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Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2017–18 Influenza Season

CDC 

Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2017–18 Influenza Season

Lisa A. Grohskopf, MD1; Leslie Z. Sokolow, MSc, MPH1,2; Karen R. Broder, MD3; Emmanuel B. Walter, MD4; Joseph S. Bresee, MD1; Alicia M. Fry, MD1; Daniel B. Jernigan, MD1

Summary

This report updates the 2016–17 recommendations of the Advisory Committee on Immunization Practices (ACIP) regarding the use of seasonal influenza vaccines (MMWR Recomm Rep 2016;65[No. RR-5]). Routine annual influenza vaccination is recommended for all persons aged ≥6 months who do not have contraindications. A licensed, recommended, and age-appropriate vaccine should be used.

For the 2017–18 season, quadrivalent and trivalent influenza vaccines will be available. Inactivated influenza vaccines (IIVs) will be available in trivalent (IIV3) and quadrivalent (IIV4) formulations. Recombinant influenza vaccine (RIV) will be available in trivalent (RIV3) and quadrivalent (RIV4) formulations. Live attenuated influenza vaccine (LAIV4) is not recommended for use during the 2017–18 season due to concerns about its effectiveness against (H1N1)pdm09 viruses during the 2013–14 and 2015–16 seasons. Recommendations for different vaccine types and specific populations are discussed. No preferential recommendation is made for one influenza vaccine product over another for persons for whom more than one licensed, recommended product is available.

Updates to the recommendations described in this report reflect discussions during public meetings of ACIP held on October 20, 2016; February 22, 2017; and June 21, 2017. New and updated information in this report includes the following:

  • Vaccine viruses included in the 2017–18 U.S. trivalent influenza vaccines will be an A/Michigan/45/2015 (H1N1)pdm09–like virus, an A/Hong Kong/4801/2014 (H3N2)-like virus, and a B/Brisbane/60/2008–like virus (Victoria lineage). Quadrivalent influenza vaccines will contain these three viruses and an additional influenza B vaccine virus, a B/Phuket/3073/2013–like virus (Yamagata lineage).
  • Information on recent licensures and labelling changes is discussed, including licensure of Afluria Quadrivalent (IIV4; Seqirus, Parkville, Victoria, Australia); Flublok Quadrivalent (RIV4; Protein Sciences, Meriden, Connecticut); and expansion of the age indication for FluLaval Quadrivalent (IIV4; ID Biomedical Corporation of Quebec, Quebec City, Quebec, Canada), previously licensed for ≥3 years, to ≥6 months.
  • Pregnant women may receive any licensed, recommended, age-appropriate influenza vaccine.
  • Afluria (IIV3; Seqirus, Parkville, Victoria, Australia) may be used for persons aged ≥5 years, consistent with Food and Drug Administration–approved labeling.
  • FluMist Quadrivalent (LAIV4; MedImmune, Gaithersburg, Maryland) should not be used during the 2017–18 season due to concerns about its effectiveness against influenza A(H1N1)pdm09 viruses in the United States during the 2013–14 and 2015–16 influenza seasons.

This report focuses on the recommendations for use of vaccines for the prevention and control of influenza during the 2017–18 season in the United States. A Background Document containing further information and a summary of these recommendations are available at https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/flu.html. These recommendations apply to licensed influenza vaccines used within Food and Drug Administration–licensed indications, including those licensed after the publication date of this report. Updates and other information are available at CDC’s influenza website (https://www.cdc.gov/flu). Vaccination and health care providers should check CDC’s influenza website periodically for additional information.

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Introduction

Influenza viruses typically circulate widely in the United States annually, from the late fall through the early spring. Although most persons with influenza will recover without sequelae, influenza can cause serious illness and death, particularly among older adults, very young children, pregnant women, and those with certain chronic medical conditions (16).

Routine annual influenza vaccination for all persons aged ≥6 months who do not have contraindications has been recommended by CDC and CDC’s Advisory Committee on Immunization Practices (ACIP) since 2010 (7). This report updates the 2016–17 ACIP recommendations regarding the use of seasonal influenza vaccines (8) and provides recommendations and guidance for vaccine providers regarding the use of influenza vaccines for the 2017–18 season. A variety of different formulations of influenza vaccine are available (Table 1). Contraindications and precautions to the use of influenza vaccines are summarized (Table 2). Abbreviations are used in this report to denote the various types of vaccines (Box).

This report focuses on the recommendations for use of influenza vaccines for the prevention and control of influenza during the 2017–18 season in the United States. A summary of these recommendations and a Background Document containing additional information on influenza-associated illnesses and influenza vaccines are available at https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/flu.html.

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Methods

ACIP provides annual recommendations for the use of influenza vaccines for the prevention and control of influenza. The ACIP Influenza Work Group meets by teleconference once to twice per month 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.

In general, the Background Document is updated to reflect recent additions to the literature related to the following: 1) recommendations that were made in previous seasons, 2) changes in the viral antigen composition of seasonal influenza vaccines, and 3) minor changes in guidance for the use of influenza vaccines (e.g., guidance for timing of vaccination and other programmatic issues, guidance for dosage in specific populations, guidance for selection of vaccines for specific populations that are already recommended for vaccination, and changes that reflect use consistent with Food and Drug Administration [FDA]–licensed indications and prescribing information). The summary included in the Background Document for such topics is not a systematic review, but is intended to provide a broad overview of current literature. In general, systematic review and evaluation of the evidence using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach is performed for new recommendations or substantial changes in the recommendations (e.g., expansion of the recommendation for influenza vaccination to new populations not previously recommended for vaccination or potential preferential recommendations for specific vaccines).

Updates and changes to the recommendations described in this report are of five types: 1) the vaccine virus composition for 2017–18 U.S. seasonal influenza vaccines; 2) recent regulatory actions, including new vaccine licensures and labeling changes for previously licensed vaccines; 3) updated recommendations for the use of influenza vaccines in pregnancy, including a recommendation that pregnant women may receive any licensed, recommended, age-appropriate influenza vaccine; 4) a recommendation that the trivalent inactivated influenza vaccine (IIV3) Afluria (Seqirus, Parkville, Victoria, Australia) may be used for persons aged ≥5 years, consistent with FDA-approved labeling; and 5) a recommendation (continued from the 2016–17 season) that LAIV4 not be used during the 2017–18 season. Systematic review and GRADE were not performed for these updates and changes. Information relevant to these changes includes the following:

  • Recommendations for composition of Northern Hemisphere influenza vaccines are made by the World Health Organization (WHO), which organizes a consultation, generally in February of each year. Surveillance data are reviewed and candidate vaccine viruses are discussed. A summary of the WHO meeting for selection of the 2017–18 Northern Hemisphere vaccine viruses is available at http://www.who.int/influenza/vaccines/virus/recommendations/201703_recommendation.pdf. Subsequently, FDA, which has regulatory authority over vaccines in the United States, convenes a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC). This committee considers the recommendations of WHO, reviews and discusses similar data, and makes a final decision regarding vaccine virus composition for influenza vaccines licensed and marketed in the United States. A summary of the FDA VRBPAC meeting of March 9, 2017, at which the composition of the 2017–18 U.S. influenza vaccines was discussed, is available at https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM552054.pdf.
  • With regard to recommendations for newly licensed influenza vaccines and changes to the licensed indications for existing vaccines, ACIP relies on FDA for review of safety, immunogenicity, and effectiveness data pertaining to the licensure of influenza vaccines. Regulatory information pertinent to the two recently licensed products and one labelling change discussed in this report is available at https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm518291.htm (for Afluria Quadrivalent; Seqirus, Parkville, Victoria, Australia), https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm524660.htm (for Flublok Quadrivalent; Protein Sciences, Meriden, Connecticut), and https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm366061.htm (for FluLaval Quadrivalent; ID Biomedical Corporation of Quebec, Quebec City, Quebec, Canada).
  • For the recommendation that pregnant women may receive any licensed, recommended, and age-appropriate influenza vaccine, because there have been no studies evaluating use of RIV3 or RIV4 in pregnancy, ACIP reviewed available information presented by the manufacturer and summarized in public documents by FDA concerning pregnancies that occurred among women participating in studies of RIV and pregnancy registry data. RIV reports to the Vaccine Adverse Event Reporting System (VAERS) also were presented. Regulatory information pertinent to this discussion is available at https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm524660.htm.
  • For the recommendation that Afluria (IIV3; Seqirus, Parkville, Victoria, Australia) may be used for persons aged ≥5 years, ACIP reviewed data from studies performed by the manufacturer concerning the cause of an increase in the rate of febrile seizures that occurred in association with the 2010 Southern Hemisphere formulation of this product, and resulting changes in the vaccine manufacturing process. This change makes the ACIP recommendation consistent with FDA-approved labelling for this product. Minutes of the ACIP presentation of these data are available at https://www.cdc.gov/vaccines/acip/meetings/downloads/min-archive/min-2017-02.pdf. Regulatory information is available at https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094043.htm.
  • The recommendation that LAIV4 not be used due to concerns regarding its effectiveness against influenza A(H1N1)pdm09 viruses during the 2013–14 and 2015–16 U.S. seasons was initially made for the 2016–17 season (9). This recommendation continues to be made for the 2017–18 season. ACIP will continue to review data concerning LAIV4 as they become available.

