Trade name (manufacturer) | Presentations | Age indication | μg HA (IIV4s and RIV4) or virus count (LAIV4) for each vaccine virus (per dose) | Route | Mercury (from thimerosal, if present), μg/0.5 mL |
---|---|---|---|---|---|
IIV4 (standard-dose, egg-based vaccines†) | |||||
Afluria Quadrivalent (Seqirus) | 0.5-mL PFS§ | ≥3 yrs§ | 15 μg/0.5 mL | IM¶ | —** |
5.0-mL MDV§ | ≥6 mos§ (needle and syringe) 18 through 64 yrs (jet injector) |
7.5 μg/0.25 mL 15 μg/0.5 mL |
IM¶ | 24.5 | |
Fluarix Quadrivalent (GlaxoSmithKline) | 0.5-mL PFS | ≥6 mos | 15 μg/0.5 mL | IM¶ | — |
FluLaval Quadrivalent (GlaxoSmithKline) | 0.5-mL PFS | ≥6 mos | 15 μg/0.5 mL | IM¶ | — |
Fluzone Quadrivalent (Sanofi Pasteur) | 0.5-mL PFS†† | ≥6 mos†† | 15 μg/0.5 mL | IM¶ | — |
0.5-mL SDV†† | ≥6 mos†† | 15 μg/0.5 mL | IM¶ | — | |
5.0-mL MDV†† | ≥6 mos†† | 7.5 μg/0.25 mL 15 μg/0.5 mL |
IM¶ | 25 | |
ccIIV4 (standard-dose, cell culture–based vaccine) | |||||
Flucelvax Quadrivalent (Seqirus) | 0.5-mL PFS | ≥6 mos | 15 μg/0.5 mL | IM¶ | — |
5.0-mL MDV | ≥6 mos | 15 μg/0.5 mL | IM¶ | 25 | |
HD-IIV4 (high-dose, egg-based vaccine†) | |||||
Fluzone High-Dose Quadrivalent (Sanofi Pasteur) | 0.7-mL PFS | ≥65 yrs | 60 μg/0.7 mL | IM¶ | — |
aIIV4 (standard-dose, egg-based vaccine† with MF59 adjuvant) | |||||
Fluad Quadrivalent (Seqirus) | 0.5-mL PFS | ≥65 yrs | 15 μg/0.5 mL | IM¶ | — |
RIV4 (recombinant HA vaccine) | |||||
Flublok Quadrivalent (Sanofi Pasteur) | 0.5-mL PFS | ≥18 yrs | 45 μg/0.5 mL | IM¶ | — |
LAIV4 (egg-based vaccine†) | |||||
FluMist Quadrivalent (AstraZeneca) | 0.2-mL prefilled single-use intranasal sprayer | 2 through 49 yrs | 106.5–7.5 fluorescent focus units/0.2 mL | NAS | — |
Influenza vaccines — United States, 2022–23 influenza season*
Abbreviations: ACIP = Advisory Committee on Immunization Practices; FDA = Food and Drug Administration; HA = hemagglutinin; IIV4 = inactivated
influenza vaccine, quadrivalent; IM = intramuscular; LAIV4 = live attenuated influenza vaccine, quadrivalent; MDV = multidose
vial; NAS = intranasal; PFS = prefilled syringe; RIV4 = recombinant influenza vaccine, quadrivalent; SDV = single-dose vial.
*Vaccination providers should consult FDA-approved prescribing information for 2022–23 influenza vaccines for the most complete and updated information, including but not limited to indications, contraindications, warnings, and precautions. Package inserts for U.S.-licensed vaccines are available at https://www.fda.gov/vaccines-blood-biologics/vaccines/vaccines-licensed-use-united-states. Availability and characteristics of specific products and presentations might change or differ from what is described in this table and in the text of this report.
