Meningococcal Groups A, C, Y, and W-135 Vaccine (Monograph)

Brand names: Menactra, MenQuadfi, Menveo
Drug class: Vaccines
ATC class: J07AH01
VA class: IM100

Medically reviewed by Drugs.com on Dec 5, 2023. Written by ASHP.

Introduction

Inactivated (polysaccharide) vaccine.^{108 152 228} Commercially available in US as 3 different quadrivalent conjugated (MenACWY) vaccines: meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine (MenACWY-D; Menactra),¹⁰⁸ meningococcal (groups A, C, Y and W-135) oligosaccharide diphtheria CRM₁₉₇ conjugate vaccine (MenACWY-CRM; Menveo),¹⁵² and meningococcal (groups A, C, Y and W-135) polysaccharide tetanus toxoid conjugate vaccine (MenACWY-TT; MenQuadfi).¹ Each contains A, C, Y, and W-135 capsular polysaccharide antigens extracted from Neisseria meningitidis linked to a carrier protein.^{1 108 152 228}

Uses for Meningococcal Groups A, C, Y, and W-135 Vaccine

Prevention of Meningococcal Infection

Prevention of meningococcal infection caused by N. meningitidis serogroups A, C, Y, and W-135 in adults, adolescents, children, and infants ≥2 months of age.^{1 105 108 152 199 200 228}

N. meningitidis can cause invasive meningococcal disease that usually presents as severe and potentially life-threatening meningitis and/or meningococcemia with abrupt onset;^{105 166 228} transmitted person to person by the respiratory route.^{105 166 228} In the US, N. meningitidis serogroups B, C, and Y cause most cases of meningococcal disease and serogroup W-135 causes a small percentage of cases;^{105 166 228 237} approximately 60% of cases in individuals ≥24 years of age are caused by serogroups C, Y, or W-135.²³⁷ Although overall incidence of meningococcal disease in the US has been historically low during the last 10–15 years (about 329 cases reported to CDC during 2018),^{105 166 228 166} overall case fatality rate has remained 10–15% (even with appropriate anti-infective treatment)^{105 166 228 237} and fatality rate can be higher in those with meningococcemia.¹⁶⁶ In addition, long-term sequelae (e.g., hearing loss, neurologic disability, digit or limb amputations) reported in up to 20% of patients.^{105 166 228 237} While 95% of US cases of meningococcal disease are sporadic, localized outbreaks do occur and most outbreaks have been caused by serogroups B and C.^{166 228}

CDC's Advisory Committee on Immunization Practices (ACIP), AAP, and others recommend routine vaccination against meningococcal serogroups A, C, Y, and W-135 infection using MenACWY vaccine in all adolescents, preferably at 11 through 12 years of age, followed by a booster dose at 16 years of age.^{105 199 228} Catch-up vaccination recommended at 13 through 18 years of age for those not previously vaccinated;^{105 199 228} catch-up vaccination also recommended for all first-year college students living in residence halls who did not receive a dose of MenACWY vaccine on or after their 16th birthday.^{200 228}

ACIP, AAP, and others also recommend routine primary and booster vaccination against meningococcal serogroups A, C, Y, and W-135 infection using age-appropriate MenACWY vaccine in selected infants, children, adolescents, and adults at increased risk because of certain chronic medical conditions or treatment (e.g., persistent complement component deficiencies, treatment with a complement inhibitor, anatomic or functional asplenia, HIV infection) or because they will be traveling to or residing in areas with hyperendemic or epidemic meningococcal disease caused by serogroups represented in the vaccine.^{105 156 199 200 228} Also recommended in some other individuals at increased risk (e.g., certain laboratory personnel, military recruits).^{200 228 235}

MenACWY vaccine may be used as an adjunct to anti-infective prophylaxis in household and other close contacts of individuals with invasive meningococcal disease when clusters or outbreaks are occurring and are caused by meningococcal serogroups represented in the vaccine (i.e., A, C, Y, W-135).^{105 199 228 235}

MenACWY vaccine provides protection only against N. meningitidis serogroups represented in the vaccine (i.e., serogroups A, C, Y, W-135);^{105 108 152 166 228} will not prevent meningococcal infection caused by other serogroups (e.g., serogroup B) and will not prevent infections caused by other pathogens.^{105 108 152 166 228}

ACIP and AAP do not state a preference for MenACWY-D, MenACWY-CRM, or MenACWY-TT; any age-appropriate vaccine can be used for primary immunization and/or revaccination or booster doses.^{134 199 200 228} Consider that dosage schedules (i.e., number and timing of doses for primary immunization) differ depending on which vaccine used.^{108 152 199 228} (See Dosage under Dosage and Administration.)

