European Commission approves MenQuadfi®, the latest innovation in
meningococcal (MenACWY) vaccination for individuals 12 months of
age and older
European Commission approves MenQuadfi®, the latest
innovation in meningococcal (MenACWY) vaccination for individuals
12 months of age and older
- EC approval based on robust data from seven pivotal Phase 2 and
3 trials1,2,3,4,5,6,7 involving more than 6,300 individuals aged 12
months and older
- First quadrivalent meningococcal conjugate vaccine available in
Europe in a fully liquid presentation, avoiding the need for
vaccine reconstitution
- Meningococcal disease is a rare but highly unpredictable deadly
bacterial infection, with more than 3,000 cases per year in
Europe8
PARIS – November 23 – The
European Commission (EC) has approved MenQuadfi® for active
immunization of individuals from the age of 12 months and older
against invasive meningococcal disease caused by Neisseria
meningitidis serogroups A, C, W and Y.9
“Meningococcal meningitis can take one’s life in
as little as one day and leave survivors with severe permanent
disabilities.10,11 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,”8 says Thomas Triomphe, Head of Sanofi
Pasteur. “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.”
Efficacy and safety profiles for
MenQuadfi confirmed in robust clinical program
The European Commission’s decision is based upon
results from a robust and comprehensive international clinical
program, including seven pivotal Phase 2 and 3 randomized,
active-controlled, multi-center studies. The immunogenicity and
safety of MenQuadfi were evaluated in over 6,300 healthy
individuals aged 12 months and older, who received a single dose of
MenQuadfi.1,2,3,4,5,6,7
MenQuadfi was compared with other licensed
combination vaccines across all age groups. It demonstrated a good
safety profile and induced a high immune response against all four
serogroups (A, C, W and Y) consistently across all
studies.1,2,3,4,5,6,7
“The introduction of a new vaccine against four
of the major serogroups of meningococcal disease is very welcome
news. The disease is unpredictable and remains the biggest cause of
sepsis and septic shock in children across Europe today,12” says
Professor Federico Martinón-Torres, Pediatrician and Clinical
Researcher, Head of Pediatrics and Vaccine Research Unit at
Hospital Clínico Universitario de Santiago in Spain. “Meningococcal
disease is vaccine-preventable but, in spite of its threat, there
is currently no common immunization schedule for it in Europe. The
approval of MenQuadfi in Europe will contribute to our efforts to
protect against, and help defeat, this truly devastating
disease.”
In order to better address the global need for
meningococcal disease prevention over the life course, Phase 3
studies are ongoing to investigate the vaccine in infants from 6
weeks of age.13,14,15,16,17,18
Invasive meningococcal disease remains a
major public health challenge
Invasive meningococcal disease (IMD)
epidemiology is highly unpredictable and varies widely across
geographies and over time. In Europe, with the increase in
incidence of IMD caused by hypervirulent serogroup W, several
countries have introduced MenACWY conjugate vaccination into their
routine vaccination schedules. However, considerable variation
remains between European countries, leaving room for outbreaks in
unprotected and vulnerable populations.19
In 2018, 3,233 individuals contracted invasive
meningococcal disease in Europe, and approximately 1 in 10 did not
survive. Of the total number of cases, 2,911 were reported to be
serogroups B, C, W or Y, of which almost half (47%) were serogroup
C, W or Y.8 Rates were highest in infants, followed by children
under 5 years, with a second peak in those aged 15–24 years.8
About MenQuadfi
MenQuadfi benefits from Sanofi’s latest
advancements in chemical design and delivers optimized stability
while maintaining the vaccine in a convenient, fully liquid
presentation. The vaccine can be administered as a single dose,
supporting primary and booster vaccination to a wide age group,
ranging from 12-month-old toddlers to children, adolescents, adults
and the elderly. It can also be co-administered with multiple
routine pediatric and adolescent vaccines.2,4
The safety of a single dose of MenQuadfi was
evaluated in 6,308 individuals 12 months of age and older. The
most frequently reported adverse reactions in toddlers 12–23 months
of age were irritability and injection site tenderness. Those in
vaccine recipients aged 2 years and above were myalgia and
injection site pain. These adverse reactions were mostly mild or
moderate in intensity. Immune non-inferiority was consistently
demonstrated across all age groups for all four serogroups and
versus all comparator vaccines.
Following EC approval, MenQuadfi is expected to
be available in several European countries from 2021 to help
protect individuals 12 months of age and older.
