The European Commission has approved the vaccine for individuals aged 12 months and older against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y.
Following the EC approval, MenQuadfi is expected to become available in several European countries from 2021. MenQuadfi was approved by the FDA in the US for children aged 2+ in April this year.
EC approval follows seven Phase 2 and 3 trials, involving more than 6,300 individuals aged 12 months and older.
The vaccine was compared with other licensed combination vaccines across all age groups. It demonstrated a good safety profile and induced a high immune response against the four serogroups consistently across all studies.
Phase 3 studies are ongoing to investigate the vaccine in infants from 6 weeks old.
Invasive meningococcal disease remains a major public health challenge
While meningococcal meningitis is a rare bacterial infection, it can claim a life in 24 hours. The disease is caused by inflammation of the membranes which surround the brain and spinal cord, and patients can be left with a lifelong disability after infection.
In 2018, 3,233 Europeans contracted invasive meningococcal disease, and approximately one in 10 did not survive. Rates were highest in infants, followed by children under five years old, with a second peak in those aged 15–24 years.
Meningococcal meningitis, caused by N. meningitidis, is of particular importance due to its potential to cause large epidemics. However, five of the most common bacterial serogroups of – ABCWY – are vaccine preventable.
Thomas Triomphe, Head of Sanofi Pasteur, said: “Meningococcal meningitis can take one’s life in as little as one day and leave survivors with severe permanent disabilities. In Europe, there were more than 3,000 cases of Invasive Meningococcal Disease in 2018, half of them caused by serogroups C, W and Y.”
“One case is one too many. It is our ambition to make this vaccine available worldwide to further expand protection to as many people as possible. The European Commission’s approval of MenQuadfi takes us one step closer to achieving this goal.”
A world free of meningitis by 2030
Sanofi says it is committed to playing its part in achieving the WHO’s vision of a world free from meningitis by 2030. A draft global road map for the goal was published in October this year.
While many cases and deaths from meningitis are vaccine preventable, progress in defeating meningitis “lags behind that for other vaccine-preventable diseases,” according to the WHO.
For prevention and epidemic control, the main goals are to achieve high vaccine coverage, develop new vaccines, improve prevention strategies and ensure a more effective response to meningitis epidemics.
Although the burden of meningitis is greatest in the meningitis belt of sub-Saharan Africa, the WHO warns that meningitis is a threat worldwide.
Licensed vaccines against meningococcal disease have been available for more than 40 years, with major improvements in strain coverage and vaccine availability seen over time. All vaccines are serogroup specific, with no universal vaccine against meningococcal disease available (There are 12 known serogroups of N. meningitides).
Conjugate vaccines are used in prevention (into routine immunization schedules and preventive campaigns) and outbreak response. Available vaccines include monovalent C, monovalent A and tetravalent (ACYW).