†Although a history of severe allergic reaction (e.g., anaphylaxis) to egg is a labeled contraindication to the use of egg-based
IIV4s and LAIV4, ACIP recommends that persons with a history of egg allergy may receive any licensed, recommended influenza
vaccine that is otherwise appropriate for their age and health status. Those who report having had reactions to egg involving
symptoms other than urticaria (e.g., angioedema or swelling, respiratory distress, lightheadedness, or recurrent emesis) or
who required epinephrine or another emergency medical intervention should be vaccinated in an inpatient or outpatient medical
setting (including but not necessarily limited to hospitals, clinics, health departments, and physician offices) supervised
by a health care provider who is able to recognize and manage severe allergic reactions, if a vaccine other than ccIIV4 or
RIV4 is used.
§The approved dose volume for Afluria Quadrivalent is 0.25 mL for children aged 6 through 35 months and 0.5 mL for persons aged ≥3 years. However, 0.25-mL prefilled syringes are not expected to be available for the 2022–23 season. For children aged 6 through 35 months, a 0.25-mL dose must be obtained from a multidose vial.
¶IM-administered influenza vaccines should be given by needle and syringe only, with the exception of the MDV presentation
of Afluria Quadrivalent, which may alternatively be given by the PharmaJet Stratis jet injector for persons aged 18 through
64 years only. For adults and older children, the recommended site for intramuscular influenza vaccination is the deltoid
muscle. The preferred site for infants and young children is the anterolateral aspect of the thigh. Additional specific guidance
regarding site selection and needle length for intramuscular administration is available in the ACIP General Best Practice
Guidelines for Immunization, available at https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/index.html.
**Not applicable.
††Fluzone Quadrivalent is currently approved for ages 6 through 35 months at either 0.25 mL or 0.5 mL per dose; however, 0.25-mL prefilled syringes are not expected to be available for the 2022–23 influenza season. If a prefilled syringe of Fluzone Quadrivalent is used for a child in this age group, the dose volume will be 0.5 mL per dose.
Vaccine type | Contraindications | Precautions |
---|---|---|
Egg-based IIV4s | • History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine† or to a previous dose of any influenza vaccine (i.e., any egg-based IIV, ccIIV, RIV, or LAIV)§ | • Moderate or severe acute illness with or without fever • History of Guillain-Barré syndrome within 6 weeks of receipt of influenza vaccine |
ccIIV4 | • History of severe allergic reaction (e.g., anaphylaxis) to a previous dose of any ccIIV or any component of ccIIV4§ | • Moderate or severe acute illness with or without fever • History of Guillain-Barré syndrome within 6 weeks of receipt of influenza vaccine • History of severe allergic reaction to a previous dose of any other influenza vaccine (i.e., any egg-based IIV, RIV, or LAIV)¶ |
RIV4 | • History of severe allergic reaction (e.g., anaphylaxis) to a previous dose of any RIV or any component of RIV4§ | • Moderate or severe acute illness with or without fever • History of Guillain-Barré syndrome within 6 weeks of receipt of influenza vaccine • History of severe allergic reaction to a previous dose of any other influenza vaccine (i.e., any egg-based IIV, ccIIV, or LAIV)¶ |
LAIV4 | • History of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine† or to a previous dose of any influenza vaccine (i.e., any egg-based IIV, ccIIV, RIV, or LAIV)§
• 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 but not limited to immunosuppression caused by medications, congenital or acquired immunodeficiency states, HIV infection, anatomic asplenia, or functional asplenia (e.g., due to sickle cell anemia) • Close contacts and caregivers of severely immunosuppressed persons who require a protected environment • Pregnancy • Persons with active communication between the CSF and the oropharynx, nasopharynx, nose, or ear or any other cranial CSF leak • Persons with cochlear implants** • Receipt of influenza antiviral medication within the previous 48 hours for oseltamivir and zanamivir, previous 5 days for peramivir, and previous 17 days for baloxavir†† |
• 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 after wild-type influenza infection (e.g., chronic pulmonary, cardiovascular [except isolated hypertension], renal, hepatic, neurologic, hematologic, or metabolic disorders [including diabetes mellitus]) |
Contraindications and precautions for the use of influenza vaccines — United States, 2022–23 influenza season*
Abbreviations: ACIP = Advisory Committee on Immunization Practices; ccIIV = cell culture–based inactivated influenza vaccine (any valency); ccIIV4 = cell culture–based inactivated influenza vaccine, quadrivalent; CSF = cerebrospinal fluid; FDA = Food and Drug Administration; IIV = inactivated influenza vaccine (any valency); IIV4 = inactivated influenza vaccine, quadrivalent; LAIV = live attenuated influenza vaccine (any valency); LAIV4 = live attenuated influenza vaccine, quadrivalent; RIV = recombinant influenza vaccine (any valency); RIV4 = recombinant influenza vaccine, quadrivalent.
