Influenza Vaccine Inactivated (Monograph)

Brand names: Afluria, Fluad, Fluarix, Flucelvax, Flulaval, Fluzone
Drug class: Vaccines

Medically reviewed by Drugs.com on Dec 10, 2024. Written by ASHP.

Introduction

Inactivated influenza vaccine.^{104 106 107 108 160 186 190} Influenza vaccine inactivated (IIV) contains noninfectious, suitably inactivated influenza virus types A and B subunits representing influenza strains likely to circulate in the US during the upcoming influenza season and is used to stimulate active immunity to influenza strains contained in the vaccine.^{100 104 106 107 108 160 186 190}

Uses for Influenza Vaccine Inactivated

Prevention of Seasonal Influenza A and B Virus Infections

Used to stimulate active immunity for prevention of disease caused by influenza virus subtypes A and B represented in the vaccine.^{104 106 107 108 160 186 190} Various preparations are commercially available in the US; these preparations differ based on dose (standard versus high dose) and method of manufacturer (cell-based versus egg-based).^{104 106 107 108 160 186 190}

Although most inactivated influenza virus vaccines available in the US for use in adults and pediatric patients ≥6 month of age are egg-based vaccines (Afluria, Fluarix, Flulaval, Fluzone),^{104 106 107 108} a cell culture-based vaccine (Flucelvax) also is available for use in individuals ≥6 months of age.¹⁹⁰ In addition, an egg-based vaccine (Fluzone High-Dose)¹⁶⁰ and adjuvant-containing egg-based vaccine (Fluad)¹⁸⁶ are available for use in adults ≥65 years of age

Annual vaccination is the primary means of preventing seasonal influenza and its complications.¹⁰⁰

ACIP and the American Academy of Pediatrics (AAP) provide recommendations and guidance for vaccination providers regarding the use of influenza vaccines in the US.^{100 112} These experts recommend routine influenza vaccination in all persons ≥6 months of age who do not have contraindications.

Seasonal influenza vaccination is particularly important for individuals at increased risk for severe influenza or influenza-related complications and those who live with or care for such individuals (e.g., health-care personnel, household or other close contacts).¹⁰⁰

All influenza vaccines available in the US for the 2024-25 season are trivalent formulations containing antigens representing influenza A (H1N1), influenza A (H3N2), and influenza B (Victoria lineage).¹⁰⁰ For the 2024–25 influenza season, the influenza vaccine composition no longer includes influenza B/Yamagata because there have been no confirmed detections of influenza B/Yamagata viruses in global influenza surveillance since March 2020.¹⁰⁰

Various preparations of influenza virus vaccines are commercially available in the US.¹⁰⁰ The vaccines can be grouped into 3 broad categories: inactivated influenza vaccines (IIV3), recombinant influenza vaccine (RIV3), and live attenuated virus vaccine (LAIV3).¹⁰⁰ Inactivated influenza vaccines (IIV3) include standard-dose egg-based vaccines, a standard-dose cell culture-based influenza vaccine (ccIIV3), a high-dose egg-based vaccine (HD-IIV3), and an adjuvanted standard-dose egg-based vaccine (aIIV3).¹⁰⁰

ACIP states that all persons ≥6 months of age should receive an age-appropriate influenza vaccine with the exception of solid organ transplant recipients 18–64 years of age who are receiving immunosuppressive medication regimens; these individuals may receive either high-dose inactivated influenza vaccine (HD-IIV3) or adjuvanted inactivated influenza vaccine (aIIV3) as acceptable options (without a preference over other age-appropriate IIV3s or RIV3).¹⁰⁰

Because influenza vaccines are often less effective in older adults, the higher dose vaccines or adjuvanted vaccine is recommended in this population.¹⁰⁰ For the 2024-25 influenza season, ACIP recommends that adults ≥65 years preferentially receive trivalent high-dose inactivated influenza vaccine (HD-IIV3), trivalent recombinant influenza vaccine (RIV3), or trivalent adjuvanted inactivated influenza vaccine (aIIV3).¹⁰⁰ If none of these vaccines is available at an opportunity for vaccine administration, then any other age-appropriate influenza vaccine should be used.¹⁰⁰