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Primary Changes and Updates in the Recommendations

Routine annual influenza vaccination of all persons aged ≥6 months without contraindications continues to be recommended. No preferential recommendation is made for one influenza vaccine product over another for persons for whom more than one licensed, recommended product is available. Updated information and guidance in this report includes the following:

  • 2017–18 U.S. trivalent influenza vaccines will contain an A/Michigan/45/2015 (H1N1)pdm09–like virus, an A/Hong Kong/4801/2014 (H3N2)–like virus and a B/Brisbane/60/2008–like virus (Victoria lineage). Quadrivalent vaccines will include an additional vaccine virus strain, a B/Phuket/3073/2013–like virus (Yamagata lineage). This represents a change in the influenza A(H1N1)pdm09 virus component from the previous season.
  • Recent regulatory actions, including two new licensures and one labelling change are described:
    • Afluria Quadrivalent (IIV4; Seqirus, Parkville, Victoria, Australia) was licensed by FDA in August, 2016 for persons aged ≥18 years. Regulatory information is available at https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm518291.htm.
    • Flublok Quadrivalent (RIV4; Protein Sciences, Meriden, Connecticut) was licensed by FDA in October 2016, for persons aged ≥18 years. Regulatory information is available at https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm524660.htm.
    • The age indication for FluLaval Quadrivalent (IIV4; ID Biomedical Corporation of Quebec, Quebec City, Quebec, Canada) was extended from ≥3 years to ≥6 months in November 2016. Regulatory information is available at https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm366061.htm. Children aged 6 through 35 months may receive FluLaval Quadrivalent at the same 0.5 mL per dose (containing 15 µg of hemagglutinin [HA] per vaccine virus) as is used for older children and adults. This licensure creates an additional option for vaccination of children aged 6 through 35 months, in addition to the previously available 0.25 mL per dose presentation (containing 7.5 µg of HA per vaccine virus) of Fluzone Quadrivalent (IIV4; Sanofi Pasteur, Swiftwater, Pennsylvania).
  • Pregnant women may receive any licensed, recommended, age-appropriate influenza vaccine.
  • Afluria (IIV3; Seqirus, Parkville, Victoria, Australia) is now recommended for persons aged ≥5 years, consistent with FDA-approved labelling.
  • In light of its low effectiveness against influenza A(H1N1)pdm09 in the United States during the 2013–14 and 2015–16 seasons, for the 2017–18 season, ACIP continues the recommendation that LAIV4 should not be used. Because LAIV4 is still a licensed vaccine that might be available and that some providers might elect to use, for informational purposes only, reference is made in this report to previous recommendations for its use.

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Recommendations for the Use of Influenza Vaccines, 2017–18 Season

Groups Recommended for Vaccination

Routine annual influenza vaccination is recommended for all persons aged ≥6 months who do not have contraindications. Recommendations regarding timing of vaccination, considerations for specific populations, the use of specific vaccines, and contraindications and precautions are summarized in the sections that follow.

Timing of Vaccination

Optimally, vaccination should occur before onset of influenza activity in the community. Health care providers should offer vaccination by the end of October, if possible. Children aged 6 months through 8 years who require 2 doses (see Children Aged 6 Months through 8 Years) should receive their first dose as soon as possible after vaccine becomes available, to allow the second dose (which must be administered ≥4 weeks later) to be received by the end of October. Although some available data indicate that early vaccination (e.g., in July and August) might be associated with suboptimal immunity before the end of the influenza season, particularly among older adults, the relative contribution of potential waning of immunity compared with those of other determinants of the impact of vaccination (e.g., timing and severity of the influenza season, the impact of missed opportunities when individuals delay vaccination and fail to return later in the season, and programmatic constraints) is unknown. Although delaying vaccination might result in greater immunity later in the season, deferral also 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 onset of influenza circulation occurs. Revaccination later in the season of persons who have already been fully vaccinated is not recommended.

Vaccination should continue to be offered as long as influenza viruses are circulating and unexpired vaccine is available. To avoid missed opportunities for vaccination, providers should offer vaccination during routine health care visits and hospitalizations when 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 season, the optimal time to vaccinate cannot be predicted precisely because influenza seasons vary in timing and duration. Moreover, more than one outbreak might occur in a given 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 74% of influenza seasons from 1982–83 through 2015–16, 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 59% of seasons, the peak was in February or later (10).

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. Several observational studies of influenza vaccine effectiveness have reported decreased vaccine protection within a single season, particularly against influenza A(H3N2) (1114). In some of these studies decline in VE was particularly pronounced among older adults (12,13). Some studies have documented decline in protective antibodies over the course of one season (1517), with antibody levels decreasing with greater time elapsed postvaccination. However, the rate and degree of decline observed has varied. Among adults in one study, HA and neuraminidase antibody levels declined slowly, with a two-fold decrease in titer estimated to take >600 days (18). A review of studies reporting postvaccination seroprotection rates among adults aged ≥60 years noted that seroprotection levels meeting Committee of Proprietary Medicinal Products standards were maintained for ≥4 months for the H3N2 component in all 8 studies and for the H1N1 and B components in five of seven studies (19). A recent multiseason analysis from the U.S. Influenza Vaccine Effectiveness (U.S. Flu VE) Network found that VE declined by about 7% per month for H3N2 and influenza B, and 6%–11% per month for H1N1pdm09 (20). VE remained greater than zero for at least 5 to 6 months after vaccination. Similar waning effects have not been observed consistently across age groups and virus subtypes in different populations, and the observed decline in protection could be attributable to bias, unmeasured confounding, or the late season emergence of antigenic drift variants that are less well-matched to the vaccine strain.

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. Although vaccination by the end of October is recommended, vaccine administered in December or later, even if influenza activity has already begun, is likely to be beneficial in the majority of influenza seasons.

Guidance for Use in Specific Populations and Situations

Populations at Higher Risk for Medical Complications Attributable to Severe Influenza

All persons aged ≥6 months without contraindications should be vaccinated annually. However, vaccination to prevent influenza is particularly important for persons who are at increased risk for severe complications from influenza and for influenza-related outpatient, ED, or hospital visits. When vaccine supply is limited, vaccination efforts should focus on delivering vaccination to the following persons at increased risk for medical complications attributable to severe influenza who do not have contraindications (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 are immunocompromised due to any cause (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 aspirin- or salicylate-containing medications and who might be at risk for experiencing Reye syndrome after influenza virus infection;
  • residents of nursing homes and other long-term care facilities;
  • American Indians/Alaska Natives; and
  • persons who are extremely obese (BMI ≥40).

ACIP recommends that LAIV4 not be used during the 2017–18 season for any population. Providers who elect to use it should consider previous guidance for use of LAIV4 for high-risk populations (Table 2).

Persons Who Live With or Care for Persons at Higher Risk for Influenza-Related Complications

All persons aged ≥6 months without contraindications should be vaccinated annually; however, 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, including physicians, nurses, and other workers in inpatient and outpatient-care settings, medical emergency-response workers (e.g., paramedics and emergency medical technicians), and 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 (21);
  • household contacts (including children) and caregivers of children aged ≤59 months (i.e., aged <5 years) and adults aged ≥50 years, particularly contacts of children aged <6 months; and
  • household contacts (including children) and caregivers of persons with medical conditions that put them at high risk for severe complications from influenza.

ACIP recommends that LAIV4 not be used during the 2017–18 season for any population. Providers who elect to use it should consider previous guidance for use of LAIV4 for persons who care for or have contact with immunocompromised persons (22). Health care personnel and persons who are contacts of persons in these groups and who are contacts of severely immunocompromised persons (those living in a protected environment) may receive any IIV or RIV that is otherwise indicated. ACIP and HICPAC have previously 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 LAIV4 should avoid contact with severely immunosuppressed persons (i.e., persons requiring a protected environment) for 7 days after vaccination. However, such persons should not be restricted from visiting less severely immunosuppressed patients.

Children Aged 6 Months Through 8 Years

Dose volume for children aged 6 through 35 months: Children aged 6 through 35 months may receive one of two products at the appropriate volume for each dose needed: 0.5 mL FluLaval Quadrivalent (containing 15 µg of HA per vaccine virus) or 0.25 mL Fluzone Quadrivalent (containing 7.5 µg of HA per vaccine virus). These are the only two influenza vaccine products licensed for this age group. Care should be taken to administer the appropriate volume for each needed dose of either product. In either instance, the needed volume may be administered from an appropriate prefilled syringe, a single dose vial, or multidose vial, as supplied by the manufacturer. Note, however, that if a 0.5 mL single-use vial of Fluzone Quadivalent is used for a child aged 6 through 35 months, only half the volume should be administered and the other half should be discarded.

Before November 2016, the only influenza vaccine formulations licensed for children aged 6 through 35 months were the 0.25 mL (containing 7.5 µg of HA per vaccine virus) dose formulations of Fluzone and Fluzone Quadrivalent. The recommendation for use of a reduced dose volume for children in this age group (half that recommended for persons aged ≥3 years) was based on increased reactogenicity noted among children (particularly younger children) following receipt of influenza vaccines in trials conducted during the 1970s. This increased reactogenicity was primarily observed with whole-virus inactivated vaccines (2327). Studies with vaccines more similar to currently available split-virus inactivated products demonstrated less reactogenicity (27). Recent comparative studies of 0.5 mL vs. 0.25 mL doses of IIV3 conducted among children aged 6 through 23 months (28) and 6 through 35 months (29) noted no significant difference in reactogenicity at the higher dose. In a randomized trial comparing immunogenicity and safety of 0.5 mL FluLaval Quadrivalent with 0.25 mL Fluzone Quadrivalent, safety and reactogenicity were similar between the two vaccines. In a post-hoc analysis, superior immunogenicity was noted for the B components of FluLaval Quadrivalent among infants aged 6 through 17 months and for unprimed children (those who had not previously received at least 2 doses of influenza vaccine) aged 6 through 35 months (30).

Number of doses 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 for optimal protection (3134). Children aged 6 months through 8 years who have previously received ≥2 total doses of trivalent or quadrivalent influenza vaccine before July 1, 2017 require only 1 dose for 2017–18. The 2 doses of influenza vaccine do not have to have been administered in the same season or consecutive seasons. Children in this age group who have not previously received ≥2 doses of trivalent or quadrivalent influenza vaccine before July 1, 2017 require 2 doses for the 2017–18 season. The interval between the 2 doses should be at least 4 weeks (Figure).

Pregnant Women

Because pregnant and postpartum women are at higher risk for severe illness and complications from influenza than women who are not pregnant, ACIP recommends that all women who are pregnant or who might be pregnant in the influenza season receive influenza vaccine. Any licensed, recommended, and age-appropriate influenza vaccine may be used. Influenza vaccine can be administered at any time during pregnancy, before and during the influenza season. ACIP recommends that LAIV4 not be used in any population for the 2017–18 season. Providers should note that, as a live virus vaccine, LAIV4 should not be used during pregnancy.

Although experience with the use of IIVs is substantial, and data from observational studies are available to support the safety of these vaccines in pregnancy, data are more limited for vaccination during the first trimester (see Safety of Influenza Vaccines: Pregnant Women and Neonates in the Background Document). Moreover, there is substantially less experience with more recently licensed IIV products (e.g., quadrivalent, cell culture-based, and adjuvanted vaccines) during pregnancy in general. For RIV (available as RIV3 since the 2013–14 influenza season, and as RIV3 and RIV4 for 2017–18), data are limited to reports of pregnancies occurring incidentally during clinical trials, VAERS reports, and pregnancy registry reports. Pregnancy registries and surveillance studies exist for some products; information may be found in package inserts (3542), available at https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094045.htm for trivalent vaccines and https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm295057.htm for quadrivalent vaccines.