*When a contraindication is present, a vaccine should not be administered. When a precaution is present, vaccination should generally be deferred but might be indicated if the benefit of protection from the vaccine outweighs the risk for an adverse reaction (see ACIP General Best Practice Guidelines for Immunization, available at https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/index.html). Vaccination providers should check FDA-approved prescribing information for 2022–23 influenza vaccines for the most complete and updated information, including (but not limited to) indications, contraindications, warnings, and precautions. Package inserts for U.S.-licensed vaccines are available at https://www.fda.gov/vaccines-blood-biologics/vaccines/vaccines-licensed-use-united-states.
†Although a history of severe allergic reaction (e.g., anaphylaxis) to egg is a labeled contraindication to the use of egg-based
IIV4s and LAIV4, ACIP recommends that persons with a history of egg allergy may receive any licensed, recommended influenza
vaccine that is otherwise appropriate for their age and health status. Those who report having had reactions to egg involving
symptoms other than urticaria (e.g., angioedema or swelling, respiratory distress, lightheadedness, or recurrent emesis) or
who required epinephrine or another emergency medical intervention should be vaccinated in an inpatient or outpatient medical
setting, including but not necessarily limited to hospitals, clinics, health departments, and physician offices, if a vaccine
other than ccIIV4 or RIV4 is used. Vaccine administration should be supervised by a health care provider who is able to recognize
and manage severe allergic reactions.
§Labeled contraindication noted in package insert.
¶If administered, vaccination should occur in a medical setting and should be supervised by a health care provider who can
recognize and manage severe allergic reactions. Providers can consider consultation with an allergist in such cases, to assist
in identification of the component responsible for the allergic reaction.
**Age-appropriate injectable vaccines are recommended for persons with cochlear implant due to the potential for CSF leak,
which might exist for a period after implantation. Providers might consider consultation with a specialist concerning risk
for persistent CSF leak if an age-appropriate inactivated or recombinant vaccine cannot be used.
††Use of LAIV4 in context of influenza antivirals has not been studied; however, interference with activity of LAIV4 is biologically
plausible, and this possibility is noted in the package insert for LAIV4. In the absence of data supporting an adequate minimum
interval between influenza antiviral use and LAIV4 administration, the intervals provided are based on the half-life of each
antiviral. The interval between influenza antiviral receipt and LAIV4 for which interference might potentially occur might
be further prolonged in the presence of medical conditions that delay medication clearance (e.g., renal insufficiency). Influenza
antivirals might also interfere with LAIV4 if initiated within 2 weeks after vaccination. Persons who receive antivirals during
the period starting with the specified time before receipt of LAIV4 through 2 weeks after receipt of LAIV4 should be revaccinated
with an age-appropriate IIV or RIV4.