Preexposure Vaccination Against Meningococcal Infection in High-risk Groups

Infants 2 through 23 months of age with certain chronic medical conditions or treatment (e.g., persistent complement component deficiencies, treatment with a complement inhibitor, anatomic or functional asplenia, HIV infection) and those who will be traveling to or residing in areas where meningococcal infection is hyperendemic or epidemic are at increased risk for meningococcal infection and should receive routine primary and booster immunization against meningococcal serogroups A, C, Y, and W-135 infection using age-appropriate MenACWY vaccine.^{156 199 228} Routine vaccination against meningococcal serogroups A, C, Y, and W-135 infection not recommended in infants not at increased risk.^{105 228}

Children 2 through 10 years of age with certain chronic medical conditions or treatment (e.g., persistent complement component deficiencies, treatment with a complement inhibitor, anatomic or functional asplenia, HIV infection) and those who will be traveling to or residing in areas where meningococcal infection is hyperendemic or epidemic are at increased risk for meningococcal infection and should receive routine primary and booster immunization against meningococcal serogroups A, C, Y, and W-135 infection using MenACWY vaccine.^{105 156 199 228} Routine vaccination against meningococcal serogroups A, C, Y, and W-135 infection not recommended in children 2 through 10 years of age not at increased risk.^{105 228}

Adolescents 11 through 18 years of age are at increased risk for meningococcal infection and should receive routine primary immunization against meningococcal serogroups A, C, Y, and W-135 disease using MenACWY vaccine.^{105 199 228} ACIP, AAP, and others recommend a dose of MenACWY vaccine in all young adolescents at 11 through 12 years of age, followed by a booster dose at 16 years of age.^{105 199 228} Catch-up vaccination recommended at first opportunity for all older adolescents 13 through 18 years of age not vaccinated at 11 through 12 years of age.^{105 199 228} If first dose of MenACWY vaccine given at 13 through 15 years of age, a booster dose is recommended at 16 through 18 years of age;^{199 228} booster dose not needed if first dose given at ≥16 years of age.^{199 228}

College freshmen living in residence halls are at increased risk for meningococcal infection and should receive at least 1 dose of MenACWY vaccine within 5 years before college entry.²²⁸ Preferred timing is on or after their 16th birthday; if a dose was given prior to the 16th birthday, a booster dose should be given before enrollment.^{228 228}

Individuals with persistent complement component deficiencies (e.g., inherited or chronic deficiencies in C3, C5–C9, properdin, factor D, factor H) or anatomic or functional asplenia (e.g., sickle cell disease) and those receiving a complement inhibitor (e.g., eculizumab, ravulizumab) are at increased risk for invasive meningococcal disease,^{53 67 85 105 228 236} and ACIP, AAP, and others recommend routine age-appropriate primary and booster immunization against meningococcal serogroups A, C, Y, and W-135 infection using age-appropriate MenACWY vaccine.^{105 135 199 200 228} If not previously vaccinated, individuals undergoing elective splenectomy should receive MenACWY vaccine ≥14 days before surgery whenever possible.¹³⁴

HIV-infected individuals are at increased risk for invasive meningococcal disease,^{156 166 228} and ACIP, AAP, and others recommend routine primary and booster immunization against meningococcal serogroups A, C, Y, and W-135 infection using age-appropriate MenACWY vaccine in all HIV-infected adults, adolescents, children, and infants ≥2 months of age.^{135 156 199 200} Consider that vaccines may be less immunogenic in immunocompromised individuals.^{108 134 152 228}

Military recruits are at increased risk for meningococcal disease²²⁸ and should receive MenACWY vaccine.^{200 228}

Travelers to and residents of areas where N. meningitidis is hyperendemic or epidemic are at risk for exposure to meningococcal disease and should be vaccinated against meningococcal serogroups A, C, Y, and W-135 infection.^{105 115 228} Although reported worldwide, highest incidence of meningococcal disease occurs in sub-Saharan Africa in area known as the “meningitis belt”;^{43 44 45 115 228} meningococcal disease is hyperendemic in this region with epidemics occurring periodically during dry season (December through June).¹¹⁵ Historically, serogroup A was the predominant cause of meningococcal disease outbreaks in the meningitis belt; endemic disease and outbreaks are now most commonly caused by serogroups C, W, and X.^{115 228} ACIP, AAP, CDC, and others recommend age-appropriate primary immunization against meningococcal serogroups A, C, Y, and W-135 disease for individuals ≥2 months of age who will be traveling to or residing in hyperendemic or epidemic areas, including the meningitis belt during dry season, especially if prolonged contact with local populations is expected.^{115 199 200 228} In those previously vaccinated, booster dose of MenACWY vaccine recommended if it has been ≥5 years since last dose of meningococcal vaccine.²²⁸ Officials in Saudi Arabia require that individuals traveling to their country for annual Hajj and Umrah pilgrimages must have documentation indicating vaccination against meningococcal serogroups A, C, Y, and W-135 administered ≥10 days and ≤3 years (unconjugated polysaccharide vaccine) or ≤5 years (conjugated polysaccharide vaccine) prior to arrival in Saudi Arabia.¹¹⁵ Consult international health clinics for travelers, state health departments, CDC at 877-394-8747, or CDC Travelers’ Health website ([Web]) for most recent information concerning geographic areas for which vaccination against meningococcal disease is recommended.^{115 228}

Household and other close contacts of individuals with invasive meningococcal disease are at increased risk for meningococcal infection.^{14 62 79 105 228} Whenever a case of invasive meningococcal disease occurs, anti-infective prophylaxis (i.e., 2-day regimen of oral rifampin or single dose of IM ceftriaxone, oral ciprofloxacin, or oral azithromycin) is indicated for close contacts of index case (e.g., household contacts, day-care center contacts, individuals exposed to index case’s oropharyngeal secretions)^{79 105 228} and is principal means of preventing secondary cases.^{79 90 228} In some situations, MenACWY vaccine may be recommended as an adjunct to anti-infective prophylaxis.^{49 62 66 90 105 228}