MenQuadfi is licensed by the Food and Drug
Administration (FDA) in the United States for the prevention of
Invasive Meningococcal Disease in individuals 2 years of age and
older, and is currently under review by several health authorities
across the world to help meet local immunization efforts.
About Sanofi Sanofi is dedicated to
supporting people through their health challenges. We are a global
biopharmaceutical company focused on human health. We prevent
illness with vaccines, provide innovative treatments to fight pain
and ease suffering. We stand by the few who suffer from rare
diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe. Sanofi, Empowering Life |
Media Relations Contact Nicolas Kressmann Tel.: +1
(732) 532-5318 Nicolas.Kressmann@sanofi.com |
Investor Relations Contacts Paris Eva
Schaefer-Jansen Arnaud DelepineYvonne Naughton
Investor Relations Contacts North America Felix
LauscherFara BerkowitzSuzanne Greco IR main line:Tel.: +33
(0)1 53 77 45 45 investor.relations@sanofi.com |
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release contains forward-looking statements as defined in the
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Forward-looking statements are statements that are not historical
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things, unexpected regulatory actions or delays, or government
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and development, including future clinical data and analysis of
existing clinical data relating to the product, including post
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1 EU Clinical Trials Register. 2016-000749-30 (MET51) results
summary. November 2018. Available at:
https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-000749-30/results
[accessed September 2020].
2 EU Clinical Trials Register. 2018-001472-38 (MET57) results
summary. August 2019. Available at:
https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-001472-38/results
[accessed September 2020].
3 EU Clinical Trials Register. 2018-001471-20 (MET35) results
summary. December 2018. Available at:
https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-001471-20/results
[accessed September 2020].
4 EU Clinical Trials Register. 2016-001963-35 (MET50) results
summary. January 2019. Available at:
https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-001963-35/results
[accessed September 2020].
5 EU Clinical Trials Register. 2018-001468-48 (MET43) results
summary. December 2018. Available at:
https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-001468-48/results
[accessed September 2020].
6 Clinicaltrials.gov. NCT02842866 (MET49) results summary.
February 2020. Available at:
https://clinicaltrials.gov/ct2/show/results/NCT02842866 [accessed
September 2020]
7 Clinicaltrials.gov. NCT02752906 (MET56) results summary. June
2020. Available at:
https://clinicaltrials.gov/ct2/show/results/NCT02752906 [accessed
September 2020].
8 European Centre for Disease Prevention and Control (ECDC).
Surveillance Atlas of Infectious Diseases. Available at:
https://www.ecdc.europa.eu/en/meningococcal-disease/surveillance-and-disease-data/atlas
[accessed September 2020].
9 MenQuadfi Summary of Product Characteristics.
10 Beebeejaun, K et al. (2020). Invasive meningococcal disease:
Timing and cause of death in England, 2008–2015. Journal of
Infection. Available at: https://doi.org/10.1016/j.jinf.2019.12.008
[accessed September 2020].
11 European Centre for Disease Prevention and Control (ECDC).
Factsheet about meningococcal disease. Available at:
https://www.ecdc.europa.eu/en/meningococcal-disease/factsheet#:~:text=In%202016%2C%203%20280%20confirmed,Member%20States%20(Figure%201)
[accessed September 2020].
12 Martinón-Torres, F et al. (2018). Life-threatening infections
in children in Europe: a prospective cohort study. The Lancet Child
& Adolescent Health 2(6):404–414.
13 Clinicaltrials.gov. NCT03632720 (MET52) results summary.
August 2018. Available at:
https://www.clinicaltrials.gov/ct2/show/NCT03632720?term=MET&cond=Meningococcal+Disease&lead=Sanofi+Pasteur&draw=2&rank=1
[accessed September 2020].
14 Clinicaltrials.gov. NCT03673462 (MET41) results summary.
September 2018. Available at:
https://clinicaltrials.gov/ct2/show/NCT03673462?term=MET41&draw=2&rank=1
[accessed September 2020].
15 Clinicaltrials.gov. NCT03691610 (MET61) results summary.
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2020].
16 Clinicaltrials.gov. NCT03547271 (MET58) results summary. June
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17 Clinicaltrials.gov. NCT03630705 (MET33) results summary.
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18 Clinicaltrials.gov. NCT03537508 (MET42) results summary. May
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19 Sanofi Pasteur (2020). Meningococcal Disease in Europe: A
Rare but Devastating Disease.
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