Vaccine (of any valency) associated with previous severe allergic reaction (e.g., anaphylaxis) | Available 2022–23 influenza vaccines | ||
---|---|---|---|
Egg-based IIV4s and LAIV4 | ccIIV4 | RIV4 | |
Any egg-based IIV or LAIV | Contraindication† | Precaution§ | Precaution§ |
Any ccIIV | Contraindication† | Contraindication† | Precaution§ |
Any RIV | Contraindication† | Precaution§ | Contraindication† |
Unknown influenza vaccine | Allergist consultation recommended |
Influenza vaccine contraindications and precautions for persons with a history of severe allergic reaction to a previous dose of an influenza vaccine* — United States, 2022–23 influenza season
Abbreviations: ACIP = Advisory Committee on Immunization Practices; ccIIV = cell culture–based inactivated influenza vaccine (any valency); ccIIV4 = cell culture–based inactivated influenza vaccine, quadrivalent; FDA = Food and Drug Administration; IIV = inactivated influenza vaccine (any valency); IIV4 = inactivated influenza vaccine, quadrivalent; LAIV = live attenuated influenza vaccine (any valency); LAIV4 = live attenuated influenza vaccine, quadrivalent; RIV = recombinant influenza vaccine (any valency); RIV4 = recombinant influenza vaccine, quadrivalent.
*Vaccination providers should check FDA-approved prescribing information for 2022–23 influenza vaccines for the most complete and updated information, including (but not limited to) indications, contraindications, warnings, and precautions. Package inserts for U.S.-licensed vaccines are available at https://www.fda.gov/vaccines-blood-biologics/vaccines/vaccines-licensed-use-united-states.
†When a contraindication is present, a vaccine should not be administered, consistent with ACIP General Best Practice Guidelines
for Immunization (Kroger A, Bahta L, Hunter P. General best practice guidelines for immunization: best practices guidance
of the Advisory Committee on Immunization Practices [ACIP]. https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/index.html).
In addition to the contraindications based on history of severe allergic reaction to influenza vaccines that are noted in
the table, each individual influenza vaccine is contraindicated for persons who have had a severe allergic reaction (e.g.,
anaphylaxis) to any component of that vaccine. Vaccine components can be found in package inserts. Although a history of severe
allergic reaction (e.g., anaphylaxis) to egg is a labeled contraindication to the use of egg-based IIV4s and LAIV4, ACIP recommends
that persons with a history of egg allergy may receive any licensed, recommended influenza vaccine that is otherwise appropriate
for their age and health status. Those who report having had reactions to egg involving symptoms other than urticaria (e.g.,
angioedema or swelling, respiratory distress, lightheadedness, or recurrent emesis) or who required epinephrine or another
emergency medical intervention should be vaccinated in an inpatient or outpatient medical setting (including but not necessarily
limited to hospitals, clinics, health departments, and physician offices), if a vaccine other than ccIIV4 or RIV4 is used.
Vaccine administration should be supervised by a health care provider who is able to recognize and manage severe allergic
reactions.
§When a precaution is present, vaccination should generally be deferred but might be indicated if the benefit of protection
from the vaccine outweighs the risk for an adverse reaction, consistent with ACIP General Best Practice Guidelines for Immunization
(Kroger A, Bahta L, Hunter P. General best practice guidelines for immunization: best practices guidance of the Advisory Committee
on Immunization Practices [ACIP]. https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/index.html). Providers can consider
using the following vaccines in these instances; however, vaccination should occur in an inpatient or outpatient medical setting
with supervision by a health care provider who is able to recognize and manage severe allergic reactions: 1) for persons with
a history of severe allergic reaction (e.g., anaphylaxis) to any egg-based IIV or LAIV of any valency, the provider can consider
administering ccIIV4 or RIV4; 2) for persons with a history of severe allergic reaction (e.g., anaphylaxis) to any ccIIV of
any valency, the provider can consider administering RIV4; and 3) for persons with a history of severe allergic reaction (e.g.,
anaphylaxis) to any RIV of any valency, the provider can consider administering ccIIV4. Providers can also consider consulting
with an allergist to help determine which vaccine component is responsible for the allergic reaction.
Trade name (Manufacturer) | Dose volume for children aged 6 through 35 mos (μg HA per vaccine virus) |
---|---|
Afluria Quadrivalent (Seqirus) | 0.25 mL (7.5 μg)† |
Fluarix Quadrivalent (GlaxoSmithKline) | 0.5 mL (15 μg) |
Flucelvax Quadrivalent (Seqirus) | 0.5 mL (15 μg) |
FluLaval Quadrivalent (GlaxoSmithKline) | 0.5 mL (15 μg) |
Fluzone Quadrivalent (Sanofi Pasteur) | 0.5 mL (15 μg)§ |
Dose volumes for inactivated influenza vaccines approved for children aged 6 through 35 months* — United States, 2022–23 influenza season
Abbreviation: HA = hemagglutinin.