Older Adults

For persons aged ≥65 years, any age-appropriate IIV formulation (standard-dose or high-dose, trivalent or quadrivalent, unadjuvanted or adjuvanted) or RIV are acceptable options. Fluzone High-Dose (HD-IIV3; Sanofi Pasteur, Swiftwater, Pennsylvania) met prespecified criteria for superior efficacy to that of SD-IIV3 in a randomized trial conducted over two seasons among 31,989 persons aged ≥65 years, and might provide better protection than SD-IIV3 for this age group (4345). In an exploratory analysis of data from a single-season randomized trial conducted among 8,604 adults aged ≥50 years, Flublok Quadrivalent (RIV4; Protein Sciences, Meriden, Connecticut) was more efficacious than SD-IIV4 (46,47); however, no claim of superiority was approved for the package insert (47). Fluad (aIIV3; Seqirus, Holly Springs, North Carolina) was more effective against laboratory-confirmed influenza than unadjuvanted SD-IIV3 among adults aged ≥65 years (N = 227) in an analysis from a small observational study (48). No preferential recommendation is made for any specific vaccine product. Vaccination should not be delayed if a specific product is not readily available.

Because of the vulnerability of this population to severe influenza illness, hospitalization, and death, efficacy and effectiveness of influenza vaccines among older adults is an area of active research (see Immunogenicity, Efficacy, and Effectiveness of Influenza Vaccines: HD-IIV3, aIIV3, and RIV4 for Older Adults in the Background Document). Recent comparative studies of efficacy/effectiveness against laboratory-confirmed influenza outcomes among older adults have focused on HD-IIV3 (Fluzone High Dose; Sanofi Pasteur, Swiftwater, Pennsylvania) (43,4951), aIIV3 (Fluad, Seqirus, Holly Springs, North Carolina) (48), and RIV4 (Flublok Quadrivalent; Protein Sciences, Meriden, Connecticut) (46). Characteristics of these studies are summarized (Table 3). In each instance, the comparator vaccines have been standard dose, inactivated vaccines (SD-IIV3 as the comparator for HD-IIV3 and aIIV3; SD-IIV4 as the comparator for RIV4). No data are yet available from studies comparing the efficacy or effectiveness of HD-IIV3, aIIV3, and RIV4 with one another among older adults. This lack of comparative data prevents recommending one of these three vaccines over another for this population. HD-IIV3 exhibited superior efficacy over a comparator standard-dose IIV3 for adults aged ≥65 years in a large (N = 31,989), two-season randomized, controlled, double-blind trial (43,44), and might provide better protection than SD-IIV3s for this age group. Additional data concerning relative efficacy of HD-IIV3 for other clinical outcomes, as well as cost-effectiveness analyses and observational studies, are summarized in the Background Document. In a single-season randomized, controlled, double-blind trial comparing RIV4 with a standard-dose unadjuvanted IIV4 among adults aged ≥50 years (N = 8,604), RIV4 was more effective; however, approval for a claim of superiority was not made as a result of this exploratory analysis (46,47). Additional data, including discussion of immunogenicity studies, are described in the Background Document. Fluad (aIIV3; Seqirus, Holly Springs, North Carolina) was more effective against laboratory-confirmed influenza than unadjuvanted SD-IIV3 among adults aged ≥65 years (N = 227) in an analysis from a small observational study (48); no data are yet available concerning efficacy of Fluad compared with nonadjuvanted IIV3 against laboratory-confirmed influenza outcomes from a randomized trial in this population. Additional data concerning aIIV3, from studies examining immunogenicity and non-laboratory confirmed influenza outcomes, are discussed in the Background Document. ACIP will continue to review data concerning the efficacy and effectiveness of these vaccines as more information emerges.

Immunocompromised Persons

Immunocompromised states comprise a heterogeneous range of conditions. In many instances, limited data are available regarding the use of influenza vaccines in the setting of specific immunocompromised states. ACIP recommends that LAIV4 not be used in any population for the 2017–18 season; providers considering its use should note that live virus vaccines should not be used for persons with most forms of altered immunocompetence (52), given the uncertain but biologically plausible risk for disease attributable to the vaccine virus. In addition to potential safety issues, immune response to live or inactivated vaccines might be blunted in some clinical situations, such as for persons with congenital immune deficiencies, persons receiving cancer chemotherapy, and persons receiving immunosuppressive medications. For this reason, timing of vaccination might be a consideration (e.g., vaccinating during some period either before or after an immunocompromising intervention).

The Infectious Diseases Society of America (IDSA) has published detailed guidance for the selection and timing of vaccines for persons with specific immunocompromising conditions, including congenital immune disorders, stem cell and solid organ transplant, anatomic and functional asplenia, and therapeutic drug-induced immunosuppression, as well as for persons with cochlear implants or other conditions leading to persistent cerebrospinal fluid-oropharyngeal communication (53). ACIP will continue to review accumulating data on use of influenza vaccines in these contexts.

Persons with a History of Guillain-Barré Syndrome Following Influenza Vaccination

A history of Guillain-Barré Syndrome (GBS) within 6 weeks following a previous dose of any type of influenza vaccine is considered a precaution to vaccination (Table 2). Persons who are not at high risk for severe influenza complications (see Populations at Higher Risk for Medical Complications Attributable to Severe Influenza) and who are known to have experienced GBS within 6 weeks of a previous influenza vaccination generally should not be vaccinated. As an alternative to vaccination, physicians might consider using influenza antiviral chemoprophylaxis for these persons (54). However, the benefits of influenza vaccination might outweigh the risks for certain persons who have a history of GBS and who also are at high risk for severe complications from influenza.

Persons with a History of Egg Allergy

As is the case for other vaccines, influenza vaccines contain various different components that might cause allergic and anaphylactic reactions. Not all such reactions are related to egg proteins; however, the possibility of reactions to influenza vaccines in egg-allergic persons might be of concern to these persons and vaccine providers. Currently available influenza vaccines, with the exceptions of RIV3, RIV4 and ccIIV4, are prepared by propagation of virus in embryonated eggs. Only RIV3 and RIV4 are considered egg-free. For ccIIV4 (Flucelvax Quadrivalent; Seqirus, Holly Springs, North Carolina), ovalbumin is not directly measured. During manufacture of ccIIV4, viruses are propagated in mammalian cells rather than in eggs; however, some of the viruses provided to the manufacturer are egg-derived, and therefore egg proteins may potentially be introduced at the start of the manufacturing process. Once these viruses are received by the manufacturer, no eggs are used, and dilutions at various steps during the manufacturing process result in a theoretical maximum of 5×10-8 μg/0.5 mL dose of total egg protein (Seqirus, unpublished data, 2016).

Severe allergic reactions to vaccines, although rare, can occur at any time, despite a recipient’s allergy history. Therefore, all vaccine providers should be familiar with the office emergency plan, and be certified in cardiopulmonary resuscitation (52). For persons who report a history of egg allergy, ACIP recommends the following (based upon the recipient’s previous symptoms after exposure to egg):

  • Persons with a history of egg allergy who have experienced only urticaria (hives) after exposure to egg should receive influenza vaccine. Any licensed and recommended influenza vaccine (i.e., any IIV or RIV) that is otherwise appropriate for the recipient’s age and health status may be used.
  • Persons who report having had reactions to egg involving symptoms other than urticaria (hives), such as angioedema, respiratory distress, lightheadedness, or recurrent emesis; or who required epinephrine or another emergency medical intervention, may similarly receive any licensed and recommended influenza vaccine (i.e., any IIV or RIV) that is otherwise appropriate for the recipient’s age and health status. The selected vaccine should be administered in an inpatient or outpatient medical setting (including, but not necessarily limited to, hospitals, clinics, health departments, and physician offices). Vaccine administration should be supervised by a health care provider who is able to recognize and manage severe allergic conditions.
  • A previous severe allergic reaction to influenza vaccine, regardless of the component suspected of being responsible for the reaction, is a contraindication to future receipt of the vaccine.

No period of postvaccination observation period is recommended specifically for egg-allergic persons. However, ACIP recommends that vaccine providers consider observing patients for 15 minutes following administration of any vaccine to decrease the risk for injury should syncope occur (52).

Persons 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 directed against egg proteins (55).

Occasional cases of anaphylaxis in egg-allergic persons have been reported to VAERS after administration of influenza vaccines (56,57). ACIP will continue to review available data regarding anaphylaxis cases following influenza vaccines.

Vaccination Issues for Travelers

Travelers who want to reduce the risk for influenza infection should consider influenza vaccination, preferably at least 2 weeks before departure. In particular, persons residing in the United States who are at high risk for complications of influenza and who were not vaccinated with influenza vaccine during the preceding Northern Hemisphere fall or winter should consider receiving influenza vaccine before departure if they plan to travel:

  • to the tropics,
  • with organized tourist groups or on cruise ships, or
  • to the Southern Hemisphere during the Southern Hemisphere influenza season (April–September).

No information is available indicating a benefit to revaccinating persons before summer travel who already were vaccinated during the preceding fall. In many cases, revaccination will not be feasible as Southern Hemisphere formulations of influenza vaccine are not generally available in the United States. Persons at high risk who receive the previous season’s vaccine before travel should receive the current vaccine the following fall or winter. Persons at higher risk for influenza complications should consult with their health care practitioner to discuss the risk for influenza or other travel-related diseases before embarking on travel during the summer.

In temperate climate regions of the Northern and Southern hemispheres, influenza activity is seasonal, occurring approximately from October through May in the Northern Hemisphere and April through September in the Southern Hemisphere. In the tropics, influenza occurs throughout the year. Travelers can be exposed to influenza when travelling to an area where influenza is circulating, or when traveling as part of large tourist groups (e.g., on cruise ships) that include persons from areas of the world in which influenza viruses are circulating (58,59). In a survey of Swiss travelers to tropical and subtropical countries, among 211 who reported febrile illness during or after travelling abroad and who provided paired serum samples, 40 demonstrated serologic evidence of influenza infection (60). Among 109 travelers returning to Australia from travel in Asia who reported acute respiratory infection symptoms, four (3.7%) had evidence of influenza A infection (evidenced by fourfold rise in antibody titer) (61).

Influenza vaccine formulated for the Southern Hemisphere might differ in viral composition from the Northern Hemisphere vaccine. However, with the exception of the Southern Hemisphere formulation of Fluzone Quadrivalent (IIV4; Sanofi Pasteur, Swiftwater, Pennsylvania), Southern Hemisphere formulation seasonal influenza vaccines are not licensed in the United States, and Southern Hemisphere formulations generally are not commercially available in the United States. More information on influenza vaccines and travel is available at https://www.cdc.gov/flu/travelers/travelersfacts.htm.