Outbreak Control

Whenever sporadic or cluster cases or outbreaks of meningococcal disease occur in US, anti-infective prophylaxis (i.e., 2-day regimen of oral rifampin or single dose of IM ceftriaxone, oral ciprofloxacin, or oral azithromycin) is the principal means of preventing secondary cases in household and other close contacts.^{105 166 228}

MenACWY vaccine does not stimulate immunity to meningococcal infection caused by serogroup B and is not indicated for meningococcal serogroup B outbreaks.^{1 108 152 166 228}

Meningococcal Groups A, C, Y, and W-135 Vaccine Dosage and Administration

Administration

MenACWY vaccine (MenACWY-D, MenACWY-CRM, MenACWY-TT): Administer IM.^{1 108 152} Do not administer sub-Q, IV, or intradermally.^{108 152}

Syncope (vasovagal or vasodepressor reaction; fainting) may occur following vaccination.^{1 134 152} Occurs most frequently in adolescents and young adults.¹³⁴ Have procedures in place to avoid falling injury and restore cerebral perfusion following syncope.¹³⁴ Syncope and secondary injuries may be averted if vaccinees sit or lie down during and for 15 minutes after vaccination.¹³⁴ If syncope occurs, observe patient until symptoms resolve.¹³⁴

Usually can be given concurrently with other age-appropriate vaccines;^{105 134 228} however, do not give MenACWY-D concurrently with pneumococcal 13-valent conjugate vaccine (PCV13) in individuals with anatomic or functional asplenia.^{134 228} (See Specific Drugs under Interactions.)

When multiple vaccines are administered during a single health-care visit, give each parenteral vaccine using separate syringes and different injection sites.^{134 228} Separate injection sites by ≥1 inch (if anatomically feasible) to allow appropriate attribution of any local adverse effects that may occur.¹³⁴

IM Administration

Depending on patient age, administer IM into deltoid muscle or anterolateral thigh.¹³⁴

Infants <12 months of age: Preferably give IM injection into anterolateral thigh.¹³⁴ 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 anatomical landmarks prior to injection.¹³⁴

Infants and children 1 through 2 years of age: Preferably give IM injection into anterolateral thigh;¹³⁴ alternatively, deltoid muscle can be used if muscle mass is adequate.¹³⁴

Adults, adolescents, and children ≥3 years of age: Preferably give IM injection into deltoid muscle;^{134 152} alternatively, anterolateral thigh can be used.¹³⁴

To ensure delivery into muscle, make IM injections at a 90° angle to the skin using a needle length appropriate for the individual’s age and body mass, thickness of adipose tissue and muscle at injection site, and injection technique.^{134 149 150} Consider anatomic variability, especially in the deltoid;^{149 150} use clinical judgment to avoid inadvertent underpenetration or overpenetration of muscle.^{149 150}

MenACWY-D (Menactra)

Administer by IM injection.¹⁰⁸

Do not dilute.¹⁰⁸

Shake well prior to use.¹⁰⁸ Should appear as a clear to slightly turbid liquid;¹⁰⁸ discard if it contains particulate matter, appears discolored, or cannot be resuspended with thorough agitation.¹⁰⁸

Does not contain thimerosal or any other preservative.¹⁰⁸

Do not mix with any other vaccine.¹⁰⁸

MenACWY-CRM (Menveo)

Administer by IM injection.¹⁵²

Supplied by manufacturer as 2 components that must be combined prior to administration: single-dose vial containing meningococcal A conjugate component (MenA) in lyophilized form and single-dose vial containing liquid meningococcal C, Y, and W-135 conjugate component (MenCYW-135).¹⁵²

Withdraw entire contents of vial containing liquid component into a syringe and inject into vial containing lyophilized component.¹⁵² Invert vial;¹⁵² shake well until completely dissolved.¹⁵²

Reconstituted vaccine should be a clear, colorless solution;¹⁵² do not use if it contains particulate matter or appears discolored.¹⁵²

Does not contain thimerosal or any other preservative.¹⁵²

Use immediately after reconstitution;¹⁵² may be stored at 2–25°C for up to 8 hours.¹⁵² Prior to administration, shake vial of reconstituted vaccine well.¹⁵² (See Storage under Stability.)

Do not mix individual components or reconstituted vaccine with any other vaccine or diluent.¹⁵²

MenACWY-TT (MenQuadfi)

Administer by IM injection.¹

Do not dilute.¹

Should appear as a clear, colorless solution;¹ do not use if it contains particulate matter or appears discolored.¹

Does not contain thimerosal or any other preservative.¹

Dosage

Dosage schedule (i.e., number and timing of doses for primary immunization) and specific vaccine administered (MenACWY-D, MenACWY-CRM, MenACWY-TT) depend on individual’s age, immunization status, and risk factors.^{1 108 152 228} Follow age-appropriate recommendations for specific preparation used.^{1 108 152 228}

ACIP states that MenACWY-D, MenACWY-CRM, and MenACWY-TT can be used interchangeably.²²⁸ ACIP also states that if the MenACWY vaccine used previously is not available or not known, any age-appropriate MenACWY vaccine can be used for subsequent doses.¹³⁴

If interruptions or delays result in an interval between vaccine doses longer than recommended, ACIP states additional doses or starting vaccination series over not necessary.¹³⁴

