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2018-19 Summary of Recommendations

Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices (ACIP)—United States, 2018-19

For additional information: MMWR Recomm Rep 2018;67(No. RR-3) Influenza ACIP Vaccine Recommendations

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Groups Recommended for Vaccination

  • Routine annual influenza vaccination is recommended for all persons aged ≥6 months who do not have contraindications.
  • A licensed, age-appropriate influenza vaccine (IIV, RIV4, or LAIV4) should be used. Consult package information for age indications.
  • Emphasis should be placed on vaccination of high-risk groups and their contacts/caregivers. When vaccine supply is limited, vaccination efforts should focus on delivering vaccination to (no hierarchy implied by order listed):
    • Children aged 6–59 months;
    • Adults aged ≥50 years;
    • Persons with chronic pulmonary (including asthma), cardiovascular (excluding isolated hypertension), renal, hepatic, neurologic, hematologic, or metabolic disorders (including diabetes mellitus);
    • Persons who are immunocompromised due to any cause, (including medications or HIV infection);
    • Women who are or will be pregnant during the influenza season;
    • Children and adolescents (aged 6 months through 18 years) receiving aspirin- or salicylate-containing medications and who might be at risk for Reye syndrome;
    • Residents of nursing homes and other long-term care facilities;
    • American Indians/Alaska Natives;
    • Persons who are extremely obese (BMI ≥40); and
    • Caregivers and contacts of those at risk:
      • Health care personnel in inpatient and outpatient care settings, medical emergency-response workers, 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;
      • Household contacts and caregivers of children aged ≤59 months (i.e., <5 years), particularly contacts of children aged <6 months, and adults aged ≥50 years; and
      • Household contacts and caregivers of persons with medical conditions that put them at high risk of severe complications from influenza.
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Influenza Vaccine Composition for 2018-19

  • 2018-19 influenza vaccines will contain hemagglutinin (HA) derived from influenza viruses antigenically similar to those recommended by FDA.
  • Trivalent vaccines will contain
    • an A/Michigan/45/2015 (H1N1)pdm09–like virus,
    • an A/Singapore/INFIMH-16-0019/2016 (H3N2)–like virus; and
    • a B/Colorado/06/2017–like virus (Victoria lineage).
  • Quadrivalent vaccines will contain the same three HA antigens as trivalent vaccines, plus a B/Phuket/3073/2013–like virus (Yamagata lineage).

Timing of Vaccination

  • Vaccination should be offered by end of October; however, vaccination should continue to be offered as long as influenza viruses are circulating and unexpired vaccine is available.
  • Children aged 6 months through 8 years who require 2 doses should receive their first dose as soon as possible after vaccine becomes available, and the second dose ≥4 weeks later.

Guidance for Use in Specific Situations

Volume per Dose for Children and Adults

  • Children aged 6 through 35 months may receive:
    • 0.5mL Fluarix Quadrivalent (IIV4) intramuscularly, or
    • 0.5mL FluLaval Quadrivalent (IIV4) intramuscularly, or
    • 0.25mL Fluzone Quadrivalent (IIV4) intramuscularly.
    • Note that dose volume differs for these different brands. Care should be taken to administer the correct dose.
  • Children aged 3 through 17 years may receive 0.5mL of an age- appropriate intramuscular IIV formulation.
  • Adults aged 18 years and older may receive 0.5mL intramuscularly of an age-appropriate IIV or RIV4.
  • If a smaller intramuscular dose (e.g., 0.25mL) is administered to a person ≥36 months of age:
    • If the error is discovered immediately, an additional 0.25mL dose should be administered to provide a full 0.5mL dose.
    • If the error is discovered later (after the recipient has left the vaccination setting), a full 0.5mL dose should be administered as soon as the recipient can return.
  • Healthy non-pregnant persons (see LAIV4 Contraindications and Precautions) aged 2 through 49 years may alternatively receive 0.2mL of LAIV4 intranasally (0.1mL per nostril using supplied sprayer).