Use of Influenza Antiviral Medications

Administration of IIV or RIV to persons receiving influenza antiviral medications for treatment or chemoprophylaxis is acceptable. ACIP recommends that LAIV4 should not be used during the 2017–18 season. If used, providers should note that influenza antiviral medications may reduce the effectiveness of LAIV4 if given within 48 hours before to 14 days after LAIV4 (62). Persons who receive influenza antiviral medications during this period surrounding receipt of LAIV4 may be revaccinated with another appropriate vaccine formulation (e.g., IIV or RIV).

Concurrent Administration of Influenza Vaccine with Other Vaccines

Data regarding potential interference following simultaneous or sequential administration for the many potential combinations of vaccines are limited. Therefore, following the ACIP General Best Practice Guidelines for Immunization is prudent (52). IIVs and RIV may be administered concurrently or sequentially with other inactivated vaccines or with live vaccines. LAIV4 is not recommended for use in 2017–18. Providers considering its use should note that although inactivated or live vaccines can be administered simultaneously with LAIV4, after administration of a live vaccine (such as LAIV4), at least 4 weeks should pass before another live vaccine is administered.

Relatively limited data are available on the concurrent administration of influenza vaccines with other vaccines. In a study comparing the immunogenicity of IIV and zoster vaccine given either concurrently or separated by a 4-week interval to adults aged ≥50 years, antibody responses were similar for both schedules (63). In some studies, reduced responses have been noted to PCV13 (64,65), tetanus antigens (66), and pertussis antigens (66) when co-administered with IIV; in most instances the clinical significance of this is uncertain. Reassuring safety profiles have been noted for simultaneous administration of zoster vaccine (63), PCV13 (64,65), PPSV23 (67) and Tdap (66) among adults and of Tdap among pregnant women (68). Increased prevalence of local and/or systemic adverse reactions have been noted with concurrent administration in some of these studies, but these symptoms have generally been reported to be mild or moderate. Among children, co-administration of IIV and PCV13 was associated with increased risk of fever on the day of vaccination and the day following (i.e., days 0–1 postvaccination) after vaccination in children aged 6 through 23 months in a study conducted during the 2011–12 season (69). Increased risk of febrile seizure in this age group has been noted within days 0–1 following coadministration of IIV with PCV7, PCV13, or DTaP-containing vaccines during the 2006–07 through 2010–11 seasons (70), and with PCV13 during the 2014–15 season (71). No changes in the recommendations for administration of these vaccines were made, and these vaccines may be given concomitantly. Surveillance of febrile seizures is ongoing through VAERS, and the Vaccine Safety Datalink annual influenza vaccine safety surveillance includes monitoring for seizures following vaccination.

Concurrent administration to children of LAIV3 with MMR and varicella vaccine was not associated with diminished immunogenicity to antigens in any of the vaccines in one study (72); diminished response to rubella was observed in another examining coadministraion of LAIV3 and MMR (73). Administration of OPV was not associated with interference when administered with LAIV (74). No safety concerns were revealed in these studies.

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Influenza Vaccine Composition and Available Products

Influenza Vaccine Composition for the 2017–18 Season

All influenza vaccines licensed in the United States will contain components derived from influenza viruses antigenically similar to those recommended by FDA (75). Both trivalent and quadrivalent influenza vaccines will be available in the United States. The 2017–18 U.S. influenza vaccines will contain the following components:

  • an A/Michigan/45/2015 (H1N1)pdm09–like virus,
  • an A/Hong Kong/4801/2014 (H3N2)–like virus, and
  • a B/Brisbane/60/2008–like virus (Victoria lineage).

The 2017–18 U.S. quadrivalent vaccines will contain the same three antigens and an additional influenza B virus component, a B/Phuket/3073/2013–like virus (Yamagata lineage). Compared with 2016–17, the composition for 2017–18 represents a change in the influenza A(H1N1)pdm09–like virus.

Vaccine Products for the 2017–18 Season

A variety of influenza vaccine products are licensed and available from several different manufacturers (Table 1). For many vaccine recipients, more than one type or brand of vaccine might be appropriate within approved indications and ACIP recommendations. A licensed, age-appropriate influenza vaccine product should be used. Not all products are likely to be uniformly available in any practice setting or locality. Vaccination should not be delayed in order to obtain a specific product when an appropriate one is already available. 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.

Since the publication of the previous season’s guidelines, two new influenza vaccine products have been licensed; Afluria Quadrivalent (IIV4; Seqirus, Parkville, Victoria, Australia) and Flublok Quadrivalent (RIV4; Protein Sciences, Meriden, Connecticut). In addition, a labeling change has been approved for a previously-licensed product: FluLaval Quadrivalent (IIV4, ID Biomedical Corporation of Quebec, Quebec City, Quebec, Canada) is now licensed for children aged 6 months and older. These are described in the New Influenza Vaccine Product Approvals section. New licensures and changes to FDA-approved labeling might occur subsequent to this report. These recommendations apply to all licensed influenza vaccines used within FDA–licensed indications, including changes in FDA-approved labeling that might occur after publication of this report. As these changes occur, they will be reflected in the online version of Table 1, available at https://www.cdc.gov/flu/protect/vaccine/vaccines.htm.

Dosage, Administration, Contraindications, and Precautions

Inactivated Influenza Vaccines (IIVs)

Available products: IIVs comprise multiple products (Table 1). Both quadrivalent and trivalent formulations are available.

With one exception, U.S.-licensed IIVs are manufactured through propagation of virus in eggs. The exception, the cell culture-based vaccine Flucelvax Quadrivalent (ccIIV4; Seqirus, Holly Springs, North Carolina), contains vaccine viruses propagated in Madin-Darby canine kidney cells. Flucelvax Quadrivalent is not considered egg-free, as some of the initial vaccine viruses provided to the manufacturer by WHO are egg-derived. For the 2017–18 season, the influenza A (H1N1) and both influenza B components will be egg-derived; the influenza A (H3N2) component will be cell-derived.

With one exception, IIVs licensed in the United States contain no adjuvant. The exception, Fluad (aIIV3; Seqirus, Holly Springs, North Carolina) contains the adjuvant MF59.

There are IIVs that are licensed for persons as young as age 6 months. However, age indications for the various individual IIVs differ (Table 1). Only age-appropriate products should be administered. Afluria (IIV3, Seqirus, Parkville, Victoria, Australia), which was previously recommended for persons aged ≥9 years, is now recommended for persons aged ≥5 years. Providers should consult package inserts and updated CDC/ACIP guidance for current information.

Dosage and administration: All IIV preparations contain 15 µg of HA per vaccine virus strain (45 µg total for IIV3s and 60 µg total for IIV4s) per 0.5 mL dose, with two exceptions. Fluzone High Dose (HD-IIV3; Sanofi Pasteur, Swiftwater, Pennsylvania), an IIV3 licensed for persons aged ≥65 years, contains 60 µg of each HA per vaccine virus strain (180 µg total) (44). Fluzone Intradermal Quadrivalent (intradermal IIV4; Sanofi Pasteur, Swiftwater, Pennsylvania), an intradermally administered IIV4 licensed for persons aged 18 through 64 years, contains 9 µg of each HA per vaccine virus strain (36 µg total) (36).

For children aged 6 through 35 months, two IIV products are licensed by FDA. The approved dose volumes differ for these two products. Children in this age group may receive either 1) 0.5 mL of FluLaval Quadrivalent (ID Biomedical Corporation of Quebec, Quebec City, Quebec, Canada) (37), which contains 15 µg of HA per virus, or 2) 0.25 mL dose Fluzone Quadrivalent (Sanofi Pasteur, Swiftwater, Pennsylvania) (35), which contains 7.5 µg of HA per virus. Care must be taken to administer each at the appropriate dose for each product in this age group. If prefilled syringes are not available, the appropriate dose can be taken from a single-use or multidose vial, at the appropriate volume for the given product.

Children aged 36 months through 17 years (for whom only intramuscular IIVs are licensed) and adults aged ≥18 years who are receiving intramuscular preparations of IIV should receive 0.5 mL per dose. If a smaller intramuscular vaccine dose (e.g., 0.25 mL) is administered inadvertently to an adult, an additional 0.25 mL dose should be administered to provide a full dose (0.5 mL). If the error is discovered later (after the patient has left the vaccination setting), a full 0.5 mL 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 Quadrivalent (Sanofi Pasteur, Swiftwater, Pennsylvania), IIVs are 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 the ACIP General Best Practice Guidelines for Immunization (52). Fluzone Intradermal Quadrivalent is administered intradermally, preferably over the deltoid muscle, using the included delivery system (36). Two IIVs, Afluria and Afluria Quadrivalent (Seqirus, Parkville, Victoria, Australia), are licensed for intramuscular administration via jet injector (Stratis; Pharmajet, Golden, Colorado) for persons aged 18 through 64 years (39,76).

Trivalent versus quadrivalent IIVs: Both trivalent and quadrivalent IIVs will be available during the 2017–18 season. Quadrivalent vaccines contain one virus from each of the two influenza B lineages (one B/Victoria virus and one B/Yamagata virus), whereas trivalent vaccines contain one influenza B virus from one lineage. Quadrivalent vaccines are thus designed to provide broader protection against circulating influenza B viruses. However, no preference is expressed for either IIV3 or IIV4.

Contraindications and precautions for the 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, history of severe allergic reaction to the vaccine or any of its components (including egg) is a labeled contraindication to the receipt of IIVs (Table 2). However, ACIP makes specific recommendations for the use of influenza vaccine for persons with egg allergy (see Persons with a History of Egg Allergy). Influenza vaccine is not recommended for persons with a history of severe allergic reaction to the vaccine or to components other than egg. Information about vaccine components is located in package inserts from each manufacturer. Prophylactic use of antiviral agents is an option for preventing influenza among persons who cannot receive vaccine (54).

Moderate or severe acute illness with or without fever is a general precaution for vaccination (52). GBS within 6 weeks following a previous dose of influenza vaccine is considered a precaution for use of influenza vaccines (Table 2).