Pediatric Patients

Preexposure Vaccination Against Meningococcal Serogroups A, C, Y, and W-135 in High-risk Groups

Infants 2 through 23 Months of Age (MenACWY-CRM; Menveo)

IM

Each dose is 0.5 mL.¹⁵²

Primary immunization in those at increased risk because of certain chronic medical conditions or treatment (see Uses) or travel to areas with hyperendemic or epidemic meningococcal disease: Series of 4 doses.^{152 199} Give doses at 2, 4, 6, and 12 months of age.^{152 199}

Primary immunization in previously unvaccinated infants 7 through 23 months of age at increased risk because of certain chronic medical conditions or treatment (see Uses) or travel to areas with hyperendemic or epidemic meningococcal disease: 2-dose regimen.^{152 199} Give second dose after first birthday and ≥3 months (12 weeks) after first dose.^{152 199}

Booster doses in those who remain at prolonged increased risk for meningococcal disease: ACIP and AAP recommend a booster dose of MenACWY vaccine at 3 years after completion of primary immunization series and every 5 years thereafter.^{105 228}

Infants 9 through 23 Months of Age (MenACWY-D; Menactra)

IM

Each dose is 0.5 mL.¹⁰⁸

Primary immunization in those at increased risk because of certain chronic medical conditions or treatment (see Uses) or travel to areas with hyperendemic or epidemic meningococcal disease: Give 2 doses 3 months apart (minimum 8 weeks apart).^{105 108 199 228} If necessary (e.g., before travel), doses can be given 2 months apart.^{105 199}

Booster doses in those who remain at prolonged increased risk for meningococcal disease: ACIP and AAP recommend a booster dose of MenACWY vaccine at 3 years after completion of primary immunization series and every 5 years thereafter.^{105 228}

Children 2 through 10 Years of Age (MenACWY-D; Menactra, MenACWY-CRM; Menveo, MenACWY-TT; MenQuadfi)

IM

Each dose is 0.5 mL.^{1 108 152}

Primary immunization in those at increased risk because of certain chronic medical conditions or treatment (see Uses): ACIP, AAP, and others recommend 2 doses of MenACWY vaccine given 2 months apart (minimum 8 weeks apart).^{105 199 228}

Primary immunization in those at increased risk because they are travelers to or residents of areas with hyperendemic or epidemic meningococcal disease: ACIP and AAP recommend a single dose of MenACWY vaccine.^{105 228}

Booster doses in those who received primary immunization at 2 through 6 years of age and remain at prolonged increased risk for meningococcal disease: ACIP and AAP recommend a booster dose of MenACWY vaccine at 3 years after completion of primary immunization series and every 5 years thereafter.^{105 228}

Booster doses in those who received primary immunization at ≥7 years of age and remain at prolonged increased risk for meningococcal disease: ACIP and AAP recommend a booster dose of MenACWY vaccine at 5 years after completion of primary immunization series and every 5 years thereafter.^{105 228}

MenACWY-D and MenACWY-TT: Manufacturers state a single dose can be used for primary immunization.^{108 1}

MenACWY-CRM: Manufacturer states a single dose can be used for primary immunization and those 2–5 years of age at continued high risk can receive a second dose 2 months after first dose.¹⁵²

Adolescents 11 through 18 Years of Age (MenACWY-D; Menactra, MenACWY-CRM; Menveo, MenACWY-TT; MenQuadfi)

IM

Each dose is 0.5 mL.^{1 108 152}

Routine primary immunization in adolescents: ACIP, AAP, and others recommend a primary dose of MenACWY vaccine at 11 through 12 years of age, followed by a booster dose at 16 years of age.^{105 199 228}

Catch-up vaccination recommended at first opportunity for all adolescents 13 through 18 years of age not vaccinated at 11 through 12 years of age.^{105 199 228} If first dose of MenACWY vaccine given at 13 through 15 years of age, give a booster dose at 16 through 18 years of age (≥8 weeks after first dose);^{199 228} booster dose not needed if first dose given at ≥16 years of age.^{199 228}

Primary immunization in adolescents 11 through 18 years of age at increased risk because of certain chronic medical conditions or treatment (see Uses): ACIP, AAP, and others recommend 2 doses of MenACWY vaccine given 2–3 months apart (minimum 8 weeks apart).^{105 199 228} Manufacturers state a single dose can be used for primary immunization.^{108 1 152}

Booster doses in those who remain at prolonged increased risk for meningococcal disease: ACIP and AAP recommend a booster dose of MenACWY vaccine every 5 years.^{166 200 228} Manufacturers state a booster dose can be given if it has been at least 4 years since the prior dose.^{1 108 152}

Adults

Preexposure Vaccination Against Meningococcal Serogroups A, C, Y, and W-135 in High-risk Groups

Adults 19 through 55 Years of Age (MenACWY-D; Menactra, MenACWY-CRM; Menveo, MenACWY-TT; MenQuadfi)

IM

Each dose is 0.5 mL.^{1 108 152}

Primary immunization in those at increased risk because of certain chronic medical conditions or treatment (see Uses): ACIP and others recommend 2 doses of MenACWY vaccine given 2–3 months apart (minimum 8 weeks apart).^{200 228} Manufacturers state a single dose can be used for primary immunization.^{1 108 152}

