GSK announces first four-strain seasonal influenza vaccine granted marketing authorisation in Germany and the UK
Issued: Wednesday 3 April 2013, London UK
GlaxoSmithKline plc announced today the marketing authorisation of its quadrivalent (four-strain) influenza vaccine in Germany and the UK. Following a decentralised procedure, Germany's Paul Ehrlich Institut (PEI) was the first national regulatory authority in Europe to grant marketing authorisation for this influenza vaccine, followed by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK. This is the first four-strain influenza vaccine to be approved in a European country for active immunisation of adults and children from three years of age for the prevention of influenza disease caused by the two influenza A virus subtypes and the two influenza B virus types contained in the vaccine. The new four-strain vaccine will be marketed as INFLUSPLIT™ TETRA* in Germany and FLUARIX™ TETRA▼ in the UK.
Human influenza virus strains A and B are responsible for causing seasonal flu epidemics globally. Current inactivated influenza vaccines in Europe are designed to provide protection against three strains of influenza virus (referred to as trivalent vaccines). They are composed of two influenza A strains (A/H1N1 and A/H3N2) and one B strain lineage, as recommended by the World Health Organization and its partners as the predominant strains in circulation for a given flu season. Currently there are 4 major strains of Influenza circulating, two influenza A strains (A/H1N1 and A/H3N2) and two B strain lineage (B-Victoria and B-Yamagata). As only one influenza B strain is selected for inclusion in trivalent vaccines, there have been seasons when the predominant circulating influenza B strain was different from that chosen for the vaccine (referred to as vaccine 'mismatch').
INFLUSPLIT™ TETRA/FLUARIX™ TETRA have been developed to provide broader influenza strain coverage by the addition of a second B strain; thereby providing coverage against two influenza A strains and two influenza B strains. The vaccine is expected to help protect against four of the predominant strains of influenza circulating, thus potentially reducing the overall influenza related burden of disease.
INFLUSPLIT™ TETRA/FLUARIX™ TETRA is expected to be available for use in Germany and the UK in time for the 2013/2014 flu season. This vaccine was approved by the US Food and Drug Administration (FDA) in December 2012 (as FLUARIX™ QUADRIVALENT). GSK has also submitted licence applications for this vaccine in Australia, Switzerland and Taiwan. Regulatory decisions for these countries are expected over the coming months.
About Seasonal Influenza
Influenza is an acute viral infection that spreads easily from person to person, causing serious illness and death and is a serious public health issue. The most common symptoms of the disease are chills, fever, sore throat, muscle pains, severe headache, coughing, and weakness/fatigue1.
Yearly outbreaks of influenza affect all age groups, but the highest risk of complications occurs in children younger than two years of age, the elderly (65 years and older) and those with particular medical conditions (e.g., chronic lung, liver, heart, kidney, blood or metabolic diseases)1.
The World Health Organization (WHO) estimates that annual epidemics can be responsible for three to five million cases of severe illness and up to 500,000 deaths per year worldwide1.
Further information about seasonal influenza can be found at: http://www.euro.who.int/en/what-we-do/health-topics/communicable-diseases/influenza
About INFLUSPLIT™ TETRA/FLUARIX™ TETRA
INFLUSPLIT™ TETRA/FLUARIX™ TETRA is indicated for active immunization of adults and children from 3 years of age for the prevention of influenza disease caused by the two influenza A virus subtypes and the two influenza B virus types contained in the vaccine.
INFLUSPLIT™ TETRA/FLUARIX™ TETRA is intended to provide protection against those strains of virus from which the vaccine is prepared and to closely related strains. As with any vaccine, a protective immune response may not be elicited in all vaccinees.
Hypersensitivity to the active substances, to any of the excipients or to any component that may be present as traces such as eggs (ovalbumin, chicken proteins), formaldehyde, gentamicin sulphate and sodium deoxycholate is a contraindication.
Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints.
In two clinical studies, healthy adults 18 years of age and older and healthy children 3 to 17 years of age were administered INFLUSPLIT™ TETRA/FLUARIX™ TETRA (more than 3,000 adults and 900 children) or GlaxoSmithKline's trivalent influenza vaccine, FLUARIX™ (more than 1,000 adults and 900 children). Similar rates of solicited adverse events were observed in recipients of INFLUSPLIT TETRA™/FLUARIX™ TETRA and FLUARIX™. In all age groups the most frequently reported local adverse reaction after vaccination was injection site pain (36.4% to 40.9%). Very common adverse reactions (≥1/10) include irritability (reported as a solicited symptom in subjects less than 6 years of age), myalgia, injection site pain, and fatigue.
Post-marketing data: There has been no post-marketing exposure to INFLUSPLIT™ TETRA/FLUARIX™ TETRA. However, as all three of the influenza strains contained in FLUARIX™ are included in INFLUSPLIT™ TETRA/FLUARIX™ TETRA, the following adverse events that have been observed for FLUARIX™ during post-marketing surveillance may occur in patients receiving INFLUSPLIT™ TETRA post-approval. All of these adverse events are classified as rare (≥1/10,000 to <1/1,000).
Blood and lymphatic system disorders: transient lymphadenopathy
Immune system disorders: allergic reactions (including anaphylactic reactions)
Nervous system disorders: neuritis, acute disseminated encephalomyelitis, Guillain-Barré syndrome*
*Spontaneous reports of Guillain-Barré syndrome have been received following vaccination with FLUARIX™; however, a causal association between vaccination and Guillain-Barré syndrome has not been established.
Skin and subcutaneous tissue disorders: urticaria, pruritus, erythema, angioedoema
General disorders and administration site conditions: influenza-like illness, malaise
Overdosage is unlikely to have any untoward effect.
Detailed information on the use of INFLUSPLIT™ TETRA/FLUARIX™ TETRA and its safety profile are described in the Summary of Product Characteristics, which is expected to be published on the PEI website (www.pei.de/influenza vaccines) and on the Electronic Medicines Compendium (www.medicines.org.uk/emc/).
About GlaxoSmithKline Vaccines
GlaxoSmithKline Vaccines is active in vaccine research and development. Headquartered in Belgium, GSK Vaccines has 13 manufacturing sites strategically positioned around the globe. Of the 883 million doses of our vaccines we distributed in 2012, over 80% went to developing countries, which include the least developed, low- and middle-income countries.
GlaxoSmithKline – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com
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Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2012.
INFLUSPLIT TETRA, FLUARIX TETRA, FLUARIX QUADRIVALENT and FLUARIX are trademarks of the GlaxoSmithKline group of companies.
Reference
1. World Health Organization. Influenza (seasonal) factsheet. http://www.who.int/mediacentre/factsheets/fs211/en/index.html