With regard to timing of vaccine, for most individuals who need only 1 dose of influenza vaccine for the season, ACIP recommends that healthcare providers ideally offer influenza vaccination during September or October.¹⁰⁰ However, vaccination should continue after October and throughout the influenza season as long as influenza viruses are circulating and unexpired vaccine is available.¹⁰⁰ For most adults, vaccination during July and August generally should be avoided unless there is a concern that vaccination during the season might not be possible; however, vaccination during these months can be considered in children who require 2 doses, children who require only 1 dose but visit their healthcare provider during late summer before the start of the school year, and pregnant persons in the third trimester.¹⁰⁰

Influenza Vaccine Inactivated Dosage and Administration

General

Pretreatment Screening

• Screen all individuals for contraindications and precautions to vaccination.^{100 112}

Patient Monitoring

• Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of influenza vaccine inactivated.^{104 106 107 108 160 186 190}

Administration

Afluria (trivalent), Fluad (trivalent), Fluarix (trivalent), Flucelvax (trivalent), Flulaval (trivalent), Fluzone (trivalent), Fluzone High-Dose (trivalent): Administer only by IM injection.^{104 106 107 108 160 186 190}

Do not administer intradermally,^{104 106 107 190} IV,^{104 106 107 160 190} or sub-Q.^{104 106 107 190}

As an alternative to IM injection using a needle and syringe, Afluria (trivalent) may be administered IM using a PharmaJet Stratis needle-free injection system only in adults 18 through 64 years of age.^{108 543} Do not administer other commercially available inactivated influenza vaccines using a jet injector.⁵⁴³

Syncope (vasovagal or vasodepressor reaction; fainting) may occur following vaccination; such reactions occur most frequently in adolescents and young adults.¹³⁴ Take appropriate measures to decrease risk of injury if patient becomes weak or dizzy or loses consciousness (e.g., have vaccinees sit or lie down during and for 15 minutes after vaccination).¹³⁴ If syncope occurs, observe patient until symptoms resolve.¹³⁴

May be given concurrently with other age-appropriate vaccines.^{100 134} When multiple vaccines are administered during a single health-care visit, give each parenteral vaccine using separate syringes and different injection sites.¹³⁴ Separate injection sites by ≥1 inch (if anatomically feasible) to allow appropriate attribution of any local adverse effects that may occur.¹³⁴

IM Administration

Administer by IM injection into deltoid muscle or anterolateral thigh depending on patient age.¹³⁴

Some clinicians recommend that infants and younger children be vaccinated in the anterolateral thigh.¹⁰⁰ In certain circumstances (e.g., physical obstruction at other sites and no reasonable indication to defer the vaccine dose), may consider IM injection into gluteal muscle using care to identify anatomic landmarks prior to injection.¹³⁴

Deltoid muscle preferred in adults, adolescents, and children ≥3 years of age.^{100 104 106 107 108 134 160 190}

To ensure delivery into muscle, administer IM injections at a 90° angle to the skin using a needle length appropriate for individual’s age and body mass, thickness of adipose tissue and muscle at injection site, and injection technique.¹³⁴ Consider anatomic variability, especially in the deltoid; use clinical judgment to avoid inadvertent underpenetration or overpenetration of muscle.¹³⁴

Do not mix with any other vaccine or solution.^{104 134 160 186 190}

Shake prefilled syringe before administering a dose.^{104 106 107 108 160 186 190}

Shake vaccine vial before withdrawing a dose.^{104 107 108}

Discard vaccine if it contains particulates, appears discolored, or cannot be resuspended with thorough agitation.^{104 106 107 108 160 190}

Jet Injector (Afluria)

Afluria may be administered IM using a PharmaJet Stratis needle-free injection system in adults 18 through 64 years of age.¹⁰⁸ Do not use jet injector to administer Afluria in children and adolescents <18 years of age or geriatric adults ≥65 years of age.¹⁰⁸

Consult manufacturer’s information for the jet injector for specific information on how to administer Afluria using the PharmaJet Stratis needle-free injection system.¹⁰⁸

Dosage

Dose and dosing schedule (i.e., number of doses) for prevention of seasonal influenza depend on individual’s age, vaccination history, and specific product administered.^{100 104 106 107 108 112 160 186 190}

