PHILADELPHIA, July 16, 2015 /PRNewswire/ -- GSK (LSE/NYSE:
GSK) announced today it has begun shipping FLUARIX®
QUADRIVALENT (Influenza Vaccine) doses to US healthcare providers,
following licensing and lot-release approval from the US Food and
Drug Administration's (FDA) Center for Biologics Evaluation and
Research.
"To help our customers meet the flu immunization needs of their
patients, GSK has shifted our flu vaccine supply to four-strain
(quadrivalent) flu vaccine," said Patrick
Desbiens, Senior Vice President, US Vaccines. "This decision
gives patients the opportunity for broader protection since it
covers a fourth flu virus strain compared to trivalent vaccines
that only cover three strains. With flu a priority focus of our
portfolio, we have made a significant investment in customer
service upgrades, designed to accelerate delivery timelines to
customers."
GSK also has received 2015-16 US license approval for its other
quadrivalent flu vaccine FLULAVAL® QUADRIVALENT
(Influenza Vaccine). Pending additional FDA lot releases, GSK
expects to begin shipping FLULAVAL® QUADRIVALENT in
August. This means that two different presentations of the
four-strain vaccines will be available to customers.
FLUARIX® QUADRIVALENT comes in a 0.5-mL, single-dose,
prefilled syringe while FLULAVAL® QUADRIVALENT comes in
a 5-mL, multidose vial containing 10 doses (0.5mL each).
GSK expects to supply an estimated 32-38 million doses across
both vaccines for the US market for the 2015-16 season. The company
shipped approximately 27 million doses for the 2014-15 season --19
million quadrivalent and eight million trivalent. This year's
anticipated volume of quadrivalent doses is nearly double the
amount shipped last year. GSK made the decision to switch to 100%
quadrivalent following customer demand from the 2014-15 flu season
and early pre-booking for the 2015-16 season.
Quadrivalent vaccines are designed to help protect against two
different types of "A" flu strains and two types of "B" flu
strains. Influenza A and Influenza B are the viruses that spread
between people and can cause mild to severe illness, leading to
seasonal flu. Most flu activity in the US occurs from October-May,
and it usually peaks in the US between December-February. According
to the US Centers for Disease Control and Prevention (CDC), each
year approximately 5-20% of people in the US get the flu and more
than 200,000 people are hospitalized for flu-related
complications.
For this year's flu season, the World Health Organization (WHO)
and FDA's Vaccines and Related Blood Products Advisory Committee
recommended that quadrivalent vaccines include an A/California/7/2009 (H1N1)pdm09-like virus, an
A/Switzerland/9715293/2013
(H3N2)-like virus, a B/Phuket/3073/2013-like (B/Yamagata lineage)
virus, and a B/Brisbane/60/2008-like (B/Victoria lineage) virus (2). This
represents a change in the influenza A (H3) and influenza B
(Yamagata lineage) components compared with the composition of the
2014-15 influenza vaccines.
The CDC has a routine recommendation for Americans over the age
of six months to get a flu vaccination each year as the first and
most important step in protecting against this disease. GSK's flu
vaccines are indicated for use in persons three years and
older.
The CDC does not make preferential recommendations about which
flu vaccine an individual should receive. Individuals should speak
with their healthcare professional about flu vaccines and which one
may be most appropriate for them.
For more information about the flu, visit
ChooseMoreChooseFour.com.
About GSK flu vaccine manufacturing
FLUARIX® QUADRIVALENT is manufactured in Dresden, Germany. FLULAVAL® QUADRIVALENT is
manufactured in Ste-Foy, Quebec,
Canada.
The following Important Safety Information is based on the
Highlights section of the Prescribing Information for
FluLaval® Quadrivalent (Influenza Vaccine) and
Fluarix® Quadrivalent (Influenza Vaccine). Please
consult the full Prescribing Information for all the labeled safety
information for FluLaval Quadrivalent and Fluarix Quadrivalent.
Professional Indication(s) for FluLaval®
Quadrivalent (Influenza Vaccine) and Fluarix®
Quadrivalent (Influenza Vaccine)
Indication for FLULAVAL QUADRIVALENT
FLULAVAL 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.
FLULAVAL QUADRIVALENT is approved for use in persons 3 years
of age and older.
Indication 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 3 years of
age and older.
Combined Important Safety Information for
FluLaval® Quadrivalent (Influenza Vaccine) and
Fluarix® Quadrivalent (Influenza Vaccine)
- Do not administer FLULAVAL QUADRIVALENT or 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
- If Guillain-Barre syndrome has occurred within 6 weeks of
receipt of a prior influenza vaccine, the decision to give FLULAVAL
QUADRIVALENT or FLUARIX QUADRIVALENT should be based on careful
consideration of the potential benefits and risks
- Syncope (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
- If FLULAVAL QUADRIVALENT or FLUARIX QUADRIVALENT is
administered to immunosuppressed persons, including individuals
receiving immunosuppressive therapy, the immune response may be
lower than in immunocompetent persons
- In clinical trials with FLULAVAL QUADRIVALENT, the most common
solicited local adverse reaction in adults was pain. The most
common solicited systemic adverse reactions in adults were muscle
aches, headache, fatigue, and arthralgia. In children 3 through 17
years of age, the most common solicited local adverse reaction was
pain. In children 3 through 4 years of age, the most
common solicited systemic adverse reactions were irritability,
drowsiness, and loss of appetite. In children 5 through
17 years of age, the most common solicited systemic adverse
reactions were muscle aches, fatigue, headache, arthralgia, and
gastrointestinal symptoms. (See Adverse Reactions section of the
Prescribing Information for FLULAVAL QUADRIVALENT for other
potential adverse reactions and events)
- In clinical trials with FLUARIX QUADRIVALENT, the most common
injection site adverse reaction in adults was pain. The most common
systemic adverse reactions in adults were muscle aches, headache,
and fatigue. In children 3 through 17 years of age, injection
site adverse reactions were pain, redness, and swelling. In
children 3 through 5 years of age, the most
common systemic adverse reactions were drowsiness,
irritability, and loss of appetite. In children 6 through
17 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)
- Vaccination with FLULAVAL QUADRIVALENT or FLUARIX QUADRIVALENT
may not result in protection in all vaccine recipients
GSK -- 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.
GSK
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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 'Risk factors' in the company's Annual Report on Form 20-F for
2014.
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