Recombinant Influenza Vaccine (RIVs)

Available products: Two RIV products, Flublok (RIV3) and Flublok Quadrivalent (RIV4), are expected to be available for the 2017–18 influenza season. RIV3 and RIV4 are indicated for persons aged ≥18 years. RIVs are manufactured without the use of influenza viruses; therefore, similarly to IIVs, no shedding of vaccine virus will occur. These vaccines are produced without the use of eggs, and are egg-free. No preference is expressed for RIVs versus IIVs within specified indications.

Dosage and administration: RIVs are administered by intramuscular injection. A 0.5 mL dose contains 45 µg of HA derived from each vaccine virus (135 µg total for RIV3 and 180 µg total for RIV4).

Trivalent versus quadrivalent RIV: Both trivalent and quadrivalent RIV will be available during the 2017–18 season. Quadrivalent vaccines contain one virus from each of the two influenza B lineages (one B/Victoria virus and one B/Yamagata virus), whereas trivalent vaccines contain one influenza B virus from one lineage. Quadrivalent vaccines are thus designed to provide broader protection against circulating influenza B viruses. However, no preference is expressed for either RIV3 or RIV4.

Contraindications and precautions for use of RIV: RIVs are 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 (52). GBS within 6 weeks following a previous dose of influenza vaccine is considered a precaution for use of influenza vaccines (Table 2). Flublok is not licensed for use in children aged <18 years.

Live Attenuated Influenza Vaccine (LAIV4)

Pending further data, for the 2017–18 season, ACIP recommends that LAIV4 not be used because of concerns regarding its effectiveness against influenza A(H1N1)pdm09 viruses in the United States during the 2013–14 and 2015–16 seasons. As it is a licensed vaccine and might be available during 2017–18, the material in this section is provided for information.

Dosage and administration: LAIV4 is administered intranasally using the supplied prefilled, single-use sprayer containing 0.2 mL of vaccine. Approximately 0.1 mL (i.e., half of the total sprayer contents) is sprayed into the first nostril while the recipient is in the upright position. An attached dose-divider clip is removed from the sprayer to administer the second half of the dose into the other 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 another appropriate vaccine should be administered instead.

Contraindications and precautions: ACIP recommends that LAIV4 not be used during the 2017–18 season. Previously issued guidance regarding contraindications and precautions is provided for informational purposes only (Table 2).

New Influenza Vaccine Product Approvals

Since the publication of the previous season’s guidance, there have been two new product approvals (Afluria Quadrivalent and Flublok Quadrivalent) and one change to the approved indication for an existing product (expansion of the age indication for FluLaval Quadrivalent from ≥3 years to ≥6 months).

Afluria Quadrivalent (IIV4)

Afluria Quadrivalent (IIV4, Seqirus, Parkville, Victoria, Australia) was licensed by FDA in August 2016, for persons aged ≥18 years, and was available during the 2016–17 season alongside the trivalent formulation of Afluria. In a prelicensure study of the safety and immunogenicity of Afluria Quadrivalent compared with two formulations of Afluria (each containing one of the two influenza B viruses contained in the quadrivalent) among persons aged ≥18 years, Afluria Quadrivalent met pre-specified criteria for immunologic noninferiority for all four vaccine viruses, and criteria for immunologic superiority for each B virus as compared to the trivalent formulation containing the alternate B virus.

Some local injection site reactions were more common among those who received Afluria Quadrivalent, including an imbalance of Grade 3 injection site induration/swelling at 0.3% in the Afluria Quadrivalent group and 0.06% in the pooled Afluria trivalent groups), but rates of these reactions were low overall (77,78).

Flublok Quadrivalent (RIV4)

Flublok Quadrivalent (RIV4; Protein Sciences, Meriden, Connecticut) was licensed by FDA in October 2016, for persons aged ≥18 years. It is anticipated that Flublok Quadrivalent will be available for the 2017–18 season, alongside the trivalent formulation of Flublok. In a prelicensure analysis of immunogenicity data from a subset of participants enrolled in a randomized relative efficacy trial comparing Flublok Quadrivalent with a licensed comparator standard-dose IIV4 among persons aged ≥50 years during the 2014–15 season, Flublok Quadrivalent met criteria for noninferiority to the comparator IIV4 for the A(H3N2) and B/Yamagata antigens, but not for the A(H1N1) or B/Victoria antigens (47). In an exploratory analysis of data from this trial (N = 8,604), Flublok Quadrivalent demonstrated 30% greater relative efficacy (95% confidence interval [CI] = 10–47) over IIV4 (46,47). In a second prelicensure study, evaluating safety, reactogenicity, and immunogenicity compared with a licensed IIV4 among persons aged 18 through 49 years during the 2014–15 season, Flublok Quadrivalent met criteria for noninferiority to the comparator IIV4 for the A(H1N1), A(H3N2) and B/Yamagata antigens, but not for the B/Victoria antigen. Safety data from both studies suggested comparable safety to the comparator IIV4 for persons aged ≥18 years (47).

FluLaval Quadrivalent (IIV4)

In November 2016, FDA approved expansion of the licensed age indication for FluLaval Quadrivalent (IIV4; ID Biomedical Corporation of Quebec, Quebec City, Quebec, Canada). Previously licensed for persons aged ≥3 years, FluLaval Quadrivalent is now licensed for persons aged ≥6 months. The approved dose volume is 0.5 mL for all ages. This represents a new option for vaccination of children aged 6 through 35 months, for whom previously the only approved influenza vaccine formulation was the 0.25 mL dose volume of Fluzone Quadrivalent. With this approval, children in this age group may receive either 0.5 mL of FluLaval Quadrivalent or 0.25 mL of Fluzone Quadrivalent for each dose needed.

In a prelicensure study comparing the immunogenicity and safety of 0.5 mL of FluLaval Quadrivalent to that of 0.25 mL of Fluzone Quadrivalent among children aged 6 through 35 months, FluLaval Quadrivalent met criteria for immunogenic noninferiority for all four vaccine strains. Safety and reactogenicity were similar between the two vaccines (30,79).

Storage and Handling of Influenza Vaccines

In all instances, approved manufacturer packaging information should be consulted for authoritative guidance concerning storage and handling of all influenza vaccines. Vaccines should be protected from light and stored at recommended temperatures. In general, influenza vaccines are recommended to be stored refrigerated between 2° to 8°C (36° to 46°F) and should not be frozen. Vaccine that has frozen should be discarded. In addition, the cold chain must be maintained when LAIV4 is transported. Single-dose vials should not be accessed for more than one dose. Multiple-dose vials should be returned to recommended storage conditions between uses, and once first accessed should not be kept beyond the recommended period of time. For information on permissible temperature excursions and other departures from recommended storage conditions that are not discussed in the package labelling, contact the manufacturer. Vaccines should not be used after the expiration date on the label.

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Additional Sources for Information Regarding Influenza and Vaccines

Influenza Surveillance, Prevention, and Control

Updated information regarding influenza surveillance, detection, prevention, and control is available at https://www.cdc.gov/flu. U.S surveillance data are updated weekly during October–May on FluView (https://www.cdc.gov/flu/weekly). In addition, periodic updates regarding influenza are published in MMWR (https://www.cdc.gov/mmwr). 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.

Vaccine Adverse Event Reporting System

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 (https://vaers.hhs.gov/docs/VAERS_Table_of_Reportable_Events_Following_Vaccination.pdf) 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 https://vaers.hhs.gov/index.html. Additional information on VAERS and vaccine safety is available by emailing info@vaers.org 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 (https://www.hrsa.gov/vaccinecompensation/vaccineinjurytable.pdf) lists the vaccines covered by VICP and the associated injuries and conditions (including death) that might 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.

To be eligible for compensation under VICP, a claim 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 that do not meet the general filing guidelines must 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 (80). Persons of all ages who receive a VICP-covered vaccine might be eligible to file a claim. Additional information is available at https://www.hrsa.gov/vaccinecompensation or by calling 1-800-338-2382.

Additional Resources

ACIP Statements

Vaccine Information Sheets (VISs)

Influenza Vaccine Package Inserts

CDC Influenza Antiviral Guidance

American Academy of Pediatrics (AAP) Guidance

Infectious Diseases Society of America (IDSA) Guidance

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ACIP Members, July 1, 2016–June 30, 2017


Preparedness and Response in Action

6 domains of preparedness

 

 

 


CDC: Disaster Preparedness for Expectant and New Parents as Maria storms in…….

CDC 

Preparedness for Expectant and New Parents

Illustration of pregnant woman with various preparation iconsDisasters, such as wildfires(https://www.cdc.gov/reproductivehealth/emergency/wildfires.htm), hurricanes(https://www.cdc.gov/disasters/hurricanes/index.html), and floods(https://www.cdc.gov/disasters/floods/index.html), can be unpredictable and devastating. In honor of National Preparedness Month, learn general tips to get prepared before a disaster and what to do in case of a disaster to help keep you and your family safe and healthy.

Get Prepared for an Emergency or Disaster

Disasters can be scary and stressful, especially if you’re expecting or have a baby. You can take the following steps now to help you prepare for an emergency and better cope if an emergency happens.

  • Talk to your doctor or other healthcare provider about—
    • What steps you should take in any emergency.
    • Where you will get prenatal care if your doctor’s office is closed.
    • Where you will deliver your baby if your hospital is closed.
  • Learn the signs of signs of preterm labor(https://www.cdc.gov/reproductivehealth/maternalinfanthealth/pretermbirth.htm#warning_signs) (labor before 37 weeks of pregnancy) and prepare emergency birth kit supplies.
  • Learn about your community’s warning signals (such as tornado sirens) and check with your state emergency management agency to find out how to get emergency alerts and about the best places to take shelter during different types of emergencies.
  • Make a family communication plan for how you and your family will contact one another and what steps you will take in different types of situations.
  • Prepare an emergency kit that includes a 3-day supply of food and water, health supplies (including any medicines you may be taking), personal and baby care items, safety supplies, electronics (flashlight, radio, cell phone with charger, and extra batteries), and important documents, such as emergency telephone numbers.
  • Plan ahead for where your baby will sleep if you have to evacuate your home. Your baby is safest sleeping on his or her back on a surface that is separate from others and does not have pillows, blankets, or toys. Learn more about these and other actions at Parents and Caregivers(https://www.cdc.gov/sids/Parents-Caregivers.htm#prevention) .

Illustration of doctor talking to pregnant woman about an emergency kitOnce you are out of immediate danger, continue your prenatal care even if it is not with your primary doctor.

What to Do During and Just After Disaster

Expectant Parents

Pregnant women have special medical needs. If you’re pregnant or think you may be pregnant, you and your partner can take the following steps to help you stay safe and healthy in the event of a disaster.