Pediatric Patients

Prevention of Seasonal Influenza A and B Virus Infections

Infants and Children 6 through 35 Months of Age (Afluria)

IM

Available in 0.25-mL single-dose syringes to provide a reduced dose for use in infants and children 6 through 35 months of age.¹⁰⁸

Did not receive a total of 2 or more doses of any seasonal influenza vaccine before July 1, 2024 or whose previous influenza vaccination history is unknown: Administer 2 doses of Afluria at least 4 weeks apart.^{100 108} Each dose consists of 0.25 mL.^{100 108}

Received a total of 2 or more doses of any seasonal influenza vaccine ≥4 weeks apart before July 1, 2024: Administer a single 0.25 mL dose of Afluria.¹⁰⁰

Infants and Children 6 through 35 Months of Age (Fluarix, Flulaval)

IM

Did not receive a total of 2 or more doses of any seasonal influenza vaccine before July 1, 2024 or whose previous influenza vaccination history is unknown: Administer 2 doses of Fluarixor Flulaval at least 4 weeks apart.^{100 106 107} Each dose consists of 0.5 mL.^{100 107 107}

Received a total of 2 or more doses of any seasonal influenza vaccine ≥4 weeks apart before July 1, 2024: Administer a single 0.5 mL dose of Fluarix or Flulaval.^{100 106 107}

Infants and Children 6 through 35 Months of Age (Fluzone)

IM

For infants and children 6 through 35 months of age, 0.25 mL or standard doses (0.5 mL) may be used.^{100 104 112}

Did not receive a total of 2 or more doses of any seasonal influenza vaccine before July 1, 2024 or whose previous influenza vaccination history is unknown: Manufacturer recommends two 0.25-mL doses, two 0.5-mL doses, or one 0.25- and one 0.5-mL dose of Fluzone administered at least 1 month (4 weeks) apart.¹⁰⁴

Received a total of 2 or more doses of any seasonal influenza vaccine ≥4 weeks apart before July 1, 2024: Administer a single 0.25 mL or 0.5 mL dose of Fluzone.^{100 104}

Children 6 months through 8 Years of Age (Flucelvax)

IM

Did not receive a total of 2 or more doses of any seasonal influenza vaccine before July 1, 2024 or whose previous influenza vaccination history is unknown: Administer 2 doses of Flucelvax at least 1 month (4 weeks) apart.^{100 190} Each dose consists of 0.5 mL.^{100 190}

Received a total of 2 or more doses of any seasonal influenza vaccine ≥4 weeks apart before July 1, 2024: administer a single 0.5 mL dose of Flucelvax.^{100 190}

Children 3 through 8 Years of Age (Afluria, Fluarix, Flulaval, Fluzone)

IM

Did not receive a total of 2 or more doses of any seasonal influenza vaccine before July 1, 2024 or whose previous influenza vaccination history is unknown: Administer 2 doses of Afluria, Fluarix, Flulaval, or Fluzone at least 1 month (4 weeks) apart.^{100 104 106 107 108} Each dose consists of 0.5 mL. ^{104 106 107 108}

Received a total of 2 or more doses of any seasonal influenza vaccine ≥4 weeks apart before July 1, 2024: administer a single 0.5 mL dose of Afluria, Fluarix, Flulaval, or Fluzone.^{100 104 106 107 108}

Children and Adolescents 9 through 17 Years of Age (Afluria, Fluarix, Flucelvax, Flulaval, Fluzone)

IM

Single 0.5-mL dose.^{100 104 106 107 108 112 190}

Adults

Prevention of Seasonal Influenza A and B Virus Infections

Adults ≥18 Years of Age (Afluria, Fluarix, Flucelvax, Flulaval, Fluzone)

IM

Single 0.5-mL dose.^{100 104 106 107 108 190}

Adults ≥65 Years of Age (Fluad, Fluzone High-Dose)

IM

Single 0.5-mL dose.¹⁶⁰

Special Populations

Hepatic Impairment

No specific dosage recommendations.^{104 106 107 108 160 186 190}

Renal Impairment

No specific dosage recommendations.^{104 106 107 108 190}

Geriatric Patients

For dosing in geriatric patients, see dosage recommendations for adults based on age.^{104 106 107 108 160 186 190}

