MenQuadfi’s indication includes infants as young as 6 weeks

The extended indication allows flexible vaccination schedules for those from 6 weeks to 55 years of age

Convenient as coadministration with pediatric vaccines shows no immune interference

On the 4th, Sanofi Kore announced that its fully liquid quadrivalent meningococcal vaccine, MenQuadfi, received expanded indication approval from the Ministry of Food and Drug Safety (MFDS) on August 26.

 

The new approval allows MenQuadfi’s vaccination for infants from 6 weeks to under 2 years of age.

 

With the indication extension, MenQuadfi has become the first quadrivalent meningococcal conjugate vaccine in Korea that can be administered to infants as young as 6 weeks.

 

This approval allows a broader age range to have preventive options against invasive meningococcal disease.

 

MenQuadfi contains 10μg of antigen each for the four meningococcal serogroups (A, C, W, and Y) and is formulated as a fully liquid formulation that requires no reconstitution or mixing, enhancing ease of use.

 

It utilizes tetanus toxoid (TT) as a protein carrier to induce a strong T cell–mediated immune response.

 

Following the indication extension, MenQuadfi now offers flexible vaccination schedules to those 6 weeks to 55 years of age.

 

Infants aged 6 weeks to under 6 months may receive a 4-dose series, with the initial three doses given at minimum 8-week intervals, and a fourth booster at least 6 months after the third dose, administered at ≥12 months of age.

 

For infants aged 6 to less than 24 months with no prior meningococcal vaccination, a 2-dose schedule is recommended, with a minimum 3-month interval between doses and the second dose administered after 12 months of age.

 

For individuals aged 2 to 55 years, a single dose is sufficient for protection.

 

MenQuadfi’s indication extension was based on results from the MET42 and MET61 studies.

 

The Phase III MET42 trial enrolled about 2,627 infants and toddlers aged 2 to 18 months to evaluate the immunogenicity and safety of MenQuadfi versus an existing quadrivalent meningococcal vaccine.

 

After just three doses starting at 2 months of age, MenQuadfi demonstrated strong immune responses across all 4 meningococcal serogroups: A (64.4%), C (96.4%), W (92.8%), and Y (88.7%).

 

These results were higher compared to the comparator vaccine (A: 50.6%, C: 82.8%, W: 85.6%, Y: 81.8%).

 

The MET61 study assessed infants aged 6 to 23 months with a 2-dose schedule, comparing the immunogenicity and safety of MenQuadfi against control vaccines, including Sanofi’s own Menactra.

 

The results confirmed that MenQuadfi induced non-inferior immune responses across all serogroups (A, C, W, Y) compared with control vaccines, with a safety profile comparable with existing vaccines.

 

Hee-kyung Park, Director of Sanofi’s Vaccines Business Unit, said, “With the indication extension of MenQuadfi in Korea, we are pleased to be able to protect infants as early as 6 weeks of age from invasive meningococcal disease.

 

Sanofi will continue to work closely with health authorities to strengthen preventive strategies and secure protection against meningococcal infections across various age groups.”