Primary immunization in those at increased risk because they are health-care or laboratory personnel, military recruits, or travelers to or residents of areas with hyperendemic or epidemic meningococcal disease: ACIP and others recommend a single dose of MenACWY vaccine.^{200 228}

Booster doses in those who remain at prolonged increased risk for meningococcal disease: ACIP and others recommend a booster dose of MenACWY vaccine every 5 years.^{200 228} Manufacturers state a booster dose can be given if it has been at least 4 years since the prior dose.^{1 108 152}

Adults ≥56 Years of Age (MenACWY-D; Menactra† [off-label], MenACWY-CRM; Menveo† [off-label], MenACWY-TT; MenQuadfi)

IM

Primary immunization in those at increased risk because of certain chronic medical conditions or treatment (see Uses): ACIP and others recommend 2 doses of MenACWY vaccine given ≥2 months apart (minimum 8 weeks apart).^{200 228} Manufacturers state a single dose can be used for primary immunization.^{1 108 152}

Primary immunization in those at increased risk because they are health-care or laboratory personnel, military recruits, or travelers to or residents of areas with hyperendemic or epidemic meningococcal disease: ACIP and others recommend a single dose of MenACWY vaccine.^{200 228}

Booster doses in those who remain at prolonged increased risk for meningococcal disease: ACIP and others recommend a booster dose of MenACWY vaccine every 5 years.^{200 228} Manufacturers state a booster dose can be given if it has been at least 4 years since the prior dose.^{1 108 152}

Special Populations

Hepatic Impairment

No specific dosage recommendations.

Renal Impairment

No specific dosage recommendations.

Geriatric Patients

MenACWY-D and MenACWY-CRM: Although not labeled by FDA for use in adults ≥56 years of age^{† [off-label]}, including those ≥65 years of age,^{108 152} ACIP states can be used when primary or booster immunization indicated in this age group.²²⁸

MenACWY-TT is labeled by FDA for use in adults ≥56 years of age, including those ≥65 years of age.¹

Cautions for Meningococcal Groups A, C, Y, and W-135 Vaccine

Contraindications

• MenACWY-D (Menactra): Severe allergic reaction (e.g., anaphylaxis) after previous dose of the vaccine, any vaccine component, or any vaccine containing meningococcal capsular polysaccharide, diphtheria toxoid, or diphtheria CRM₁₉₇.¹⁰⁸

• MenACWY-CRM (Menveo): Severe allergic reaction (e.g., anaphylaxis) after previous dose of the vaccine or any vaccine containing meningococcal antigens, diphtheria toxoid, or diphtheria CRM₁₉₇.¹⁵²

• MenACWY-TT (MenQuadfi): Severe allergic reaction to any vaccine component or after a previous dose of the vaccine or any vaccine containing tetanus toxoid.¹

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

MenACWY-D: Hypersensitivity reactions (e.g., anaphylactic/anaphylactoid reaction, wheezing, difficulty breathing, upper airway swelling, urticaria, erythema, pruritus, hypotension, erythema multiforme) reported rarely.^{108 146 152}

MenACWY-CRM: Hypersensitivity reactions reported.¹⁵²

MenACWY-TT: Hypersensitivity reactions possible.¹

Prior to administration of MenACWY vaccine, take all known precautions to prevent adverse reactions, including a review of patient’s history with respect to possible hypersensitivity to the vaccine, vaccine components, or similar vaccines.¹⁰⁸

Epinephrine and other appropriate agents and equipment should be readily available in case anaphylaxis or other serious allergic reaction occurs.^{1 108 152}

Guillain-Barré Syndrome

MenACWY-D: Postmarketing reports of Guillain-Barré syndrome (GBS) temporally associated with vaccination.^{1 108 110 111 122 123 124 238}

GBS is a serious neurologic disorder involving inflammatory demyelination of peripheral nerves and may occur spontaneously or after certain antecedent events (e.g., infections).^{110 111} Characterized by subacute onset of progressive, symmetrical weakness in legs and arms, with loss of reflexes.¹¹⁰ Sensory abnormalities, cranial nerve involvement, and paralysis of respiratory muscles may also develop.¹¹⁰ GBS can be fatal; up to 20% of hospitalized patients may have prolonged disability.¹¹⁰

Based on data from one postmarketing, retrospective, safety study that evaluated risk of GBS following administration of MenACWY-D, attributable risk of GBS ranged from 0–5 additional cases per 1 million vaccinees within the 6-week period following vaccination.¹⁰⁸ In another retrospective, cohort study involving 12.6 million individuals 11–21 years of age, >1.4 million doses of MenACWY-D had been administered and there were 99 confirmed cases of GBS (5.4 cases per 1 million vaccinees);²³⁸ none of these GBS cases occurred within the 6-week period following vaccination.²³⁸

MenACWY-D: Manufacturer states that individuals with a history of GBS may be at increased risk of GBS following administration of the vaccine and potential benefits and risks should be considered when deciding whether to administer the vaccine in such individuals.¹⁰⁸

MenACWY-CRM and MenACWY-TT: Manufacturers state that, because GBS reported in temporal relationship following administration of another US quadrivalent polysaccharide meningococcal conjugate vaccine, take into account potential benefits and risks when deciding whether to administer the vaccine in an individual with a history of GBS.^{1 152}