Cautions for Influenza Vaccine Inactivated

Contraindications

• History of severe hypersensitivity (e.g., anaphylaxis) to previous dose of any influenza vaccine.^{104 106 107 108 160 186}

• Egg-based influenza vaccine inactivated: History of severe hypersensitivity (e.g., anaphylaxis) to any component of the vaccine, including egg protein.^{104 106 107 108 112 160 186}

• Cell culture-based influenza vaccine inactivated: History of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine.^{100 190}

Warnings/Precautions

Hypersensitivity Reactions

Allergic or immediate hypersensitivity reactions (e.g., urticaria, angioedema, anaphylaxis, anaphylactic shock, serum sickness, allergic asthma) reported rarely.^{100 104 106 107 108}

Prior to administration, review patient’s history with respect to possible sensitivity reactions to the vaccine or vaccine components, including egg protein, and prior vaccination-related adverse effects and assess benefits versus risks.^{100 106 107 108 112}

Administer in a setting where appropriate medical treatment and supervision are available to manage possible anaphylactic reactions if they occur.^{100 104 106 107 108 112 134 160 186 190}

Most seasonal inactivated influenza vaccines (Afluria, Fluad, Fluarix, Flulaval, Fluzone) are produced using embryonated chicken eggs;^{100 104 106 107 108 112 160 186} these vaccines can contain residual egg protein (ovalbumin).^{106 107 186} Manufacturers of egg-based inactivated influenza vaccines state that these vaccines are contraindicated in individuals who have had a severe allergic reaction (e.g., anaphylaxis) to egg protein.^{104 106 107 108 160 186} ACIP states that all individuals ≥6 months of age with egg allergy should receive influenza vaccine with any influenza vaccine (egg-based or nonegg-based) that is otherwise appropriate for the recipient’s age and health status.¹⁰⁰ Egg allergy alone necessitates no additional safety measures for influenza vaccination beyond those recommended for any recipient of any vaccine, regardless of severity of previous reaction to egg.¹⁰⁰ All vaccines should be administered in settings in which personnel and equipment needed for rapid recognition and treatment of acute hypersensitivity reactions are available.¹⁰⁰ Although egg allergy is neither a contraindication nor precaution to the use of any influenza vaccine, there are contraindications and precautions related to allergies to vaccine components, including egg protein, or following a previous administration of any influenza vaccines.^{100 104 106 107 108}

Some preparations of influenza vaccine inactivated (e.g., Afluria, Fluad) contain trace amounts of neomycin, although allergies to neomycin are rare.^{108 186 134} Neomycin hypersensitivity usually manifests as a delayed-type (cell-mediated) contact dermatitis.¹³⁴ ACIP states that a history of delayed-type allergic reaction to neomycin is not a contraindication to the use of vaccines containing trace amounts of neomycin; however, it is recommended that individuals with a history of anaphylactic reaction to neomycin be evaluated by an allergist prior to receiving a neomycin-containing vaccine.¹³⁴

Some multi-dose vials of influenza vaccine inactivated (Afluria, Flucelvax, Fluzone) contain trace amounts of thimerosal, a mercury derivative, as a preservative.^{104 108 134 190} Hypersensitivity reactions to thimerosal contained in vaccines have been reported in some individuals.^{140 498 500} ACIP states that a history of local or delayed-type hypersensitivity to thimerosal is not a contraindication to use of vaccines that contain thimerosal.¹³⁴

Guillain-Barré Syndrome (GBS)

If GBS occurred within 6 weeks after previous influenza vaccination, manufacturers state base decision to administer influenza vaccine on careful consideration of potential benefits and risks.^{104 106 107 108 160 186 190}

The 1976 swine influenza vaccine was associated with increased frequency of GBS.^{104 106 107 108 160 186 190} Evidence for causal relationship between other influenza vaccines and GBS is inconclusive;^{104 106 107 108 160 190} if an excess risk exists, it is probably slightly more than 1 additional case of GBS per 1 million vaccinees.^{104 106 107 108 160 186 190}

