Sanofi’s Meningococcal Conjugate Vaccine secures FDA approval in patients aged two and up
pharmafile | April 27, 2020 | News story | Sales and Marketing | FDA, MenQuadfi, Sanofi, US, meningococcal disease, pharma
Sanofi’s MedQuadfi Meningococcal Conjugate Vaccine has scored FDA approval for the prevention of invasive meningococcal disease, becoming the first and only product available in the US for this indication in patients of at least two years old.
According to Sanofi, the product is also the first and only quadrivalent vaccine available in the US for the prevention of the disease that uses tetanus toxoid as a protein carrier, while the company also confirmed that the product will be made available in a ready-to-use liquid formulation.
The vaccine is designed to prevent meningococcal meningitis caused by serogroups A, C, W, and Y of the bacterium N meningitidis. However, it does not protect against disease originating from serogroup B. It proved its efficacy in five Phase 2 and 3 trials of almost 5,000 total patients, with four investigating its use in meningococcal-naïve participants, and a fifth investigating its use in participants who had already received a quadrivalent meningococcal vaccine.
MenQuadfi proved non-inferior in terms of elicited immune response compared to other licensed quadrivalent vaccines, with data showing that between 55.4% and 97.2% of previously untreated patients in each of the four serogroups achieved an immune response 30 days after receiving vaccination. This figure rose to between 92.2% and 98.2% against each serogroup in patients who had previously been vaccinated.
“Given the severity and unpredictability of meningococcal disease, there is a public health need to ensure immunisation across multiple ages, consistent with US recommendations,” commented Dr Corey Robertson, Senior Director, Scientific and Medical Affairs at Sanofi. “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.”
The vaccine is expected to be available in 2021. Vaccination from meningococcal disease is recommended by the US Centers for Disease Control and Prevention (CDC) to occur at 11 or 12 years of age, with a second dose following at 16 years of age.
Matt Fellows
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