Sanofi Pasteur announces another advancement in the fight to prevent meningococcal disease. MenQuadfi™ (Meningococcal [Groups A, C, Y, W] Conjugate Vaccine) has been approved by the FDA for active immunization for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. MenQuadfi is approved for use in individuals 2 years of age and older. MenQuadfi does not prevent N meningitidis serogroup B disease.

The development of MenQuadfi and the high seroresponse generated in clinical trials illustrates Sanofi Pasteur’s continued commitment and leadership as a longstanding pioneer in meningococcal

vaccines. ¹⁻⁴

Linked to this webpage are documents with additional information on MenQuadfi:

MenQuadfi Flashcard – contains information on studies in which MenQuadfi was compared head-to-head with other licensed quadrivalent meningococcal vaccines

MenQuadfi Prescribing Information – contains important clinical and product information

IMPORTANT SAFETY INFORMATION

MenQuadfi should not be administered to anyone who has had a severe allergic reaction to any component of the vaccine, or after a previous dose of MenQuadfi or any other tetanus toxoid-containing vaccine.

Appropriate observation and medical treatment should always be readily available in case of an anaphylactic event following the administration of the vaccine.

Some individuals with altered immunocompetence, including some individuals receiving immunosuppressant therapy, may have reduced immune responses to MenQuadfi. Persons with certain complement deficiencies and persons receiving treatment that inhibits terminal complement activation (eg, eculizumab) are at increased risk for invasive disease caused by N meningitidis, including invasive disease caused by serogroups A, C, W, and Y, even if they develop antibodies following vaccination with MenQuadfi.

Syncope can occur following, or even before, vaccination with MenQuadfi. Procedures should be in place to prevent falling and injury and to manage syncope.

Guillain-Barré syndrome (GBS) has been reported in temporal relationship following administration of another US-licensed meningococcal quadrivalent polysaccharide conjugate vaccine. The decision to give MenQuadfi to persons with a history of GBS should take into account the expected benefits and potential risks.

Immunization with MenQuadfi does not substitute for routine tetanus immunization.

Vaccination with MenQuadfi may not protect all vaccine recipients.

The most common adverse reactions following a primary dose of MenQuadfi in individuals 2 years of age and older include pain at the injection site; myalgia, headache, and malaise. Other common adverse reactions in children 2 through 9 years of age include erythema and swelling at the injection site. In adolescents and adults, rates of solicited adverse reactions following a booster dose were comparable to those observed following primary vaccination. Other adverse reactions may occur.

Please see the full Prescribing Information for MenQuadfi.

Reference:

1. MenQuadfi [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc.

2. Immunization Action Coalition (IAC). Vaccine timeline. https://www.immunize.org/timeline/. Accessed July 17, 2020.

3. Menactra [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc. Menactra [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc.

4. Federal Drug Administration. September 4, 2014 approval letter - Menactra [letter]. September 4, 2014.

http://wayback.archiveit.org/7993/20170723032500/https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm413177.htm. Accessed July 17, 2020

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