MenQuadfi  Meningococcal (Groups A, C, Y, W) Conjugate is a new Vaccine for the prevention of invasive meningococcal disease in persons 2 years of age and older.

“Meningococcal meningitis remains a major global health challenge because it can strike quickly and with devastating effect, taking a life in less than 24 hours. With the ability to help prevent this disease through vaccination, Sanofi believes one case is one too many,” said David Loew, Executive Vice President, Sanofi Pasteur. “Approval of this new vaccine in the U.S. represents an important milestone in the ongoing fight to help protect as many people as possible from meningococcal disease. It is our ambition to make this vaccine available to further expand protection to individuals worldwide.”

MenQuadfi was designed to elicit and demonstrated a high immune response across all four serogroups for multiple ages and was well tolerated. MenQuadfi is intended to protect an expanded age group. Licensure marks MenQuadfi as the only U.S. FDA-approved quadrivalent meningococcal vaccine indicated for persons 2 through 56 years of age and older. MenQuadfi is the first and only quadrivalent meningococcal vaccine in the U.S. that uses tetanus toxoid as a protein carrier. It will be available in a ready-to-use liquid formulation allowing healthcare providers to avoid vaccine reconstitution.

The ongoing Phase 3 trials are investigating use in infants as young as 6 weeks of age to better address the worldwide needs for meningococcal disease prevention throughout life.

“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,” said Corey Robertson, MD, Senior Director, Scientific and Medical Affairs at Sanofi Pasteur. “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.”

MenQuadfi is expected to be available to providers and pharmacies nationwide in the U.S. for immunization efforts in 2021.

In the U.S., the 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. Despite strong public health recommendations, about half of teens have not received the recommended second dose of MenACWY vaccine by 17 years of age, leaving them vulnerable when they are at increased risk for the disease. Hundreds of cases of vaccine-preventable meningococcal disease (caused by serogroups B, C, W, Y) still occur annually in the U.S. and, despite treatment, one in five survivors suffer from permanent complications such as hearing loss, organ damage, and limb amputations.

Around the world, meningococcal disease is highly unpredictable, and it varies widely across regions and ages. Accordingly, vaccination recommendations differ from country to country. Disease still occurs in unvaccinated individuals. MenQuadfi’s safety and effectiveness data are currently under review though not yet fully evaluated by other health authorities, including those in several other countries and the European Union, to help address their local vaccination recommendations.