Vaccine; meningococcal manufacturers

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vaccine; meningococcal

Injection 0.5 ml

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #20401
This pharmaceutical company has two decades of experience manufacturing cost-effective medications across various therapeutic areas. Their product portfolio includes tablets, capsules, injectables, liquid orals, and topical solutions. They specialize in expert formulation development and possess advanced analytical capabilities to ensure quality and regulatory compliance. The company's key markets include the EU and North America. Their GMP certified manufacturing facility is strategically located near a major commercial hub.

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About meningococcal vaccine

Meningococcal vaccine manufacturers include GSK (Menveo, Bexsero, Penmenvy), Pfizer (Nimenrix, Trumenba, Penbraya), Sanofi (MenQuadfi) and Serum Institute of India (MenFive, MenAfriVac). Meningococcal vaccines protect against Neisseria meningitidis, a bacterium that causes meningitis and bloodstream infections. They target different serogroups, mainly A, B, C, W, X and Y. Pharmaceutical companies can source meningococcal vaccines through supply, regional licensing or technology transfer.

Meningococcal vaccine key facts

Property

Meningococcal vaccine

ATC code

J07AH (meningococcal vaccines)

Vaccine class

Bacterial conjugate or protein vaccines

MenACWY conjugate vaccines

Menveo (GSK); Nimenrix (Pfizer); MenQuadfi (Sanofi)

MenB protein vaccines

Bexsero (GSK); Trumenba (Pfizer)

MenABCWY pentavalent vaccines

Penbraya (Pfizer, US, October 2023); Penmenvy (GSK, US, February 2025)

Africa-focused conjugates

MenAfriVac (MenA, Serum Institute of India, 2010); MenFive (MenACYWX, Serum Institute of India, WHO prequalified July 2023)

Dosage form

Suspension or powder for intramuscular injection

Indications

Prevention of invasive meningococcal disease in infants, adolescents, adults and high-risk groups

Discontinued products

Menactra (Sanofi) replaced by MenQuadfi

Generic / biosimilar status

Not applicable; each vaccine licensed separately

Meningococcal vaccine manufacturers and licensing history

Early meningococcal vaccines were polysaccharides, which gave short protection and worked poorly in infants. Conjugate vaccines, linking the sugars to a carrier protein, replaced them from the late 1990s. Today, MenACWY conjugate vaccines from GSK, Pfizer and Sanofi are standard in high-income countries.

Serogroup B needed a different approach, because its sugar resembles human tissue. GSK's Bexsero and Pfizer's Trumenba use bacterial proteins instead. Pentavalent MenABCWY vaccines combine both approaches: Pfizer's Penbraya was approved in the US in October 2023 and GSK's Penmenvy in February 2025.

For Africa's meningitis belt, Serum Institute of India developed MenAfriVac (MenA) in 2010 and MenFive (MenACYWX), WHO prequalified in July 2023. Buyers should confirm serogroup coverage, WHO prequalification or national licensing, GMP status and supply capacity before choosing a supplier.

Meningococcal vaccine dosage forms and dossier types

Meningococcal vaccines are supplied as suspensions or lyophilised powders for intramuscular injection.

Form

Serogroups

Typical dossier

Notes

MenACWY conjugate vaccine

A, C, W, Y

US BLA; EU MAA; WHO PQ

Infants, adolescents, travellers

MenB protein vaccine

B

US BLA; EU MAA

Infants and adolescents

MenABCWY pentavalent vaccine

A, B, C, W, Y

US BLA

Adolescents and young adults

MenACYWX conjugate vaccine

A, C, W, X, Y

WHO PQ

African meningitis belt

Target market

Dossier format

Key requirement

United States, European Union

BLA / MAA

National immunisation schedules

African meningitis belt

WHO prequalification

Gavi and UNICEF procurement

Travel and Hajj markets

National licence

MenACWY required for Hajj pilgrims

Meningococcal vaccine regulatory and patent status

Each meningococcal vaccine is licensed separately on its own clinical data. Conjugate and protein vaccine technologies are protected by patents and know-how, especially for newer MenB and pentavalent vaccines. The WHO prequalified Serum Institute of India's MenFive in July 2023 for use in Africa. Check national schedules, as recommendations differ between countries.

Meningococcal vaccine mechanism of action and therapeutic use

Conjugate vaccines link meningococcal capsular sugars to a carrier protein, producing strong, long-lasting immunity even in infants. MenB vaccines use surface proteins of the bacteria instead. Antibodies kill the bacteria before they can cause disease. Meningococcal vaccines are used in infants, adolescents, travellers, Hajj pilgrims and people with weakened immunity.

Meningococcal vaccine licensing and sourcing

Meningococcal vaccine suppliers and licensing partners typically offer finished vaccine supply, regional licensing or technology transfer. Buyers usually compare serogroup coverage, WHO prequalification, GMP status and price. Current offers and supplier contacts are listed among the meningococcal vaccine manufacturers on Pipelinepharma.

Frequently asked questions about meningococcal vaccine

Who are the main meningococcal vaccine manufacturers? GSK, Pfizer and Sanofi are the main suppliers in high-income markets. Serum Institute of India supplies MenAfriVac and MenFive for Africa.

What is the difference between MenACWY and MenB vaccines? MenACWY vaccines are conjugate vaccines against serogroups A, C, W and Y. MenB vaccines use proteins to protect against serogroup B.

What is a pentavalent meningococcal vaccine? Pentavalent MenABCWY vaccines, such as Penbraya and Penmenvy, protect against serogroups A, B, C, W and Y in one vaccine.

Which meningococcal vaccine is used in Africa? MenAfriVac (MenA) and MenFive (MenACYWX), both from Serum Institute of India, are used in the African meningitis belt.

Is meningococcal vaccine required for travel? MenACWY vaccine is required for Hajj and Umrah pilgrims and is recommended for travel to the African meningitis belt.

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