Sanofi vaccine is approved by the European Union for the prevention of meningococcal disease in people 12 months and older

On 23 November, the European Commission (EC) approved the Sanofi-Pasteur vaccine MenQuadfi® to be actively immunized against invasive meningococcal disease caused by Meningitis A, C, W and Y.
The EC decision was based on the results of a strong, comprehensive international clinical project that included seven key Phase 2 and Phase 3 randomized, actively controlled, multi-center clinical studies evaluating immunogenicity and safety of single-dose MenQuadfi vaccinations in 6,300 healthy people 12 months and older.
compared MenQuadfi vaccination with other approved combined vaccines for all age group participants.
all studies have shown that MenQuadfi is safe and has a high immune response to all four serum groups (A, C, W and Y) of meningococcal disease.
in children between 12 and 23 months of age, the most common adverse reactions were irritability and pain at the injection site.
those aged 2 years and older have myalgia and pain at the injection site.
these adverse reactions are mostly mild or moderate.
non-poor effectiveness of all four serum groups was consistent across all age groups and all controlled vaccines.
the effectiveness and safety of MenQuadfi has been proven in the above clinical projects.
addition, in order to better meet the global demand for lifelong prevention of meningococcal disease, Phase 3 clinical studies are still under way to investigate the vaccine's use to protect infants under 6 weeks of age.
according to Sanofi Pasteur, invasive meningococcal disease (IMD) epidemiology is highly unpredictable and varies greatly geographically over time.
in Europe, some countries have introduced Novartis' meningococcal-binding vaccine MenACWY in their routine vaccination programmes as the incidence of IMD caused by the highly pathogenic meningococcal serum group W increases.
, however, the differences between European countries remain large, leaving room for outbreaks among unpthoned and vulnerable populations.
, IMD remains a major public health challenge.
, MenQuadfi had been licensed by the FDA to prevent IMD in people 2 years of age and older.
EC approval, MenQuadfi is expected to be available in several European countries from 2021 to help protect individuals 12 months and older.
source: European Commission approves Men Quidfi®, the latest innovation in meningoccal (MenACWY) ingingoccal (MenACWY) for individuals 12 months of age and older