After reviewing available safety data for MenACWY vaccine, ACIP concluded that benefits of vaccination against meningococcal serogroups A, C, Y, and W-135 outweigh potential increased risk for GBS.²²⁸ ACIP states that, although early postmarketing surveillance raised concern of a potential risk for GBS, subsequent evaluations have not identified an increased risk for GBS after MenACWY-D vaccination.²²⁸

Bell's Palsy

MenACWY-CRM: Postmarketing reports of Bell's palsy in temporal association with administration of MenACWY-CRM in adolescents and young adults 11–21 years of age.^{152 239} Symptoms of Bell's palsy resolved in all reported cases to date.¹⁵² In 6 of 8 cases that occurred within 84 days after vaccination, MenACWY-CRM had been administered concomitantly with ≥1 other vaccine (i.e., human papillomavirus [HPV] vaccine; tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed [Tdap]; influenza vaccine).^{152 239}

Individuals with Altered Immunocompetence

May be administered to individuals immunosuppressed as the result of disease or immunosuppressive therapy.^{105 134 135 228} Consider possibility that immune responses to vaccines and efficacy may be reduced in these individuals.^{1 105 108 134 135 152 228}

HIV-infected individuals ≥2 months of age: Age-appropriate regimen of MenACWY vaccine recommended by ACIP, AAP, and others for routine primary and booster immunization against meningococcal serogroups A, C, Y, and W-135 infection.^{105 135 156}

Individuals with functional or anatomic asplenia (including sickle cell disease): Age-appropriate regimen of MenACWY vaccine recommended by ACIP and others for routine primary and booster immunization against meningococcal serogroups A, C, Y, and W-135 infection.^{105 134 135} When planning immunization against meningococcal disease and pneumococcal disease in individuals with anatomic or functional asplenia, consider that MenACWY-D should not be given concomitantly with or within 4 weeks after PCV13 (see Specific Drugs under Interactions).¹³⁴

Individuals scheduled for elective splenectomy: Give MenACWY vaccine ≥14 days prior to surgery;^{105 134 228} if not given prior to surgery, administer as soon as possible ≥2 weeks after the procedure when patient's condition is stable.^{105 134 228}

Individuals with persistent complement component deficiency and those receiving treatment with a complement inhibitor (e.g., eculizumab, ravulizumab): Increased risk for invasive disease caused by meningococcal serogroups A, C, Y, and W-135, even if they develop antibodies following vaccination with MenACWY vaccine.^{1 108 152 229 230} Life-threatening and fatal meningococcal infections have occurred in patients receiving eculizumab or ravulizumab.^{229 230} Administer MenACWY vaccines ≥2 weeks prior to the first dose of eculizumab or ravulizumab, unless risks of delaying initiation of drug outweigh risks of meningococcal infection.^{229 230}

Individuals receiving immunosuppressive therapy: Generally give inactivated vaccines prior to initiation of immunosuppressive therapy or defer until immunosuppressive therapy discontinued.^{105 134} (See Immunosuppressive Agents under Interactions.)

Concomitant Illness

Base decision to administer or delay vaccination in an individual with a current or recent acute illness on severity of symptoms and etiology of the illness.^{108 134}

ACIP states mild acute illness generally does not preclude vaccination.¹³⁴

ACIP states moderate or severe acute illness (with or without fever) is a precaution for vaccination;¹³⁴ defer vaccines 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

Individuals with Bleeding Disorders

Advise individuals who have bleeding disorders or are receiving anticoagulant therapy and/or their family members about the risk of hematoma from IM injections.¹³⁴

ACIP states IM vaccines may be given to such individuals if a clinician familiar with the patient’s bleeding risk determines that the vaccines can be administered IM with reasonable safety.¹³⁴ In these cases, use a fine needle (23 gauge) 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 shortly after a dose of such therapy.¹³⁴

Limitations of Vaccine Effectiveness

MenACWY vaccine may not protect all vaccine recipients against meningococcal serogroups A, C, Y, and W-135 infection.^{1 105 108}

MenACWY vaccine provides protection only against those meningococcal serogroups represented in the vaccine (i.e., serogroups A, C, Y, W-135).^{1 105 108 152 166 228} Will not prevent infection caused by other serogroups (e.g., serogroup B) and will not prevent infections caused by other pathogens.^{1 105 108 152 166 228}

MenACWY-TT: Immunization with the vaccine is not a substitute for routine immunization against tetanus.¹

Duration of Immunity

Duration of immunity after primary immunization with MenACWY vaccine (MenACWY-D. MenACWY-CRM, MenACWY-TT) or previously available unconjugated vaccine (MPSV4) not fully determined.^{1 105 108 152 228}

MenACWY vaccine is expected to provide a longer duration of protection than the previously available unconjugated vaccine (MPSV4).²²⁸

Meningococcal antigens in MenACWY-D. MenACWY-CRM, and MenACWY-TT are conjugated to protein carriers containing T-cell epitopes.^{1 108 152 228} This may result in improved primary response to the antigens and strong anamnestic response after reexposure to the antigens.^{1 108 134 152 228}

Booster doses of MenACWY vaccine may be necessary in individuals who previously received MenACWY or MPSV4 (no longer available in the US) and continue to be at prolonged increased risk for exposure to meningococcal serogroups A, C, Y, and W-135 infection.^{105 166 199 200 228}

Improper Storage and Handling

Improper storage or handling of vaccines may reduce vaccine potency resulting in reduced or inadequate immune response in vaccinees.¹³⁴

Inspect all vaccines upon delivery and monitor during storage to ensure that the appropriate temperature is maintained.¹³⁴ (See Storage under Stability.)

