GlaxoSmithKline receives FDA approval to ship four-strain (quadrivalent)
influenza vaccine to healthcare providers
- First broadening of influenza-strain protection to occur in more than 30
PHILADELPHIA, Aug. 5, 2013
PHILADELPHIA, Aug. 5, 2013 /PRNewswire/ --GlaxoSmithKline [NYSE: GSK]
announced today it has received U.S. Food and Drug Administration (FDA)
approval to start shipping 2013-2014 FLUARIX^® QUADRIVALENT (Influenza Virus
Vaccine) to CDC distribution centers and U.S. healthcare providers. This is
the first season that vaccines protecting against more than three strains of
influenza (flu) will be commercially available.
Fluarix Quadrivalent was the first intramuscular quadrivalentinfluenza
vaccine approved by the FDA [on December 14, 2012] for the immunization
ofchildren (three years and older)and adults to help prevent disease caused
by seasonal influenza virus subtypes A and B contained in the vaccine. Before
vaccine manufacturers can begin shipping influenza vaccines each season, the
FDA first must certify that the supplies to be provided to healthcare
providers meet the agency's quality and safety standards.
Scientists classify the influenza strains that cause seasonal influenza as A
or B strains. Most current influenza vaccines provide trivalent (three-strain)
influenza protection. Trivalent influenza vaccines protect against the two A
virus strains most common in humans and the B strain expected to be
predominant in a given year.
"Trivalent (three-strain) influenza vaccines offer important protection
against influenza. But since the late 1980s, scientists noted that two B virus
lineage strains circulate to varying degrees each year, and it's difficult to
predict which one will cause the most illness in a particular influenza
season," said Dr. Leonard Friedland, VP, Scientific Affairs and Public Policy,
GSK Vaccines, North America. "Fluarix Quadrivalent addresses this by
protecting against both B strains."
With today's FDA lot release, GSK's Fluarix Quadrivalent influenza vaccine
soon will be supplied to U.S. healthcare providers who placed orders for the
new vaccine after it was approved late last year. The CDC (U.S. Centers for
Disease Controland Prevention) placed the largest order for Fluarix
Quadrivalent- for more than four million doses-and will allocate those
doses to U.S. state and local healthcare providers. The CDC annually purchases
large quantities of influenza vaccines from multiple influenza manufacturers.
For this influenza season, GSK will supplement the supply of Fluarix
Quadrivalent with its trivalent seasonal influenza vaccines. In the U.S., GSK
estimates it will provide up to 10 million doses of quadrivalent influenza
vaccines, and 22 to 24 million doses of influenza vaccines overall. GSK
believes the healthcare community will steadily transition in coming years to
quadrivalent influenza vaccines, and the company is in the process of
increasing its capability to provide substantially more quadrivalent influenza
vaccine doses for coming influenza seasons.
Fluarix Quadrivalent also is approved in Germany (marketed as
INFLUSPLIT™Tetra^®) and the UK (as FLUARIX™ TETRA). The full U.S. Prescribing
Information is available on http://www.gsk.com/products/index.htm.
For a link to the GSK Fluarix Quadrivalent electronic press kit, U.S.
journalists can click here.
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 hospitalizations. The U.S. Centers for Disease Controland
Prevention (CDC) recommends that children six months of age and older and
adults receive an influenza vaccine 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
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 please visit http://us.gsk.com/.
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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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