The U.S. Food and Drug Administration (FDA) has greenlit Sanofi’s MenQuadfi Meningococcal Conjugate Vaccine for the prevention of invasive meningococcal disease in individuals at least two years old, the company announced this morning.
David Loew, head of Sanofi Pasteur, the vaccines division of the French pharma giant, said U.S. approval of the vaccine is an important milestone in the fight against meningococcal meningitis, a serious global health challenge that can be fatal within 24 hours. The U.S. Centers for Disease Control and Prevention recommends vaccination against meningococcal disease at 11-12 years of age and a second dose at 16 years of age. Loew said the company hopes the vaccine will be available across the globe. It remains under review in Europe, as well as in other parts of the world.
The newly-approved vaccine is meant to treat meningococcal meningitis caused by serogroups A, C, W, and Y of the bacterium N meningitidis. MenQuadfi does not prevent serogroup B disease, Sanofi noted in its announcement. MenQuadfi is the first and only quadrivalent meningococcal vaccine in the U.S. that uses tetanus toxoid as a protein carrier, Sanofi said. Additionally, Sanofi said licensure marks MenQuadfi as the only U.S. FDA-approved quadrivalent meningococcal vaccine indicated for persons 2 through 56 years of age and older. The company added the medication will be available in a ready-to-use liquid formulation allowing healthcare providers to avoid vaccine reconstitution.
MenQuadfi was approved based on the results of five Phase II and III trials that demonstrated the safety and efficacy of the treatment. Four studies evaluated MenQuadfi in meningococcal-naïve persons; the other study evaluated MenQuadfi in persons previously immunized with a quadrivalent meningococcal vaccine. Against each of the four meningococcal serogroups (A, C, W, Y), the majority, 55.4% to 97.2% of meningococcal-naïve trial participants, had a vaccine-induced immune response 30 days following vaccination with MenQuadfi. Among adolescents and adults previously vaccinated, 92.2% to 98.2% demonstrated an immune response against each serogroup, Sanofi said in its announcement.
“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,” Corey Robertson, head of Scientific and Medical Affairs at Sanofi Pasteur said in a statement. “MenQuadfi’s pivotal clinical trials demonstrated a high immune response across all four serogroups and provides a new vaccine option to help protect an expanded age group.”
Sanofi continues to test MenQuadfi in Phase III studies in infants as young as 6 weeks of age.
A Product Manager with expertise in pharma marketing and sales operations