ACIP states that a history of GBS within 6 weeks after receipt of any influenza vaccine is a precaution to the use of all influenza vaccines.¹⁰⁰

Individuals with Altered Immunocompetence

Consider possibility that immune response may be reduced in immunosuppressed individuals.^{100 160 186 190}

ACIP states that all non-live vaccines can be administered safely to individuals with altered immunocompetence.¹³⁴

Individuals with Bleeding Disorders

Advise individuals and/or their family about the risk of hematoma from IM injections.¹³⁴

ACIP states that IM administered vaccines may be given to such individuals if a clinician familiar with the patient’s bleeding risk determines that the preparation can be administered with reasonable safety.¹³⁴ In these cases, use a fine needle (23 gauge or smaller) to administer the vaccine and apply firm pressure to the injection site (without rubbing) for ≥2 minutes.¹³⁴

In individuals receiving therapy for hemophilia, IM vaccines can be scheduled for administration shortly after a dose of such therapy.¹³⁴

Concomitant Illness

The decision to administer or delay vaccination in an individual with a current or recent acute illness should be based on severity of symptoms and etiology of the illness.¹³⁴

ACIP states mild acute illness does not preclude vaccination.¹³⁴

Moderate or severe acute illness (with or without fever) is a precaution for vaccination; defer vaccination until individual has recovered from the acute phase of the illness.¹³⁴ This avoids superimposing vaccine adverse effects on the underlying illness or mistakenly concluding that a manifestation of the underlying illness resulted from vaccine administration.¹³⁴

Limitations of Vaccine Effectiveness

May not protect all vaccine recipients against influenza.^{104 106 107 108 160 186 190}

Seasonal influenza vaccines are formulated annually to contain influenza A and B antigens predicted to represent strains of influenza virus likely to circulate in the US during the upcoming influenza season.¹⁰⁰ Efficacy of seasonal influenza vaccine during any given year depends on how closely viral strains represented in the vaccine match viral strains circulating during the season.¹⁰⁰

Syncope

Syncope reported; implement procedures to avoid injury from fainting.^{104 106 107 108 160 186 190}

Specific Populations

Pregnancy

Data from some quadrivalent influenza vaccines inactivated (Afluria, Fluarix, Flucelvax) found no evidence of a vaccine-associated increase in risk of major birth defects and miscarriages when administered during any trimester of pregnancy.^{106 107 108 190} Data insufficient to assess risk if used during pregnancy for other vaccine preparations (Fluzone, Fluad, Flulaval).^{106 104 107 160 186}

Animal reproduction studies have not revealed evidence of harm to fetus.^{104 106 107 108 186 190}

Pregnant and postpartum women are at higher risk for severe influenza and influenza-related complications, particularly during the second and third trimesters, which may lead to adverse pregnancy outcomes including preterm labor and delivery.^{100 104 106 107 190}

To monitor pregnancy outcomes and newborn health status following influenza vaccination of pregnant women, some manufacturers have established pregnancy registries.^{104 106 107 190}

Lactation

Not known whether influenza vaccine inactivated distributed into human milk.^{104 106 107 108 190} Data insufficient to assess effects on the breast-fed infant or on milk production.^{104 106 107 108 186 190}

Consider benefits of breast-feeding and importance of the vaccine to the woman; also consider potential adverse effects on the breast-fed child from the vaccine or underlying maternal condition (i.e., susceptibility to influenza infection).^{104 106 107 108 190}

ACIP states that breast-feeding is not a contraindication to influenza vaccine inactivated and that the vaccines do not pose any unusual risks for the mother or her nursing infant. ¹³⁴

Pediatric Use

Afluria, Fluarix, Flulaval, Fluzone, Flucelvax: Safety and efficacy not established in infants <6 months of age.^{104 106 107 108}

Fluad adjuvant-containing: Safety and efficacy not established in pediatric patients.¹⁸⁶

Fluzone High-Dose: Safety and efficacy not established in pediatric patients.¹⁶⁰

Because seasonal influenza vaccine inactivated is not indicated in infants <6 months of age, all household and other close contacts (e.g., day-care providers) of infants <6 months of age should be vaccinated against seasonal influenza using vaccine appropriate for their age and target group since this may provide some protection for these young infants.¹⁰⁰

