Meningococcal vaccine! EU Approved Sanofi Men Quadfi: The first all-liquid 4-price vaccine ≥ 12-month-olds!

Nov 23, 2020 // -- Sanofi (EC) has approved Meningococcal conjunctivation vaccine Men Quardfi for active immunization in people 12 months and older to prevent invasive meningococcal disease caused by meningococcal groups A, C, W and Y.
in Europe, meningococcal disease is a rare but highly unpredictable and deadly bacterial infection, but there are more than 3,000 cases each year.
it is worth mentioning that MenQuadfi is the first European-approved quadrant meningococcal vaccine to be available in ready-to-use, all-liquid preparations, eliminating the need for vaccine reconstruction for healthcare providers.
expected MenQuadfi to be available in several European countries from 2021 to help protect people 12 months and older.
U.S., MenQuadfi was approved by the FDA in April to prevent invasive meningococcal disease in people 2 years and older.
it's worth noting that MenQuadfi is the only FDA-approved four-price meningococcal vaccine for people ages 2 to 56 and older.
the vaccine is also the first and only teyrobacterial meningococcal vaccine in the United States that uses tethroid toxins as a protein carrier.
the vaccine as a ready-to-use liquid preparation, eliminating the need for vaccine reconstruction for healthcare providers.
MenQuadfi is the latest innovation in MenacWY immunity, a vaccine that produces a high immune response and is well-resistant to all four serum groups in multiple age groups.
the vaccine is designed to protect an expanded age group.
, MenQuadfi's regulatory review in other countries is ongoing.
meningococcal (photo: britannica.com) invasive meningococcal disease (IMD) remains a major public health challenge, with a high degree of unforced epidemiology and significant geographical differences over time.
in Europe, some countries have introduced MenACWY-binding vaccines in their routine vaccination programmes as the incidence of IMD caused by highly pathogenic serum group W increases.
, however, there are still significant differences between European countries, leaving room for outbreaks among unpthoned and vulnerable populations.
In 2018, 3,233 people in Europe were infected with invasive meningococcal disease, about one in ten died;
incidence was highest among infants, followed by children under 5 years of age, with another peak occurring in the 15-24 age group. Thomas Triomphe, head of Sanofi Pasteur, said:
Meningococcal meningitis remains a major global health challenge, taking lives in just one day and severely and permanently disabling survivors.
europe, there were more than 3,000 cases of invasive meningococcal disease in 2018, half of which were caused by C, W and Y serum groups.
our goal is to make this vaccine available worldwide to further expand the protection of as many people as possible.
the European Commission's approval of Men Quadfi brings us one step closer to achieving this goal.
" MenQuadfi benefits from Sanofi's latest advances in chemical design, providing optimal stability while maintaining a vaccine that is convenient and fully liquid.
the vaccine can be given in single doses, supporting primary and intensive vaccinations for a wide range of age groups, from 12-month-olds to children, adolescents, adults and the elderly.
can also be used in combination with a variety of conventional vaccines for children and adolescents.
EU approval of MenQuadfi is based on the results of a robust and comprehensive international clinical project, including reliable data from 7 key Phase 2 and Phase 3 randomized, positive control, multi-center studies.
study assessed the immunogenicity and safety of MenQuadfi vaccination, with 6,308 healthy subjects aged 12 months and older immunized against a single dose of MenQuadfi.
in all age groups, MenQuadfi compared it with other vaccines that have been marketed.
results showed that MenQuadfi showed good safety in all age groups in all studies, induced high levels of immune response for all four serum groups (A, C, W, Y), and showed non-poor effectiveness compared to controlled vaccines.
in children between 12 and 23 months of age, the most common adverse reactions are irritability and pain at the injection site.
the most ≥ reactions among 2-year-olds are myalgia and injection site pain.
these reactions are mostly mild or moderate.
to better meet the global demand for lifelong prevention of meningococcal disease, Sanofi is currently conducting a number of Phase 3 clinical trials to investigate MenQuadfi in infants and young children 6 weeks and older.
() Original origin: European Commission approves Men Quadfi ®, the latest innovation in menacococcal (MenACWY) for individuals 12 months of age and older