Drug Insights

Is MenQuadfi approved by the FDA?

1 July 2024
3 min read

Yes, MenQuadfi, a meningococcal conjugate vaccine, is FDA approved. The FDA granted approval for MenQuadfi on April 23, 2020.

What is MenQuadfi?

MenQuadfi is a vaccine used to prevent infection caused by Neisseria meningitidis serogroups A, C, W, and Y. This bacterial infection can lead to severe illnesses like meningitis, which is an inflammation of the membranes surrounding the brain and spinal cord. Meningococcal disease can be fatal or result in significant long-term health problems.

How Does MenQuadfi Work?

MenQuadfi helps your body develop immunity to meningococcal bacteria. It does not treat active infections but is designed to prevent the onset of disease by triggering the immune system to produce antibodies against the meningococcal bacteria.

Who Should Get MenQuadfi?

MenQuadfi is recommended for:

  • Children and adults aged 2 years and older.
  • Individuals exposed to meningococcal disease outbreaks.
  • Military personnel.
  • Laboratory workers exposed to meningococcal bacteria.
  • People living in group settings like dormitories.
  • Travelers to areas where meningococcal disease is common.
  • Individuals with medical conditions affecting the spleen or those who have had their spleen removed.
  • People with HIV.
  • Users of certain medications such as eculizumab (Soliris) or ravulizumab (Ultomiris).
  • Those with a complement component deficiency, an immune system disorder.

Administration and Dosage

MenQuadfi is administered as an injection into a muscle. It is typically given as a single dose, but a booster may be needed for those at high risk if it has been at least four years since the last dose. The CDC recommends that all adolescents aged 11 to 12 years receive a single dose of a meningococcal conjugate vaccine, with a booster dose at age 16.

Side Effects

Common side effects of MenQuadfi may include:

  • Nausea, vomiting, diarrhea
  • Appetite changes
  • Redness, pain, swelling, or a lump at the injection site
  • Joint or muscle pain
  • Headache, drowsiness, tiredness
  • Low fever, feeling unwell
  • Irritability in infants

Serious side effects, although rare, can include severe weakness, high fever, or unusual behavior. Allergic reactions, while infrequent, may present as hives, dizziness, fast heartbeats, difficulty breathing, or swelling of the face, lips, tongue, or throat.

Precautions

Before receiving MenQuadfi, inform your healthcare provider if you have had:

  • Severe allergic reactions to previous meningococcal, diphtheria, or tetanus vaccines.
  • A severe illness with fever or infection.
  • A weakened immune system due to disease or medication.
  • A history of Guillain-Barré syndrome or premature birth.

MenQuadfi may not be suitable during pregnancy or breastfeeding unless deemed necessary by a healthcare provider.

Conclusion

MenQuadfi is an important vaccine for preventing meningococcal disease caused by serogroups A, C, W, and Y. Its approval by the FDA on April 23, 2020, highlights its significance in protecting against these potentially life-threatening infections. Always consult with your healthcare provider to determine the best vaccination schedule for you or your child.

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