  • If you have any signs of preterm labor(https://www.cdc.gov/reproductivehealth/maternalinfanthealth/pretermbirth.htm#warning_signs) (labor before 37 weeks of pregnancy), call your healthcare provider or 911, or go to the hospital immediately if it is safe to leave.
  • If you have to evacuate, be prepared to leave quickly and have your emergency kit ready to go.
  • If staying at a shelter or in temporary housing, tell the staff as soon as possible that you are pregnant and if you have any health problems.
  • Once you are out of immediate danger, continue your prenatal care, even if it is not with your primary doctor. Tell the doctor or other healthcare provider if you have any health problems and if you take any medications (both over-the-counter and prescription).
  • If you have your prenatal vitamins or prescription medicines with you, take them as directed. If you don’t have your prenatal vitamins or prescription medicines with you, ask staff at the shelter for help getting them.
  • Protect yourself from infections by washing your hands often and staying away from people who are sick.
  • During disasters, harmful chemicals(https://www.cdc.gov/disasters/chemicals.html) from businesses and other places may be released into the environment. Listen to announcements from emergency officials about chemical safety and actions you may need to take to protect yourself. If you have questions about exposure to harmful chemicals during pregnancy, call MotherToBaby at 1-866-626-6847. To reach the nationwide poison control center, call 1-800-222-1222.
  • To help with physical stress, drink plenty of water and rest as often as you can. To help relieve emotional stress, talk to a healthcare provider, friend, or family member about your concerns and feelings.

Illustration of woman tucking baby into crib with words safe sleepYour baby is safest sleeping on his or her back on a surface that is separate from others and does not have pillows, blankets, or toys.

Parents of Infants

A disaster can make it difficult to access necessary supplies and health care. Parents and caregivers of infants can take the following steps to help keep their families safe and healthy in the event of a disaster.

  • If you have to evacuate, be prepared to leave quickly and have your emergency kit that includes infant care supplies, such as baby food and a portable crib, ready to go.
  • If you breastfeed your baby, continue to do so. Clean water may not be available for mixing formula or washing bottles. If you have questions about exposure to harmful chemicals while breastfeeding, call MotherToBaby at 1-866-626-6847. To reach the nationwide poison control center, call 1-800-222-1222.
  • If you are away from your home during a disaster, take these actions to help your baby sleep safely(https://www.cdc.gov/sids/Parents-Caregivers.htm#prevention) .
  • As soon as it is safe to do so, get a postpartum checkup if you are due for a visit, even if it is not with your usual doctor. If you’re not ready to get pregnant, you can ask for several months’ supply of the pill, patch, or ring or consider using a birth control method(https://www.cdc.gov/reproductivehealth/contraception/index.htm) that will prevent pregnancy for several months.
  • As soon as it is safe to do so, see a doctor or other healthcare provider for well-baby checkups or if you’re concerned about a health problem, even if it is not with your baby’s usual doctor.
  • If you have your prescription medicines with you, take them as directed. If you don’t have your medicines with you, ask staff at the shelter for help getting them.
  • If your baby is currently taking prescription or over-the-counter medicines, and you have them, continue giving them as directed.
  • To help relieve emotional stress, talk to a healthcare provider, friend, or family member about your concerns and feelings.

Secretary Price Appoints Brenda Fitzgerald, M.D., as CDC Director and ATSDR Administrator

 

HHS-CDC-ATSDR

Secretary Price Appoints Brenda Fitzgerald, M.D., as CDC Director and ATSDR Administrator

Today, Health and Human Services Secretary Tom Price, M.D., named Brenda Fitzgerald, M.D., as the 17th Director of the Centers for Disease Control and Prevention (CDC) and Administrator of the Agency for Toxic Substances and Disease Registry (ATSDR).

“Today, I am extremely proud and excited to announce Dr. Brenda Fitzgerald as the new Director of the CDC,” said Secretary Price. “Having known Dr. Fitzgerald for many years, I know that she has a deep appreciation and understanding of medicine, public health, policy and leadership—all qualities that will prove vital as she leads the CDC in its work to protect America’s health 24/7. We look forward to working with Dr. Fitzgerald to achieve President Trump’s goal of strengthening public health surveillance and ensuring global health security at home and abroad. Congratulations to Dr. Fitzgerald and her family.”

Dr. Fitzgerald has been the commissioner of the Georgia Department of Public Health (DPH) and state health officer for the past six years. She replaces Dr. Anne Schuchat, who has been the acting CDC director and acting ATSDR administrator since January 20. Dr. Schuchat is returning to her role as CDC’s principal deputy director.

“Additionally, I’d like to extend my deep appreciation and thanks to Dr. Anne Schuchat for her exemplary service as acting director of the CDC,” said Secretary Price. “We thank Dr. Schuchat and her team for their dedication in our public health efforts to keep Americans safe and for their work to ensure a seamless transition. We look forward to continuing to work with Dr. Schuchat in her role as principal deputy director of CDC.”

Dr. Fitzgerald, a board-certified obstetrician-gynecologist, has practiced medicine for three decades. As Georgia DPH Commissioner, Dr. Fitzgerald oversaw various state public health programs and directed the state’s 18 public health districts and 159 county health departments. Prior to that, Dr. Fitzgerald held numerous leadership positions. She served on the board and as president of the Georgia OB-GYN Society and she worked as a health care policy advisor with House Speaker Newt Gingrich and Senator Paul Coverdell. She has served as a Senior Fellow and Chairman of the Board for the Georgia Public Policy Foundation.

Dr. Fitzgerald holds a Bachelor of Science degree in Microbiology from Georgia State University and a Doctor of Medicine degree from Emory University School of Medicine. She completed post-graduate training at the Emory-Grady Hospitals in Atlanta and held an assistant clinical professorship at Emory Medical Center. As a Major in the U.S. Air Force, Dr. Fitzgerald served at the Wurtsmith Air Force Strategic Air Command (SAC) Base in Michigan and at the Andrews Air Force Base in Washington, D.C.

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CDC’s Emergency Drugs for US Clinicians and Hospitals

CDC

Our Formulary

The following information is provided as an informational resource for guidance only. It is not intended as a substitute for professional judgment. These highlights and any hyperlinks may not include all the information needed to use each respective drug or biologic safely and effectively. See full prescribing information (package insert) or IND protocol for each respective drug or biologic, which accompany the product when it is delivered to the treating physician and/or pharmacist.

The Drug Service formulary is subject to change based on current public health needs, updates to treatment guidelines, and/or drug availability. For historical reference, we have included products no longer supplied by the Drug Service.

Product & Supplier Indication & Eligibility How Supplied
Anthrax Vaccine Absorbed

(Also known as “AVA”; BioThrax®, Emergent BioSolutions)

For the active immunization for the prevention of disease caused by Bacillus anthracis, in persons 18 through 65 years of age at high risk for exposure

Because the risk for anthrax infection in the general population is low, routine immunization is not recommended

The safety and efficacy of BioThrax® in a post-exposure setting have not been established.

Suspension for injection in 5 mL multidose vials, each containing 10 doses
Artesunate, intravenous

(Supplied to CDC by the Walter Reed Army Institute of Research)

For the treatment of severe malaria in patients who require parenteral (IV) therapy

Patient must meet the eligibility criteria in the IND protocol

110 mg; sterile dry-filled powder with phosphate buffer diluent for reconstitution
Benznidazole

(Benznidazol, Manufactured by LAFEPE)

For the treatment of American trypanosomiasis (Chagas disease)

Patient must meet the eligibility criteria in the IND protocol

100 mg double-scored tablet

12.5 mg dispersible tablet for pediatric use

Botulism Antitoxin Heptavalent (Equine), Types A-G

(Also known as “HBAT”; Manufactured by Cangene Corp. – BAT™)

For the treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin 20 mL or 50 mL single-use glass vial

May be received frozen or thawed

Diethylcarbamazine

(Also known as “DEC”; Supplied to CDC by the World Health Organization; Manufactured by E.I.P.I.C.O.)

For the treatment of certain filarial diseases, including lymphatic filariasis caused by infection with Wuchereria bancrofti, Brugia malayi, or Brugia timori; tropical pulmonary eosinophilia; and loiasis

For prophylactic use in persons determined to be at increased risk for Loa loa infection

Patient must meet the eligibility criteria in the IND protocol

100 mg tablet
Diphtheria Antitoxin (Equine)

(Also known as “DAT”; Manufactured by Instituto Butantan)

For prevention or treatment of actual or suspected cases of diphtheria

Patient must meet the eligibility criteria in the IND protocol

1 mL single-use ampule containing 10,000 units
Eflornithine

(Also known as “DFMO”; Supplied to CDC by the World Health Organization; Manufactured by Sanofi Aventis – Ornidyl®)

For the treatment of second-stage African trypanosomiasis (sleeping sickness) caused by Trypanosoma brucei gambiense, with involvement of the central nervous system 20 g/100 mL hypertonic solution for IV infusion

Must be diluted with Sterile Water for Injection before use

Melarsoprol

(Supplied to CDC by the World Health Organization; Manufactured by Sanofi Aventis – Arsobal®)

For the treatment of second-stage African trypanosomiasis (sleeping sickness), with involvement of the central nervous system

Patient must meet the eligibility criteria in the IND protocol

5 mL glass ampule containing 180 mg/5 mL (36 mg/mL)
Nifurtimox

(Supplied to CDC by the World Health Organization; Manufactured by Bayer – Lampit®)

For the treatment of American trypanosomiasis (Chagas disease)

Patient must meet the eligibility criteria in the IND protocol

120 mg double-scored tablet
Sodium Stibogluconate

(Manufactured by GlaxoSmithKline, UK – Pentostam®)

For the treatment of leishmaniasis

Patient must meet the eligibility criteria in the IND protocol

Solution for injection in 100 mL multidose bottle

100 mg pentavalent antimony (Sb) per mL

Suramin

(Supplied to CDC by the World Health Organization; Manufactured by Bayer – Germanin)

For the treatment of first-stage African trypanosomiasis (sleeping sickness) caused by Trypanosoma brucei rhodesiense, without involvement of the central nervous system

Patient must meet the eligibility criteria in the IND protocol

1 gram of suramin for injection in a 10 mL vial (100 mg/mL solution of suramin sodium)

Must be reconstituted with 10 mL Sterile Water for Injection before use

Vaccinia Vaccine

(Also known as the “Smallpox Vaccine”; Manufactured by Sanofi Aventis – ACAM2000®)

For active immunization against smallpox disease for persons determined to be at high risk for smallpox infection Lyophilized powder reconstituted with diluent (provided)

Contains 100 doses per vial

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Anthrax Vaccine Adsorbed

Anthrax Vaccine Adsorbed (AVA) is indicated for the active immunization for the prevention of disease caused by Bacillus anthracis, in persons 18 through 65 years of age at high risk for exposure. The safety and efficacy of AVA in a post-exposure setting have not been established.