*For persons aged ≥36 months (≥3 years), the dose volume is 0.5 mL per dose for all inactivated influenza vaccines with the exception of Fluzone High-Dose Quadrivalent (HD-IIV4), which is licensed for persons aged ≥65 years and for which the dose volume is 0.7 mL per dose.
†The approved dose volume for Afluria Quadrivalent is 0.25 mL for children aged 6 through 35 months and 0.5 mL for persons aged ≥3 years. However, 0.25-mL prefilled syringes are not expected to be available for the 2022–23 season. For children aged 6 through 35 months, a 0.25-mL dose must be obtained from a multidose vial.
§Per the package insert, Fluzone Quadrivalent is currently approved for children aged 6 through 35 months at either 0.25 mL
or 0.5 mL per dose; however, 0.25-mL prefilled syringes are no longer available. If a prefilled syringe of Fluzone Quadrivalent
is used for a child in this age group, the dose volume will be 0.5 mL per dose. The 0.5-mL single-dose vials should be accessed
for only 1 dose and multidose vials for only 10 doses, regardless of the volume of the doses obtained or any remaining volume
in the vial. Any vaccine remaining in a vial after the maximum number of doses has been removed should be discarded.
• Main influenza vaccine types: • IIV = inactivated influenza vaccine • RIV = recombinant influenza vaccine • LAIV = live attenuated influenza vaccine • Numerals following letter abbreviations indicate valency (the number of influenza virus hemagglutinin [HA] antigens represented in the vaccine): • 4 for quadrivalent vaccines: one A(H1N1), one A(H3N2), and two B viruses (one from each lineage) • 3 for trivalent vaccines: one A(H1N1), one A(H3N2), and one B virus (from one lineage) • All influenza vaccines expected to be available in the United States for the 2022–23 season are quadrivalent vaccines. However, abbreviations for trivalent vaccines (e.g., IIV3) might be used in this report when discussing information specific to trivalent vaccines. • Abbreviations for general vaccine categories (e.g., IIV) might be used when discussing information that is not specific to either trivalent or quadrivalent vaccines. • Prefixes are used when necessary to refer to certain specific IIVs: • a for MF59-adjuvanted inactivated influenza vaccine (e.g., aIIV3 and aIIV4) • cc for cell culture–based inactivated influenza vaccine (e.g., ccIIV3 and ccIIV4) • HD for high-dose inactivated influenza vaccine (e.g., HD-IIV3 and HD-IIV4) • SD for standard-dose inactivated influenza vaccine (e.g. SD-IIV3 and SD-IIV4) |
Abbreviation conventions for influenza vaccines discussed in this report
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All influenza vaccines licensed in the United States will contain components derived from influenza viruses antigenically similar to those recommended by FDA (https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-march-3-2022-meeting-announcement). All influenza vaccines expected to be available in the United States for the 2022–23 season will be quadrivalent vaccines. For the 2022–23 season, U.S. egg-based influenza vaccines (i.e., vaccines other than ccIIV4 and RIV4) will contain HA derived from
For the 2022–23 season, U.S. cell culture–based inactivated (ccIIV4) and recombinant (RIV4) influenza vaccines will contain HA derived from
Availability of specific types and brands of licensed seasonal influenza vaccines in the United States is determined by the manufacturers of the vaccines. Information presented concerning vaccines expected to be available and their approved indications and usage reflects current knowledge and is subject to change.
Various influenza vaccines will be available for the 2022–23 season (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 influenza vaccine that is appropriate for the recipient's age and health status should be used. Specific age indications for licensed influenza vaccines are summarized (Table 1). Current prescribing information should be consulted for authoritative, up-to-date information. Contraindications and precautions for the different types of influenza vaccines are summarized (Table 2 and Table 3), as are dose volumes (Table 4).
