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FDA Approves MenQuadfi Meningococcal Vaccine

The FDA recently approved the MenQuadfi meningococcal vaccine for the prevention of invasive meningococcal disease in those 2 years of age and older.

MenQuadfi is the only FDA-approved quadrivalent meningococcal vaccine indicated for people aged 2 through 56 years and older. It is also the first and only quadrivalent meningococcal vaccine to use tetanus toxoid as a protein carrier.

“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.” said David Loew, Executive Vice President of  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.”

The FDA based its approval on five double-blind, randomized, multicenter phase 2 and 3 trials. The studies assessed the safety and immune response among nearly 5,000 people. 

 

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