CDC provides anthrax vaccine for laboratory workers conducting research under federally funded projects who require preexposure vaccination based on their occupational risk.

Preexposure vaccination is recommended for laboratorians at risk for repeated exposure to fully virulent B. anthracis spores, such as those who 1) work with high concentrations of spores with potential for aerosol production; 2) handle environmental samples that might contain powders and are associated with anthrax investigations; 3) routinely work with pure cultures of B. anthracis; 4) frequently work in spore-contaminated areas after a bioterrorism attack; or 5) work in other settings where repeated exposures to B. anthracis aerosols may occur. Read more[PDF – 36 pages](https://www.cdc.gov/mmwr/pdf/rr/rr5906.pdf).

More Information for Clinicians

CDC’s Anthrax Vaccination Website

Educational Toolkit for Clinicians (from Department of Defense Anthrax Immunization Program)

Vaccine Information Statement (VIS) for Anthrax Vaccine[PDF – 2 pages](https://www.cdc.gov/vaccines/hcp/vis/vis-statements/anthrax.pdf)

Full Prescribing Information for BioThrax®

How to Request

Anthrax vaccine must be administered by or under the supervision of the physician who registers with CDC.

Contact the CDC Drug Service for more information.

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Artesunate, Intravenous

Artesunate is in the class of medications known as artemesinins, which are derivatives from the “qinghaosu” or sweet wormwood plant (Artemisia annua). Artesunate is not currently licensed by FDA but is made available in the United States under a CDC-sponsored IND protocol for treatment of documented cases of severe malaria(https://www.cdc.gov/malaria/about/index.html) that require parenteral therapy. Read more(https://www.cdc.gov/malaria/diagnosis_treatment/artesunate.html).

More Information for Clinicians

Diagnostic assistance for malaria is available through DPDx.

How to Request

Clinicians who wish to obtain artesunate for severe malaria should contact the CDC Malaria Hotline at 770-488-7788 (M-F, 8am-4:30pm, Eastern time) or, after hours, the CDC Emergency Operations Center (EOC) at 770-488-7100, and request to speak with a CDC Malaria Branch clinician. A Malaria Branch clinician will provide clinical consultation by telephone and, if indicated, authorize the emergency release of artesunate from one of the CDC Quarantine Stations located in major airports around the nation, ensuring delivery to any location in the United States within hours.

Requests for unapproved uses cannot be granted.

For non-emergency questions related to artesunate IV, contact the CDC Drug Service.

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Benznidazole

Benznidazole is a 2-nitroimidazole trypanocidal agent that was introduced in 1971 for the treatment of Trypanosoma cruzi infection—i.e., Chagas disease, also known as American trypanosomiasis(https://www.cdc.gov/parasites/chagas/). Benznidazole is one of two drugs available from CDC for the treatment of Chagas disease (the other is nifurtimox). In the United States, the need to have drugs available for treating Chagas disease has been increasing, largely because of implementation of T. cruzi blood-donor screening in 2007, which has identified chronically infected persons (mainly Latin American immigrants) who might benefit from treatment and has heightened awareness of Chagas disease.

More Information for Clinicians

Evaluation and Treatment of Chagas Disease in the United States: A Systematic Review (JAMA 2007: 298:2171-81)

Screening and Treatment of Chagas Disease in Organ Transplant Recipients in the United States: Recommendations from the Chagas in Transplant Working Group (American Journal of Transplantation, 2011: 672–680)

Diagnostic assistance for American trypanosomiasis is available through DPDx.

How to Request

Contact the CDC Drug Service for more information.

Questions regarding treatment of Chagas disease should be directed to CDC Parasitic Diseases Inquiries (404-718-4745; email chagas@cdc.gov) M-F 7:30am-4pm EST.

For emergencies (for example, acute Chagas disease with severe manifestations, Chagas disease in a newborn, or Chagas disease in an immunocompromised person) outside of regular business hours, call the CDC Emergency Operations Center (770-488-7100) and ask for the person on call for Parasitic Diseases.

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Botulism Antitoxin Heptavalent (Equine), Types A-G

Botulism Antitoxin Heptavalent (HBAT) contains equine-derived antibody to the seven known botulinum toxin types (A-G). HBAT is composed of <2% intact immunoglobulin G (IgG) and ≥90% Fab and F(ab’)2 immunoglobulin fragments. These fragments are created by the enzymatic cleavage and removal of Fc immunoglobulin components in a process sometimes referred to as despeciation. HBAT is supplied on an emergency basis for the treatment of persons thought to be suffering from botulism and works by neutralizing unbound toxin molecules. In 2010, HBAT became the only botulism antitoxin available in the United States for naturally occurring non-infant botulism.

It is available only from CDC because of its limited use and its relatively short expiration date. The antitoxin is stored at CDC Quarantine Stations located in major airports around the nation, ensuring delivery to any location in the United States within hours.

BabyBIG® (botulism immune globulin) remains available for infant botulism through the California Infant Botulism Treatment and Prevention Program.

More Information for Clinicians

Clinical Guidance

How to Request

Clinicians who suspect a diagnosis of botulism in a patient should immediately call their state health department’s 24-hour telephone number(https://www.cdc.gov/mmwr/international/relres.html) to maintain effective botulism surveillance and to facilitate rapid detection of outbreaks. The state health department will contact CDC to arrange for a clinical consultation by telephone and, if indicated, release of botulism antitoxin. State health departments requesting botulism antitoxin should contact the CDC Emergency Operations Center (EOC) at 770-488-7100. Read more(https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5232a8.htm).

For non-emergency questions concerning botulism antitoxin, contact the CDC Drug Service.

 Top of Page

Diethylcarbamazine (DEC)

DEC is an antihelminthic agent used for treatment of lymphatic filariasis (caused by infection with Wuchereria bancrofti, Brugia malayi, or Brugia timori), tropical pulmonary eosinophilia, and loiasis(https://www.cdc.gov/parasites/loiasis/); DEC also has prophylactic benefit for Loa loa infection. DEC has been used worldwide for more than 50 years. In the past, Wyeth-Ayerst Laboratories made DEC available as a licensed drug; in the late 1990s, because of unavailability of a bulk chemical supplier, Wyeth-Ayerst discontinued distribution of DEC in the United States.

More Information for Clinicians

Diagnostic assistance for filarial diseases is available through DPDx.

How to Request

Contact the CDC Drug Service for more information.

Questions regarding treatment of filarial diseases should be directed to CDC Parasitic Diseases Inquiries (404-718-4745; email parasites@cdc.gov) M-F 7:30am-4pm EST.

After-hours emergencies: 1-770-488-7100

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Diphtheria Antitoxin (Equine)

Diphtheria antitoxin (DAT) is used to prevent or treat diphtheria by neutralizing the toxins produced by Corynebacterium diphtheriae. DAT is a sterile, aqueous solution of the refined and concentrated proteins, chiefly globulins, containing antibodies obtained from the serum of horses that have been immunized against diphtheria toxin. DAT is available under an IND protocol sponsored by CDC and is released only for actual or suspected cases of diphtheria(https://www.cdc.gov/diphtheria/about/index.html). The antitoxin is stored at CDC Quarantine Stations located in major airports around the nation, ensuring delivery to any location in the United States within hours.

More Information for Clinicians

CDC’s Vaccine-Related Topics: Diphtheria Antitoxin(https://www.cdc.gov/diphtheria/dat.html)

How to Request

Clinicians who suspect a diagnosis of respiratory diphtheria can obtain DAT by contacting the Emergency Operations Center at 770-488-7100. They will be connected with the diphtheria duty officer, who will provide clinical consultation and, if indicated, initiate the release of diphtheria antitoxin.

For non-emergency questions concerning diphtheria antitoxin, contact the CDC Drug Service.

 Top of Page

Eflornithine

Eflornithine is an antitrypanosomal agent that inhibits the enzyme ornithine decarboxylase. Antitrypanosomal treatment is indicated for all persons diagnosed with African trypanosomiasis (sleeping sickness)(https://www.cdc.gov/parasites/sleepingsickness/); the choice of therapy depends on the infecting subspecies of the parasite and on the stage of the infection. Eflornithine is considered the drug of choice for the treatment of second-stage Trypanosoma brucei gambiense (West African) infection, with involvement of the central nervous system. It is not effective against T. b. rhodesiense (East African) infection (see melarsoprol). Although the manufacturer, Aventis, maintains its US licensure, eflornithine is not commercially available in the United States.

More Information for Clinicians

Human African trypanosomiasis, WHO

Diagnostic assistance for African trypanosomiasis is available through DPDx.

How to Request

Contact the CDC Drug Service for more information.

Questions regarding treatment of African trypanosomiasis should be directed to CDC Parasitic Diseases Inquiries (404-718-4745; email parasites@cdc.gov) M-F 7:30am-4pm EST.

For emergencies outside of regular business hours, call the CDC Emergency Operations Center (770-488-7100) and ask for the person on call for Parasitic Diseases.

 Top of Page

Melarsoprol

Melarsoprol is an organoarsenic compound with trypanocidal effects that has been used outside the United States since 1949. Antitrypanosomal treatment is indicated for all persons diagnosed with African trypanosomiasis (sleeping sickness)(https://www.cdc.gov/parasites/sleepingsickness/); the choice of therapy depends on the infecting subspecies of the parasite and on the stage of the infection. Melarsoprol is used for the treatment of second-stage infection (involving the central nervous system). It is the only available therapy for second-stage Trypanosoma brucei rhodesiense (East African) infection, whereas eflornithine typically is used for second-stage T. b. gambiense (West African) infection.

More Information for Clinicians

Human African trypanosomiasis, WHO

Diagnostic assistance for African trypanosomiasis is available through DPDx.

How to Request

Contact the CDC Drug Service for more information.

Questions regarding treatment of African trypanosomiasis should be directed to CDC Parasitic Diseases Inquiries (404-718-4745; email parasites@cdc.gov) M-F 7:30am-4pm EST.

For emergencies outside of regular business hours, call the CDC Emergency Operations Center (770-488-7100) and ask for the person on call for Parasitic Diseases.

