Sanofi Meningococcal Vaccine 'MenQuadfi' Approved for Use in Infants as Young as 6 Weeks Old

Expanded Indication Allows MenQuadfi Vaccination
for Infants as Young as 6 Weeks Old
First Quadrivalent Meningococcal Conjugate Vaccine Approved
for This Age Group in Korea

Sanofi Korea announced on September 4 that its fully liquid quadrivalent meningococcal vaccine, MenQuadfi, received approval from the Ministry of Food and Drug Safety on August 26 to expand its indication for use in infants from 6 weeks to under 2 years of age.

With this expanded indication, MenQuadfi has become the first quadrivalent meningococcal polysaccharide-protein conjugate vaccine in Korea that can be administered to infants as young as 6 weeks old.

For infants aged 6 weeks to under 6 months, a total of four doses can be administered. The initial three doses are given at intervals of at least eight weeks, and the fourth dose is recommended at least six months after the third dose and after the child is at least 12 months old.

For infants aged 6 to 24 months with no history of meningococcal vaccination, two doses are administered at intervals of at least three months, with the second dose given after the child reaches 12 months of age.

For individuals aged 2 years to 55 years, a single dose is expected to provide preventive efficacy.

This approval was based on the results of a Phase 3 clinical trial that compared the immunogenicity and safety of MenQuadfi with existing quadrivalent meningococcal vaccines in approximately 2,627 infants aged 2 to 18 months, as well as a clinical study applying a two-dose schedule in infants aged 6 to 23 months.

Park Heekyung, Head of the Vaccine Division at Sanofi, stated, "Meningococcal infection is a rapidly progressing and potentially fatal disease in infants and young children, underscoring the importance of prevention. We will continue to work closely with health authorities to strengthen prevention strategies and ensure safety from meningococcal infection across various age groups."

Meningococcal infection, an acute infectious disease caused by Neisseria meningitidis, initially presents with symptoms such as fever, loss of appetite, and nausea. However, if treatment is delayed, it can lead to meningitis and sepsis, with a mortality rate reaching up to 50%.

This content was produced with the assistance of AI translation services.