Quadrivalent influenza vaccine manufacturers

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Country of origin : Argentina
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quadrivalent influenza vaccine

Injection, pre-filled syringe 0.25 ml, 0.5 ml

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Argentina
GMP approvals
PICS
Comments
Two different influenza type A and type B strains
Manufacturer #16454

A pharmaceutical company based in South America with 15+ years of experience in a drug market. More than 40 products in 25+ countries: LATAM; Wester, Southern and South-eastern Asia. Company’s therapeutic areas consist of products that can used in such areas as: urology, oncology, rare diseases and more.

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About quadrivalent influenza vaccine

Quadrivalent influenza vaccine manufacturers include Sanofi, GSK, CSL Seqirus, AstraZeneca and Viatris, plus producers in China, Korea and India. Quadrivalent vaccines protect against four flu strains: two influenza A and two influenza B (Victoria and Yamagata). Because the B/Yamagata strain has not been detected since 2020, the US and most of Europe have switched to trivalent vaccines. Quadrivalent vaccines remain in use in some other markets. Pharmaceutical companies can source influenza vaccines through supply, regional licensing or technology transfer.

Quadrivalent influenza vaccine key facts

Property

Quadrivalent influenza vaccine

Strains

Two influenza A (H1N1, H3N2) and two influenza B (Victoria, Yamagata)

ATC codes

J07BB02 (inactivated split or subunit); J07BB03 (live attenuated)

Vaccine types

Egg-based inactivated; cell-based inactivated; recombinant; live attenuated nasal; adjuvanted; high-dose

Example brands (quadrivalent forms)

Vaxigrip Tetra, Fluzone (Sanofi); Fluarix Tetra (GSK); Flucelvax, Afluria, Fluad (CSL Seqirus); FluMist (AstraZeneca); Influvac Tetra

Dosage form

Suspension for intramuscular injection; nasal spray (live vaccine)

Indication

Prevention of seasonal influenza

Strain updates

Strains updated every year based on WHO recommendations

Key change

WHO advised in 2023 that B/Yamagata is no longer needed; US vaccines trivalent from the 2024–25 season

Where still used

Some markets in Asia and elsewhere

Generic / biosimilar status

Not applicable; each vaccine licensed separately

Quadrivalent influenza vaccine manufacturers and licensing history

Quadrivalent influenza vaccines were introduced from 2012 to protect against both influenza B lineages, Victoria and Yamagata. They replaced trivalent vaccines in many high-income countries during the 2010s.

The B/Yamagata lineage has not been detected since March 2020. In 2023, the WHO advised that it should no longer be included in vaccines. The US switched to trivalent vaccines for the 2024–25 season, and most of Europe has also moved to trivalent. Manufacturers such as Sanofi, GSK and CSL Seqirus now supply trivalent versions in these markets.

Quadrivalent vaccines are still produced and used in some markets, including in Asia. Buyers should confirm whether a market still requires quadrivalent vaccine, the season's strain composition, WHO prequalification or national licensing, and supply timing before choosing a supplier.

Quadrivalent influenza vaccine dosage forms and dossier types

Influenza vaccines are supplied as injectable suspensions in prefilled syringes or multi-dose vials, and as a live nasal spray.

Form

Strengths

Typical dossier

Notes

Inactivated quadrivalent vaccine (egg-based)

15 mcg haemagglutinin per strain

National licence; WHO PQ

Most common type

Cell-based or recombinant quadrivalent vaccine

Per product

US BLA; EU MAA

Egg-free production

Live attenuated quadrivalent nasal vaccine

Per product

US BLA; EU MAA

Children and young adults

Target market

Dossier format

Key requirement

United States, European Union

BLA / MAA (annual strain change)

Now trivalent; quadrivalent no longer recommended

Asia, other markets

National licence

Check whether quadrivalent is still required

WHO / UNICEF tenders

WHO prequalification

Annual strain updates

Quadrivalent influenza vaccine regulatory and patent status

Influenza vaccines are licensed separately and updated every year with new strains, based on WHO recommendations. Since the B/Yamagata lineage disappeared, the WHO and major regulators have moved to trivalent vaccines, and the US has used trivalent vaccines since the 2024–25 season. Quadrivalent vaccines remain licensed in some countries. Manufacturing processes may be patented, but the vaccine concept is not.

Quadrivalent influenza vaccine mechanism of action and therapeutic use

Influenza vaccines contain antigens, mainly haemagglutinin, from the flu strains expected to circulate. These trigger antibodies that protect against infection with matching strains. Vaccination is recommended every year, especially for older people, young children, pregnant women and people with chronic diseases.

Quadrivalent influenza vaccine licensing and sourcing

Influenza vaccine suppliers and licensing partners typically offer seasonal vaccine supply, regional licensing or technology transfer. Buyers usually compare WHO prequalification, production platform, supply timing and price. Current offers and supplier contacts are listed among the quadrivalent influenza vaccine manufacturers on Pipelinepharma.

Frequently asked questions about quadrivalent influenza vaccine

Who are the main quadrivalent influenza vaccine manufacturers? Sanofi, GSK, CSL Seqirus, AstraZeneca and Viatris are major producers. Companies in China, Korea and India also make influenza vaccines.

Are quadrivalent flu vaccines still used? The US and most of Europe have switched to trivalent vaccines because the B/Yamagata strain has disappeared. Some other markets still use quadrivalent vaccines.

What is the difference between trivalent and quadrivalent flu vaccines? Quadrivalent vaccines cover two influenza A strains and two influenza B strains. Trivalent vaccines drop the B/Yamagata strain.

Why was B/Yamagata removed? The B/Yamagata lineage has not been detected anywhere since March 2020, so the WHO advised removing it from vaccines.

How often do flu vaccines change? Flu vaccines are updated every year to match the strains expected to circulate.

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