Schaffner, MD, Nashville, Tennessee; National Immunization Council and Child Health Program, Mexico, Ignacio Villaseñor Ruiz, Mexico City, Federal District, Mexico; National Medical Association, Patricia Whitley-Williams, MD, New Brunswick, New Jersey; National Vaccine Advisory Committee, Walt Orenstein, MD, Atlanta, Georgia; Pediatric Infectious Diseases Society, Janet A. Englund, MD, Seattle, Washington; Pharmaceutical Research and Manufacturers of America, Damian A. Braga, Swiftwater, Pennsylvania; Society for Adolescent Health and Medicine, Amy B. Middleman, MD, Houston, Texas; Society for Healthcare Epidemiology of America, Harry L. Keyserling, MD, Atlanta, Georgia

ACIP Influenza Vaccine Work Group

Chair: Wendy Keitel, MD, Houston, Texas

Members: Kevin Ault, MD, Atlanta, Georgia; Henry Bernstein, DO, Hempstead, New York; Jeff Duchin, MD, Seattle, Washington; Janet Englund, MD, Seattle, Washington; Sandra Fryhofer, MD, Atlanta, Georgia; Lee H. Harrison, MD, Pittsburgh, Pennsylvania; Lisa Ipp, MD, New York, New York; Ruth A. Karron, MD, Baltimore, Maryland; Marie‐Michèle Léger, MPH, Alexandria, Virginia; Susan Lett, MD, Jamaica Plain, Massachusetts; Jamie Loehr, MD, Ithaca, New York; Kathleen M. Neuzil, MD, Seattle, Washington; William Schaffner, MD, Nashville, Tennessee; Robert Schechter, MD, Richmond, California; Kenneth Schmader, MD, Durham, North Carolina; Tamara Sheffield, MD, Salt Lake City, Utah; Nadine Sicard, MD, Montreal, Quebec, Canada; Patricia Stinchfield, St. Paul, Minnesota; Matthew Zahn, MD, Santa Ana, California

Financial Disclosures/Conflicts of Interest

Given the substantial financial implications that Advisory Committee on Immunization Practices (ACIP) recommendations may have for the public and private sectors, as well as for vaccine manufacturers, candidates who are nominated for ACIP membership undergo careful screening for potential conflicts of interest before their names are submitted for final consideration. To ensure integrity of the ACIP, all nominees are reviewed by the ACIP Steering Committee. Stringent measures are taken to assure that there is not only technical compliance with ethics statutes and regulations regarding financial conflicts but also that more general concerns regarding potential for appearance of a conflict of interest are addressed or avoided altogether through both pre- and post-appointment considerations. People with specific vaccine-related interests at the time of application are not considered for appointment to the Committee. Examples of such interests include direct employment of the candidate or an immediate family member by a vaccine manufacturer or its parent company, serving on a board of a vaccine manufacturer, and holding a patent on a vaccine or related product. Potential ACIP members are asked before submission of their names for final selection to recuse themselves during the term of membership from activities that are, or could be construed as, conflicts of interest. These activities include provision of advisory or consulting services to a vaccine manufacturer or its parent company and acceptance of honoraria or travel reimbursement from a vaccine manufacturer. Once accepted for membership, ACIP members are required every year to file confidential financial reports with the Office of Government Ethics and to disclose publicly all vaccine-related interests and work, including participation in clinical trials, at each meeting. If, despite all these safeguards, a conflict exists, limited waivers allow members to participate in committee discussions with the condition that they are prohibited from voting on matters involving the specific or competing vaccine manufacturers. A member who develops an important conflict of interest during the 4-year term will be required to resign from the ACIP.

Screening for conflicts of interest is rigorous and balances the possibility of bias caused by a conflict with the need for vaccine and immunization expertise, including cross-cutting knowledge and experience in the various components of the immunization field. Some data important to the committee can be obtained only through working relationships with vaccine manufacturers. Representatives of vaccine manufacturers may present data on vaccine immunogenicity, effectiveness, and safety to ACIP workgroups and at meetings of the full ACIP, but they are not permitted to serve as members of workgroups, or have any input into ACIP deliberations.

Source: Smith JC, Snider DE, Pickering LK; Advisory Committee on Immunization Practices. Immunization policy development in the United States: the role of the Advisory Committee on Immunization Practices. Ann Intern Med. 2009 Jan 6;150(1):45-9.

Disclosure of Relationship

Centers for Disease Control and Prevention (CDC), their planners, and their content experts disclose that they have no financial interests or other relationships with the manufacturers of commercial products, suppliers of commercial services, or commercial supporters. Presentations will not include any discussion of the unlabeled use of a product or a product under investigational use. CDC does not accept commercial support.

