GSK receives European approval for expanded indication for Fluarix Tetra (Influenza Vaccine) for ages six months and older

Issued: London, UK

Thomas Breuer, Chief Medical Officer, GSK Vaccines said, “Fluarix Tetra can help protect both healthy people and those who are more vulnerable from seasonal influenza and its complications. By expanding our indication for Fluarix Tetra in Europe, we can help ensure parents have the ability to help protect their children even earlier against the flu.”

With this approval, healthcare providers would be able to use the same dose of Fluarix Tetra (15 µg of hemagglutinin per virus strain in 0.5 mL) to cover all eligible people from six months of age and older.

The global disease burden associated with influenza in children under five years of age is substantial.[1] Studies have shown that vaccinating children against influenza may induce herd immunity against influenza for adults aged 65 years and older.[2] The expanded indication was based on a Phase III pivotal efficacy study of Fluarix Tetra in children six months through 35 months of age and on two supportive studies.

About Seasonal Influenza

Influenza is an acute, highly contagious, respiratory disease caused by influenza viruses, mainly spread through respiratory droplets. The illness is accompanied by fever and variable degrees of other systemic symptoms, ranging from mild fatigue to respiratory failure and death.

Yearly outbreaks of influenza affect all age groups, but the greatest risk of severe disease or complications when infected are adults aged 65 years and older, children under 59 months, individuals with immunosuppressive conditions (e.g., HIV/AIDS, receiving chemotherapy or steroids, or malignancy) and pregnant women.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 650,000 deaths per year worldwide.¹

Further information about seasonal influenza can be found at: http://www.who.int/mediacentre/factsheets/fs211/en/

About Fluarix Tetra

Fluarix Tetra was first approved in 2013 in the following European countries: Germany, France and UK, for the prevention of influenza disease in people three years of age and older. It is also currently approved in more than 30 other countries worldwide, and more than 100 million doses have been distributed since launch.

Fluarix Tetra is now indicated for active immunisation of adults and children from six months 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, in several countries, including EU and US.

The use of Fluarix Tetra should be based on official recommendations.

Annual revaccination with the current vaccine is recommended because immunity declines during the year after vaccination, and because circulating strains of influenza virus might change from year to year.

Important Safety Information

• Fluarix Tetra can be concomitantly administered with pneumococcal polysaccharide vaccines in subjects aged 50 years and above.
• Inactivated flu vaccines can be used in all stages of pregnancy.
• If Fluarix Tetra is to be given at the same time as another injectable vaccine, the vaccines should always be administered at different injection sites.
• As with any vaccine, a protective immune response may not be elicited in all vaccinees.
• The most frequently reported general adverse reactions in young children 6-35 months of age after vaccination were irritability/fussiness (14.9%) and loss of appetite (12.9%).
• Fluarix Tetra should not be administered to anyone with a history of severe allergic reactions to any component of the vaccine, or following a previous administration of any influenza vaccine.

See Adverse Reactions section of the Prescribing Information for Fluarix Tetra for other potential adverse reactions and events.

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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. Such factors include, but are not limited to, those described under Item 3.D 'Principal risks and uncertainties' in the company's Annual Report on Form 20-F for 2016.

[1] WHO. Influenza Disease Burden. Taken from: www.who.int/immunization/sage/meetings/2012/april/1_J.Bresee_SAGE_DB_Final.pdf. Last accessed: January 2018

[2] Cohen SA, Chui KKH, Naumova EN. Influenza Vaccination in Young Children Reduces Influenza-Associated Hospitalizations in Older Adults, 2002–2006. Journal of the American Geriatrics Society. 2011;59(2):327-332. doi:10.1111/j.1532-5415.2010.03271.x.Taken from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3111961/. Last accessed: January 2018