European Fee approves MenQuadfi®, the newest innovation in meningococcal (MenACWY) vaccination for people 12 months of age and older
- EC approval based mostly on strong information from seven pivotal Part 2 and three trials1,2,3,4,5,6,7 involving greater than 6,300 people aged 12 months and older
- First quadrivalent meningococcal conjugate vaccine accessible in Europe in a totally liquid presentation, avoiding the necessity for vaccine reconstitution
- Meningococcal illness is a uncommon however extremely unpredictable lethal bacterial an infection, with greater than 3,000 circumstances per yr in Europe8
PARIS – November 23 – The European Fee (EC) has accepted MenQuadfi® for energetic immunization of people from the age of 12 months and older towards invasive meningococcal illness brought on by Neisseria meningitidis serogroups A, C, W and Y.9
“Meningococcal meningitis can take one’s life in as little as at some point and depart survivors with extreme everlasting disabilities.10,11 In Europe, there have been greater than 3,000 circumstances of Invasive Meningococcal Illness in 2018, half of them brought on by serogroups C, W and Y,”8 says Thomas Triomphe, Head of Sanofi Pasteur. “One case is one too many. It’s our ambition to make this vaccine accessible worldwide to additional develop safety to as many individuals as doable. The European Fee’s approval of MenQuadfi takes us one step nearer to attaining this objective.”
Efficacy and security profiles for MenQuadfi confirmed in strong scientific program
The European Fee’s resolution relies upon outcomes from a sturdy and complete worldwide scientific program, together with seven pivotal Part 2 and three randomized, active-controlled, multi-center research. The immunogenicity and security of MenQuadfi had been evaluated in over 6,300 wholesome people aged 12 months and older, who obtained a single dose of MenQuadfi.1,2,3,4,5,6,7
MenQuadfi was in contrast with different licensed mixture vaccines throughout all age teams. It demonstrated a great security profile and induced a excessive immune response towards all 4 serogroups (A, C, W and Y) constantly throughout all research.1,2,3,4,5,6,7
“The introduction of a brand new vaccine towards 4 of the foremost serogroups of meningococcal illness could be very welcome information. The illness is unpredictable and stays the most important reason for sepsis and septic shock in kids throughout Europe at the moment,12” says Professor Federico Martinón-Torres, Pediatrician and Scientific Researcher, Head of Pediatrics and Vaccine Analysis Unit at Hospital Clínico Universitario de Santiago in Spain. “Meningococcal illness is vaccine-preventable however, despite its risk, there’s at present no frequent immunization schedule for it in Europe. The approval of MenQuadfi in Europe will contribute to our efforts to guard towards, and assist defeat, this actually devastating illness.”
With the intention to higher handle the worldwide want for meningococcal illness prevention over the life course, Part Three research are ongoing to research the vaccine in infants from 6 weeks of age.13,14,15,16,17,18
Invasive meningococcal illness stays a significant public well being problem
Invasive meningococcal illness (IMD) epidemiology is extremely unpredictable and varies extensively throughout geographies and over time. In Europe, with the rise in incidence of IMD brought on by hypervirulent serogroup W, a number of international locations have launched MenACWY conjugate vaccination into their routine vaccination schedules. Nonetheless, appreciable variation stays between European international locations, leaving room for outbreaks in unprotected and weak populations.19
In 2018, 3,233 people contracted invasive meningococcal illness in Europe, and roughly 1 in 10 didn’t survive. Of the entire variety of circumstances, 2,911 had been reported to be serogroups B, C, W or Y, of which just about half (47%) had been serogroup C, W or Y.8 Charges had been highest in infants, adopted by kids underneath 5 years, with a second peak in these aged 15–24 years.8
MenQuadfi advantages from Sanofi’s newest developments in chemical design and delivers optimized stability whereas sustaining the vaccine in a handy, absolutely liquid presentation. The vaccine will be administered as a single dose, supporting major and booster vaccination to a large age group, starting from 12-month-old toddlers to kids, adolescents, adults and the aged. It may also be co-administered with a number of routine pediatric and adolescent vaccines.2,4
The security of a single dose of MenQuadfi was evaluated in 6,308 people 12 months of age and older. Essentially the most continuously reported antagonistic reactions in toddlers 12–23 months of age had been irritability and injection web site tenderness. These in vaccine recipients aged 2 years and above had been myalgia and injection web site ache. These antagonistic reactions had been largely delicate or average in depth. Immune non-inferiority was constantly demonstrated throughout all age teams for all 4 serogroups and versus all comparator vaccines.
Following EC approval, MenQuadfi is predicted to be accessible in a number of European international locations from 2021 to assist defend people 12 months of age and older.
MenQuadfi is licensed by the Meals and Drug Administration (FDA) in the US for the prevention of Invasive Meningococcal Illness in people 2 years of age and older, and is at present underneath assessment by a number of well being authorities the world over to assist meet native immunization efforts.
Sanofi is devoted to supporting individuals by means of their well being challenges. We’re a world biopharmaceutical firm targeted on human well being. We forestall sickness with vaccines, present progressive therapies to battle ache and ease struggling. We stand by the few who are suffering from uncommon ailments and the hundreds of thousands with long-term continual circumstances.
With greater than 100,000 individuals in 100 international locations, Sanofi is remodeling scientific innovation into healthcare options across the globe.
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