Not all influenza vaccines are likely to be uniformly available in any specific practice setting or geographic locality. Vaccination should not be delayed to obtain a specific product when an appropriate one is available. Within these guidelines and approved indications, ACIP makes no preferential recommendation for the use of any one influenza vaccine over another when more than one licensed, recommended, and age-appropriate vaccine is available, with the exception of selection of influenza vaccines for persons aged ≥65 years (see Older Adults).
Since the publication of the previous season's recommendations, FDA has approved a labeling change for Flucelvax Quadrivalent (see Recent Influenza Vaccine Labeling Changes). Additional new licensures and changes to FDA-approved labeling might occur after publication of this report. As these changes occur and new vaccines become available, they will be reflected in the online version of Table 1, available at https://www.cdc.gov/flu/professionals/acip/2022-2023/acip-table.htm.
Quadrivalent Inactivated Influenza Vaccines (IIV4s). Available Vaccines: As in recent seasons, various inactivated influenza vaccines (IIVs) are expected to be available for 2022–23 (Table 1); all are expected to be quadrivalent (IIV4s). Standard-dose, nonadjuvanted IIV4s are licensed for persons aged as young as 6 months. However, for certain IIV4s, the approved dose volume for children aged 6 through 35 months differs from that for older children and adults (Table 4). Two IIV4s, the MF59-adjuvanted IIV4 (aIIV4) and the high-dose IIV4 (HD-IIV4), are approved for persons aged ≥65 years. Care should be taken to administer the appropriate dose volume of an age-appropriate vaccine to each recipient.
Standard-dose, nonadjuvanted IIV4s contain 15 μg of HA per vaccine virus in a 0.5-mL dose (7.5 μg of HA per vaccine virus in a 0.25-mL dose). For 2022–23, this category is expected to include five different vaccines (Table 1). Four of these are egg-based vaccines, and one is a cell culture–based vaccine. All are approved for persons aged ≥6 months. Egg-based and cell culture–based vaccines differ in the substrate in which reference vaccine viruses supplied to the manufacturer are propagated in quantities sufficient to produce the needed number of doses of vaccine. For the IIV4s Afluria Quadrivalent,[43] Fluarix Quadrivalent,[123] FluLaval Quadrivalent,[124] and Fluzone Quadrivalent,[44] reference vaccine viruses are propagated in eggs. For Flucelvax Quadrivalent, reference vaccine viruses are propagated in Madin-Darby canine kidney cells instead of eggs.[125]
Two additional IIV4s that will be available for the 2022–23 season are approved for persons aged ≥65 years. These vaccines are egg based. Quadrivalent high-dose inactivated influenza vaccine (Fluzone High-Dose Quadrivalent; HD-IIV4) contains 60 μg of HA per vaccine virus (240 μg total) in a 0.7-mL dose.[126] Quadrivalent adjuvanted inactivated influenza vaccine (Fluad Quadrivalent; aIIV4) contains 15 μg of HA per vaccine virus (60 μg total) and MF59 adjuvant.[120]
Dosage and Administration: Standard-dose nonadjuvanted IIV4s are approved for children aged as young as 6 months. Certain of these IIV4s are approved at different dose volumes for very young children than for older children and adults. Care should be taken to administer an age-appropriate vaccine at the approved dose volume for each needed dose (see Children Aged 6 Through 35 Months: Influenza Vaccine Dose Volumes) (Table 1 and Table 4):
If prefilled syringes are not available, the appropriate volume can be administered from a single-dose or multidose vial. If a 0.5-mL single-dose vial is used for a 0.25-mL dose for a child aged 6 through 35 months, only half of the vial volume should be administered, and the remaining half should be discarded. Of note, dose volume is distinct from the number of doses. Children in this age group who require 2 doses for 2022–23 need 2 separate doses administered ≥4 weeks apart, regardless of the specific IIV4 used and volume given for each dose (see Children Aged 6 Months Through 8 Years: Number of Influenza Vaccine Doses) (Figure).