Geriatric Use

Afluria, Fluarix, Flucelvax, Flulaval, Fluzone: No overall differences in safety relative to younger adults;^{104 106 107 190} may be less immunogenic in geriatric individuals.^{100 108 190}

Fluad adjuvant-containing: Use only in adults ≥65 years of age.^{100 186} Safety profile of this standard-dose, adjuvant-containing vaccine similar to that of standard-dose, non-adjuvant-containing vaccine.¹⁰⁰ Although some local and systemic adverse events reported more frequently with the adjuvant-containing vaccine, most adverse reactions have been mild in severity.¹⁰⁰

Fluzone High-Dose: Use in adults ≥65 years of age.^{100 160} Each 0.5 mL of Fluzone High-Dose contains 4 times the amount of antigen contained in standard-dose Fluzone.^{100 160} In adults ≥65 years of age, higher incidence of injection site reactions and systemic adverse effects reported with trivalent Fluzone High-Dose compared with standard-dose Fluzone.¹⁰⁰ Some evidence that the high-dose formulation elicits higher antibody titers and higher seroconversion rates than the standard-dose formulation in adults ≥65 years of age and may be more effective in preventing laboratory-confirmed influenza in this age group.¹⁰⁰

ACIP states that all adults ≥65 years of age should be vaccinated against influenza using influenza virus vaccine inactivated or influenza vaccine recombinant.¹⁰⁰ ACIP states a preference for Fluzone High-Dose, Flublok recombinant influenza vaccine , or the standard-dose adjuvant-containing vaccine (Fluad), but if none of these 3 vaccines are available at the time of vaccine administration, then they state that adults ≥65 years may receive a standard-dose preparation.¹⁰⁰

Common Adverse Effects

Individual Vaccine Preparations

Fluzone

In children 6 months through 8 years of age, the most common injection-site adverse reactions were pain or tenderness (>50%) and redness (>25%); the most common solicited systemic adverse reactions were irritability and drowsiness (>25% of children 6 months through 35 months) and myalgia (>20% of children 3 years through 8 years).¹⁰⁴

In adults 18 through 64 years of age, the most common injection-site adverse reaction was pain (>50%); the most common solicited systemic adverse reactions were headache and myalgia (>30%).¹⁰⁴

In adults ≥65 years of age, the most common injection-site adverse reaction was pain (>20%); the most common solicited systemic adverse reactions were headache, myalgia, and malaise (>10%).¹⁰⁴

Fluarix

In adults, the most common (≥10%) solicited local adverse reactions were pain and redness; the most common systemic adverse reactions were muscle aches, fatigue, and headache.¹⁰⁶

In children 5 through 17 years of age, the most common (≥10%) solicited local adverse reactions were pain, redness, and swelling; the most common systemic adverse reactions were muscle aches, fatigue, and headache.¹⁰⁶

In children 3 through 4 years of age, the most common (≥10%) solicited local adverse reactions were pain, redness, and swelling; the most common systemic adverse reactions were irritability, loss of appetite (13%), and drowsiness.¹⁰⁶

In children 6 through 35 months of age who received Fluarix Quadrivalent, the most common (≥10%) solicited local adverse reactions were pain and redness; the most common systemic adverse reactions were irritability, loss of appetite, and drowsiness.¹⁰⁶

Flulaval

In adults, the most common (≥10%) solicited local adverse reactions were pain, redness, and swelling; the most common solicited systemic adverse reactions were fatigue, headache, and muscle aches/arthralgia.¹⁰⁷

In children 3 through 17 years of age, the most common (≥10%) solicited local adverse reaction was pain.¹⁰⁷

In children 3 through 4 years of age, the most common (≥10%) solicited systemic adverse reactions were irritability, drowsiness, and loss of appetite.¹⁰⁷

In children 5 through 17 years of age, the most common (≥10%) solicited systemic adverse reactions were muscle aches, headache, and fatigue.¹⁰⁷

In children 6 through 35 months of age who received Flulaval QUADRIVALENT, the most common (≥10%) solicited local adverse reaction was pain; most common solicited systemic adverse reactions were irritability, drowsiness, and loss of appetite.¹⁰⁷