Number of Doses for Children Aged 6 Months through 8 Years

  • Determine the number of doses needed for this age group as follows:
    • Has the child received ≥2 doses of trivalent or quadrivalent influenza vaccine before July 1, 2018? (Doses need not have been given during same or consecutive seasons)
      • If Yes: 1 dose of 2018-19 influenza vaccine
      • If No/Don’t Know: 2 doses of 2018-19 influenza vaccine (administered ≥4 weeks apart)

Pregnant Women

  • All women who are pregnant or who might be pregnant during the influenza season should receive influenza vaccine.
    • An age-appropriate IIV or RIV4 may be used.
    • LAIV4 should not be used during pregnancy.
  • Influenza vaccine can be administered at any time during pregnancy.

Adults Aged ≥65 years

  • Persons aged ≥65 years may receive any age-appropriate IIV (standard- or high-dose, trivalent or quadrivalent, adjuvanted or unadjuvanted) or RIV4.
  • High-dose IIV3 exhibited superior efficacy over comparator standard-dose IIV3 in a large randomized trial, and may provide better protection than standard dose IIV3 for this age group.
  • However, vaccination should not be delayed to find a particular product if an appropriate one is available.

Immunocompromised Persons

  • Immunocompromised persons should receive an age-appropriate IIV or RIV4.
  • LAIV4 should not be used for immunocompromised persons.
  • Immune response to vaccines might be blunted in immunocompromised persons.
  • Timing of vaccination might be a consideration (e.g., in some period before or after an immunocompromising intervention).

Caregivers and Contacts of  High-Risk Persons

  • Caregivers and contacts (including those of immunosuppressed persons) may receive any age-appropriate IIV or RIV4.
  • LAIV4 may be given to caregivers and contacts of persons who are not severely immunocompromised (i.e., who do not require a protected environment).
  • Health care personnel or hospital visitors who receive LAIV4 should avoid providing care for severely immunosuppressed persons (those requiring a protected environment) for 7 days after vaccination.

Persons with Egg Allergy

  • Persons who are able to eat lightly cooked egg (e.g., scrambled egg) without reaction are unlikely to be egg-allergic.
  • Persons who have experienced only hives after exposure to egg should receive any licensed, recommended, age-appropriate influenza vaccine (i.e., IIV, RIV4, or LAIV4).
  • Persons reporting symptoms other than hives after exposure to egg (such as angioedema, respiratory distress, lightheadedness, or recurrent emesis; or who required epinephrine or another emergency medical intervention) may also receive any licensed and recommended influenza vaccine that is otherwise appropriate.
    • Additionally, for these persons, vaccine should be administered in an inpatient or outpatient medical setting and supervised by a health care provider who is able to recognize and manage severe allergic reactions.
  • A previous severe allergic reaction to influenza vaccine, regardless of the component suspected of causing the reaction, is a contraindication to future receipt of the vaccine.

Vaccination Issues for Travelers

  • Travelers who wish to reduce the risk for influenza infection should consider influenza vaccination, preferably ≥2 weeks before departure.
  • Persons at high risk for complications of influenza who were not vaccinated during the preceding 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 April–September.
  • Influenza vaccine formulated for the Southern Hemisphere might differ in viral composition from Northern Hemisphere vaccine.
  • Vaccination with Southern Hemisphere influenza vaccine prior to travel to the Southern Hemisphere may be reasonable; however, only one Southern Hemisphere formulation is licensed by FDA (Fluzone Quadrivalent, Sanofi Pasteur), and it is generally not commercially available in the U.S.

Vaccination and Influenza Antiviral Medications

  • IIV and RIV4 may be administered to persons receiving influenza antiviral medications for treatment orchemoprophylaxis.
  • Influenza antivirals may reduce the effectiveness of LAIV4, if administered from 48 hours before until 2 weeks after vaccination.

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Administration of Influenza Vaccine with Other Vaccines

  • IIIVs and RIV4 may be administered concurrently or sequentially with other inactivated or live vaccines.
  • Vaccines administered simultaneously should be given at separate anatomic sites.
  • LAIV4 may be administered simultaneously with other live vaccines, however if not given simultaneously ≥4 weeks should pass between administration of LAIV4 and another live vaccine.
  • Immunogenicity and safety of simultaneous or sequential administration of two vaccines containing novel (non-aluminum) adjuvants has not yet been evaluated.

