MedPath
EMA Approval

MenQuadfi

J07AH08

meningococcus A,C,Y,W-135, tetravalent purified polysaccharides antigen conjugated

Vaccines

meningococcal group A, C, W-135 and Y conjugate vaccine

Meningitis, Meningococcal

Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid
Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid
Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid
Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid

Basic Information

EMA regulatory identification and product classification information

EMA Identifiers

ATC CodeJ07AH08
EMA European Classification

Overview Summary

Comprehensive product overview and regulatory summary

MenQuadfi is a vaccine used to protect adults and children from the age of 12 months against invasive meningococcal disease caused by four groups of the Neisseria meningitidis bacteria (group A, C, W, and Y). Invasive disease occurs when the bacteria spread through the body causing serious infections such as meningitis (infection of the membranes that surround the brain and spine) and septicaemia (blood poisoning).

The vaccine contains substances from the outer coat of N. meningitidis bacteria.

Authorisations (1)

EMEA/H/C/005084

Sanofi Winthrop Industrie,82 Avenue Raspail,94250 Gentilly,FRANCE

Authorised

November 18, 2020

Active Substances (4)

Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid

Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid

Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid

Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid

Documents (16)

MenQuadfi : EPAR - Procedural steps taken and scientific information after authorisation (archive)

April 19, 2021

CHANGES_SINCE_INITIAL_AUTHORISATION

MenQuadfi : EPAR - Public assessment report

November 27, 2020

CHANGES_SINCE_INITIAL_AUTHORISATION

CHMP summary of positive opinion for MenQuadfi

September 18, 2020

CHANGES_SINCE_INITIAL_AUTHORISATION

MenQuadfi H/C/005084/P46/013 - Assessment report

October 16, 2024

CHANGES_SINCE_INITIAL_AUTHORISATION

MenQuadfi-PAM-0000250392 : EPAR - Assessment report

June 11, 2025

CHANGES_SINCE_INITIAL_AUTHORISATION

MenQuadfi : EPAR - Procedural steps taken and scientific information after authorisation

March 3, 2025

CHANGES_SINCE_INITIAL_AUTHORISATION

MenQuadfi : EPAR - Medicine overview

November 27, 2020

OVERVIEW_DOCUMENT

MenQuadfi-H-C-005084-P46-009 : EPAR - Assessment report

February 8, 2024

CHANGES_SINCE_INITIAL_AUTHORISATION

MenQuadfi-H-C-005084-P46-007 : EPAR - Assessment report

May 3, 2024

CHANGES_SINCE_INITIAL_AUTHORISATION

MenQuadfi H/C/005084/P46/012 - Assessment report

July 30, 2024

CHANGES_SINCE_INITIAL_AUTHORISATION

MenQuadfi : EPAR - Public assessment report

November 27, 2020

INITIAL_MARKETING_AUTHORISATION_DOCUMENTS

MenQuadfi : EPAR - Risk management plan

November 27, 2020

RISK_MANAGEMENT_PLAN_SUMMARY

MenQuadfi-H-C-005084-P46-008 : EPAR - Assessment report

February 8, 2024

CHANGES_SINCE_INITIAL_AUTHORISATION

MenQuadfi : EPAR - Product information

November 27, 2020

DRUG_PRODUCT_INFORMATION

CHMP summary of positive opinion for MenQuadfi

September 18, 2020

INITIAL_MARKETING_AUTHORISATION_DOCUMENTS

MenQuadfi : EPAR - All authorised presentations

November 27, 2020

AUTHORISED_PRESENTATIONS

Overview Q&A (7)

Question

How is MenQuadfi used?

Answer

MenQuadfi is given as a single injection into the shoulder muscle or on the side of the thigh. Some people can be given a booster dose.

MenQuadfi can only be obtained with a prescription and should be used according to available official recommendations. For more information about using MenQuadfi, see the package leaflet or contact your doctor or pharmacist.

Question

How does MenQuadfi work?

Answer

MenQuadfi is a vaccine. Vaccines work by preparing the immune system (the body’s natural defences) to defend the body against a specific disease.

MenQuadfi contains small amounts of sugars from the outer coat of four groups of the N. meningitidis bacteria: A, C, W and Y. When a person is given the vaccine, the immune system recognises the sugars as ‘foreign’ and makes antibodies against them. If the person later comes into contact with the bacteria, these antibodies, together with other components of the immune system, will be able to fight off the bacteria more effectively and so help protect the person against the disease.

Question

What benefits of MenQuadfi have been shown in studies?

Answer

The ability of MenQuadfi to trigger the production of antibodies (immunogenicity) was assessed in seven main studies involving over 9,000 participants aged 1 year or older. MenQuadfi was compared with several other similar vaccines against N. meningitidis. Results showed that a single injection of MenQuadfi was as effective as the other vaccines in stimulating the body to produce antibodies that would protect against the four types of N. meningitidis.

Question

What are the risks associated with MenQuadfi?

Answer

The most common side effects with MenQuadfi (which may affect more than 1 in 10 people) are headache, muscle pain, malaise (feeling unwell) and pain at the site of injection. For the full list of side effects and restrictions of MenQuadfi, see the package leaflet.

Question

Why is MenQuadfi authorised in the EU?

Answer

MenQuadfi had been shown to be at least as effective as similar vaccines at stimulating an immune response to the four groups of the N. meningitidis bacteria in people of different age groups. Furthermore, MenQuadfi is well tolerated and there were no reports of serious or unexpected side effects. The European Medicines Agency therefore decided that MenQuadfi’s benefits are greater than its risks and it can be authorised for use in the EU.

Question

What measures are being taken to ensure the safe and effective use of MenQuadfi?

Answer

The company that markets MenQuadfi will complete studies to assess the effects of a second dose of the vaccine (a booster) after previous vaccination with MenQuadfi or a similar vaccine.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of MenQuadfi have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of MenQuadfi are continuously monitored. Side effects reported with MenQuadfi are carefully evaluated and any necessary action taken to protect patients.

Question

Other information about MenQuadfi

Answer

MenQuadfi received a marketing authorisation valid throughout the EU on 18.11.2020.

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