For children aged 36 months (3 years) through 17 years and adults aged ≥18 years, the dose volume for IIV4s is 0.5 mL per dose, with the exception of Fluzone High-Dose Quadrivalent (HD-IIV4, licensed for persons aged ≥65 years), for which the correct volume is 0.7 mL per dose. If a smaller vaccine dose (e.g., 0.25 mL) is inadvertently administered to a person aged ≥36 months, the remaining volume needed to make a full dose should be administered during the same vaccination visit or, if measuring the needed remaining volume is a challenge, administering a repeat dose at the full volume is acceptable. If the error is discovered later (after the recipient has left the vaccination setting), a full dose should be administered as soon as the recipient can return. Vaccination with a formulation approved for adult use should be counted as a single dose if inadvertently administered to a child.
IIV4s are administered intramuscularly (IM). For adults and older children, the deltoid muscle 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 IM injection is provided in the ACIP General Best Practice Guidelines for Immunization.[42]
One IIV4, Afluria Quadrivalent, is licensed for IM injection via the PharmaJet Stratis jet injector for persons aged 18 through 64 years.[43] Persons in this age group may receive Afluria Quadrivalent via either needle and syringe or this specific jet injection device. Children aged 6 months through 17 years and adults aged ≥65 years should receive this vaccine by needle and syringe only. No other IIV4s are licensed for administration by jet injector.
Contraindications and Precautions for the use of IIV4s: Manufacturer package inserts and updated CDC and ACIP guidance should be consulted for information on contraindications and precautions for individual influenza vaccines. Each IIV, whether egg-based or cell culture–based, has a labeled contraindication for persons with a history of a severe allergic reaction to any component of that vaccine (Table 2). Although egg is a component of all IIV4s other than ccIIV4, ACIP makes specific recommendations for the use of influenza vaccine for persons with egg allergy (see Persons with a History of Egg Allergy). All egg-based IIV4s are contraindicated in persons who have had a severe allergic reaction (e.g., anaphylaxis) to a previous dose of any influenza vaccine (any egg-based IIV, ccIIV, RIV, or LAIV of any valency). Use of ccIIV4 is contraindicated in persons who have had a severe allergic reaction (e.g., anaphylaxis) to any ccIIV of any valency. A history of severe allergic reaction (e.g., anaphylaxis) to any other influenza vaccine (i.e., any egg-based IIV, RIV, or LAIV of any valency) is a precaution for the use of ccIIV4 (see Persons with Previous Allergic Reactions to Influenza Vaccines) (Table 2 and Table 3). If ccIIV4 is administered in such an instance, vaccination should occur in an inpatient or outpatient medical setting and should be supervised by a health care provider who is able to recognize and manage severe allergic reactions. Providers can also consider consultation with an allergist to help identify the vaccine component responsible for the reaction. Information about vaccine components can be found in the package inserts for each vaccine. Prophylactic use of antiviral agents is an option that can be considered for preventing influenza among persons who cannot receive vaccine, particularly for those who are at higher risk for medical complications attributable to severe influenza.[91]
Moderate or severe acute illness with or without fever is a general precaution for vaccination.[42] A history of GBS within 6 weeks after receipt of a previous dose of influenza vaccine is considered a precaution for the use of all influenza vaccines (Table 2).
Quadrivalent Recombinant Influenza Vaccine (RIV4). Available Vaccine: One recombinant influenza vaccine, Flublok Quadrivalent (RIV4), is expected to be available during the 2022–23 influenza season. RIV4 is approved for persons aged ≥18 years. This vaccine contains recombinant HA produced in an insect cell line using genetic sequences from cell-derived influenza viruses and is manufactured without the use of influenza viruses or eggs.[127]
Dosage and Administration: RIV4 is administered by IM injection via needle and syringe. A 0.5-mL dose contains 45 μg of HA derived from each vaccine virus (180 μg total).