Storage and Handling of Influenza Vaccines

  • In all cases, manufacturer packaging information should be consulted for authoritative guidance regarding storage and handling of influenza vaccines.
  • For guidance on specific situations not addressed in packaging materials, contact the manufacturer directly.
  • In general:
    • Vaccines should be protected from light and stored at recommended temperatures.
    • Influenza vaccines are recommended to be stored refrigerated between 2° to 8°C (36° to 46°F).
    • Vaccine that has been frozen should be discarded.
    • 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 initially accessed should not be kept beyond the recommended period of time.
    • Vaccines should not be used after the expiration date on the label.

Vaccine Adverse Event Reporting System (VAERS)

Further Information

CDC Influenza Information

American Academy of Pediatrics (AAP) Guidance

Infectious Diseases Society of America (ISDA) Guidance

Manufacturer package inserts

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U.S. Influenza Vaccine Products for the 2018-19 Season

Inactivated Influenza Vaccines (IIVs) and Recombinant Influenza Vaccine (RIV4)
Trade Name [Manufacturer] Presentation Age Indication HA, µG/dose (each virus) Egg-grown virus, Cell culture-grown virus, or Recombinant HA Adjuvanted Yes/No Latex Yes/No Thimerosal Yes/No
If yes, Mercury,
μg/0.5mL
Quadrivalent IIVs (IIV4s)
Afluria Quadrivalent Seqirus 0.5 mL prefilled syringe ≥5 yrs 15 Egg No No No
5.0 mL multi-dose vial ≥5 yrs (needle/syringe)

18 through 64 yrs (jet injector)

 15 Egg No No Yes (24.5)
Fluarix Quadrivalent GlaxoSmithKline 0.5 mL prefilled syringe ≥6 months 15 Egg No No No
FluLaval Quadrivalent ID Biomedical Corp. of Quebec 0.5 mL prefilled syringe ≥6 months 15 Egg No No No
5.0 mL multi-dose vial ≥6 months  15 Egg No No Yes (<25)
Flucelvax Quadrivalent Seqirus (ccIIV4) 0.5 mL prefilled syringe ≥4 yrs 15 Cell No No No
5.0 mL multi-dose vial ≥4 yrs  15 Cell No No Yes (25)
Fluzone Quadrivalent Sanofi Pasteur 0.25 mL prefilled syringe 6 through 35 months 7.5/0.25 mL Egg No No No
0.5 mL prefilled syringe ≥3 yrs 15/0.5 mL  Egg No No No
0.5 mL single-dose vial ≥3 yrs  15/0.5 mL  Egg  No No No
5.0 mL multi-dose vial ≥6 months 15/0.5 mL  Egg  No No Yes (25)
Trivalent IIV (IIV3s)
Afluria Seqirus 0.5 mL prefilled syringe ≥5 yrs 15 Egg No No No
5.0 mL multi-dose vial ≥5 yrs (needle/syringe)
18 through 64 yrs (jet injector)		  15 Egg  No No Yes (24.5)
Fluad Seqirus (aIIV3) 0.5 mL prefilled syringe ≥65 yrs 15 Egg Yes No No
Fluzone High-Dose Sanofi Pasteur (HD-IIV3) 0.5 mL prefilled syringe ≥65 yrs 60 Egg No No No
Quadrivalent RIV (RIV4)
Flublok Quadrivalent Sanofi Pasteur 0.5 mL prefilled syringe ≥18 yrs 45 Recombinant No No No

Abbreviations: IIV=inactivated influenza vaccine; RIV=recombinant influenza vaccine; HA=hemagglutinin; mos=months; yrs=years.

