GSK-3536819 (MenABCWY)

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Fact Table

Fact Table
Formula Not applicable (vaccine – multicomponent protein/polysaccharide)
License Pending FDA approval (BLA submitted 2023)
Bioavailability Not applicable (administered intramuscularly)
Legal status Investigational (not yet approved)
Chemical Name GSK-3536819 (MenABCWY)
Elimination half-life Not established
Dosage (Strength) As per clinical trial protocol – single-dose injection (volume varies by age)
Pregnancy Consult doctor – safety in pregnancy not fully evaluated
Brands MenABCWY (development name)
Protein binding Not applicable (vaccine)
PubChem CID Not available
MedlinePlus Not listed
ChEBI Not available
ATC code J07AH09 (proposed)
DrugBank Not listed
KEGG Not available
Routes of administration Intramuscular injection

GSK-3536819 (MenABCWY), branded under the MenABCWY GSK designation, is a next-generation meningococcal vaccine that offers broad protection against five major serogroups: A, B, C, W, and Y. This pentavalent vaccine is formulated to address the limitations of separate MenB and MenACWY immunizations by delivering a more comprehensive solution in a single injection series. Ideal for individuals between 10 and 25 years of age, the MenABCWY vaccine reduces the risk of life-threatening meningococcal infections. Clinics, hospitals, and vaccination centers seeking to buy MenABCWY now have access to a streamlined approach for adolescent meningococcal disease prevention.

Directions

MenABCWY is given as a two-dose series administered via intramuscular injection, preferably into the deltoid region of the upper arm. The second dose should be administered six months after the first. Compliance with the recommended interval is critical to ensure long-lasting immunity. Doses should not be interchanged with other meningococcal vaccines.

Ingredients

Each 0.5 mL dose of MenABCWY contains a combination of capsular polysaccharide conjugates from serogroups A, C, W, and Y along with recombinant serogroup B antigens. The active ingredients are adsorbed onto aluminum hydroxide and stabilized with histidine and sodium chloride. The formulation is preservative-free and latex-free.

Cautions

Precaution is warranted in patients with bleeding disorders or compromised immunity, including those undergoing immunosuppressive therapy. In individuals with febrile illness or acute infection, vaccination should be postponed. The MenABCWY GSK vaccine should be administered under appropriate medical supervision. For institutions planning to buy MenABCWY in bulk, informed consent protocols and adverse event reporting mechanisms must be in place.

Contraindications

Use of the MenABCWY vaccine is contraindicated in individuals with known allergies to any of its components or to previous meningococcal vaccines. This includes known hypersensitivity to CRM197, diphtheria toxoid, or aluminum-based adjuvants.

Side Effects

Frequently reported side effects include:

  • Soreness at the injection site
  • Low-grade fever
  • Headache
  • Joint or muscle pain
  • Nausea
  • Fatigue

Adverse events are generally mild and resolve within 48 to 72 hours. Any signs of hypersensitivity or anaphylaxis require immediate medical attention.

Frequently Asked Questions about GSK-3536819 (MenABCWY)


What is GSK-3536819 (MenABCWY)?

GSK-3536819, also known as MenABCWY, is a 5-in-1 meningococcal vaccine developed by GSK.


What does the MenABCWY vaccine protect against?

It provides protection against five major groups of Neisseria meningitidis bacteria: A, B, C, W, and Y.


Who is the MenABCWY vaccine intended for?

The vaccine is approved for individuals aged 10 through 25 years.


How is the MenABCWY vaccine administered?

It is given as a two-dose series, with doses administered six months apart.


What are common side effects of the MenABCWY vaccine?

Common side effects may include pain at the injection site, fatigue, headache, and muscle aches.


Can the MenABCWY vaccine be given with other vaccines?

Consult your healthcare provider to determine the best vaccination schedule, especially if receiving multiple vaccines.


Is the MenABCWY vaccine a live vaccine?

No, it is not a live vaccine and cannot cause meningococcal disease.


How effective is the MenABCWY vaccine?

Clinical trials have demonstrated that MenABCWY elicits a robust immune response against all five targeted serogroups.


Why combine protection into a single vaccine?

Combining protection simplifies immunization schedules and may improve vaccination coverage among adolescents and young adults.


Where can I get the MenABCWY vaccine?

Availability may vary; consult your local healthcare provider or public health department for information on obtaining the vaccine.