Summary

Name:

FocetriaŽ

Synonyms:

FocetriaŽ A(H1N1); Focetria A(H1N1); Focetria A/H1N1; Influenza A (H1N1) 2009 Monovalent Vaccine

Sponsor:

Novartis (global presence)

Co-Sponsor:

Chiron (now part of Novartis; global presence)

Type of product:

Vaccine

Viral family:

Orthomyxoviridae

Status:

Market
Approved by EMEA for distribution in EU (Sept. 29, 2009) under control of health authorities and governments; WHO-Prequalification status; No longer available (2015); See Remarks

FocetriaŽ 

Synonyms:FocetriaŽ A(H1N1); Focetria A(H1N1); Focetria A/H1N1; Influenza A (H1N1) 2009 Monovalent Vaccine       Sponsor:Novartis (global presence)       Co-Sponsor:Chiron (now part of Novartis; global presence)       Type of product:Vaccine       Mode of action:Non-recombinant protein vaccine       Viral family:Orthomyxoviridae       Virus:Swine Influenza virus      

Details

Characteristics:
Vaccine initially developed as a mock-up vaccine against Avian Influenza virus in the form of inactivated viral surface antigens obtained by treatment of purified virions with detergent cetyltrimethylammonium bromide (CTAB), and prepared using proprietary adjuvant MF59C.1 to boost immune response;
Same overall manufacture process is followed for preparation of so-called "Swine" A/H1N1 Influenza virus vaccine;
 
Virions are produced in embryonated chicken eggs to assure adequate supply of vaccine doses and maintain known safety profile, with the whole manufacturing procedure based on Fluad vaccine from same sponsor;
 
Manufacturing process was optimized and scaled up to serve as the basis to produce in the shortest possible time any Influenza vaccine in the event of a pandemic, with minimal approbation time from regulatory authorities;

    

Initially represented "mock-up vaccine", filed as normal step for eventual accelerated approval of final vaccine once a pandemic has been declared;
Designed to eventually contain any pandemic Influenza virus strain designated by WHO at the time of pandemic, along with adjuvant MF59;
Mock-up vaccine preparations were made with viral strain H5N3 (1999) and H9N2 (2004);
File submitted for approbation in 2006 was based on clinical trials conducted with various strains of Avian Influenza virus, but more specifically with reverse genetic-engineered strain H5N1 A/Vietnam/1194/2004, with adjuvant MF59C.1;
 
After emergence of "Swine" Influenza virus in early 2009, viral strain A/California/7/2009 (H1N1)v-like was used instead of Avian Influenza strains
 
Ref.: Sponsor's website
PK Data, Dosage or Route of Administration:

Each dose contains 7.5 μg of viral hemagglutinins with adjuvant

Development status

Market
Approved by EMEA for distribution in EU (Sept. 29, 2009) under control of health authorities and governments; WHO-Prequalification status; No longer available (2015); See Remarks

Remarks

Influenza virus vaccine to be used only when a pandemic has been declared by WHO and a specific viral strain has been identified to be included in vaccine;

The pandemic stage was announced by WHO on June 11, 2009;

 

MF59C.1 adjuvant present in the vaccine consists mainly in squalene, an intermediate in the biosynthesis of cholesterol, extracted from shark liver;

 

Derived from Focetria® mock-up vaccine, which was based on Avian Influenza virus strains (H5N3, H9N2 and more specifically H5N1) and which received positive opinion from EU CHMP on Feb. 23, 2007, with final acceptation on May 2, 2007;

 

A positive opinion from EU CHMP was received for Focetria® made for A(H1N1) Influenza virus on Sept. 25, 2009, with final marketing authorization granted by EMEA on Sept. 29, 2009;

 

NIAID and US DHHS initially contracted Chiron (before acquisition by Novartis) to produce vaccine in view of potential pandemic caused by Avian Influenza virus H5N1 derivative;
Collaboration including sharing of development costs with NIAID;

 

For the US market, Novartis has developed a pandemic vaccine called Fluvirin® A(H1N1), with clinical trials performed by NIAID;

 
Pandemic vaccines are being stockpiled by US, UK and EU governments for global pandemic;
UK Government has also contracted Chiron (Novartis) for H5N1 vaccine containing MF59C.1 proprietary adjuvant;
 

Novartis has also received contract from US DHHS to further develop MF59C.1 adjuvant technology to potentially extend vaccine supplies in case of Influenza pandemic outbreak;

 

Pre-qualification status granted by WHO on Dec. 16, 2009;

 

MAA expired on 13 Aug. 2015 following the decision of the marketing authorisation holder, Novartis Vaccines and Diagnostics S.r.l. (now called Seqirus), not to apply for a renewal of the marketing authorisation