Do not administer meningococcal vaccine that has been mishandled or has not been stored at the recommended temperature.¹³⁴

If there are concerns about mishandling, contact the manufacturer or state or local immunization or health departments for guidance on whether the vaccine is usable.¹³⁴

Specific Populations

Pregnancy

No adequate and well-controlled studies evaluating MenACWY vaccine (MenACWY-D, MenACWY-CRM, MenACWY-TT) in pregnant women.^{1 108 152}

MenACWY-D: Available data suggest that rates of major birth defects and miscarriage in women who received the vaccine 30 days prior to pregnancy or during pregnancy are consistent with estimated background rates.¹⁰⁸ Animal studies have not revealed any evidence of harm to the fetus.¹⁰⁸ Pregnancy registry at 800-822-2463.¹⁰⁸

MenACWY-CRM: Data from a pregnancy registry conducted from 2014–2017 do not suggest an increased risk of major birth defects or miscarriage in women who received the vaccine within 28 days prior to conception or during pregnancy.¹⁵² Animal reproduction studies have not revealed evidence of harm to the fetus.¹⁵²

MenACWY-TT: Animal reproduction studies performed in female rabbits did not reveal evidence of harm to the fetus or adverse effects on postnatal development.¹ Report any exposure to MenACWY-TT that occurs during pregnancy to the manufacturer’s pregnancy registry at 800-822-2463.¹

ACIP and AAP state MenACWY vaccine may be used during pregnancy if indicated.^{105 228} Although data are limited, postmarketing surveillance has not identified any concerning safety signals regarding use of MenACWY vaccines during pregnancy.²²⁸

Lactation

Not known whether antigens contained in MenACWY vaccine (MenACWY-D, MenACWY-CRM, MenACWY-TT) are distributed into milk.^{1 108 152}

Manufacturers state consider benefits of breast-feeding and the importance of MenACWY vaccine to the woman;^{1 108 152} also consider potential adverse effects on breast-fed child from the vaccine or from the underlying maternal condition (i.e., susceptibility to meningococcal infection).^{1 108 152}

ACIP states that breast-feeding women should receive MenACWY vaccine if indicated.²²⁸

Pediatric Use

MenACWY-D (Menactra): Safety and efficacy not established in pediatric patients <9 months of age.¹⁰⁸

MenACWY-CRM (Menveo): Safety and efficacy not established in pediatric patients <2 months of age.¹⁵²

MenACWY-TT (MenQuadfi): Safety and efficacy not established in pediatric patients <2 years of age.¹

Apnea reported following IM administration of vaccines in some infants born prematurely.¹⁵² Base decisions regarding when to administer an IM vaccine in premature infants on consideration of the individual infant's medical status and potential benefits and possible risks of vaccination.¹⁵²

Geriatric Use

MenACWY-D (Menactra): Safety and efficacy not established in adults ≥56 years of age, including geriatric adults.¹⁰⁸ ACIP states the vaccine may be used if indicated in this age group.²²⁸

MenACWY-CRM (Menveo): Safety and efficacy not established in adults ≥56 years of age, including those ≥65 years of age.¹⁵² ACIP states the vaccine may be used if indicated in this age group.²²⁸

MenACWY-TT (MenQuadfi): Clinical studies included 249 individuals ≥65 years of age, including 71 individuals ≥75 years of age.¹ Antibody responses to all 4 serotypes represented in the vaccine were diminished in vaccine recipients ≥65 years of age compared with those 56–64 years of age.¹

Common Adverse Effects

MenACWY-D (Menactra): Injection site reactions (e.g., pain, induration, erythema, swelling), headache, fatigue, malaise, arthralgia, diarrhea, anorexia, chills, fever, vomiting, rash.¹⁰⁸ Most common adverse effects in those 11 through 55 years of age after a booster dose were injection site pain and myalgia; overall rates of solicited local and systemic reactions similar to those observed after a primary dose.¹⁰⁸

MenACWY-CRM (Menveo): Injection site reactions (tenderness, erythema), irritability, sleepiness, persistent crying, change in eating habits, vomiting, diarrhea in infants 2 through 23 months of age; injection site reactions (pain, erythema, induration), irritability, sleepiness, malaise, headache in children 2 through 10 years of age;¹⁵² injection site pain, headache, myalgia, malaise, nausea in adults and adolescents.¹⁵² Most common adverse effects after a booster dose in those 15 through 55 years of age were injection site pain and fatigue.¹⁵²

MenACWY-TT (MenQuadfi): Injection site reactions (e.g., pain, erythema, swelling), myalgia, headache, malaise.¹ Most common adverse effects after a booster dose in those ≥15 years of age were injection site pain, myalgia, and malaise; overall rates of solicited local and systemic reactions similar to those observed after a primary dose.¹

Drug Interactions

Immunosuppressive Agents

Immune responses to vaccines, including MenACWY vaccine, may be reduced in individuals receiving immunosuppressive therapy.^{1 61 72 105 108 134 135 152 228}

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.^{105 134 135}

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

Although specific studies may not be available,¹⁵² concurrent administration with other age-appropriate vaccines, including live virus vaccines, toxoids, or inactivated or recombinant vaccines, during the same health-care visit generally is not expected to affect immunologic responses or adverse reactions to any of the preparations.^{90 105 108 134 228} (See Specific Drugs under Interactions.)