Administration of IIVs and RIV4

  • IIVs and RIV4 are administered intramuscularly (IM):
    • Adults and older children: the deltoid is the preferred site;
    • Infants and younger children (IIVs only): the anterolateral thigh is the preferred site.
    • Detailed guidance for administration sites and needle length is available in Best Practices Guidance of the Advisory Committee on Immunization Practices (ACIP)
    • Afluria and Afluria Quadrivalent are licensed for intramuscular administration via jet injector (the Pharmajet Stratis), for persons aged 18-64 years only.
    • RIV4 is licensed for persons aged ≥18 years

IIV and RIV4 Contraindications and Precautions

Contraindications:

  • History of severe allergic reaction to the vaccine or any of its components
    • ACIP recommends that persons with egg allergy of any severity receive influenza vaccine (see Persons with a History of Egg Allergy, above)
    • Information about vaccine components is located in package inserts from each manufacturer.

Precautions:

  • Moderate or severe acute illness with or without fever.
  • Guillain–Barré syndrome within 6 weeks following a previous dose of influenza vaccine.

Live Attenuated Influenza Vaccine (LAIV4)
Trade Name Manufacturer Presentation Age Indication Virus Dose
per 0.2mL
(each virus)		 Egg-grown virus, Cell
culture-grown virus,
or Recombinant HA		 Adjuvanted
(Yes/No)		 Latex
(Yes/No)		 Thimerosal
Yes/No
If yes, Mercury,
μg/0.5mL
FluMist Quadrivalent
AstraZeneca 		0.2 prefilled
intranasal sprayer		 2 through 49 yrs 106.5–7.5
fluorescent
focus units		 Egg No No No

Abbreviations: LAIV=live attenuated influenza vaccine; mos=months; yrs=years.

LAIV4 Administration

  • LAIV is administered intranasally using the supplied prefilled, single-use sprayer containing 0.2 mL of vaccine.
    • Half of the total sprayer contents is sprayed into the first nostril while the recipient is in the upright position.
    • The attached divider clip is removed and the second half of the dose administered into the other nostril.
  • If the vaccine recipient sneezes immediately after administration, the dose should not be repeated.
  • If nasal congestion impedes delivery of the vaccine to the nasopharyngeal mucosa, deferral should be considered, or another age appropriate vaccine should be administered.

LAIV4 Contraindications and Precautions

Contraindications:

  • History of severe allergic reaction to any vaccine component or after previous dose of any influenza vaccine;
    • ACIP recommends that persons with egg allergy of any severity receive influenza vaccine (see Persons with a History of Egg Allergy, above)
    • Information about vaccine components is located in package inserts from the manufacturer.
  • Concomitant aspirin or salicylate-containing therapy in children and adolescents;
  • Children aged 2 through 4 years who have received a diagnosis of asthma or whose parents or caregivers report that a health care provider has told them during the preceding 12 months that their child had wheezing or asthma or whose medical record indicates a wheezing episode has occurred during the preceding 12 months;
  • Children and adults who are immunocompromised due to any cause (including immunosuppression caused by medications or by HIV infection);
  • Close contacts and caregivers of severely immunosuppressed persons who require a protected environment;
  • Pregnancy;
  • Receipt of influenza antiviral medication within previous 48 hours.

Precautions:

  • Moderate or severe acute illness with or without fever;
  • History of Guillain-Barré syndrome within 6 weeks of receipt of influenza vaccine;
  • Asthma in persons aged ≥5 years;
  • Other underlying medical conditions that might predispose to complications attributable to severe influenza (e.g., chronic pulmonary, cardiovascular [excluding isolated hypertension], renal, hepatic, neurologic, hematologic, or metabolic disorders (including diabetes mellitus)).

Vaccine Abbreviations

  • IIV = Inactivated Influenza Vaccine.
    • IIV3 = Trivalent Inactivated Influenza Vaccine;
    • IIV4 = Quadrivalent Inactivated Influenza Vaccine.
  • RIV4 = Quadrivalent Recombinant Influenza Vaccine.
  • LAIV4 = Quadrivalent Live Attenuated Influenza Vaccine
  • aIIV3 refers specifically to adjuvanted IIV3
  • ccIIV4 refers specifically to cell-culture based IIV4
  • HD-IIV3 refers specifically to high-dose IIV3
  • SD-IIV3 and SD-IIV4 refer specifically to standard-dose IIVs
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