Afluria

In adults 18 through 64 years, the most commonly reported injection-site adverse reaction was pain (≥40%). The most common systemic adverse reactions were myalgia and headache (≥20%).¹⁰⁸

In adults 65 years of age and older, the most commonly reported injection-site adverse reaction was pain (≥20%).¹⁰⁸ The most common systemic adverse reaction was myalgia (≥10%).¹⁰⁸

In children 6 through 35 months of age, the most commonly reported injection-site reactions were pain and redness (≥20%).¹⁰⁸ The most common systemic adverse reactions were irritability (≥30%), diarrhea, and loss of appetite (≥20%).¹⁰⁸

In children 36 through 59 months of age, the most commonly reported injection site reactions were pain (≥30%) and redness (≥20%).¹⁰⁸ The most commonly reported systemic adverse reactions were malaise, fatigue, and diarrhea (≥10%).¹⁰⁸

In children 5 through 8 years of age, the most commonly reported injection-site adverse reactions were pain (≥50%), redness, and swelling (≥10%).¹⁰⁸ The most common systemic adverse reaction was headache (≥10%).¹⁰⁸

In children 9 through 17 years, the most commonly reported injection-site adverse reactions were pain (≥50%), redness, and swelling (≥10%).¹⁰⁸ The most common systemic adverse reactions were headache, myalgia, malaise, and fatigue (≥10%).¹⁰⁸

In adults 18 through 64 years of age receiving the PharmaJet Stratis needle-free injection system, the most commonly reported injection-site adverse reactions were tenderness (≥80%), swelling, pain, redness (≥60%), itching (≥20%), and bruising (≥10%).¹⁰⁸ The most common systemic adverse reactions were myalgia, malaise (≥30%), and headache (≥20%).¹⁰⁸

Fluzone High-Dose

In adults ≥65 years of age, the most common (>10%) injection-site adverse reaction was pain; the most common solicited systemic adverse reactions were myalgia, malaise, and headache.¹⁶⁰

Fluad

The most common (≥10%) local and systemic adverse reactions in adults ≥65 years of age were injection site pain, injection site tenderness, myalgia, fatigue, and headache.¹⁸⁶

Flucelvax

In children 6 months through 3 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were tenderness (28%), erythema (26%), induration (17%), and ecchymosis (11%).¹⁹⁰ The most common systemic adverse reactions were irritability (28%), sleepiness (27%), diarrhea (18%), and change of eating habits (17%).¹⁹⁰

In children 4 through 8 years of age, the most commonly reported local injection-site adverse reactions were pain (29%) and erythema (11%). The most common systemic adverse reaction was fatigue (10%).¹⁹⁰

In children and adolescents 9 through 17 years of age, the most commonly reported injection-site adverse reactions were pain (34%) and erythema (14%).¹⁹⁰ The most common systemic adverse reactions were myalgia (15%) and headache (14%).¹⁹⁰

In adults 18 through 64 years of age, the most commonly reported injection-site adverse reactions were pain (28%) and erythema (13%).¹⁹⁰ The most common systemic adverse reactions were headache (16%), fatigue (12%), myalgia (11%), and malaise (10%).¹⁹⁰

In adults ≥65 years of age, the most commonly reported injection-site reaction was erythema (10%).¹⁹⁰ The most common systemic adverse reactions were fatigue (11%), headache (10%), and malaise (10%).¹⁹⁰

Drug Interactions

Immunosuppressive Agents

Immune responses to vaccines, including influenza vaccine inactivated, may be reduced in individuals receiving immunosuppressive agents.^{104 105 106 107 108 134 160 190}

Generally, give inactivated vaccines ≥2 weeks prior to initiation of immunosuppressive therapy and, because of possible suboptimal response, do not give during and for certain periods of time after immunosuppressive therapy discontinued.^{105 134}

Time to restoration of immune competence varies depending on type and intensity of immunosuppressive therapy, underlying disease, and other factors; optimal timing for vaccine administration after discontinuance of immunosuppressive therapy not identified for every situation.¹⁰⁵

