FDA Approves GlaxoSmithKline's four-strain seasonal influenza vaccine for use in the U.S.

FDA Approves GlaxoSmithKline's four-strain seasonal influenza vaccine for use
                                 in the U.S.

PR Newswire

LONDON, Dec. 17, 2012

LONDON, Dec. 17, 2012 /PRNewswire/ --GlaxoSmithKline plc [LSE/NYSE: GSK]
announced today that the U.S. Food and Drug Administration (FDA) has approved
FLUARIX® QUADRIVALENT (Influenza Virus Vaccine) for the immunisation of
children (three years and older) and adults to help prevent disease caused by
seasonal influenza (flu) virus subtypes A and type B contained in the vaccine.
Fluarix Quadrivalent is the first intramuscular vaccine to cover against four
influenza strains.

Scientists classify the influenza strains that cause seasonal flu as A or B
strains. Currently administered trivalent (three-strain) flu vaccines help
protect against the two A virus strains most common in humans and the B strain
expected to be predominant in a given year. But since the year 2000, two B
virus strains (Victoria and Yamagata) have co-circulated to varying degrees
each season. Various degrees of mismatch have occurred between the B strain
included in trivalent vaccines and the B strain that actually circulated,
causing an increased risk of influenza-related morbidity across all age groups
– children, adults and the elderly. Fluarix Quadrivalent helps protect against
the two A strains and adds coverage against a second B strain. 

"Trivalent influenza vaccines have helped protect millions of people against
flu, but in six of the last 11 flu seasons, the predominant circulating
influenza B strain was not the strain that public health authorities
selected," said Dr. Leonard Friedland, V.P. and Head, GSK North America
Vaccines Clinical Development and Medical Affairs. "Fluarix Quadrivalent will
help protect individuals against both B strains and from a public-health
standpoint, can help decrease the burden of disease."

GSK will make Fluarix Quadrivalent available in time for the 2013-14 flu
season and and also plans to fulfill orders for its trivalent vaccines.
Healthcare providers traditionally order flu vaccines about a year in advance
of each flu season.

Fluarix Quadrivalent is not currently approved or licensed in any country
outside of the U.S. The full U.S. Prescribing Information will be available on

About Seasonal Influenza

Seasonal influenza may cause three to five million cases of severe illness and
up to 500,000 deaths per year worldwide. Vaccination against influenza is
considered one of the most effective ways of preventing mortality,
complications, and hospitalisations. The U.S. Centers for Disease Control and
Prevention (CDC) recommends that children six months of age and older and
adults receive a flu shot annually. More information about seasonal influenza
can be found at http://flu.gov and

Important Safety Information for Fluarix Quadrivalent 

Fluarix Quadrivalent is a vaccine indicated for active immunization for the
prevention of disease caused by influenza A subtype viruses and type B viruses
contained in the vaccine. Fluarix Quadrivalent is approved for use in persons
3years of age and older.

  oDo not administer Fluarix Quadrivalent to anyone with known severe
    allergic reactions (anaphylaxis) to any component of the vaccine,
    including egg protein, or a life-threatening reaction to previous
    administration of any influenza vaccine.
  oIf Guillain-Barre syndrome has occurred within 6 weeks of receipt of prior
    influenza vaccine, the decision to give Fluarix Quadrivalent should be
    based on careful consideration of the potential benefits and risks.
  oThe tip caps of the prefilled syringes may contain natural rubber latex
    which may cause allergic reactions in latex sensitive individuals.
  oIf Fluarix Quadrivalent is administered to immunosuppressed persons,
    including individuals receiving immunosuppressive therapy, the immune
    response may be lower than in immunocompetent persons.
  oSyncope (fainting) can occur in association with administration of
    injectable vaccines. Procedures should be in place to avoid falling injury
    and to restore cerebral perfusion following syncope.
  oIn clinical trials with Fluarix Quadrivalent, the most common adverse
    reactions in adults were pain at the injection site, muscle aches,
    headaches and fatigue. In children 3years to less than 18 years of age,
    the most common adverse reactions were pain at the injection site, redness
    and swelling. In children 3 years to less than 6 years of age, the most
    common adverse reactions were drowsiness, irritability, and loss of
    appetite. In children 6 to less than 18 years of age, the most common
    systemic adverse reactions were fatigue, muscle aches, headache,
    arthralgia and gastrointestinal symptoms. (See Adverse Reactions section
    of the Prescribing Information for Fluarix Quadrivalent for other
    potential adverse reactions and events).
  oVaccination with Fluarix Quadrivalent may not result in protection in all
    vaccine recipients.

About GlaxoSmithKline Vaccines

GlaxoSmithKline Vaccines, a division of GlaxoSmithKline group, is the world's
leading vaccine company and a leader in innovation. The company is active in
vaccine research, development and production with over 30 vaccines approved
and 20 more in development - both in the prophylactic and therapeutic fields.
Headquartered in Belgium, GSK Vaccines has 14 manufacturing sites
strategically positioned around the globe. In 2011, GSK Vaccines distributed
1.1 billion doses to 173 countries in both the developed and the developing
world. Through its accomplished and dedicated workforce, GSK Vaccines applies
its expertise to the discovery of innovative vaccines that contribute to the
health and well-being of people of all generations around the world.

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, go to us.gsk.com, follow us on twitter.com/GSKUSor visit our U.S.
company blog.

Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation
Reform Act of 1995, 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 'Risk factors' in the 'Financial review & risk' section in the
company's Annual Report 2011 included as exhibit 15.2 to the company's Annual
Report on Form 20-F for 2011.

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SOURCE GlaxoSmithKline

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