Immunization with MenACWY vaccine can be integrated with immunization against diphtheria, tetanus, pertussis, Hib, hepatitis A, hepatitis B, HPV, influenza, measles, mumps, rubella, pneumococcal disease, poliomyelitis, and varicella.^{105 134} Administer each parenteral vaccine using a separate syringe and different injection site.^{105 134 228}

Specific Drugs

Stability

Storage

Parenteral

Solution, for IM Use

MenACWY-D (Menactra): 2–8°C.¹⁰⁸ Do not freeze;¹⁰⁸ if freezing occurs, discard vaccine.¹⁰⁸ Protect from light.¹³⁴

MenACWY-CRM (Menveo) lyophilized and liquid components: 2–8°C;¹⁵² protect from light.¹⁵² Do not freeze;¹⁵² discard if freezing occurs.¹⁵² Maintain at 2–8°C during transport.¹⁵² Use immediately after reconstitution, but may be stored at 2–25°C for up to 8 hours.¹⁵²

MenACWY-TT (MenQuadfi): 2–8°C.¹ Do not freeze;¹ if freezing occurs, discard vaccine.¹

Actions

• MenACWY-D (Menactra) contains purified capsular polysaccharide antigens A, C, Y, and W-135 extracted from N. meningitidis and conjugated to diphtheria toxoid protein.¹⁰⁸

• MenACWY-CRM (Menveo) contains purified capsular polysaccharide antigens A, C, Y, and W-135 extracted from N. meningitidis and conjugated to diphtheria CRM₁₉₇ protein.¹⁵²

• MenACWY-TT (MenQuadfi) contains purified capsular polysaccharide antigens A, C, Y, and W-135 extracted from N. meningitidis and conjugated to tetanus toxoid protein.¹

• MenACWY vaccine stimulates active immunity to infections caused by meningococcal serotypes represented in the vaccine (i.e., groups A, C, Y, W-135).^{1 105 108 152 228}

• Meningococcal vaccines stimulate active immunity to meningococcal infection by inducing production of specific IgG, IgM, and IgA antibodies.^{13 17 18 33 69 79} The relative importance of each type of antibody in providing initial and long-term bactericidal protection against N. meningitidis not determined.^{13 17 42 46 69 79}

• Antigens contained in MenACWY vaccine are conjugated to protein carriers containing T-cell epitopes; these can elicit immune responses involving T cells and may provide longer-lasting immunity than that provided by previously available unconjugated meningococcal vaccine (MPSV4).^{106 108 134 228}

• Reduced immune responses to meningococcal vaccines and lower antibody titers may occur in immunocompromised individuals (e.g., HIV-infected individuals, those with leukemia, lymphoma, or generalized malignancy, those receiving immunosuppressive therapy).^{1 108 134 152 228} (See Individuals with Altered Immunocompetence under Cautions.)

• Duration of immunity against N. meningitidis serogroups A, C, Y, and W-135 after primary immunization with MenACWY vaccine not fully determined.^{105 108 152 228} Booster doses of MenACWY vaccine may be indicated in individuals at increased susceptibility to meningococcal disease caused by serogroups A, C, Y, and W-135 because of certain chronic medical conditions or treatment and in those who are at continued increased risk of exposure to the disease.^{105 166 199 200 228}

Advice to Patients

• Prior to administration of MenACWY vaccine, provide a copy of the appropriate CDC Vaccine Information Statement (VIS) to the patient or patient’s legal representative (VISs are available at [Web]).^{1 108 120 152}

• Advise patient and/or patient’s parent or guardian of the risks and benefits of vaccination with MenACWY vaccine.^{1 108 152}

• Advise patient and/or patient's parent or guardian of the importance of completing the full primary immunization series.¹⁵²

• Advise patient and/or patient’s parent or guardian that routine meningococcal vaccination is recommended in US for all adolescents at 11 through 12 years of age, followed by a booster dose at 16 years of age; catch-up vaccination recommended at 13 through 18 years of age for those not previously vaccinated.^{199 228} Also advise that meningococcal vaccine is recommended for certain individuals at increased risk for exposure to meningococcal disease (e.g., college students through 21 years of age, individuals with certain chronic medical conditions, international travelers, household and other close contacts of individuals with invasive meningococcal disease, health-care or laboratory workers, military personnel).^{199 200 228}

• Advise patient and/or patient’s parent or guardian that revaccination or booster doses of MenACWY vaccine may be needed in individuals who receive primary immunization and remain at prolonged increased risk for disease caused by meningococcal serogroups A, C, Y, and W-135.²²⁸

• Advise patient and/or patient’s parent or guardian that MenACWY vaccine may not provide protection in all vaccinees.^{1 108 152}

• Importance of informing clinicians if any adverse reactions (including allergic reactions) occur with MenACWY vaccine.^{1 108 152} 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].^{1 108 152}

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.^{1 108 152}

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^{1 108 152}

• Importance of informing patients of other important precautionary information.^{1 108 152} (See Cautions.)

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.

Medical Disclaimer