Vaccines

Concurrent administration with other age-appropriate vaccines, including live virus vaccines, toxoids, or inactivated or recombinant vaccines, during same health-care visit not expected to affect immunologic responses or adverse reactions to any of the preparations.^{100 105 134} However, vaccines administered at the same times as influenza vaccines that are more likely to be associated with local injection site reactions (e.g., HD-IIV, aIIV) should be administered in different limbs, if possible.¹⁰⁰

Immunization with influenza vaccine inactivated can be integrated with immunization against diphtheria, tetanus, pertussis, Haemophilus influenzae type b (Hib), hepatitis A, hepatitis B, human papillomavirus (HPV), measles, mumps, rubella, meningococcal disease, pneumococcal disease, poliomyelitis, rotavirus, and varicella.^{100 105 134} However, administer each parenteral vaccine using separate syringes and different injection sites.¹³⁴

Specific Drugs

Stability

Storage

Parenteral

Injectable Suspension, for IM Use

2–8°C; do not freeze.^{104 106 107 108 160 186 190} If freezing occurs, discard vaccine.^{104 106 107 108 160 186}

Return multiple-dose vials to 2–8ºC between uses.^{104 108} Manufacturer of Afluria states discard any vaccine remaining in multiple-dose vial after a total of 20 doses has been removed from the vial and discard multiple-dose vial if not used within 28 days after vial first entered.¹⁰⁸

Protect from light.^{106 108 186 190}

Single-dose syringes are preservative-free.^{104 106 107 108 160 186 190} Multiple-dose vials contain thimerosal as a preservative.^{104 108 190}

Actions

• Inactivated influenza vaccines are noninfectious, sterile suspensions of suitably inactivated influenza virus types A and B subunits.^{104 106 107 108 190}

• Seasonal influenza vaccines are formulated annually to contain antigens representative of the strains of influenza A (H1N1), influenza A (H3N2), and influenza B viruses likely to circulate in the US during the upcoming influenza season.^{100 578}

• All inactivated influenza vaccines (egg- or cell culture-based) available in the US are trivalent vaccines containing 2 influenza type A antigens (H1N1 and H3N2) and an influenza type B antigens (B/Victoria lineages).^{100 104 106 107}

• Influenza vaccines stimulate active immunity to influenza virus strains represented in the vaccines.¹⁰⁰

• Efficacy of influenza vaccines in preventing seasonal influenza virus infection depends on whether the virus strains represented in the vaccines are antigenically similar to influenza virus strains circulating during the influenza season.¹⁰⁰

Advice to Patients

• Prior to administration of seasonal influenza vaccine inactivated, provide a copy of the appropriate CDC Vaccine Information Statement (VIS) to the patient or patient’s legal representative.^{20 104 106 107 108 160 190}

• Advise patient and/or patient’s parent or guardian of the risks and benefits of vaccine administration.^{104 106 107 108 160 190}

• Advise patients that influenza vaccine inactivated contains noninfectious killed viruses and cannot cause influenza.^{100 104 106 107 108 160 190}

• Advise patients that influenza vaccine inactivated provides protection against illness due to influenza viruses represented in the vaccine and cannot provide protection against all respiratory illness.^{104 106 107 108 160 190}

• Advise patient and/or patient’s parent or guardian that annual vaccination against seasonal influenza is necessary.^{104 106 107 108 160 190}

• Stress importance of receiving influenza vaccine for the upcoming (current) influenza season, even if the individual received influenza vaccine for the previous influenza season.^{100 112}

• Advise patient and/or patient’s parent or guardian that a single dose of seasonal influenza vaccine is necessary each year in adults, adolescents, and children ≥9 years of age, but that 2 doses of seasonal influenza vaccine may be necessary in some infants and children 6 months through 8 years of age.^{100 112}

• Stress importance of informing clinicians of severe or unusual adverse effects.^{104 106 107 160 190} Clinicians or individuals can report any adverse reactions that occur following vaccination to the Vaccine Adverse Event Reporting System (VAERS) at 800-822-7967 or [Web].^{104 106 107 160 190}

• Stress importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses (e.g., GBS).^{104 106 107 160 190}

• Stress importance of patients informing clinician if they are or plan to become pregnant or plan to breast-feed.^{104 106 107 160 190}

• Inform patients of other important precautionary information.^{104 106 107 160 190}

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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