FDA approves Sanofi’s meningococcal conjugate vaccine

April 28, 2020

The US FDA has approved Sanofi’s meningococcal (groups A, C, Y, W) conjugate vaccine (MenQuadfi) to prevent invasive meningococcal disease in children aged 2 years or older.

The US FDA has approved Sanofi’s meningococcal (groups A, C, Y, W) conjugate vaccine (MenQuadfi) to prevent invasive meningococcal disease in children aged 2 years or older. The vaccine will be available in a ready-to-use liquid formulation and should be available for use in the United States in 2021.

The approval was based on results from 5 double-blind, randomized, multicenter phase 2 and 3 trials. The phase 3 trials are ongoing and are also examining the use of the vaccine in children aged as young as 6 weeks.

The most common adverse effects at the time of the first dose was pain at the injection site (25.5% to 45.2%), muscle ache (20.1% to 35.6%), headache (12.5% to 30.2%), and tiredness (14.5% to 26.0%). Booster doses had similar adverse events.

 

For more on the approval, see coverage from our sister publication Drug Topics.