MenQuadfi FDA Approval History

Last updated by Judith Stewart, BPharm on June 13, 2025.

FDA Approved: Yes (First approved April 23, 2020)
Brand name: MenQuadfi
Generic name: meningococcal (groups A, C, Y, W) conjugate vaccine
Dosage form: Injection
Company: Sanofi
Treatment for: Meningococcal Disease Prophylaxis

MenQuadfi (meningococcal (groups A, C, Y, W) conjugate vaccine) is a MenACWY vaccine indicated for active immunization for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y in individuals 6 weeks of age and older.

• MenQuadfi does not prevent Neisseria meningitidis serogroup B disease.
• MenQuadfi is administered as an intramuscular injection.
  - Primary Vaccination
  • Infants aged from 6 weeks: 4-dose series administered at 2, 4, 6, and 12 through 18 months of age. The first dose may be given as early as 6 weeks of age.
  • Infants aged 6 months through 11 months: 2-dose series with the second dose administered in the second year of life and at least 3 months after the first dose.
  • Infants aged 12 months through 23 months: 2-dose series with the second dose administered at least 3 months after the first dose.
  • Individuals 2 years of age and older: A single dose.
  - Booster Vaccination
  A single dose of MenQuadfi may be administered to individuals 13 years of age and older who are at continued risk for meningococcal disease if at least 3 years have elapsed since a prior dose of meningococcal (groups A, C, W, Y) conjugate vaccine.
  - Vaccination Following Prior Dose of Meningococcal Polysaccharide Vaccine
  A single dose of MenQuadfi may be administered if at least 3 years have elapsed since a prior dose of meningococcal polysaccharide vaccine.
• MenQuadfi should not be given to people who have had a severe allergic reaction after a previous dose of MenQuadfi, any of its ingredients, or another vaccine that contains tetanus toxoid.
• Most commonly reported adverse reactions (≥10%)
  - Infants 6 weeks through 23 months of age
  • who received 4-dose series given at 2, 4, 6, and 12 through 18 months of age include tenderness (38.5%-45.6%), erythema (12.5%-19.5%), and swelling (9.6%-12.7%) at the injection site; irritability (40.1%-51.9%), abnormal crying (27.3%-42.1%), drowsiness (25.1%-43.4%), lost appetite (17.3%-21.8%), fever (7.8%-17.6%), vomiting (3.5%- 13.2%).
  • who received 2-dose series given at 6 through 7 months and 12 through 13 months of age include tenderness (30.1%-42.7%), erythema (21.1%- 21.8%), and swelling (14.5%-16.0%) at the injection site; irritability (40.0%-49.0%), abnormal crying (26.6%-35.0%), drowsiness (27.7%-36.5%), lost appetite (15.2%-17.1%), fever (9.3%-12.9%), vomiting (5.5%-8.5%).
  - Children 2 through 9 years of age include pain (38.6%), erythema (22.6%), and swelling (13.8%) at the injection site; malaise (21.1%), myalgia (20.1%), and headache (12.5%).
  - Adolescents aged 10 through 17 years of age include injection site pain (34.8%– 45.2%), myalgia (27.4%–35.3%), headache (26.5%–30.2%), and malaise (19.4%–26.0%).
  - Adults aged 18 through 55 years include injection site pain (41.9%), myalgia (35.6%), headache (29.0%), and malaise (22.9%).
  - Adults 56 years of age and older include pain at the injection site (25.5%), myalgia (21.9%), headache (19.0%), and malaise (14.5%).
  In adolescents and adults, rates of solicited adverse reactions following a booster dose were comparable to those observed following primary vaccination.

Development timeline for MenQuadfi

Further information

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