Contraindications and Precautions for the Use of RIV4: RIV4 is contraindicated in persons who have had a severe allergic reaction (e.g., anaphylaxis) to a previous dose of any RIV of any valency or any component of RIV4. A history of a severe allergic reaction (e.g., anaphylaxis) to any other influenza vaccine (i.e., any egg-based IIV, ccIIV, or LAIV of any valency) is a precaution for the use of RIV4. If RIV4 is administered in such an instance, vaccination should occur in an inpatient or outpatient medical setting and should be supervised by a health care provider who is able to recognize and manage severe allergic reactions. Providers can also consider consulting with an allergist to help identify the vaccine component responsible for the reaction. Moderate or severe acute illness with or without fever is a general precaution for vaccination.[42] A history of GBS within 6 weeks after receipt of a previous dose of influenza vaccine is considered a precaution for the use of all influenza vaccines (Table 2). RIV4 is not licensed for children aged <18 years.
Quadrivalent Live Attenuated Influenza Vaccine (LAIV4). Available Vaccine: One live attenuated influenza vaccine, FluMist Quadrivalent (LAIV4), is expected to be available during the 2022–23 influenza season. LAIV4 is approved for persons aged 2 through 49 years. LAIV4 contains live attenuated influenza viruses that are propagated in eggs. These viruses are cold adapted (so that they replicate efficiently at 25°C) and temperature sensitive (so that their replication is restricted at higher temperatures, 39°C for influenza A viruses and 37°C for influenza B viruses). These viruses replicate in the nasopharynx, which is necessary to promote an immune response.[99] No preference is expressed for LAIV4 versus other influenza vaccines used within specified indications.
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 permit administration of the second half of the dose into the other nostril. If the 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. Each total dose of 0.2 mL contains 106.5–7.5 fluorescent focus units of each vaccine virus.[99]
Contraindications and Precautions for the use of LAIV4: Conditions considered by ACIP to be contraindications and precautions for the use of LAIV4 are summarized (Table 2). These include two labeled contraindications that appear in the package insert[99] and other conditions for which there is uncertain but biologically plausible potential risk associated with live viruses or limited data for use of LAIV.
Contraindications to use of LAIV4 include the following:
Precautions for use of LAIV4 include the following:
Flucelvax Quadrivalent. Since the publication of the 2021–22 ACIP influenza vaccine recommendations, a labeling change for Flucelvax Quadrivalent (ccIIV4) has occurred. Flucelvax Quadrivalent was initially approved in 2016 for persons aged ≥4 years. Approval for persons aged ≥18 years was based on a randomized immunogenicity and safety trial that compared Flucelvax Quadrivalent with the previously approved trivalent formulation of Flucelvax (ccIIV3), which had previously been licensed for persons aged ≥18 years on the basis of data from a randomized clinical efficacy trial. Approval for children aged 4 through 17 years also was based on immunogenicity and safety data compared with ccIIV3, with a postmarketing requirement to conduct a clinical efficacy study.[128] In March 2021, FDA approved Flucelvax Quadrivalent for persons aged ≥2 years on the basis of a randomized clinical efficacy trial conducted among 4,514 children aged ≥2 to <18 years over three influenza seasons (Southern Hemisphere 2017 and Northern Hemisphere 2017–18 and 2018–19).[129]
Subsequently, in October 2021, FDA approved Flucelvax Quadrivalent for persons aged ≥6 months. Approval was based on a randomized immunogenicity and safety study conducted among 2,402 children aged 6 through 47 months (of whom 894 were aged 6 through 23 months). Children were randomized in a 2:1 ratio to receive either Flucelvax Quadrivalent (0.5 mL/dose containing 15 μg HA per virus for all ages) or a licensed comparator egg-based IIV4 (0.25 mL/dose containing 7.5 μg HA per virus for those aged 6 through 35 months and 0.5 mL/dose containing 15 μg HA per virus for those aged 36 through 47 months).[130] Flucelvax Quadrivalent met prespecified immunogenicity criteria for all four viruses. No new safety signals were noted, and prevalence of solicited injection site and systemic reactions was similar between the two groups.