FDA approves Sanofi’s meningococcal conjugate vaccine

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.