meningococcal ABCWY pentavalent vaccine (Rx)

>10%

Injection site pain, moderate (48.8-49.4%)

Injection site pain, mild (29.1-32.3%)

Headache, mild (21.3-25.7%)

Fatigue, moderate (21.8-25.5%)

Fatigue, mild (22.8-23.5%)

Headache, moderate (16.8-19.2%)

Injection site redness, moderate (12.6-14.4%)

Muscle pain, mild (non-injection site) (10-13.6%)

Injection site swelling, moderate (12.8-13.3%)

Chills, mild (9.9-12.6%)

Muscle pain, moderate (non-injection site) (10.5-11.9%)

Injection site swelling, mild (10.4-10.6%)

Joint pain (9.6-10.7%)

1-10%

Injection site redness, mild (7.7-8.9%)

Joint pain, moderate (8.3-8.6%)

Diarrhea, mild (6.9-8.7%)

Injection site pain, mild (6.5-7.5%)

Chills, moderate (6-6.7%)

Fever ≥38ºC (2.4-5.9%)

Fatigue, severe (2.9-3.2%)

Vomiting, mild (1.5-3.2%)

Injection site redness, severe (2.6-3%)

Diarrhea, moderate (1.4-2%)

Headache, severe (1.7-1.9%)

Muscle pain, severe (non-injection site) (0.8-1.6%)

Injection site swelling, severe (1-1.2%)

Joint pain, severe (0.4-1%)

<1%

Chills, severe (0.4-0.8%)

Vomiting, moderate (0.1-0.6%)

Diarrhea, severe (0.3%)

Postmarketing Reports

Immune system disorders: Allergic reactions, including anaphylaxis

Nervous system: Syncope (fainting)

Contraindications

History of severe allergic reaction (eg, anaphylaxis) to any component of the vaccine

Cautions

Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an anaphylactic reaction occurs following administration

Syncope may occur in association with administration of injectable vaccines; procedures should be in place to avoid injury from fainting

Vaccination with MenABCWY does not substitute for vaccination with a tetanus toxoid containing vaccine to prevent tetanus (lyophilized MenACWY polysaccharides individually conjugated to TT)

Guillain-Barré syndrome (GBS) reported in temporal relationship following administration of another meningococcal quadrivalent polysaccharide conjugate vaccine; consider the expected benefits and potential risks when administering to persons with a history of GBS

Vaccination may not protect all vaccine recipients

Altered immunocompetence

• Some individuals with altered immunocompetence may have reduced immune responses to vaccines
• Individuals with certain complement deficiencies and individuals receiving treatment that inhibits terminal complement activation are at increased risk for invasive disease caused by N meningitidis groups A, B, C, W, and Y, even if they develop antibodies following vaccination

Pregnancy

Available human data on the vaccine administered to pregnant individuals are insufficient to inform vaccine-associated risks in pregnancy

There were no developmental toxicity studies performed

Pregnancy registry

• Individuals who received MenABCWY vaccine during pregnancy are encouraged to contact, or have their healthcare provider contact, 1-877-390-2953 to enroll in or obtain information about the registry

Lactation

There are no data available to assess the effects on breastfed infants or on milk production/excretion

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Pentavalent vaccine targeting meningococcal serogroups A, B, C, Y and W

Conveys active immunity via stimulation of production of endogenously produced antibodies

Protection against invasive meningococcal disease is conferred mainly by complement-mediated, antibody-dependent killing of N meningitidis

IM Preparation

Supplied in a kit that includes a vial of lyophilized MenACWY component, a prefilled syringe containing the MenB component, and a vial adapter

Reconstitute lyophilized MenACWY component with the MenB component

Instructions

• Prepare vial and adapter

  • Remove plastic flip-off cap from vial containing lyophilized MenACWY component
  • Cleanse rubber stopper
  • Without removing vial adapter from its packaging, peel off top cover

• Attach vial adapter

  • Hold base of vial on flat surface
  • Keep vial adapter in packaging and orient it vertically over center of the vial so that the adapter spike aligns with the center of the vial’s rubber stopper
  • Connect vial adapter to the vial with a straight downward push; vial adapter will lock into place
  • Do not push vial adapter in at an angle as this may result in leaking during use
  • Remove vial adapter packaging

• Resuspension of MenB component

  • Shake syringe vigorously to obtain a white homogenous suspension
  • Do not use if contents cannot be resuspended

• Remove syringe cap

  • For all syringe assembly steps, hold syringe only by Luer lock adapter located at tip of the syringe
  • This will prevent the Luer lock adapter from detaching during use
  • Remove syringe cap by slowly turning cap counter-clockwise while holding the Luer lock adapter

• Connect syringe to vial adapter

  • Hold Luer lock adapter and connect it to vial adapter by turning clockwise
  • Stop turning once there is resistance, overtightening syringe may result in leaking during use
  • Once syringe is securely attached to vial adapter, there will be a small space between the top of vial adapter and Luer lock adapter

• Reconstitute lyophilized MenACWY component with MenB component to form pentavalent MenABCWY

  • Inject entire contents of syringe containing the MenB component into vial
  • Do not remove empty syringe
  • While holding plunger rod down, gently swirl vial in a circular motion until powder is completely dissolved (<1 minute)

• Withdraw MenABCWY suspension

  • Invert vial completely with vial adapter and syringe still attached
  • Slowly withdraw entire contents into syringe to ensure ~0.5 mL dose
  • Do not pull plunger rod out

• Disconnect syringe

  • Hold Luer lock adapter of syringe and disconnect syringe from vial adapter by turning counter-clockwise

• Attach new sterile needle

  • Attach a sterile needle suitable for IM injection to syringe containing vaccine

• Visually inspect

  • MenABCWY is a homogeneous white suspension
  • If vaccine is not a homogenous suspension, shake to resuspend before administration
  • Inspect visually for particulate matter and discoloration before administration
  • Discard if either condition is present

IM Administration

For IM use only

Storage

Unopened kit

• Refrigerate at 2-8ºC (36-46ºF) in original carton
• During storage, a white deposit and clear supernatant may be observed in the prefilled syringe containing the MenB component
• Store carton horizontally to minimize time necessary to resuspend the MenB component
• Do not freeze
• Discard if carton has been frozen

After reconstitution

• Store between 2-30ºC (36-86ºF) and use within 4 hr
• Discard reconstituted vaccine if not used within 4 hr