 Top of Page

Nifurtimox

Nifurtimox is a nitrofuran analog that was introduced in 1965 for the treatment of Trypanosoma cruzi infection—i.e., Chagas disease, also known as American trypanosomiasis(https://www.cdc.gov/parasites/chagas/). Nifurtimox is one of two drugs available from CDC for the treatment of Chagas disease (the other is benznidazole). In the United States, the need to have drugs available for treating Chagas disease has been increasing, largely because of implementation of T. cruzi blood-donor screening in 2007, which has identified chronically infected persons (mainly Latin American immigrants) who might benefit from treatment and has heightened awareness of Chagas disease.

More Information for Clinicians

Evaluation and Treatment of Chagas Disease in the United States: A Systematic Review (JAMA 2007: 298:2171-81)

Screening and Treatment of Chagas Disease in Organ Transplant Recipients in the United States: Recommendations from the Chagas in Transplant Working Group (American Journal of Transplantation, 2011: 672–680)

Diagnostic assistance for American trypanosomiasis is available through DPDx.

How to Request

Contact the CDC Drug Service for more information.

Questions regarding treatment of Chagas disease should be directed to CDC Parasitic Diseases Inquiries (404-718-4745; email chagas@cdc.gov) M-F 7:30am-4pm EST.

For emergencies (for example, acute Chagas disease with severe manifestations, Chagas disease in a newborn, or Chagas disease in an immunocompromised person) outside of regular business hours, call the CDC Emergency Operations Center (770-488-7100) and ask for the person on call for Parasitic Diseases.

 Top of Page

Sodium Stibogluconate

Sodium stibogluconate (Pentostam®) is a pentavalent antimony compound used for treatment of leishmaniasis(https://www.cdc.gov/parasites/leishmaniasis). The three main clinical syndromes in humans are visceral, cutaneous, and mucosal leishmaniasis. Pentostam is a well-established antileishmanial agent that has been used in many countries of the world for more than half a century.

More Information for Clinicians

Recommendations for Treating Leishmaniasis with Sodium Stibogluconate (Pentostam) and Review of Pertinent Clinical Studies (Am J Trop Med 1992:46(3):296-306)[PDF, 11 pages]

Diagnostic assistance for leishmaniasis is available through DPDx.

Practical Guide for Laboratory Diagnosis of Leishmaniasis[PDF, 4 pages](https://www.cdc.gov/parasites/leishmaniasis/resources/pdf/cdc_diagnosis_guide_leishmaniasis.pdf)

How to Request

Contact the CDC Drug Service for more information.

Questions regarding treatment of leishmaniasis should be directed to CDC Parasitic Diseases Inquiries (404-718-4745; email parasites@cdc.gov) M-F 7:30am-4pm EST.

After-hours emergencies: 1-770-488-7100

 Top of Page

Suramin

Suramin is a negatively charged, high-molecular-weight sulfated naphthylamine. It was introduced in the 1920s for the treatment of African trypanosomiasis (sleeping sickness)(https://www.cdc.gov/parasites/sleepingsickness/). Suramin generally is considered the drug of choice for first-stage Trypanosoma brucei rhodesiense (East African) infection, without involvement of the central nervous system. Pentamidine typically is used for first-stage T. b. gambiense (West African) infection.

More Information for Clinicians

Human African trypanosomiasis, WHO

Diagnostic assistance for African trypanosomiasis is available through DPDx.

How to Request

Contact the CDC Drug Service for more information.

Questions regarding treatment of African trypanosomiasis should be directed to CDC Parasitic Diseases Inquiries (404-718-4745; email parasites@cdc.gov) M-F 7:30am-4pm EST.

For emergencies outside of regular business hours, call the CDC Emergency Operations Center (770-488-7100) and ask for the person on call for Parasitic Diseases.

 Top of Page

Vaccinia Vaccine, “Smallpox Vaccine”

Smallpox vaccine is made of live vaccinia virus derived from plaque purification cloning of Dryvax® (calf lymph vaccine, New York City Board of Health Strain) and grown in African Green Monkey kidney (Vero) cells and tested to be free of adventitious agents. It contains approximately 2.5 – 12.5 x 105 plaque-forming units per dose.

Smallpox was declared globally eradicated in 1980. In 1982, Wyeth Laboratories, the only active manufacturer of licensed vaccinia vaccine in the United States, discontinued production; and, in 1983, distribution to the civilian population was discontinued. Since January 1982, smallpox vaccination has not been required for international travelers, and International Certificates of Vaccination no longer include smallpox vaccination. ACAM2000® is a new-generation smallpox vaccine that was licensed in 2010 for use as a medical countermeasure held by the Strategic National Stockpile.

CDC recommends vaccinia vaccine for laboratory workers who directly handle a) cultures or b) animals contaminated or infected with nonhighly attenuated vaccinia virus, recombinant vaccinia viruses derived from nonhighly attenuated vaccinia strains, or other orthopoxviruses that infect humans (e.g., monkeypox, cowpox, vaccinia, and variola). Other health-care workers (e.g., physicians and nurses) whose contact with nonhighly attenuated vaccinia viruses is limited to contaminated materials (e.g., dressings) and who adhere to appropriate infection control measures are at lower risk for inadvertent infection than laboratory workers. However, because a theoretical risk for infection exists, vaccination can be offered to this group. Read more[PDF – 930KB](https://www.cdc.gov/mmwr/pdf/rr/rr5010.pdf).

More Information for Clinicians

Full Prescribing Information for ACAM2000®[PDF – 11 pages]

ACAM2000® Medication Guide[PDF – 6 pages]

MMWR Notice to Readers: Newly Licensed Smallpox Vaccine to Replace Old Smallpox Vaccine(https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5708a6.htm)

CDC’s Vaccine-Related Topics: Smallpox Vaccine

How to Request

Smallpox vaccine must be administered by or under the supervision of the physician who registers with CDC.

Ancillary supplies, such as bifurcated needles (for administration) and 1 mL tuberculin syringes with 25 gauge x 5/8″ needles (for reconstitution), are supplied with the vaccine.

Contact the CDC Drug Service for more information.

Requests for unapproved uses cannot be granted.

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Products No Longer Supplied by Drug Service*

Botulinum Toxoid

Pentavalent (ABCDE) botulinum toxoid is a combination of aluminum phosphate-adsorbed toxoid derived from formalin-inactivated types A, B, C, D, and E botulinum toxins, with formaldehyde and thimerosal used as preservatives. Botulinum toxoid was distributed by CDC under an IND protocol for at-risk persons who were actively working or expected to be working with cultures of Clostridium botulinum or the toxins; in 2011, CDC discontinued its program to supply this vaccine. Read more(https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6042a3.htm).

Botulinum Antitoxin Types AB & E

In March 2010, CDC announced the availability of a new heptavalent botulinum antitoxin (HBAT, Cangene Corporation). HBAT replaced the licensed bivalent botulinum antitoxin AB and an investigational monovalent botulinum antitoxin E (BAT-AB and BAT-E, Sanofi Pasteur), becoming the only botulinum antitoxin available in the United States for naturally occurring non-infant botulism. Read more(https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5910a4.htm).

Vaccinia Immune Globulin (VIG)

Vaccinia immune globulin (VIG) is released from the CDC Strategic National Stockpile, if indicated, for the treatment of complications associated with vaccinia vaccination. Clinicians wishing to obtain VIG should contact the Emergency Operations Center (EOC) at 770-488-7100. They will be connected with CDC medical staff who can assist them in the diagnosis and management of patients with suspected complications of vaccinia vaccination.

*this list is not all-inclusive

Use of trade names is for identification only and does not imply endorsement by the U.S. Department of Health and Human Services.


USA: High-level isolation units in select Ebola hospitals report struggling to fund ongoing operations and sustain readiness.

CDC-EID

Volume 23, Number 6—June 2017

Dispatch

Sustainability of High-Level Isolation Capabilities among US Ebola Treatment Centers

Jocelyn J. Herstein, Paul D. Biddinger, Shawn G. Gibbs, Aurora B. Le, Katelyn C. Jelden, Angela L. Hewlett, and John J. Lowe
 

Main Article(https://wwwnc.cdc.gov/eid/article/23/6/17-0062_article)

Figure 1

Diseases that 31 HLIUs reported they would treat, United States, 2016. HLIU, high-level isolation unit.

Figure 1. Diseases that 31 HLIUs reported they would treat, United States, 2016. HLIU, high-level isolation unit.

Main Article(https://wwwnc.cdc.gov/eid/article/23/6/17-0062_article)


Protecting the nation from deadly pathogens, man-made or natural: More difficult under the Prez’ budget.

NY Times

“….The Office of Public Health Preparedness and Response, which tracks outbreaks of disease, would be cut by $136 million, or 9.7 percent. The National Center for Emerging and Zoonotic Infectious Diseases — a branch of the Centers for Disease Control and Prevention that fights threats like anthrax and Ebola — would be cut by $65 million, or 11 percent.

The C.D.C.’s Center for Global Health would lose $76 million, or 18 percent. Its Emergency Operations Center, which conducts real-time monitoring of outbreak responses, and its Select Agents Program, which sets regulations in lethal toxin labs and helps researchers stay ahead of bioterrorists, face unspecified cuts as well…..”


Candida auris: 61 cases of the fungus have been reported in the U.S. since 2013

CDC

Candida auris is an emerging fungus that presents a serious global health threat. Healthcare facilities in several countries have reported that C. auris has caused severe illness in hospitalized patients. Some strains of Candida auris are resistant to all three major classes of antifungal drugs. This type of multidrug resistance has not been seen before in other species of Candida. Also of concern, C. auris can persist on surfaces in healthcare environments and spread between patients in healthcare facilities, unlike most other Candida species. CDC has developed Interim Recommendations(https://www.cdc.gov/fungal/diseases/candidiasis/recommendations.html) to help prevent the spread of C. auris.

C. auris is difficult to identify with standard laboratory methods and can be misidentified in labs without specific technology. CDC encourages all U.S. laboratory staff who identify C. auris strains to notify their state or local public health authorities and CDC at candidaauris@cdc.gov. Find answers to frequently asked questions about C. auris on our questions and answers page(https://www.cdc.gov/fungal/diseases/candidiasis/candida-auris-qanda.html) and in the Candida auris: Interim Recommendations(https://www.cdc.gov/fungal/diseases/candidiasis/recommendations.html).

CDC is working with state and local health departments to identify and investigate cases of C. auris. The following map displays where C. auris cases have been identified in the United States as of April 13, 2017.

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