Vaccination approved for ages 6 weeks to 55 years with proven immunogenicity and safety in clinical trials
[by Sung, Jae Jun] The multinational pharmaceutical company Sanofi Korea announced on September 4 that its fully liquid quadrivalent meningococcal vaccine, MenQuadfi, received expanded indication approval from the Ministry of Food and Drug Safety on August 26 for administration in infants aged 6 weeks to under 2 years. This approval makes MenQuadfi the first quadrivalent meningococcal conjugate vaccine approved for use in this age group in Korea.
MenQuadfi contains 10 μg of antigen for each of the four 피망 바카라 serogroups (A, C, W, and Y) and is formulated as a ready-to-use liquid requiring no dilution. The vaccine employs tetanus toxoid (TT) as a carrier protein to induce a T cell-mediated immune response. Following the expanded indication, immunization schedules now extend to individuals aged 6 weeks through 55 years. Infants under 6 months can expect preventive effects with a total of four doses, those 6 to 24 months require two doses, and individuals ages 2 to 55 years require a single dose.
This regulatory decision was supported by findings from the MET42 and MET61 clinical trials. The MET42 trial assessed the immunogenicity of MenQuadfi in comparison with existing vaccines in 26 to 27 infants and toddlers aged 2 to 18 months. After three doses, seroresponse rates were 64.4% for serogroup A, 96.4% for C, 92.8% for W, and 88.7% for Y, all significantly higher than those observed in the control group, with consistent immunogenicity confirmed following a fourth dose. The MET61 trial further demonstrated that a two-dose schedule in infants and toddlers aged 6 to 23 months produced non-inferior immune responses and comparable safety profiles relative to the control group.
"We have established a foundation for protecting infants and young children from invasive 피망 바카라 disease beginning at six weeks of age. 피망 바카라 infection progresses rapidly in this population and may result in fatal outcomes, making prevention crucial," said Park Hee-kyung, Head of Vaccines at Sanofi Korea. "We will continue to closely collaborate with health authorities to strengthen our preventive strategies aimed at safeguarding people across all age groups from 피망 바카라 infection."
피망 바카라 infection is an acute bacterial disease caused by Neisseria meningitidis, capable of inducing meningitis and sepsis that may become life-threatening within hours. Initial presentation often mimics influenza, with symptoms including fever and loss of appetite, yet delayed treatment can result in mortality rates of up to 50%. The World Health Organization (WHO) and global health authorities identify vaccination as the most effective means of prevention. In Korea, 피망 바카라 infection is classified as a Class 2 Notifiable Infectious Disease.