Guideline Status

This is the current release of the guideline.

This guideline updates a previous version: Centers for Disease Control and Prevention (CDC). Prevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP) - United States, 2012-13 influenza season. MMWR Morb Mortal Wkly Rep. 2012 Aug 17;61(32):613-8.

Guideline Availability

Electronic copies: Available from the Morbidity and Mortality Weekly Report (MMWR) Web site External Web Site Policy.

Print copies: Available from the Centers for Disease Control and Prevention, MMWR, Atlanta, GA 30333. Additional copies can be purchased from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402-9325; (202) 783-3238.

Availability of Companion Documents

The following are available:

  • Centers for Disease Control and Prevention (CDC). New framework (GRADE) for development of evidence-based recommendations by the Advisory Committee on Immunization Practices. MMWR. 2012;61(18):327. Electronic copies: Available from the Morbidity and Mortality Weekly Report (MMWR) Web site External Web Site Policy.
  • Ahmed F, Temte JL, Campos-Outcalt D, Schünemann HJ; ACIP Evidence Based Recommendations Work Group (EBRWG). Methods for developing evidence-based recommendations by the Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control and Prevention (CDC). Vaccine. 2011 Nov 15;29(49):9171–6. Electronic copies: Available to subscribers from the Vaccine Journal Web site External Web Site Policy.
  • Smith JC, Snider DE, Pickering LK; Advisory Committee on Immunization Practices. Immunization policy development in the United States: the role of the Advisory Committee on Immunization Practices. Ann Intern Med. 2009 Jan 6;150(1):45–9. Electronic copies: Available from the Annals of Internal Medicine Web site External Web Site Policy.

The following are also available:

  • CDC. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices, 2011. MMWR 2011;60(No. RR-2). Electronic copies: Available from the MMWR Web site External Web Site Policy.
  • CDC. Immunization of health-care personnel: recommendations of the Advisory Committee on Immunization Practices, 2011. MMWR 2011;60(No. RR-7). Electronic copies: Available from the MMWR Web site External Web Site Policy.
  • 2013 adult immunization schedule (vaccines recommended for adults 19 years of age and older). Electronic copies: Available in Portable Document Format (PDF), as well as a variety of formats, including pocket-size, from the CDC Web site External Web Site Policy.
  • 2013 child & adolescent immunization schedules (birth-18 years and "catch-up" schedule). Electronic copies: Available in Portable Document Format (PDF) in English and Spanish, as well as a variety of formats including pocket-size, from the CDC Web site External Web Site Policy.
  • CDC. Antiviral agents for the treatment and chemoprophylaxis of influenza: recommendations of the Advisory Committee on Immunization Practices, 2011. MMWR 2011;60(No. RR-1). Electronic copies: Available from the MMWR Web site External Web Site Policy.

In addition, a number of free resources and tools on seasonal influenza, including brochures, fact sheets, articles, posters, stickers, media toolkits, and videos, are available from the CDC Web site External Web Site Policy.

Patient Resources

The following are available:

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC Status

This summary was completed by ECRI on July 17, 2000, and updated on October 20, 2000. The summary was verified by the guideline developer as of January 18, 2001. The summary was updated by ECRI on August 6, 2001, June 12, 2002, May 14, 2003, December 18, 2003, June 15, 2004, October 6, 2004, October 30, 2004, and on December 29, 2004 in response to interim recommendations published by the CDC on December 24, 2004. This NGC summary was updated by ECRI on July 21, 2005. This NGC summary was updated on September 23, 2005, in response to the update issued on September 16, 2005 for the 2005-2006 influenza season. It was updated on January 19, 2006, in response to updated guidelines for the use of antivirals. This NGC summary was updated on July 6, 2006, in response to the recommendations issued on June 28, 2006 for the 2006-2007 influenza season. This summary was updated by ECRI on November 21, 2006 following the FDA advisory on Tamiflu. This NGC summary was updated by ECRI Institute most recently on July 5, 2007. This summary was updated by ECRI Institute on March 10, 2008 following the U.S. Food and Drug Administration (FDA) advisory on Tamiflu (oseltamivir phosphate). This summary was updated by ECRI Institute on April 9, 2008 following the U.S. Food and Drug Administration (FDA) advisory on Relenza (zanamivir). This summary was updated by ECRI Institute on August 25, 2008. This summary was updated by ECRI Institute on November 20, 2009. This summary was updated by ECRI Institute on August 16, 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). This summary was updated by ECRI Institute on July 15, 2011 following the U.S. Food and Drug Administration advisory on Tamiflu (oseltamivir phosphate). This NGC summary was updated on September 27, 2012. This NGC summary was updated by ECRI Institute on October 10, 2013.

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