the Food and Drug Management (FDA) has broadened the approved use of the quadrivalent meningococcal vaccine (MenQuadfi) to include infants aged 6 weeks to 23 months, for the prevention of invasive meningococcal disease.

David Loew, executive vice president of Sanofi Pasteur, stated in a news release that “Meningococcal meningitis remains a major global health challenge as it can strike quickly and with devastating effect, taking a life in less than 24 hours.”

MenQuadfi is administered as a single 0.5 mL intramuscular injection for active immunization against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. Neisseria meningitidis are bacteria residing in the nasal passages and throat,and can sometimes spread to other areas of the body,leading to infection.

For infants aged 6 weeks and older, the recommended dosing schedule involves a 4-dose series, administered at 2, 4, 6, and between 12 and 18 months of age. Infants aged 6 months through 23 months should receive a 2-dose series, with the second dose given during the second year of life, at least 3 months after the initial dose.

Meningococcal Disease: Understanding the Risks

The Centers for Disease Control and Prevention (CDC) reports that meningococcal bacteria are transmitted through respiratory and throat secretions via close or prolonged contact, such as kissing or cohabitation. Meningitis and bloodstream infections are the most prevalent forms of meningococcal infections. Meningitis causes inflammation of the membranes surrounding the brain and spinal cord, while bloodstream infections can lead to bleeding in the skin and organs.

Symptoms of meningococcal meningitis include fever, stiff neck, headache, confusion, increased sensitivity to light, nausea, and vomiting. Infants may exhibit atypical symptoms such as vomiting, abnormal reflexes, a bulging anterior fontanelle, poor feeding, irritability, and lethargy.

Corey Robertson, head of scientific and medical affairs at Sanofi Pasteur, emphasized the importance of broad immunization, stating, “Given the severity and unpredictability of meningococcal disease, there is a public health need to ensure immunization across multiple ages, consistent with U.S. recommendations.”

key Features of MenQuadfi

MenQuadfi stands out as the first and only quadrivalent meningococcal vaccine in the U.S. that utilizes tetanus toxoid as a protein carrier. It is also the sole FDA-approved quadrivalent meningococcal vaccine for individuals aged 2 through 56 years.

Prior FDA Approval

The FDA initially approved MenQuadfi in April 2020 for individuals aged 2 years and older, based on data from five phase 2 and 3 trials. These trials assessed the vaccine’s safety and immune responses in nearly 5,000 participants. Results indicated that MenQuadfi demonstrated non-inferiority in immune responses compared to other licensed quadrivalent meningococcal vaccines. Four of the studies involved individuals who had not previously received a meningococcal vaccine, while the fifth study included those with prior immunization.

Among individuals new to meningococcal vaccination, 55.4% to 97.2% exhibited a vaccine-induced immune response against each of the four meningococcal serogroups (A,C,W,Y) 30 days post-vaccination. In previously vaccinated adolescents and adults, 92.2% to 98.2% developed an immune response against each serogroup.

The most commonly reported adverse events following the first dose included injection site pain, muscle ache, headache, and fatigue.

Roberton noted that “MenQuadfi’s pivotal clinical trials demonstrated a high immune response across all four serogroups and provide a new vaccine option to help protect an expanded age group.”